NiQuitin 2 mg Mint Gum

1. Name Of The Medicinal Product

NiQuitin 2 mg Mint Gum.

2. Qualitative And Quantitative Composition

Chewing gum containing 2 mg nicotine. For excipients see 6.1.

3. Pharmaceutical Form

Chewing gum.

Off-white rectangular pillow-shaped gum.

4. Clinical Particulars 4.1 Therapeutic Indications

NiQuitin Mint Gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

NiQuitin Mint Gum is indicated in pregnant and lactating women making a quit attempt.

NiQuitin Mint Gum should preferably be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

Directions for use:

NiQuitin Mint Gum should be chewed slowly according to the instructions.

NiQuitin 2 mg Mint Gum is suitable for smokers who have their first cigarette of the day more than 30 minutes after waking up.

Behavioural therapy, advice and support will normally improve the success rate.

The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Not more than 15 pieces of the chewing gum may be used each day. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver.

Adults (18 years and over)

Abrupt cessation of smoking:

Users should make every effort to stop smoking completely during treatment with NiQuitin Mint Gum.

NiQuitin Mint Gum should be chewed as directed whenever there is an urge to smoke to maintain complete abstinence from smoking.

Sufficient gums should be used each day, usually 8

Continue use for up to three months to break the habit of smoking, then gradually reduce gum use. When daily use is 1

Those who have quit smoking but are having difficulty discontinuing using the gum are recommended to seek additional help and advice from a healthcare professional.

For those using the 4 mg gum, the 2 mg gum will be helpful during withdrawal from treatment.

Gradual cessation of smoking:

For smokers who are unwilling or unable to quit abruptly. Use a piece of gum whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. The number of pieces of gum a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 pieces per day.

If a reduction in cigarette consumption has not been achieved after 6 weeks of treatment, a healthcare professional should be consulted.

Reduced tobacco consumption should lead to complete cessation of smoking. This should be attempted as soon as possible. When the number of cigarettes has been reduced to a level from which the user feels able to quit completely, then start on the schedule for “abrupt cessation” as given above.

If an attempt to stop smoking completely has not been started within 6 months after the beginning of treatment, it is recommended to consult a healthcare professional.

Reduction in smoking:

For smokers who wish to cut down with no immediate plans to quit.

Use a piece of gum whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. Users should be encouraged to stop smoking completely as soon as possible.

The number of pieces of gum a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 pieces per day.

If users are still feeling the need to use the gum on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Temporary abstinence:

Use a piece of gum whenever there is a strong urge to smoke to control troublesome withdrawal symptoms including cravings. Users should not take more than 15 pieces of gum per day.

Users should be encouraged to stop smoking completely as soon as possible.

If users are still feeling the need to use gum on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Adolescents and children

Adolescents (12 to 17 years) should follow the above usage advice for abrupt cessation of smoking. Where adolescents are unwilling or unable to quit smoking abruptly, advice from a healthcare professional should be sought.

Safety and effectiveness in children who smoke has not been evaluated. NiQuitin Mint Gum is not recommended for use in children under 12 years of age.

4.3 Contraindications

Hypersensitivity to nicotine or any of the other ingredients in this product.

4.4 Special Warnings And Precautions For Use

The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well established dangers of continued smoking.

Patients hospitalised for MI, severe dysrhythmia or CVA who are considered to be haemadynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, NiQuitin Mint Gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital they can use NRT as normal.

Diabetes Mellitus. Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Allergic reactions: susceptibility to angioedema and urticaria.

A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:

• Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

• Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.

• GI Disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. NiQuitin Mint Gum should be disposed of with care.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Smokers who wear dentures may experience difficulty in chewing NiQuitin Mint Gum.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.

4.6 Pregnancy And Lactation Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but NRT may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

NRT may cause adverse reactions similar to those associated with nicotine administered by other means, including smoking. These may be attributable to the pharmacological effects of nicotine, some of which are dose dependent. In relation to this some reported symptoms, such as dizziness, headache and sleep disturbances may be related to withdrawal symptoms associated with abstinence from smoking. Increased frequency of aphthous ulcer may occur after abstinence from smoking.

NiQuitin Mint Gum in the recommended dose has not been found to cause any serious adverse effects. Excessive consumption of NiQuitin Mint Gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headache (as may be experienced by such a patient if tobacco smoke is inhaled). Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation. Excessive swallowing of dissolved nicotine may, at first, cause hiccuping.

Those with a tendency to indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4 mg nicotine gum is used; slower chewing and the use of the 2 mg nicotine gum (if necessary more frequently) will usually overcome this problem.

Common (>1/100)

CNS:

Dizziness, headache

Gastro-intestinal:

Nausea, gastro-intestinal discomfort, hiccups

   

Local:

Sore mouth or throat. Jaw-muscle ache. The gum may stick to, and may in rare cases, damage dentures.

Uncommon (1/100

Circulatory:

Palpitation

Dermatological:

Erythema, urticaria

   

Local:

Stomatitis

Rare (<1/1000)

Cardiovascular

Atrial fibrillation

Other:

Allergic reactions such as angio-oedema

 

Very Rare (<1/10000)

 

Anaphylactic reactions

4.9 Overdose Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC code: N07B A01

The pharmacological effects of nicotine are well documented. Those resulting from chewing NiQuitin Mint Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs.

The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis.

5.2 Pharmacokinetic Properties

Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5

5.3 Preclinical Safety Data

The general toxicity of nicotine is well known and taken into account in the recommended posology. Nicotine was not mutagenic in appropriate assays. The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine. In studies in pregnant animals, nicotine showed maternal toxicity, and consequential mild fetal toxicity. Additional effects included pre-and post natal growth retardation and delays and changes in post

6. Pharmaceutical Particulars 6.1 List Of Excipients

Chewing gum base

Calcium carbonate

Butylhydroxytoluene

Sorbitol

Maltitol liquid

Glycerol

Acesulfame potassium

Flavour

Mannitol

Sodium Carbonate, Anhydrous

Sodium Hydrogen Carbonate

Carnauba wax

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25?C. Store in the original package.

6.5 Nature And Contents Of Container

NiQuitin 2 mg Mint Gum is available in packages of 12, 24, 36, 48 and 96 gums.

Gums are packed 12 to a blister strip in 3 rows of 4 gums. The blister is part

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as GlaxoSmithKline Consumer Healthcare

Brentford TW8 9GS, UK.

8. Marketing Authorisation Number(S)

PL 00079/0376

9. Date Of First Authorisation/Renewal Of The Authorisation

07 February 2002

10. Date Of Revision Of The Text

30/09/2010

Read More:

NiQuitin 4 mg Mint Gum

1. Name Of The Medicinal Product

NiQuitin 4 mg Mint Gum.

2. Qualitative And Quantitative Composition

Chewing gum containing 4 mg nicotine. For excipients see 6.1.

3. Pharmaceutical Form

Chewing gum.

Yellow rectangular pillow-shaped gum.

4. Clinical Particulars 4.1 Therapeutic Indications

NiQuitin Mint Gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

NiQuitin Mint Gum is indicated in pregnant and lactating women making a quit attempt.

NiQuitin Mint Gum should preferably be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

Directions for use:

NiQuitin Mint Gum should be chewed slowly according to the instructions.

NiQuitin 4 mg Mint Gum is suitable for smokers who have their first cigarette of the day within 30 minutes of waking up.

Behavioural therapy, advice and support will normally improve the success rate.

The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Not more than 15 pieces of the chewing gum may be used each day. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver.

Adults (18 years and over)

Abrupt cessation of smoking:

Users should make every effort to stop smoking completely during treatment with NiQuitin Mint Gum.

NiQuitin Mint Gum should be chewed as directed whenever there is an urge to smoke to maintain complete abstinence from smoking.

Sufficient gums should be used each day, usually 8

Continue use for up to three months to break the habit of smoking, then gradually reduce gum use. When daily use is 1

Those who have quit smoking but are having difficulty discontinuing using the gum are recommended to seek additional help and advice from a healthcare professional.

For those using the 4 mg gum, the 2 mg gum will be helpful during withdrawal from treatment.

Gradual cessation of smoking:

For smokers who are unwilling or unable to quit abruptly. Use a piece of gum whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. The number of pieces of gum a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 pieces per day.

If a reduction in cigarette consumption has not been achieved after 6 weeks of treatment, a healthcare professional should be consulted.

Reduced tobacco consumption should lead to complete cessation of smoking. This should be attempted as soon as possible. When the number of cigarettes has been reduced to a level from which the user feels able to quit completely, then start on the schedule for “abrupt cessation” as given above.

If an attempt to stop smoking completely has not been started within 6 months after the beginning of treatment, it is recommended to consult a healthcare professional.

Reduction in smoking:

For smokers who wish to cut down with no immediate plans to quit.

Use a piece of gum whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. Users should be encouraged to stop smoking completely as soon as possible.

The number of pieces of gum a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 pieces per day.

If users are still feeling the need to use the gum on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Temporary abstinence:

Use a piece of gum whenever there is a strong urge to smoke to control troublesome withdrawal symptoms including cravings. Users should not take more than 15 pieces of gum per day.

Users should be encouraged to stop smoking completely as soon as possible.

If users are still feeling the need to use gum on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Adolescents and children

Adolescents (12 to 17 years) should follow the above usage advice for abrupt cessation of smoking. Where adolescents are unwilling or unable to quit smoking abruptly, advice from a healthcare professional should be sought.

Safety and effectiveness in children who smoke has not been evaluated. NiQuitin Mint Gum is not recommended for use in children under 12 years of age.

4.3 Contraindications

Hypersensitivity to nicotine or any of the other ingredients in this product.

4.4 Special Warnings And Precautions For Use

The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well established dangers of continued smoking.

Patients hospitalised for MI, severe dysrhythmia or CVA who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, NiQuitin Mint Gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital they can use NRT as normal.

Diabetes Mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Allergic reactions: susceptibility to angioedema and urticaria.

A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:

• Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

• Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.

• GI Disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. NiQuitin Mint Gum should be disposed of with care.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Smokers who wear dentures may experience difficulty in chewing NiQuitin Mint Gum.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.

4.6 Pregnancy And Lactation Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but NRT may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

NRT may cause adverse reactions similar to those associated with nicotine administered by other means, including smoking. These may be attributable to the pharmacological effects of nicotine, some of which are dose dependent. In relation to this some reported symptoms, such as dizziness, headache and sleep disturbances may be related to withdrawal symptoms associated with abstinence from smoking. Increased frequency of aphthous ulcer may occur after abstinence from smoking.

NiQuitin Mint Gum in the recommended dose has not been found to cause any serious adverse effects. Excessive consumption of NiQuitin Mint Gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headache (as may be experienced by such a patient if tobacco smoke is inhaled). Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation. Excessive swallowing of dissolved nicotine may, at first, cause hiccuping.

Those with a tendency to indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4 mg nicotine gum is used; slower chewing and the use of the 2 mg nicotine gum (if necessary more frequently) will usually overcome this problem.

Common (>1/100)

CNS:

Dizziness, headache

Gastro-intestinal:

Nausea, gastro-intestinal discomfort, hiccups

   

Local:

Sore mouth or throat. Jaw-muscle ache. The gum may stick to, and may in rare cases, damage dentures.

Uncommon (1/100

Circulatory:

Palpitation

Dermatological:

Erythema, urticaria

   

Local:

Stomatitis

Rare (<1/1000)

Cardiovascular

Atrial fibrillation

Other:

Allergic reactions such as angio-oedema

 

Very Rare (<1/10000)

 

Anaphylactic reactions

4.9 Overdose Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: N07B A01

The pharmacological effects of nicotine are well documented. Those resulting from chewing NiQuitin Mint Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs.

The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis.

5.2 Pharmacokinetic Properties

Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5

5.3 Preclinical Safety Data

The general toxicity of nicotine is well known and taken into account in the recommended posology. Nicotine was not mutagenic in appropriate assays. The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine. In studies in pregnant animals, nicotine showed maternal toxicity, and consequential mild fetal toxicity. Additional effects included pre-and post natal growth retardation and delays and changes in post

6. Pharmaceutical Particulars 6.1 List Of Excipients

Chewing gum base

Calcium carbonate

Butylhydroxytoluene

Sorbitol

Maltitol liquid

Glycerol

Acesulfame potassium

Flavour

Mannitol

Sodium Carbonate, Anhydrous

Sodium Hydrogen Carbonate

Eurolake Quinoline Yellow, E104

Carnauba wax

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25?C. Store in the original package.

6.5 Nature And Contents Of Container

NiQuitin 4 mg Mint Gum is available in packages of 12, 24, 36 and 96 gums.

Gums are packed 12 to a blister strip in 3 rows of 4 gums. The blister is part

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as GlaxoSmithKline Consumer Healthcare

Brentford TW8 9GS, UK.

8. Marketing Authorisation Number(S)

PL 00079/0377

9. Date Of First Authorisation/Renewal Of The Authorisation

07 February 2002

10. Date Of Revision Of The Text

30/09/2010

Read More:

NiQuitin 4 mg Mint Lozenges / NiQuitin Pre-Quit 4 mg Mint Lozenges

1. Name Of The Medicinal Product

NiQuitin 4 mg Mint Lozenges.

NiQuitin Pre-Quit 4 mg Mint Lozenges.

2. Qualitative And Quantitative Composition

Each lozenge contains 4 mg nicotine (as nicotine resinate). For excipients see Section 6.1.

3. Pharmaceutical Form

Lozenge.

White, round lozenge with convex surfaces, debossed NL4S on one side.

4. Clinical Particulars 4.1 Therapeutic Indications

NiQuitin Mint Lozenges relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence. They are indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

NiQuitin Mint Lozenges are indicated in pregnant and lactating women making a quit attempt.

NiQuitin Mint Lozenges should preferably be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

Directions for use:

NiQuitin 4 mg Mint Lozenges are suitable for smokers who have their first cigarette of the day within 30 minutes of waking up.

One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately 20 – 30 minutes). The lozenge should not be chewed or swallowed whole.

Users should not eat or drink while a lozenge is in the mouth.

Behavioural therapy, advice & support will normally improve the success rate.

Adults (18 years and over):

Abrupt cessation of smoking:

Users should make every effort to stop smoking completely during treatment with NiQuitin Mint Lozenges.

Recommended treatment schedule:

Step 1

Weeks 1 to 6

Step 2

Weeks 7 to 9

Step 3

Weeks 10 to 12

Initial treatment period

Step down treatment period

Step down treatment period

1 lozenge every 1 to 2 hours

1 lozenge every 2 to 4 hours

1 lozenge every 4 to 8 hours

During weeks 1 to 6 it is recommended that users take a minimum of 9 lozenges per day. Users should not exceed 15 lozenges per day.

To help stay smoke free beyond 12 weeks, users may take 1-2 lozenges per day only on occasions when they are strongly tempted to smoke.

Those who have quit smoking but are having difficulty discontinuing using the lozenges are recommended to seek additional help and advice from a healthcare professional.

Gradual cessation of smoking:

For smokers who are unwilling or unable to quit abruptly.

Use a lozenge whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible.

The number of lozenges a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 lozenges per day.

If a reduction in cigarette consumption has not been achieved after 6 weeks of treatment, a healthcare professional should be consulted.

Reduced tobacco consumption should lead to complete cessation of smoking. This should be attempted as soon as possible. When the number of cigarettes has been reduced to a level from which the user feels able to quit completely, then start on the schedule for “abrupt cessation” as given above.

If an attempt to stop smoking completely has not been started within 6 months after the beginning of treatment, it is recommended to consult a healthcare professional.

Reduction in smoking:

For smokers who wish to cut down with no immediate plans to quit.

Use a lozenge whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. Users should be encouraged to stop smoking completely as soon as possible.

The number of lozenges a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 lozenges per day.

If users are still feeling the need to use the lozenges on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Temporary abstinence:

Use a lozenge every 1-2 hours to control troublesome withdrawal symptoms including cravings. Users should not take more than 15 lozenges per day.

Users should be encouraged to stop smoking completely as soon as possible.

If users are still feeling the need to use lozenges on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Adolescents and children:

Adolescents (12-17 years) should follow the schedule of treatment for abrupt cessation of smoking as given above. Where adolescents are unwilling or unable to quit smoking abruptly, advice from a healthcare professional should be sought.

Safety and effectiveness in children who smoke has not been evaluated. NiQuitin Mint Lozenges are not recommended for use in children under 12 years of age.

4.3 Contraindications

NiQuitin Mint Lozenges are contraindicated in:

• those with hypersensitivity to nicotine or any of the excipients;

• children under the age of 12 years and non-smokers.

4.4 Special Warnings And Precautions For Use

The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well established dangers of continued smoking.

Patients hospitalised for MI, severe dysrhythmia or CVA who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, NiQuitin Mint Lozenges may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital they can use NRT as normal.

Diabetes Mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Allergic reactions: Susceptibility to angioedema and urticaria

A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:

• Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

• Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.

• GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Phenylketonuria: NiQuitin Mint Lozenges contain a source of phenylalanine equivalent to 3mg/dose. May be harmful for people with phenylketonuria.

Sodium content: Each NiQuitin Mint Lozenge contains 15 mg of sodium. People on a low sodium diet should take this into account.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.

4.6 Pregnancy And Lactation

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but NRT may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

NRT can cause adverse reactions similar to those associated with nicotine administered in other ways, including smoking. These may be attributed to the pharmacological effects of nicotine, some of which are dose dependent. At recommended doses NiQuitin Mint Lozenges have not been found to cause any serious adverse effects. Excessive consumption of NiQuitin Mint Lozenges by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Certain symptoms which have been reported such as depression, irritability, anxiety and insomnia may be related to withdrawal symptoms associated with smoking cessation. Subjects quitting smoking by any means could expect to suffer from headache, dizziness, sleep disturbance, increased coughing or a cold.

Related adverse events with excess in active compared to placebo group in a controlled study.

Immune system disorder

   

Very rare <1/10000: anaphylactic reactions

   

Platelet, bleeding and clotting disorders

   

Uncommon >1/1000; <1/100: gingival bleeding

   

Metabolic and nutritional disorders

   

Uncommon >1/1000; <1/100: thirst; excessive thirst

   

Psychiatric disorders

   

Common >1/100; >1/10: insomnia

 

Uncommon >1/1000; <1/100: anxiety; anxiety attack; anxiety reaction; nightmares; marked restlessness; decreased appetite; lost appetite; lethargy

   

Central and peripheral nervous system disorders

   

Common >1/100; <1/10: dizziness; headache

 

Uncommon >1/1000; <1/100; migraine; mucosal burning; burning sensation; paraesthesia mouth; sensory disturbance; hyperalertness

   

Respiratory system disorders

   

Common >1/100; <1/10: coughing; pharyngitis; sore throat

 

Uncommon >1/1000; <1/100: dyspnoea; shortness of breath; aggravated cough; lower respiratory tract infection; respiratory disorder; excessive sneezing

   

Gastrointestinal system disorders

   

Very common >1/10: nausea; hiccup, flatulence

 

Common >1/100; <1/10: vomiting; constipation, diarrheoa; dysphagia; dyspepsia; heartburn; indigestion; belching; mouth irritation, mouth ulceration; tongue ulceration; dry mouth; bloating

 

Uncommon >1/1000; <1/100: gastroesophageal reflux; oesophageal reflux aggravated; retching; eructation; gagging; catarrh; increased saliva; lip ulceration; GI disorder; abdominal griping; sore lips; dry throat

   

Special senses other, disorders:

   

Uncommon >1/1000; <1/100: taste perversion

   

Skin and appendages disorders:

   

Uncommon >1/1000; <1/100: itching; rash

   

Body as a whole: general disorders:

   

Uncommon >1/1000; <1/100: throat swelling; chest pain; tightness of chest; overdose effect; withdrawal syndrome; malaise; hot flushes; halitosis

4.9 Overdose Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: N07B A01

Nicotine is an agonist at nicotine receptors in the peripheral and central nervous system and has pronounced CNS and cardiovascular effects. When consumed in tobacco products, it has been shown to be addictive and abstinence is linked to craving and withdrawal symptoms. These craving and withdrawal symptoms include urge to smoke, depressed mood, insomnia, irritability, frustration or anger, anxiety, difficulty in concentrating, restlessness and increased appetite or weight gain. The lozenges replace some of the nicotine provided by tobacco and help reduce the severity of these nicotine craving and withdrawal symptoms.

5.2 Pharmacokinetic Properties

NiQuitin Mint Lozenges dissolve completely in the oral cavity, and the entire amount of nicotine contained in the lozenge becomes available for buccal absorption or ingestion (swallowing). The complete dissolution of NiQuitin Mint Lozenges is typically achieved in 20-30 minutes. The peak plasma concentrations of nicotine achieved after single dose are approximately 10.8 ng/ml. When dosed every 1.5 hours, the steady state peak and trough concentrations are 26.0 and 19.7 ng/ml respectively. Ingestion of NiQuitin Mint Lozenges not following dosing instruction (chewed, retained in the mouth, and swallowed; chewed and immediately swallowed) does not result in faster or higher absorption, but a substantial amount of nicotine (80-93%) is still absorbed.

As the plasma protein binding of nicotine is low (4.9% - 20%), the volume of distribution of nicotine is large (2.5 l/kg). The distribution of nicotine to tissue is pH dependent, with the highest concentrations of nicotine found in the brain, stomach, kidney and liver.

Nicotine is extensively metabolized to a number of metabolites, all of which are less active than the parent compound. The metabolism of nicotine primarily occurs in the liver, but also in the lung and kidney. Nicotine is metabolized primarily to cotinine but is also metabolized to nicotine N?-oxide. Cotinine has a half-life of 15-20 hours and its blood levels are 10 times higher than nicotine. Cotinine is further oxidized to trans-3?-hydroxycotinine, which is the most abundant metabolite of nicotine in the urine. Both nicotine and cotinine undergo glucuronidation.

The elimination half-life of nicotine is approximately 2 hours (range 1 - 4 hours). Total clearance for nicotine ranges from approximately 62 to 89 l/hr. Non-renal clearance for nicotine is estimated to be about 75% of total clearance. Nicotine and its metabolites are excreted almost exclusively in the urine. The renal excretion of unchanged nicotine is highly dependent on urinary pH, with greater excretion occurring at acidic pH.

5.3 Preclinical Safety Data

The general toxicity of nicotine is well known and taken into account in the recommended posology. Nicotine was not mutagenic in appropriate assays. The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine. In studies in pregnant animals, nicotine showed maternal toxicity, and consequential mild fetal toxicity. Additional effects included pre- and postnatal growth retardation and delays and changes in postnatal CNS development.

Effects were only noted following exposure to nicotine at levels in excess of those which will result from recommended use of NiQuitin Mint Lozenges. Effects on fertility have not been established.

Comparison of the systemic exposure necessary to elicit these adverse responses from preclinical test systems with that associated with the recommended use of NiQuitin Mint Lozenges indicate that the potential risk is low and outweighed by the demonstrable benefit of nicotine therapy in smoking cessation. However, NiQuitin Mint Lozenges should only be used by pregnant women on medical advice if other forms of treatment have failed.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Mannitol

Sodium alginate

Xanthan gum

Potassium bicarbonate

Calcium polycarbophil

Sodium carbonate anhydrous

Aspartame

Magnesium stearate

Mint flavour powder 57581

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Clear or opaque Polyvinyl Chloride/Polyethylene/Polyvinylidene Chloride blisters in packs of 12, 24, 36, 48, 72, 96, 108 and 144, or a polypropylene tablet container with cap containing 24 lozenges in packs of 24, 48 and 72.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

T/A GlaxoSmithKline Consumer Healthcare

Brentford, TW8 9GS, UK

8. Marketing Authorisation Number(S)

PL 00079/0370

9. Date Of First Authorisation/Renewal Of The Authorisation

24 September 2001

10. Date Of Revision Of The Text

23/03/2011

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Neutra Maxx

Dosage Form: oral gel
ACTIVE INGREDIENTS

ACTIVE INGREDIENT                                      PURPOSE
SODIUM FLUORIDE (NaF) 1.1% (w/v)               ANTICAVITY
INACTIVE INGREDIENTS
DEIONIZED WATER, XYLITOL, POTASSIUM NITRATE, SODIUM CARBOXYMETHYLCELLOSE, GLYCERIN, FLAVORING,SODIUM SACCHARIN, SODIUM PHOSPHATE .

USE

USE: AIDS IN THE PREVENTION OF DENTAL DECAY IN PEDIATRIC PATIENTS AND ADULTS

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.  IF MORE SOLUTION IS ACCIDENTALLY SWALLOWED THAN USED FOR BRUSHING, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

DIRECTIONS:  (UNLESS INSTRUCTED OTHERWISE BY YOUR DENTAL PROFESSIONAL)   
ADULTS AND CHILDREN 6 YEARS AND OLDER:  USE ONCE A DAY AFTER BRUSHING TEETH WITH TOOTHPASTE.  AFTER RINSING, APPLY THIN RIBBON OF GEL TO TEETH WITH TOOTHBRUSH OR MOUTH TRAYS FOR AT LEASE ONE MINUTE.  BEFORE BEDTIME IS BEST.  ADULTS SHOULD EXPECTORATE AFTER USE.  CHILDREN AGES 6-16 SHOULD EXPECTORATE GEL AND RINSE MOUTH THOROUGHLY.  DO NOT EAT OR DRINK FOR 30 MINUTES AFTER USE.

Warnings

WHEN USING THIS PRODUCT DO NOT SWALLOW UNLESS TOLD TO DO SO BY A DENTIST OR PHYSICIAN.

PACKAGE LABEL

Neutra Maxx 5000PPM GEL  REFRESHING MINT FLAVOR
THE MAXIMUM AMOUNT OF FLUORIDE AVAILABLE  1.1% SODIUM FLUORIDE 5% POTASSIUM  NITRATE XYLITOL SLS FREE Rx ONLY.  NET WT 4.3 oz  (120 g)
MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS  GRAVETTE, AR 72736  THE MEDICINE AVAILABLE EXCLUSIVELY THROUGH YOUR DENTAL OFFICE. 

OTHER INFORMATION: STORE AT ROOM TEMPERATURE   QUESTION? COMMENTS? CALL 1-479-787-5168 M-F 9AM TO 5PM CST

Neutra Maxx 5000 
sodium fluoride  gel Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-504 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 1.428 g  in 120 g Inactive Ingredients Ingredient Name Strength WATER   XYLITOL   POTASSIUM NITRATE   CARBOXYMETHYLCELLULOSE SODIUM   GLYCERIN   SODIUM PHOSPHATE   SACCHARIN SODIUM DIHYDRATE   Product Characteristics Color      Score      Shape Size Flavor MINT (Mint) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-504-06 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Establishment Name Address ID/FEI Operations Massco Dental A Division of Dunacin Pharmaceuticals 008081858 manufacture Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals

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Gelato Chlorhexidine Rinse

Generic Name: chlorhexidine gluconate
Dosage Form: oral rinse
Gelato Chlorhexidine Distilled Water, Glycerin, Polysorbate 20, Poloxamer 407, Sodium Saccharin, Mint Flavor, FD and C Blue #1

The effect of Chlohexidrine Gluconate Oral Rinse on periodontitis has not been determined. An increase in supragingival calculus was not noted in clinical testing in chlohexidine gluconate oral rinse users compared with control users. It is not known if Chlorhexidine Gluconate oral rinse use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Hypersensitivity and generalized allergic reactions have occured. read CONTRAINDICATIONS indicated on the insert inside the box.

To open, press down while turning cap. To seal, turn until cap clicks and is tight. Fill dosage cup to the fill like (150ml). Swish in your mouth undiluted for 30 seconds, the spit out. Use after breakfast and before bedtime. Or, use as prescribed by your dentist.

Chlorhexidine Gluconate Oral Rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. For patients having coexisting gingivitis and periodontitis, read PRECAUTIONS indicated on the insert inside the box.

Store at controlled room temperature 68-77F (20-25C). Protect from freezing.

0.12% Chlorhexidine Gluconate

Antigingivitis

GELATO CHLOROHEXIDINE 
chlorhexidine gluconate  rinse Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68400-500 Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 56.76 mL  in 473 mL Inactive Ingredients Ingredient Name Strength Water   Glycerin   FD&C BLUE NO. 1   SACCHARIN SODIUM   POLYSORBATE 20   POLOXAMER 407   Product Characteristics Color      Score      Shape Size Flavor MINT Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68400-500-16 473 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/31/2010
Labeler - Deepak Products, inc. (124886743) Establishment Name Address ID/FEI Operations Deepak Products, inc. 124886743 manufacture Revised: 04/2011Deepak Products, inc.
More Gelato Chlorhexidine Rinse resources Gelato Chlorhexidine Rinse Side Effects (in more detail) Gelato Chlorhexidine Rinse Use in Pregnancy & Breastfeeding Gelato Chlorhexidine Rinse Support Group 1 Review for Gelato Chlorhexidine - Add your own review/rating Compare Gelato Chlorhexidine Rinse with other medications Gingivitis Mucositis Periodontitis

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CaviRinse Sodium Fluoride Oral Rinse

Dosage Form: oral mouthwash
CaviRinse™
0.2% Sodium Fluoride Oral Rinse DESCRIPTION:

CaviRinse oral rinse is a prescription formulation for use in the prevention of dental caries. This formulation contains 0.2% sodium fluoride in a neutral pH base to help prevent caries and enhance remineralization.

ACTIVE INGREDIENT: Sodium Fluoride 0.2% w/v.

INACTIVE INGREDIENTS: Water, Glycerine, Microdent® (Ultramulsion® of dimethicone and poloxamer), sodium saccharin, flavoring, cetylpyridinum chloride.

CLINICAL PHARMACOLOGY:

The use of higher-concentration fluoride products results in greater reductions in the incidence of dental caries. CaviRinse oral rinse provides enhanced remineralization of demineralized enamel and enhanced protection against subsequent acid challenges.

INDICATIONS AND USAGE:

CaviRinse oral rinse is indicated for use as part of a professional program for the prevention and control of dental caries. CaviRinse oral rinse should be swished vigorously between your teeth once weekly after brushing with conventional toothpaste, unless otherwise instructed by a dental professional.

CONTRAINDICATIONS:

Do not use in children less than 6 years of age unless recommended by a dental professional.

WARNINGS:

DO NOT SWALLOW. Keep out of reach of children. Frequent ingestion may result in dental fluorosis in children less than 6 years of age, especially if community water fluoridation exceeds 0.6ppm fluoride ion. Use in children less than 6 years of age requires special supervision to prevent swallowing. Carefully read all instructions before using this product.

ADVERSE REACTIONS:

Allergic reactions and other idiosyncrasies have been rarely reported.

OVERDOSAGE:

Medical attention should be sought if more than a standard dose is accidentally swallowed. A single 10ml application of CaviRinse oral rinse contains approximately 9mg of fluoride ion.

DOSAGE AND ADMINISTRATION:

Follow these instructions unless otherwise instructed by a dental professional. Use once weekly after brushing your teeth with a toothpaste. Pour 10ml of CaviRinse oral rinse into the dosage cup, vigorously swish between your teeth for one minute and then spit out. Children 6 to 16 years of age should thoroughly rinse mouth with water.

HOW SUPPLIED:

8oz (236.59ml) of rinse in a plastic bottle with dosage cup.

STORAGE: Do not freeze or expose to extreme heat.

Rx Only

Vanilla Mint Flavor – NDC 48878-3223-8

Made in U.S.A. by
3M ESPE
Dental Products
St. Paul, MN 55144-1000 U.S.A.
1-800-634-2249

CaviRinse is a trademark of 3M or 3M ESPE AG. MICRODENT and ULTRAMULSION are registered trademarks of Whitehill Oral Technologies, Inc.

© 3M 2010. All rights reserved.

Principal Display Panel – Carton Label

NDC 48878-3223-8

Mint

3M ESPE

CaviRinse™

0.2 % Sodium Fluoride

Oral Rinse

Rx Only

Keep out of reach of children.

IMPORTANT: Read

directions thoroughly.

OMNI™

Contents:

8 fl oz

(236.59ml)

Principal Display Panel – Bottle Label

NDC 48878-3223-8

Mint

3M ESPE

CaviRinse™

0.2 % Sodium Fluoride

Oral Rinse

Rx Only

Keep out of reach of children.

IMPORTANT: Read

directions thoroughly.

OMNI™

Contents:

8 fl oz

(236.59ml)

CAVIRINSE 
sodium fluoride  mouthwash Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 48878-3223 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (fluoride ion) sodium fluoride 2 mg  in 1 mL Inactive Ingredients Ingredient Name Strength water   glycerin   saccharin sodium   cetylpyridinium chloride anhydrous   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 48878-3223-8 1 BOTTLE In 1 BOX contains a BOTTLE 1 236.59 mL In 1 BOTTLE This package is contained within the BOX (48878-3223-8)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2005
Labeler - 3M ESPE Dental Products (799975909) Establishment Name Address ID/FEI Operations 3M ESPE Dental Products 799975909 MANUFACTURE Revised: 08/20093M ESPE Dental Products
More CaviRinse Sodium Fluoride Oral Rinse resources CaviRinse Sodium Fluoride Oral Rinse Use in Pregnancy & Breastfeeding CaviRinse Sodium Fluoride Oral Rinse Support Group 3 Reviews for CaviRinse Sodium Fluoride Oral - Add your own review/rating Compare CaviRinse Sodium Fluoride Oral Rinse with other medications Prevention of Dental Caries

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NiQuitin 4 mg Lozenges

1. Name Of The Medicinal Product

NiQuitin 4 mg Lozenges

2. Qualitative And Quantitative Composition

Each lozenge contains 4 mg nicotine (as nicotine resinate). For excipients see Section 6.1.

3. Pharmaceutical Form

Lozenge

White, round lozenge with convex surfaces, debossed NL4 on one side.

4. Clinical Particulars 4.1 Therapeutic Indications

NiQuitin Lozenges relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence. They are indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

NiQuitin Lozenges are indicated in pregnant and lactating women making a quit attempt.

NiQuitin Lozenges should preferably be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

Directions for use:

NiQuitin 4 mg Lozenges are suitable for smokers who have their first cigarette of the day within 30 minutes of waking up.

One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately 20 – 30 minutes). The lozenge should not be chewed or swallowed whole.

Users should not eat or drink while a lozenge is in the mouth.

Behavioural therapy, advice & support will normally improve the success rate.

Adults (18 years and over):

Abrupt cessation of smoking:

Users should make every effort to stop smoking completely during treatment with NiQuitin Lozenges.

Recommended treatment schedule:

Step 1

Weeks 1 to 6

Step 2

Weeks 7 to 9

Step 3

Weeks 10 to 12

Initial treatment period

Step down treatment period

Step down treatment period

1 lozenge every 1 to 2 hours

1 lozenge every 2 to 4 hours

1 lozenge every 4 to 8 hours

During weeks 1 to 6 it is recommended that users take a minimum of 9 lozenges per day. Users should not exceed 15 lozenges per day.

To help stay smoke free beyond 12 weeks, users may take 1-2 lozenges per day only on occasions when they are strongly tempted to smoke

Those who quit smoking but have difficulty discontinuing using the lozenges are recommended to seek additional help and advice from a healthcare professional.

Gradual cessation of smoking:

For smokers who are unwilling or unable to quit abruptly.

Use a lozenge whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible.

The number of lozenges a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 lozenges per day.

If a reduction in cigarette consumption has not been achieved after 6 weeks of treatment, a healthcare professional should be consulted.

Reduced tobacco consumption should lead to complete cessation of smoking. This should be attempted as soon as possible. When the number of cigarettes has been reduced to a level from which the user feels able to quit completely, then start on the schedule for “abrupt cessation” as given above.

If an attempt to stop smoking completely has not been started within 6 months after the beginning of treatment, it is recommended to consult a healthcare professional.

Reduction in smoking:

For smokers who wish to cut down with no immediate plans to quit.

Use a lozenge whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. Users should be encouraged to stop smoking completely as soon as possible.

The number of lozenges a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 lozenges per day.

If users are still feeling the need to use the lozenges on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Temporary abstinence:

Use a lozenge every 1-2 hours to control troublesome withdrawal symptoms including cravings. Users should not take more than 15 lozenges per day.

Users should be encouraged to stop smoking completely as soon as possible.

If users are still feeling the need to lozenges on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Adolescents and children:

Adolescents (12-17 years) should follow the schedule of treatment for abrupt cessation of smoking as given above. Where adolescents are unwilling or unable to quit smoking abruptly, advice from a healthcare professional should be sought.

Safety and effectiveness in children who smoke has not been evaluated. NiQuitin Lozenges are not recommended for use in children under 12 years of age.

4.3 Contraindications

NiQuitin Lozenges are contraindicated in:

• those with hypersensitivity to nicotine or any of the excipients;

• children under the age of 12 years and non-smokers.

4.4 Special Warnings And Precautions For Use

The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well established dangers of continued smoking.

Patients hospitalised for MI, severe dysrhythmia or CVA who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, NiQuitin Lozenges may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital they can use NRT as normal.

Diabetes Mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Allergic reactions: Susceptibility to angioedema and urticaria

A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:

• Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

• Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.

• GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Phenylketonuria: NiQuitin Lozenges are sugar free, but do contain aspartame which metabolises to phenylalanine, which is of relevance for those with phenylketonuria.

Sodium content: Each NiQuitin Lozenge contains 15 mg of sodium. People on a low sodium diet should take this into account.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.

4.6 Pregnancy And Lactation

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but NRT may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

NRT can cause adverse reactions similar to those associated with nicotine administered in other ways, including smoking. These may be attributed to the pharmacological effects of nicotine, some of which are dose dependent. At recommended doses NiQuitin Lozenges have not been found to cause any serious adverse effects. Excessive consumption of NiQuitin Lozenges by those who have not been in the habit of inhaling tobacco smoke could possible lead to nausea, faintness or headaches.

Certain symptoms which have been reported such as depression, irritability, anxiety and insomnia may be related to withdrawal symptoms associated with smoking cessation. Subjects quitting smoking by any means could expect to suffer from headache, dizziness, sleep disturbance, increased coughing or a cold.

Related adverse events with excess in active compared to placebo group in a controlled study.

Immune system disorders

   

Very rare <1/10000: anaphylactic reactions

Platelet, bleeding and clotting disorders

   

Uncommon >1/1000; <1/100: gingival bleeding

Metabolic and nutritional disorders

   

Uncommon >1/1000; <1/100: thirst; excessive thirst

Psychiatric disorders

   

Common >1/100; <1/10: insomnia

 

Uncommon >1/1000; <1/100: anxiety; anxiety attack; anxiety reaction; nightmares; marked restlessness; decreased appetite; lost appetite; lethargy

Central and peripheral nervous system disorders

   

Common >1/100; <1/10: dizziness; headache

 

Uncommon >1/1000; <1/100; migraine; mucosal burning; burning sensation; paraesthesia mouth; sensory disturbance; hyperalertness

Respiratory system disorders

   

Common >1/100; <1/10: coughing; pharyngitis; sore throat

 

Uncommon >1/1000; <1/100: dyspnoea; shortness of breath; aggravated cough; lower respiratory tract infection; respiratory disorder; excessive sneezing

Gastrointestinal system disorders

   

Very common >1/10: nausea; hiccup, flatulence

 

Common >1/100; <1/10: vomiting; constipation, diarrheoa; dysphagia; dyspepsia; heartburn; indigestion; belching; mouth irritation, mouth ulceration; tongue ulceration; dry mouth; bloating

 

Uncommon >1/1000; <1/100: gastroesophageal reflux; oesophageal reflux aggravated; retching; eructation; gagging; catarrh; increased saliva; lip ulceration; GI disorder; abdominal griping; sore lips; dry throat

Special senses other, disorders:

   

Uncommon >1/1000; <1/100: taste perversion

Skin and appendages disorders:

   

Uncommon >1/1000; <1/100: itching; rash

Body as a whole: general disorders:

   

Uncommon >1/1000; <1/100: throat swelling; chest pain; tightness of chest; overdose effect; withdrawal syndrome; malaise; hot flushes; halitosis

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: N07B A01

Nicotine is an agonist at nicotine receptors in the peripheral and central nervous system and has pronounced CNS and cardiovascular effects. When consumed in tobacco products, it has been shown to be addictive and abstinence is linked to craving and withdrawal symptoms. These craving and withdrawal symptoms include urge to smoke, depressed mood, insomnia, irritability, frustration or anger, anxiety, difficulty in concentrating, restlessness and increased appetite or weight gain. The lozenges replace some of the nicotine provided by tobacco and help reduce the severity of these nicotine craving and withdrawal symptoms.

5.2 Pharmacokinetic Properties

NiQuitin Lozenges dissolve completely in the oral cavity, and the entire amount of nicotine contained in the lozenge becomes available for buccal absorption or ingestion (swallowing). The complete dissolution of NiQuitin Lozenges is typically achieved in 20-30 minutes. The peak plasma concentrations of nicotine achieved after single dose are approximately 10.8 ng/ml. When dosed every 1.5 hours, the steady state peak and trough concentrations are 26.0 and 19.7 ng/ml respectively. Ingestion of NiQuitin Lozenges not following dosing instruction (chewed, retained in the mouth, and swallowed; chewed and immediately swallowed) does not result in faster or higher absorption, but a substantial amount of nicotine (80-93%) is still absorbed.

As the plasma protein binding of nicotine is low (4.9% - 20%), the volume of distribution of nicotine is large (2.5 l/kg). The distribution of nicotine to tissue is pH dependent, with the highest concentrations of nicotine found in the brain, stomach, kidney and liver.

Nicotine is extensively metabolized to a number of metabolites, all of which are less active than the parent compound. The metabolism of nicotine primarily occurs in the liver, but also in the lung and kidney. Nicotine is metabolized primarily to cotinine but is also metabolized to nicotine N?-oxide. Cotinine has a half-life of 15-20 hours and its blood levels are 10 times higher than nicotine. Cotinine is further oxidized to trans-3?-hydroxycotinine, which is the most abundant metabolite of nicotine in the urine. Both nicotine and cotinine undergo glucuronidation.

The elimination half-life of nicotine is approximately 2 hours (range 1 - 4 hours). Total clearance for nicotine ranges from approximately 62 to 89 l/hr. Non-renal clearance for nicotine is estimated to be about 75% of total clearance. Nicotine and its metabolites are excreted almost exclusively in the urine. The renal excretion of unchanged nicotine is highly dependent on urinary pH, with greater excretion occurring at acidic pH.

5.3 Preclinical Safety Data

The general toxicity of nicotine is well known and taken into account in the recommended posology. Nicotine was not mutagenic in appropriate assays. The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine. In studies in pregnant animals, nicotine showed maternal toxicity, and consequential mild fetal toxicity. Additional effects included pre- and postnatal growth retardation and delays and changes in postnatal CNS development.

Effects were only noted following exposure to nicotine at levels in excess of those which will result from recommended use of NiQuitin Lozenges. Effects on fertility have not been established.

Comparison of the systemic exposure necessary to elicit these adverse responses from preclinical test systems with that associated with the recommended use of NiQuitin Lozenges indicate that the potential risk is low and outweighed by the demonstrable benefit of nicotine therapy in smoking cessation. However, NiQuitin Lozenges should only be used by pregnant women on medical advice if other forms of treatment have failed.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Mannitol

Sodium alginate

Xanthan gum

Potassium bicarbonate

Calcium polycarbophil

Sodium carbonate anhydrous

Aspartame

Magnesium stearate

Menthol mint flavour

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Clear or opaque Polyvinyl Chloride/Polyethylene/Polyvinylidene Chloride blisters in packs of 12, 36, 72, 96, 108 and 144.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

T/A GlaxoSmithKline Consumer Healthcare

Brentford, TW8 9GS, UK

8. Marketing Authorisation Number(S)

PL 00079/0607

9. Date Of First Authorisation/Renewal Of The Authorisation

29/03/2007

10. Date Of Revision Of The Text

18/04/2011

Read More:

NiQuitin 2 mg Lozenges

1. Name Of The Medicinal Product

NiQuitin 2 mg Lozenges

2. Qualitative And Quantitative Composition

Each lozenge contains 2 mg nicotine (as nicotine resinate). For excipients see Section 6.1.

3. Pharmaceutical Form

Lozenge

White, round lozenge with convex surfaces, debossed NL2 on one side.

4. Clinical Particulars 4.1 Therapeutic Indications

NiQuitin Lozenges relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence. They are indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

NiQuitin Lozenges are indicated in pregnant and lactating women making a quit attempt.

NiQuitin Lozenges should preferably be used in conjunction with a behavioral support programme.

4.2 Posology And Method Of Administration

Directions for use:

NiQuitin 2 mg Lozenges are suitable for smokers who have their first cigarette of the day more than 30 minutes after waking up.

One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately 20 – 30 minutes). The lozenge should not be chewed or swallowed whole.

Users should not eat or drink while a lozenge is in the mouth.

Behavioural therapy, advice and support will normally improve the success rate.

Adults (18 years and over):

Abrupt cessation of smoking:

Users should make every effort to stop smoking completely during treatment with NiQuitin Lozenges.

Recommended treatment schedule:

Step 1

Weeks 1 to 6

Step 2

Weeks 7 to 9

Step 3

Weeks 10 to 12

Initial treatment period

Step down treatment period

Step down treatment period

1 lozenge every 1 to 2 hours

1 lozenge every 2 to 4 hours

1 lozenge every 4 to 8 hours

During weeks 1 to 6 it is recommended that users take a minimum of 9 lozenges per day. Users should not exceed 15 lozenges per day.

To help stay smoke free beyond 12 weeks, users may take 1-2 lozenges per day only on occasions when they are strongly tempted to smoke

Those who have quit smoking but are having difficulty discontinuing using the lozenges are recommended to seek additional help and advice from a healthcare professional.

Gradual cessation of smoking:

For smokers who are unwilling or unable to quit abruptly.

Use a lozenge whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible.

The number of lozenges a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 lozenges per day.

If a reduction in cigarette consumption has not been achieved after 6 weeks of treatment, a healthcare professional should be consulted.

Reduced tobacco consumption should lead to complete cessation of smoking. This should be attempted as soon as possible. When the number of cigarettes has been reduced to a level from which the user feels able to quit completely, then start on the schedule for “abrupt cessation” as given above.

If an attempt to stop smoking completely has not been started within 6 months after the beginning of treatment, it is recommended to consult a healthcare professional.

Reduction in smoking:

For smokers who wish to cut down with no immediate plans to quit.

Use a lozenge whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. Users should be encouraged to stop smoking completely as soon as possible.

The number of lozenges a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 lozenges per day.

If users are still feeling the need to use the lozenges on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Temporary abstinence:

Use a lozenge every 1-2 hours to control troublesome withdrawal symptoms including cravings. Users should not take more than 15 lozenges per day.

Users should be encouraged to stop smoking completely as soon as possible.

If users are still feeling the need to use lozenges on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Adolescents and children:

Adolescents (12-17 years) should follow the schedule of treatment for abrupt cessation of smoking as given above. Where adolescents are unwilling or unable to quit smoking abruptly, advice from a healthcare professional should be sought.

Safety and effectiveness in children who smoke has not been evaluated. NiQuitin Lozenges are not recommended for use in children under 12 years of age.

4.3 Contraindications

NiQuitin Lozenges are contraindicated in:

• those with hypersensitivity to nicotine or any of the excipients;

• children under the age of 12 years and non-smokers.

4.4 Special Warnings And Precautions For Use

The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well established dangers of continued smoking.

Patients hospitalised for MI, severe dysrhythmia or CVA who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, NiQuitin Lozenges may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital they can use NRT as normal.

Diabetes Mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Allergic reactions: Susceptibility to angioedema and urticaria

A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:

• Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

• Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.

• GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Phenylketonuria: NiQuitin Lozenges are sugar free, but do contain aspartame which metabolises to phenylalanine, which is of relevance for those with phenylketonuria.

Sodium content: Each NiQuitin Lozenge contains 15 mg of sodium. People on a low sodium diet should take this into account.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.

4.6 Pregnancy And Lactation

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but NRT may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

NRT can cause adverse reactions similar to those associated with nicotine administered in other ways including smoking. These may be attributed to the pharmacological effects of nicotine, some of which are dose dependent. At recommended doses NiQuitin Lozenges have not been found to cause any serious adverse effects. Excessive consumption of NiQuitin Lozenges by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Certain symptoms which have been reported such as depression, irritability, anxiety and insomnia may be related to withdrawal symptoms associated with smoking cessation. Subjects quitting smoking by any means could expect to suffer from headache, dizziness, sleep disturbance, increased coughing or a cold.

Related adverse events with excess in active compared to placebo group in a controlled study.

Immune system disorders

   

Very rare <1/10000: anaphylactic reactions

 

 

Platelet bleeding and clotting disorders

   

Uncommon >1/1000; <1/100: gingival bleeding; nosebleed

   

Psychiatric disorders

   

Common >1/100; <1/10: insomnia; anxiety; irritability; increased appetite

 

Uncommon >1/1000; <1/100: anger; aggravated anxiety; abnormal dreaming; abnormal hunger; mood swings; wakefulness

   

Central and peripheral nervous system disorders

   

Common >1/100; <1/10: headache

 

Uncommon >1/1000; <1/100: lightheaded feeling; localised numbness

   

Heart rate and rhythm disorders

   

Uncommon >1/1000; <1/100: aggravated palpitations; palpitations; tachycardia

   

Vascular (extracardiac) disorders

   

Uncommon >1/1000; <1/100: vascular disorder; flushing; skin flushed

   

Respiratory system disorders

   

Common >1/100; <1/10: pharyngitis

 

Uncommon >1/1000; <1/100: laryngismus; aggravated asthma; lower respiratory tract infection; coughing; nasal irritation; throat irritation; nasal congestion

   

Gastrointestinal system disorders

   

Very common >1/10: nausea

 

Common >1/100; <1/10: vomiting; dyspepsia, heartburn, indigestion; hiccup; mouth irritation, mouth ulceration; tongue ulceration; diarrhoea; belching; flatulence

 

Uncommon >1/1000; <1/100: peptic ucler; dysphagia; aggravated dyspepsia; gastroesophageal reflux; hiatus hernia; oesophagitis; eructation; buccal mucosa ulceration; borborygmus; dry lips; dry throat; tongue disorder; tooth ache

   

Special senses other, disorders

   

Uncommon >1/1000; <1/100: parageusia, metallic taste; taste perversion

   

Skin and appendages disorders

   

Uncommon >1/1000; <1/100: erythema; itching; rash; skin reaction localised; increased sweating

   

Musculoskeletal system disorders

   

Uncommon >1/1000; <1/100: jaw pain

   

Urinary system disorders

   

Uncommon >1/1000; <1/100: nocturia

   

Body as a whole - general disorders

   

Uncommon >1/1000; <1/100: overdose effect; pain; leg pain; oedema legs

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: N07B A01

Nicotine is an agonist at nicotine receptors in the peripheral and central nervous system and has pronounced CNS and cardiovascular effects. When consumed in tobacco products, it has been shown to be addictive and abstinence is linked to craving and withdrawal symptoms. These craving and withdrawal symptoms include urge to smoke, depressed mood, insomnia, irritability, frustration or anger, anxiety, difficulty in concentrating, restlessness and increased appetite or weight gain. The lozenges replace some of the nicotine provided by tobacco and help reduce the severity of these nicotine craving and withdrawal symptoms.

5.2 Pharmacokinetic Properties

NiQuitin Lozenges completely dissolve in the oral cavity, and the entire amount of nicotine contained in the lozenge becomes available for buccal absorption or ingestion (swallowing). The complete dissolution of NiQuitin Lozenge is typically achieved in 20-30 minutes. The peak plasma concentrations of nicotine achieved after a single dose are approximately 4.4 ng/ml. When dosed every 1.5 hours, the steady state peak and trough concentrations are 12.7 and 9.4 ng/ml respectively. Ingestion of NiQuitin Lozenges not following dosing instructions (chewed, retained in the mouth, and swallowed; chewed and immediately swallowed) does not result in faster or higher absorption, but a substantial amount of nicotine (80-93%) is still absorbed.

As the plasma protein binding of nicotine is low (4.9% - 20%), the volume of distribution of nicotine is large (2.5 l/kg). The distribution of nicotine to tissue is pH dependent, with the highest concentrations of nicotine found in the brain, stomach, kidney and liver.

Nicotine is extensively metabolized to a number of metabolites, all of which are less active than the parent compound. The metabolism of nicotine primarily occurs in the liver, but also in the lung and kidney. Nicotine is metabolized primarily to cotinine but is also metabolized to nicotine N?-oxide. Cotinine has a half-life of 15-20 hours and its blood levels are 10 times higher than nicotine. Cotinine is further oxidized to trans-3?-hydroxycotinine, which is the most abundant metabolite of nicotine in the urine. Both nicotine and cotinine undergo glucuronidation.

The elimination half-life of nicotine is approximately 2 hours (range 1 - 4 hours). Total clearance for nicotine ranges from approximately 62 to 89 l/hr. Non-renal clearance for nicotine is estimated to be about 75% of total clearance. Nicotine and its metabolites are excreted almost exclusively in the urine. The renal excretion of unchanged nicotine is highly dependent on urinary pH, with greater excretion occurring at acidic pH.

5.3 Preclinical Safety Data

The general toxicity of nicotine is well known and taken into account in the recommended posology. Nicotine was not mutagenic in appropriate assays. The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine. In studies in pregnant animals, nicotine showed maternal toxicity, and consequential mild fetal toxicity. Additional effects included pre- and postnatal growth retardation and delays and changes in postnatal CNS development.

Effects were only noted following exposure to nicotine at levels in excess of those which will result from recommended use of NiQuitin Lozenges. Effects on fertility have not been established.

Comparison of the systemic exposure necessary to elicit these adverse responses from preclinical test systems with that associated with the recommended use of NiQuitin Lozenges indicate that the potential risk is low and outweighed by the demonstrable benefit of nicotine therapy in smoking cessation. However, NiQuitin Lozenges should only be used by pregnant women on medical advice if other forms of treatment have failed.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Mannitol

Sodium alginate

Xanthan gum

Potassium bicarbonate

Calcium polycarbophil

Sodium carbonate anhydrous

Aspartame

Magnesium stearate

Menthol mint flavour

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Clear or opaque Polyvinyl Chloride/Polyethylene/Polyvinylidene Chloride blisters in packs of 12, 36, 72, 96, 108 and 144.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

T/A GlaxoSmithKline Consumer Healthcare

Brentford TW8 9GS, UK.

8. Marketing Authorisation Number(S)

PL 00079/0606

9. Date Of First Authorisation/Renewal Of The Authorisation

29/03/2007

10. Date Of Revision Of The Text

18/04/2011

Read More:

Super Dent Topical Anesthetic Gel

benzocaine
Dosage Form: gel
Super Dent Topical Anesthetic Gel 20% Benzocaine DIRECTIONS FOR USE

Gel – 1oz/30mL
REF 14-31021 Cherry
REF 14-31022 Mint
REF 14-31023 Banana
REF 14-31024 Pina Colada
REF 14-31025 Bubble-Num
REF 14-31026 Strawberry
REF 14-31027 Razzberry

For dental use only.
USA: Rx only.

1. DESCRIPTION

Flavored 20% benzocaine gel for topical mucosal anesthesia.

2. INDICATIONS

Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intra-oral radiographs.

3. CONTRAINDICATIONS

Should not be used with individuals with a known sensitivity to benzocaine or PABA.

4. WARNINGS

Keep out of reach of children. For professional dental use only.

5. PRECAUTIONS

Super Dent 20% benzocaine gels are supplied in multiple use containers. Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle.

6. DOSAGE AND ADMINISTRATION Each gram of Super Dent 20% benzocaine gel contains between 180-220mg benzocaine in a flavored base. Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle. For topical tissue anesthesia during scaling procedures, dispense a small amount of Topex gel into a dappen dish, then coat the scaler with the product prior to use. Tightly re-cap the jar after each use. 7. STORAGE

Store between 59°-86°F (15°-30°C). Protect from freezing.

Darby Dental Supply LLC
Jericho, NY 11753

Made in the USA
Form #0030502DF (R 2/22/10)

PRINCIPAL DISPLAY PANEL - 30 g Label (Cherry)

super dent®

20% Benzocaine Gel

Cherry Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1737
NDC 6646720021

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

PRINCIPAL DISPLAY PANEL - 30 g Label (Mint)

super dent®

20% Benzocaine Gel

Mint Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1738
NDC 6646720031

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

PRINCIPAL DISPLAY PANEL - 30 g Label (Banana)

super dent®

20% Benzocaine Gel

Banana Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1743
NDC 6646720051

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

PRINCIPAL DISPLAY PANEL - 30 g Label (Bubble Gum)

super dent®

20% Benzocaine Gel

Bubble Gum Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1736
NDC 6646720011

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

PRINCIPAL DISPLAY PANEL - 30 g Label (Strawberry)

super dent®

20% Benzocaine Gel

Strawberry Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1744
NDC 6646720061

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

PRINCIPAL DISPLAY PANEL - 30 g Label (Raspberry)

super dent®

20% Benzocaine Gel

Raspberry Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1734
NDC 6646720001

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

PRINCIPAL DISPLAY PANEL - 30 g Label (Pi?a Colada)

super dent®

20% Benzocaine Gel

Pi?a Colada Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1739
NDC 6646720041

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

SUPERDENT  CHERRY
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2002 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color RED Score      Shape Size Flavor CHERRY Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2002-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
SUPERDENT  MINT
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2003 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color GREEN Score      Shape Size Flavor MINT Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2003-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
SUPERDENT  BANANA
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2005 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color YELLOW Score      Shape Size Flavor BANANA Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2005-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
SUPERDENT  BUBBLE GUM
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2001 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color PINK Score      Shape Size Flavor BUBBLE GUM Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2001-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
SUPERDENT  STRAWBERRY
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2006 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color RED Score      Shape Size Flavor STRAWBERRY Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2006-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
SUPERDENT  RASPBERRY
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2000 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color RED Score      Shape Size Flavor RASPBERRY Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2000-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
SUPERDENT  PINA COLADA
benzocaine  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-2004 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score      Shape Size Flavor COCONUT (Pina Colada) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66467-2004-1 34 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/19/1963
Labeler - Darby Dental Supply LLC (825137818) Registrant - DSHealthcare (056296981) Establishment Name Address ID/FEI Operations DENTSPLY Caulk 083235549 MANUFACTURE Revised: 08/2010Darby Dental Supply LLC
More Super Dent Topical Anesthetic Gel resources Super Dent Topical Anesthetic Gel Side Effects (in more detail) Super Dent Topical Anesthetic Gel Use in Pregnancy & Breastfeeding 0 Reviews for Super Dent Topical Anesthetic - Add your own review/rating Compare Super Dent Topical Anesthetic Gel with other medications Anal Itching Anesthesia Aphthous Ulcer Burns, External Cold Sores Hemorrhoids Oral and Dental Conditions Pain Pruritus Sunburn Tonsillitis/Pharyngitis

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NiQuitin 7 mg transdermal patches

1. Name Of The Medicinal Product

NiQuitin 7 mg transdermal patches.

2. Qualitative And Quantitative Composition

Each 7 cm2 transdermal patch contains 36 mg nicotine, equivalent to 5.1 mg/cm2 of nicotine and delivering 7 mg over 24 hours.

For excipients, see section 6.1.

3. Pharmaceutical Form

Transdermal patch.

Each patch is rectangular and is comprised of an outer matt pinkish tan-coloured layer, a middle silver layer and an outer clear layer which is removed prior to use.

4. Clinical Particulars 4.1 Therapeutic Indications

NiQuitin patches relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence. They are indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

NiQuitin patches are indicated in pregnant and lactating women making a quit attempt.

If possible, when stopping smoking, NiQuitin patches should be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

NiQuitin patches should be applied once a day, at the same time each day and preferably soon after waking, to a non-hairy, clean, dry skin site and worn continuously for 24 hours. The NiQuitin patch should be applied promptly on removal from its protective sachet.

Avoid applying to any skin which is broken, red or irritated. After 24 hours the used patch should be removed and a new patch applied to a fresh skin site. The patch should not be left on for longer than 24 hours. Skin sites should not be reused for at least seven days. Only one patch should be worn at a time.

Patches may be removed before going to bed if desired. However use for 24 hours is recommended to optimise the effect against morning cravings.

Concurrent behavioural support is recommended, as such programmes have been shown to be beneficial for smoking cessation.

Adults 18 years and over

Abrupt cessation of smoking:

During a quit attempt every effort should be made to stop smoking with NiQuitin patches.

NiQuitin therapy should usually begin with NiQuitin 21 mg and be reduced according to the following dosing schedule:-

Dose

Duration

Step 1 NiQuitin 21 mg

First 6 weeks

Step 2 NiQuitin 14 mg

Next 2 weeks

Step 3 NiQuitin 7 mg

Last 2 weeks

Light smokers (e.g. those who smoke less than 10 cigarettes per day) are recommended to start at Step 2 (14 mg) for 6 weeks and decrease the dose to NiQuitin 7 mg for the final 2 weeks.

Patients on NiQuitin 21 mg who experience excessive side-effects (please refer to precautions), which do not resolve within a few days, should change to NiQuitin 14mg. This strength should then be continued for the remainder of the 6 week course before stepping down to NiQuitin 7mg for two weeks. If the symptoms persist the patient should be advised to seek the advice of a healthcare professional.

For optimum results, the 10 week treatment course (8 weeks for light smokers or patients who have reduced strength as above), should be completed in full. Treatment with NiQuitin patch may be continued beyond 10 weeks if needed to stay cigarette free, however, those who have quit smoking but are having difficulty discontinuing using the patches recommended to seek additional help and advice from a healthcare professional.

Further courses may be used at a later time, for NiQuitin patch users who continue or resume smoking.

Gradual Cessation:

For smokers who are unwilling or unable to quit abruptly.

The 21 mg patch can be used daily for 2-4 weeks while the user continues to smoke as needed. At the end of the 2-4 weeks the user should quit completely and continue using Step 1 21 mg patch for 6 weeks daily without smoking. Thereafter following the Step 2 and 3 directions for abrupt cessation above. Should the patient feel able to quit completely before their designated quit date they can do so.

Reduction in smoking:

For smokers who wish to cut down with no immediate plans to quit.

A patch can be used while the user continues to smoke as needed. The user should reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. Users should be encouraged to stop smoking completely as soon as possible.

If users are still feeling the need to use the patches on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Temporary Abstinence

Apply a patch to control troublesome withdrawal symptoms including craving during the period when smoking is being avoided. Users should be encouraged to stop smoking completely as soon as possible.

If users are still feeling the need to use the patches on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Adolescents and children

Adolescents (12 to 17 years) should follow the schedule of treatment for abrupt cessation of smoking as given above. Where adolescents are not ready or not able to stop smoking abruptly, advice from a healthcare professional should be sought.

Safety and effectiveness in children who smoke has not been evaluated. NiQuitin is not recommended for use in children under 12 years of age.

4.3 Contraindications

NiQuitin is contraindicated in patients with hypersensitivity to the system, the active substance, or any of the excipients.

NiQuitin patches should not be used by non-smokers, occasional smokers or children under 12 years.

4.4 Special Warnings And Precautions For Use

The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well established dangers of continued smoking.

Patients hospitalised for MI, severe dysrhythmia or CVA who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, NiQuitin patches may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital they can use NRT as normal.

Diabetes Mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Allergic reactions: Susceptibility to angioedema and urticaria.

Atopic or eczematous dermatitis (due to localised patch sensitivity): In the case of severe or persistent local reactions at the site of application (e.g. severe erythema, pruritus or oedema) or a generalised skin reaction (e.g. urticaria, hives or generalised skin rashes), users should be instructed to discontinue use of NiQuitin and contact their physician.

Contact sensitisation: Patients with contact sensitisation should be cautioned that a serious reaction could occur from exposure to other nicotine-containing products or smoking.

A risk benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:

• Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

• Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. The patches should be folded in half with the adhesive side innermost and disposed of with care.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Safety on handling: NiQuitin is potentially a dermal irritant and can cause contact sensitisation. Care should be taken during handling and in particular contact with the eyes and nose avoided. After handling, wash hands with water alone as soap may increase nicotine absorption.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.

4.6 Pregnancy And Lactation

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but NRT may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects NRT may cause adverse reactions similar to those associated with nicotine administered by other means, including smoking. These may be attributable to the pharmacological effects of nicotine, some of which are dose dependent. At recommended doses, NiQuitin patches have not been found to cause any serious adverse effects. Excessive use of NiQuitin patches by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Subjects quitting smoking by any means could expect to suffer from asthenia, headache, dizziness, sleep disturbance, coughing or influenza-like illness. Certain symptoms which have been reported such as depression, irritability, nervousness, restlessness, mood lability, anxiety, drowsiness, impaired concentration and insomnia may be related to withdrawal symptoms associated with smoking cessation.

Application site reactions are the most frequent adverse reaction associated with NiQuitin. NiQuitin can cause other adverse reactions related to the pharmacological effect of nicotine or withdrawal effects related to smoking.

The following undesirable effects have been reported in clinical trials or spontaneously post-marketing.

Certain symptoms which have been reported such as depression, irritability, nervousness, restlessness, mood lability, anxiety, drowsiness, impaired concentration, insomnia and sleep disturbances may be related to withdrawal symptoms associated with smoking cessation. Subjects quitting smoking by any means could expect to suffer from asthenia, headache, dizziness, coughing or influenza-like illness.

Immune System Disorders

Uncommon>1/1000; <1/100: hypersensitivity NOS*

Very rare <1/10000: anaphylactic reactions

Psychiatric

Very common>1/10: sleep disorders including abnormal dreams and insomnia

Common>1/100; <1/10: nervousness

Nervous system disorders

Very Common>1/10: headache, dizziness

Common>1/100; <1/10: tremor

Cardiac disorders

Common>1/100; <1/10: palpitations

Uncommon>1/1000; <1/100: tachycardia NOS

Respiratory, Thoracic and Mediastinal Disorders

Common>1/100; <1/10: dyspnoea, pharyngitis, cough

Gastrointestinal Disorders

Very Common>1/10: nausea, vomiting

Common>1/100; <1/10: dyspepsia, abdominal pain upper, diarrhea NOS, dry mouth, constipation

Skin and Subcutaneous Tissue Disorders

Common>1/100; <1/10: sweating increased

Very rare> 1/100000; <1/10000: dermatitis allergic*, dermatitis contact*, photosensitivity

Musculoskeletal and Connective Tissue Disorders

Common>1/100; <1/10: arthralgia, myalgia

General Disorders and Administration Site Conditions

Very Common>1/10: application site reactions NOS*

Common>1/100; <1/10: chest pain, pain in limb, pain NOS, asthenia, fatigue

Uncommon>1/1000; <1/100 malaise, influenza-like illness

* see below

Application site reactions, including transient rash, itching, burning, tingling, numbness, swelling, pain and urticaria are the most frequent undesirable effects of NiQuitin patch. The majority of these topical reactions are minor and resolve quickly following removal of the patch. Pain or sensation of heaviness in the limb or area around which the patch is applied (e.g. chest) may be reported.

Hypersensitivity reactions, including contact dermatitis and allergic dermatitis have also been reported. In the case of severe or persistent local reactions at the application site (e.g. severe erythema, pruritus or oedema) or a generalized skin reaction (e.g. urticaria, hives or generalised skin rashes) users should be instructed to discontinue use of NiQuitin and contact their physician.

If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the NiQuitin dose should be reduced or discontinued.

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine

Overdose from topical exposure: The NiQuitin system should be removed immediately if the patient shows signs of overdosage and the patient should seek immediate medical care. The skin surface may be flushed with water and dried. No soap should be used since it may increase nicotine absorption. Nicotine will continue to be delivered into the bloodstream for several hours after removal of the system because of a depot of nicotine in the skin.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic classification: N07BA01

(Anti-smoking agents: N07BA, Nicotine 01)

Nicotine, the chief alkaloid in tobacco products and a naturally occurring autonomic drug, is an agonist at nicotine receptors in the peripheral and central nervous system and has pronounced CNS and cardiovascular effects. Withdrawal from nicotine in addicted individuals is characterised by craving, nervousness, restlessness, irritability, mood lability, anxiety, drowsiness, sleep disturbances, impaired concentration, increased appetite, minor somatic complaints (headache, myalgia, constipation, fatigue) and weight gain. Withdrawal symptoms, such as cigarette craving, may be controlled in some individuals by steady-state plasma levels lower than those for smoking.

In clinically controlled trials, NiQuitin was shown to alleviate nicotine withdrawal symptoms as well as craving. NiQuitin reduced the severity of cravings by at least 35% at all times of day during the first two weeks of abstinence, compared to placebo (p<0.05).

5.2 Pharmacokinetic Properties

Absorption

Following transdermal application, the skin rapidly absorbs nicotine released initially from the patch adhesive. The plasma concentrations of nicotine reach a plateau within 2-4 hours after initial application of NiQuitin with relatively constant plasma concentrations persisting for 24 hours or until the patch is removed. Approximately 68% of the nicotine released from the patch enters systemic circulation and the remainder of the released nicotine is lost via vaporisation from the edge of the patch.

With continuous daily application of NiQuitin (worn for 24 hours), dose-dependent steady state plasma nicotine concentrations are achieved following the second NiQuitin application and are maintained throughout the day. These steady state maximum concentrations are approximately 30% higher than those following a single application of NiQuitin.

Plasma concentrations of nicotine are proportional to dose for the three dosage forms of NiQuitin. The mean plasma steady state concentrations of nicotine are approximately 17 ng/ml for the 21 mg/day patch, 12 ng/ml for the 14 mg /day patch and 6 ng/ml for the 7 mg/day patch. For comparison, half-hourly smoking of cigarettes produces average plasma concentrations of approximately 44 ng/ml.

The pronounced early peak in nicotine blood levels seen with inhalation of cigarette smoke is not observed with NiQuitin.

Distribution

Following removal of NiQuitin, plasma nicotine concentrations decline with an apparent mean half-life of 3 hours, compared with 2 hours for IV administration due to continued absorption of nicotine from the skin depot. If NiQuitin is removed most non-smoking patients will have non-detectable nicotine concentrations in 10 to 12 hours.

A dose of radiolabelled nicotine given intravenously showed a distribution of radioactivity corresponding to the blood supply with no organ selectively taking up nicotine. The volume of distribution of nicotine is approximately 2.5 l/kg.

Metabolism

The major elimination organ is the liver and average plasma clearance is about 1.2 l/min; the kidney and the lung also metabolise nicotine. More than 20 metabolites of nicotine have been identified, all of which are believed to be pharmacologically inactive. The principal metabolites are cotinine and trans

Excretion

Both nicotine and its metabolites are excreted through the kidneys and about 10% of nicotine is excreted unchanged in the urine. As much as 30% may be excreted in the urine with maximum flow rates and extreme urine acidification (pH

There were no differences in nicotine kinetics between men and women using NiQuitin. Obese men using NiQuitin had significantly lower AUC and Cmax values compared with normal weight men. Linear regression of AUC vs total body weight showed the expected inverse relationship (AUC decreases as weight increases). Nicotine kinetics were similar for all sites of application on the upper body and upper outer arm.

5.3 Preclinical Safety Data

The general toxicity of nicotine is well known and taken into account in the recommended posology. Nicotine was not mutagenic in appropriate assays. The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine. In studies in pregnant animals, nicotine showed maternal toxicity, and consequential mild fetal toxicity. Additional effects included pre- and postnatal growth retardation and delays and changes in postnatal CNS development.

Effects were only noted following exposure to nicotine at levels in excess of those which will result from recommended use of NiQuitin. Effects on fertility have not been established.

Comparison of the systemic exposure necessary to elicit these adverse responses from preclinical test systems with that associated with the recommended use of NiQuitin indicate that the potential risk is low and outweighed by the demonstrable benefit of nicotine therapy in smoking cessation. However, NiQuitin should only be used by pregnant women on medical advice if other forms of treatment have failed.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Drug Reservoir:

Ethylene Vinyl Acetate Copolymer

Occlusive Backing:

Polyethylene/Aluminium/Polyethylene Terephthalate/ Ethylene vinyl acetate

Rate Controlling Membrane:

Polyethylene Film

Contact Adhesive:

Polyisobutylene B100 and B12 SFN

Protective Layer:

Siliconised Polyester Film

Printing Ink:

PMS 465 Brown Ink

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

7 or 14 patches in a carton. Each patch is contained in a laminate sachet.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Beecham Group PLC

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

T/A GlaxoSmithKline Consumer Healthcare

Brentford

TW8 9GS

8. Marketing Authorisation Number(S)

PL 00079/0366

9. Date Of First Authorisation/Renewal Of The Authorisation

22/04/2009

10. Date Of Revision Of The Text

11/10/2010

Read More:

NiQuitin 14 mg transdermal patches.

1. Name Of The Medicinal Product

NiQuitin 14 mg transdermal patches.

2. Qualitative And Quantitative Composition

Each 15 cm2 contains 78 mg nicotine, equivalent to 5.1 mg/cm2 of nicotine and delivering 14 mg over 24 hours.

For excipients, see section 6.1.

3. Pharmaceutical Form

Transdermal patch.

Each patch is rectangular and is comprised of an outer matt pinkish tan-coloured layer, a middle silver layer and an outer clear layer which is removed prior to use.

4. Clinical Particulars 4.1 Therapeutic Indications

NiQuitin patches relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence. They are indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

NiQuitin patches are indicated in pregnant and lactating women making a quit attempt.

If possible, when stopping smoking, NiQuitin patches should be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

NiQuitin patches should be applied once a day, at the same time each day and preferably soon after waking, to a non-hairy, clean, dry skin site and worn continuously for 24 hours. The NiQuitin patch should be applied promptly on removal from its protective sachet.

Avoid applying to any skin which is broken, red or irritated. After 24 hours the used patch should be removed and a new patch applied to a fresh skin site. The patch should not be left on for longer than 24 hours. Skin sites should not be reused for at least seven days. Only one patch should be worn at a time.

Patches may be removed before going to bed if desired. However use for 24 hours is recommended to optimise the effect against morning cravings.

Concurrent behavioural support is recommended, as such programmes have been shown to be beneficial for smoking cessation.

Adults 18 years and over

Abrupt cessation of smoking:

During a quit attempt every effort should be made to stop smoking with NiQuitin patches.

NiQuitin therapy should usually begin with NiQuitin 21 mg and be reduced according to the following dosing schedule:-

Dose

Duration

Step 1 NiQuitin 21 mg

First 6 weeks

Step 2 NiQuitin 14 mg

Next 2 weeks

Step 3 NiQuitin 7 mg

Last 2 weeks

Light smokers (e.g. those who smoke less than 10 cigarettes per day) are recommended to start at Step 2 (14 mg) for 6 weeks and decrease the dose to NiQuitin 7 mg for the final 2 weeks.

Patients on NiQuitin 21 mg who experience excessive side-effects (please refer to precautions), which do not resolve within a few days, should change to NiQuitin 14mg. This strength should then be continued for the remainder of the 6 week course before stepping down to NiQuitin 7mg for two weeks. If the symptoms persist the patient should be advised to seek the advice of a healthcare professional.

For optimum results, the 10 week treatment course (8 weeks for light smokers or patients who have reduced strength as above), should be completed in full. Treatment with NiQuitin patch may be continued beyond 10 weeks if needed to stay cigarette free, however, those who have quit smoking but are having difficulty discontinuing using the patches recommended to seek additional help and advice from a healthcare professional.

Further courses may be used at a later time, for NiQuitin patch users who continue or resume smoking.

Gradual Cessation:

For smokers who are unwilling or unable to quit abruptly.

The 21 mg patch can be used daily for 2-4 weeks while the user continues to smoke as needed. At the end of the 2-4 weeks the user should quit completely and continue using Step 1 21 mg patch for 6 weeks daily without smoking. Thereafter following the Step 2 and 3 directions for abrupt cessation above. Should the patient feel able to quit completely before their designated quit date they can do so.

Reduction in smoking:

For smokers who wish to cut down with no immediate plans to quit.

A patch can be used while the user continues to smoke as needed. The user should reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. Users should be encouraged to stop smoking completely as soon as possible.

If users are still feeling the need to use the patches on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Temporary Abstinence

Apply a patch to control troublesome withdrawal symptoms including craving during the period when smoking is being avoided. Users should be encouraged to stop smoking completely as soon as possible.

If users are still feeling the need to use the patches on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Adolescents and children

Adolescents (12 to 17 years) should follow the schedule of treatment for abrupt cessation of smoking as given above. Where adolescents are not ready or not able to stop smoking abruptly, advice from a healthcare professional should be sought.

Safety and effectiveness in children who smoke has not been evaluated. NiQuitin is not recommended for use in children under 12 years of age.

4.3 Contraindications

NiQuitin is contraindicated in patients with hypersensitivity to the system, the active substance, or any of the excipients.

NiQuitin patches should not be used by non-smokers, occasional smokers or children under 12 years.

4.4 Special Warnings And Precautions For Use

The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well established dangers of continued smoking.

Patients hospitalised for MI, severe dysrhythmia or CVA who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, NiQuitin patches may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital they can use NRT as normal.

Diabetes Mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Allergic reactions: Susceptibility to angioedema and urticaria.

Atopic or eczematous dermatitis (due to localised patch sensitivity): In the case of severe or persistent local reactions at the site of application (e.g. severe erythema, pruritus or oedema) or a generalised skin reaction (e.g. urticaria, hives or generalised skin rashes), users should be instructed to discontinue use of NiQuitin and contact their physician.

Contact sensitisation: Patients with contact sensitisation should be cautioned that a serious reaction could occur from exposure to other nicotine-containing products or smoking.

A risk benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:

• Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

• Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. The patches should be folded in half with the adhesive side innermost and disposed of with care.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Safety on handling: NiQuitin is potentially a dermal irritant and can cause contact sensitisation. Care should be taken during handling and in particular contact with the eyes and nose avoided. After handling, wash hands with water alone as soap may increase nicotine absorption.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.

4.6 Pregnancy And Lactation

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but NRT may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects NRT may cause adverse reactions similar to those associated with nicotine administered by other means, including smoking. These may be attributable to the pharmacological effects of nicotine, some of which are dose dependent. At recommended doses, NiQuitin patches have not been found to cause any serious adverse effects. Excessive use of NiQuitin patches by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Subjects quitting smoking by any means could expect to suffer from asthenia, headache, dizziness, sleep disturbance, coughing or influenza-like illness. Certain symptoms which have been reported such as depression, irritability, nervousness, restlessness, mood lability, anxiety, drowsiness, impaired concentration and insomnia may be related to withdrawal symptoms associated with smoking cessation.

Application site reactions are the most frequent adverse reaction associated with NiQuitin. NiQuitin can cause other adverse reactions related to the pharmacological effect of nicotine or withdrawal effects related to smoking.

The following undesirable effects have been reported in clinical trials or spontaneously post-marketing.

Certain symptoms which have been reported such as depression, irritability, nervousness, restlessness, mood lability, anxiety, drowsiness, impaired concentration, insomnia and sleep disturbances may be related to withdrawal symptoms associated with smoking cessation. Subjects quitting smoking by any means could expect to suffer from asthenia, headache, dizziness, coughing or influenza-like illness.

Immune System Disorders

Uncommon>1/1000; <1/100: hypersensitivity NOS*

Very rare <1/10000: anaphylactic reactions

Psychiatric

Very common>1/10: sleep disorders including abnormal dreams and insomnia

Common>1/100; <1/10: nervousness

Nervous system disorders

Very Common>1/10: headache, dizziness

Common>1/100; <1/10: tremor

Cardiac disorders

Common>1/100; <1/10: palpitations

Uncommon>1/1000; <1/100: tachycardia NOS

Respiratory, Thoracic and Mediastinal Disorders

Common>1/100; <1/10: dyspnoea, pharyngitis, cough

Gastrointestinal Disorders

Very Common>1/10: nausea, vomiting

Common>1/100; <1/10: dyspepsia, abdominal pain upper, diarrhea NOS, dry mouth, constipation

Skin and Subcutaneous Tissue Disorders

Common>1/100; <1/10: sweating increased

Very rare> 1/100000; <1/10000: dermatitis allergic*, dermatitis contact*, photosensitivity

Musculoskeletal and Connective Tissue Disorders

Common>1/100; <1/10: arthralgia, myalgia

General Disorders and Administration Site Conditions

Very Common>1/10: application site reactions NOS*

Common>1/100; <1/10: chest pain, pain in limb, pain NOS, asthenia, fatigue

Uncommon>1/1000; <1/100 malaise, influenza-like illness

* see below

Application site reactions, including transient rash, itching, burning, tingling, numbness, swelling, pain and urticaria are the most frequent undesirable effects of NiQuitin patch. The majority of these topical reactions are minor and resolve quickly following removal of the patch. Pain or sensation of heaviness in the limb or area around which the patch is applied (e.g. chest) may be reported.

Hypersensitivity reactions, including contact dermatitis and allergic dermatitis have also been reported. In the case of severe or persistent local reactions at the application site (e.g. severe erythema, pruritus or oedema) or a generalized skin reaction (e.g. urticaria, hives or generalised skin rashes) users should be instructed to discontinue use of NiQuitin and contact their physician.

If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the NiQuitin dose should be reduced or discontinued.

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine

Overdose from topical exposure: The NiQuitin system should be removed immediately if the patient shows signs of overdosage and the patient should seek immediate medical care. The skin surface may be flushed with water and dried. No soap should be used since it may increase nicotine absorption. Nicotine will continue to be delivered into the bloodstream for several hours after removal of the system because of a depot of nicotine in the skin.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic classification: N07BA01

(Anti-smoking agents: N07BA, Nicotine 01)

Nicotine, the chief alkaloid in tobacco products and a naturally occurring autonomic drug, is an agonist at nicotine receptors in the peripheral and central nervous system and has pronounced CNS and cardiovascular effects. Withdrawal from nicotine in addicted individuals is characterised by craving, nervousness, restlessness, irritability, mood lability, anxiety, drowsiness, sleep disturbances, impaired concentration, increased appetite, minor somatic complaints (headache, myalgia, constipation, fatigue) and weight gain. Withdrawal symptoms, such as cigarette craving, may be controlled in some individuals by steady-state plasma levels lower than those for smoking.

In clinically controlled trials, NiQuitin was shown to alleviate nicotine withdrawal symptoms as well as craving. NiQuitin reduced the severity of cravings by at least 35% at all times of day during the first two weeks of abstinence, compared to placebo (p<0.05).

5.2 Pharmacokinetic Properties

Absorption

Following transdermal application, the skin rapidly absorbs nicotine released initially from the patch adhesive. The plasma concentrations of nicotine reach a plateau within 2-4 hours after initial application of NiQuitin with relatively constant plasma concentrations persisting for 24 hours or until the patch is removed. Approximately 68% of the nicotine released from the patch enters systemic circulation and the remainder of the released nicotine is lost via vaporisation from the edge of the patch.

With continuous daily application of NiQuitin (worn for 24 hours), dose-dependent steady state plasma nicotine concentrations are achieved following the second NiQuitin application and are maintained throughout the day. These steady state maximum concentrations are approximately 30% higher than those following a single application of NiQuitin.

Plasma concentrations of nicotine are proportional to dose for the three dosage forms of NiQuitin. The mean plasma steady state concentrations of nicotine are approximately 17 ng/ml for the 21 mg/day patch, 12 ng/ml for the 14 mg /day patch and 6 ng/ml for the 7 mg/day patch. For comparison, half-hourly smoking of cigarettes produces average plasma concentrations of approximately 44 ng/ml.

The pronounced early peak in nicotine blood levels seen with inhalation of cigarette smoke is not observed with NiQuitin.

Distribution

Following removal of NiQuitin, plasma nicotine concentrations decline with an apparent mean half-life of 3 hours, compared with 2 hours for IV administration due to continued absorption of nicotine from the skin depot. If NiQuitin is removed most non-smoking patients will have non-detectable nicotine concentrations in 10 to 12 hours.

A dose of radiolabelled nicotine given intravenously showed a distribution of radioactivity corresponding to the blood supply with no organ selectively taking up nicotine. The volume of distribution of nicotine is approximately 2.5 l/kg.

Metabolism

The major elimination organ is the liver and average plasma clearance is about 1.2 l/min; the kidney and the lung also metabolise nicotine. More than 20 metabolites of nicotine have been identified, all of which are believed to be pharmacologically inactive. The principal metabolites are cotinine and trans

Excretion

Both nicotine and its metabolites are excreted through the kidneys and about 10% of nicotine is excreted unchanged in the urine. As much as 30% may be excreted in the urine with maximum flow rates and extreme urine acidification (pH

There were no differences in nicotine kinetics between men and women using NiQuitin. Obese men using NiQuitin had significantly lower AUC and Cmax values compared with normal weight men. Linear regression of AUC vs total body weight showed the expected inverse relationship (AUC decreases as weight increases). Nicotine kinetics were similar for all sites of application on the upper body and upper outer arm.

5.3 Preclinical Safety Data

The general toxicity of nicotine is well known and taken into account in the recommended posology. Nicotine was not mutagenic in appropriate assays. The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine. In studies in pregnant animals, nicotine showed maternal toxicity, and consequential mild fetal toxicity. Additional effects included pre- and postnatal growth retardation and delays and changes in postnatal CNS development.

Effects were only noted following exposure to nicotine at levels in excess of those which will result from recommended use of NiQuitin. Effects on fertility have not been established.

Comparison of the systemic exposure necessary to elicit these adverse responses from preclinical test systems with that associated with the recommended use of NiQuitin indicate that the potential risk is low and outweighed by the demonstrable benefit of nicotine therapy in smoking cessation. However, NiQuitin should only be used by pregnant women on medical advice if other forms of treatment have failed.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Drug Reservoir:

Ethylene Vinyl Acetate Copolymer

Occlusive Backing:

Polyethylene/Aluminium/Polyethylene Terephthalate/ Ethylene vinyl acetate

Rate Controlling Membrane:

Polyethylene Film

Contact Adhesive:

Polyisobutylene B100 and B12 SFN

Protective Layer:

Siliconised Polyester Film

Printing Ink:

PMS 465 Brown Ink

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

7 or 14 patches in a carton. Each patch is contained in a laminate sachet.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Beecham Group PLC

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

T/A GlaxoSmithKline Consumer Healthcare

Brentford

TW8 9GS

8. Marketing Authorisation Number(S)

PL 00079/0367

9. Date Of First Authorisation/Renewal Of The Authorisation

03 April 2001

10. Date Of Revision Of The Text

11/10/2010

Read More:

Nicorette Mint 4mg Gum

1. Name Of The Medicinal Product

Nicorette Mint 4 mg Gum / Boots NicAssist 4 mg mint gum

2. Qualitative And Quantitative Composition

Chewing Gum containing 4mg nicotine, as nicotine resinate.

For excipients see section 6.1

3. Pharmaceutical Form

Chewing Gum

4. Clinical Particulars 4.1 Therapeutic Indications

Nicorette Mint 4mg Gum is indicated for the relief of nicotine withdrawal symptoms as an aid to smoking cessation in adults and children over 12 years of age. It is also indicated in pregnant and lactating women (see section 4.6).

In smokers currently unable or not ready to stop smoking abruptly, the gum may also be used as part of a programme to reduce smoking prior to stopping completely.

If possible, Nicorette Mint 4mg Gum should be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

Nicorette Mint 4 mg Gum should be chewed slowly according to the instructions.

The strength of gum to be used will depend on the smoking habits of the individual. In general, if the patient smokes 20 or less cigarettes a day, 2mg nicotine gum is indicated. If more that 20 cigarettes per day are smoked, 4mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking.

The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Not more than 15 pieces of the chewing gum may be used each day. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver.

Behavioural therapy, advice and support will normally improve the success rate.

Smoking cessation

Adults (over 18 years of age)

The patient should make every effort to stop smoking completely during treatment with Nicorette Mint 4mg Gum.

Use the gum whenever there is an urge to smoke to maintain complete abstinence from smoking. Sufficient gums should be used, usually 8-12, up to a maximum of 15.

Continue use for up to three months to break the habit of smoking, then gradually reduce gum use. When daily use is 1-2 gums, use should be stopped.

For those using 4 mg nicotine gum, the 2 mg nicotine gum will be helpful during withdrawal from treatment.

Any spare gum should be retained, as craving may suddenly return. Adults who use NRT beyond 9 months for smoking cessation are recommended to seek additional help and advice from a healthcare professional.

Adolescents (12 to 18 years)

The patient should make every effort to stop smoking completely during treatment with Nicorette Mint 4mg Gum.

Use the gum whenever there is an urge to smoke to maintain complete abstinence from smoking. Sufficient gums should be used, usually 8-12, up to a maximum of 15.

Continue use for up to 8 weeks to break the habit of smoking, then gradually reduce gum use over a 4 week period. When daily use is 1-2 gums, use should be stopped.

For those using 4 mg nicotine gum, the 2 mg nicotine gum will be helpful during withdrawal from treatment.

As data are limited in this age group, the recommended duration of treatment is 12 weeks. If longer treatment is required, advice from a healthcare professional should be sought.

Smoking reduction

Adults (over 18 years of age)

Use the gum between smoking episodes to manage the urge to smoke, to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought.

A quit attempt should be made as soon as the smoker feels ready, but not later than 6 months after start of treatment. If a quit attempt cannot be made within 9 months after starting treatment, professional advice should be sought.

When making a quit attempt the smoking cessation instructions above can be followed.

Adolescents (12 to 18 years)

Where adolescents are motivated to stop smoking abruptly, smoking cessation should be recommended. However, smoking reduction can be considered where adolescents are not ready or able to stop smoking abruptly. As data are limited in this age group, and the recommended duration of NRT is 12 weeks, adolescents should consult a healthcare professional before starting the “smoking reduction prior to stopping” regimen.

Use the gum between smoking episodes to manage the urge to smoke, to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought.

A quit attempt should be made as soon as the smoker feels ready, but not later than 6 months after start of treatment. If a quit attempt cannot be made within 9 months after starting treatment, professional advice should be sought.

When making a quit attempt the smoking cessation instructions for adolescents (12 to 18 years) given above can be followed.

4.3 Contraindications

Hypersensitivity to any component of the chewing gum.

4.4 Special Warnings And Precautions For Use

Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.

Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Mint 4mg Gum presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette Mint 4mg Gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.

Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Renal or hepatic impairment: Nicorette Mint 4mg Gum should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotine gum should be disposed of with care.

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Mint 4mg Gum should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.

Excipients: Nicorette Mint 4mg Gum also contains butylated hydroxy toluene (E321); this may cause irritation to the mucous membranes.

Denture warning: Smokers who wear dentures may experience difficulty in chewing Nicorette Mint 4mg Gum. The chewing gum may stick to, and may in rare cases damage dentures.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.

4.6 Pregnancy And Lactation

Pregnancy

NRT is not contraindicated in pregnancy. The decision to use NRT should be made on a risk-benefit assessment as early on in the pregnancy as possible with the aim of discontinuing use as soon as possible.

Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or stillbirth. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby. The earlier abstinence is achieved the better.

Ideally smoking cessation during pregnancy should be achieved without NRT. However for women unable to quit on their own, NRT may be recommended to assist a quit attempt.

Nicotine passes to the fetus affecting breathing movements and has a dose-dependent effect on placental/fetal circulation. However the risk of using NRT to the fetus is lower than that expected with tobacco smoking, due to lower maximal plasma nicotine concentration and no additional exposure to polycyclic hydrocarbons and carbon monoxide.

Intermittent dosing products may be preferable as these usually provide a lower daily dose of nicotine than patches. However, patches may be preferred if the woman is suffering from nausea during pregnancy. If patches are used they should be removed before going to bed.

Lactation

NRT is not contraindicated in lactation. Nicotine from smoking and NRT is found in breast milk. However the amount of nicotine the infant is exposed to is relatively small and less hazardous than the second-hand smoke they would otherwise be exposed to.

Using intermittent dose NRT preparations, compared with patches, may minimize the amount of nicotine in the breast milk as the time between administrations of NRT and feeding can be more easily prolonged.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.

Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.

Nicorette Mint 4mg Gum may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses Nicorette Mint 4mg Gum has not been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients occur during the first 3-4 weeks after start of treatment.

Excessive consumption of Nicorette Mint 4mg Gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at first, cause hiccupping.

Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation.

Those who are prone to indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4mg nicotine gum is used; slower chewing and the use of the 2mg nicotine gum (if necessary more frequently) will usually overcome this problem.

The chewing gum may stick to, and may in rare cases damage dentures.

Reported adverse events associated with Nicorette 2mg and 4mg gum include:

Body System

Incidence*

Reported adverse event

Nervous system disorders:

Very common:

Headache

 

Common:

Dizziness

Cardiac disorders:

Uncommon:

Palpitations

 

Very rare:

Reversible atrial fibrillation

Gastrointestinal disorders:

Very common:

Gastrointestinal discomfort, hiccups, nausea

 

Common:

Vomiting

Skin and subcutaneous tissue disorders:

Uncommon:

Erythema, urticaria

General disorders and administration site conditions:

Very common:

Sore mouth or throat, jaw-muscle ache

 

Rare:

Allergic reactions including angioedema

* Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The pharmacological effects of nicotine as well documented. Those resulting from chewing Nicorette Mint 4 mg Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs. The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis.

5.2 Pharmacokinetic Properties

Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5 – 7 minutes and reach a maximum about 30 minutes after the start of chewing. Blood levels are roughly proportional to the amount of nicotine chewed and have been shown never to exceed those obtained from smoking cigarettes.

5.3 Preclinical Safety Data

Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.

There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product which have not been considered in other relevant sections of this Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Polacrilin

Chewing gum base, containing butylated hydroxy toluene (E321)

Xylitol

Peppermint oil

Menthol

Sodium carbonate anhydrous

Quinoline Yellow Al-lake (E104)

Magnesium oxide, light

Talc

6.2 Incompatibilities

None relevant

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Do not store above 25oC

6.5 Nature And Contents Of Container

PVC/PVDC/Al Blister packed strips each containing 15 pieces supplied in a pack of 15, 30 or 105 pieces. Packs containing a blister strip of 6 pieces (not marketed).

6.6 Special Precautions For Disposal And Other Handling

See section 4.2

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

8. Marketing Authorisation Number(S)

PL 15513/0172

9. Date Of First Authorisation/Renewal Of The Authorisation

21 January 2008

10. Date Of Revision Of The Text

21 January 2008

Read More:

Good Neighbor Anti-Diarrheal

Generic Name: loperamide hydrochloride
Dosage Form: oral solution
Amerisource Bergen Anti-Diarrheal Drug Facts Active ingredient (in each 5 mL)

Loperamide HCl 1 mg

Purpose

Anti-diarrheal

Uses

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Do not use

if you have bloody or black stool

Ask a doctor before use if you have fever mucus in the stool a history of liver disease Ask a doctor or pharmacist before use if you are

taking antibiotics

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition. If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. If possible, use weight to dose; otherwise use age. only use attached measuring cup to dose product adults and children 12 years and over 4 teaspoonfuls (1 dosage cup) after the first loose stool; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose stool; but no more than 8 teaspoonfuls in 24 hours children 9-11 years (60-95 lbs) 2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 6 teaspoonfuls in 24 hours children 6-8 years (48-59 lbs) 2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 4 teaspoonfuls in 24 hours children under 6 years (up to 47 lbs) ask a doctor Other information do not use if carton is opened or if printed plastic neckband is broken or missing store between 20°-25°C (68°-77°F) see bottom panel for lot number and expiration date Inactive ingredients

alcohol (0.5%), benzoic acid, citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to active ingredient in Imodium® A-D

Loperamide Hydrochloride Oral Solution

Anti-Diarrheal

Controls the Symptoms of Diarrhea

Non-Chalky Liquid

Cherry Mint Flavor

Each teaspoonful (5 mL) contains 1 mg Loperamide Hydrochloride

Contains 0.5% Alcohol

Anti-Diarrheal Carton

GOOD NEIGHBOR PHARMACY ANTI DIARRHEAL 
loperamide hcl  solution Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 24385-377 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 1 mg  in 5 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color ORANGE (amber, clear, pale) Score      Shape Size Flavor CHERRY (cherry mint) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 24385-377-26 1 BOTTLE In 1 CARTON contains a BOTTLE 1 120 mL In 1 BOTTLE This package is contained within the CARTON (24385-377-26)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA073243 09/19/2003
Labeler - Amerisource Bergen (007914906) Revised: 06/2009Amerisource Bergen
More Good Neighbor Anti-Diarrheal resources Good Neighbor Anti-Diarrheal Side Effects (in more detail) Good Neighbor Anti-Diarrheal Use in Pregnancy & Breastfeeding Drug Images Good Neighbor Anti-Diarrheal Drug Interactions Good Neighbor Anti-Diarrheal Support Group 8 Reviews for Good Neighbor Anti-Diarrheal - Add your own review/rating Compare Good Neighbor Anti-Diarrheal with other medications Diarrhea Diarrhea, Acute Diarrhea, Chronic Lymphocytic Colitis Traveler's Diarrhea

Read More:

Alavert

loratadine
Dosage Form: tablet, orally disintegrating
Alavert Allergy (Fresh Mint)
Alavert Allergy (Bubble Gum)
Alavert Allergy (Citrus Burst)
(loratadine) DRUG FACTS ACTIVE INGREDIENT (IN EACH TABLET)

Loratadine 10 mg

PURPOSE

Antihistamine

USES

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose sneezing itchy, watery eyes itching of the nose or throat Warnings Do not use

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

do not use more than directed. Taking more than recommended may cause drowsiness.

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS tablet melts in mouth. Can be taken with or without water. Age Dose adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet daily children under 6 ask a doctor consumers who have liver or kidney disease ask a doctor OTHER INFORMATION Phenylketonurics: Contains Phenylalanine 8.4 mg per tablet store at 20-25?C (68-77?F) keep in a dry place

INACTIVE INGREDIENTS Alavert Allergy Fresh Mint

artificial & natural flavors, anhydrous citric acid, aspartame, colloidal silicone dioxide, corn syrup solids, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, modified food starch, sodium bicarbonate

Alavert Allergy Bubble Gum

anhydrous citric acid, artificial and natural flavor, ascorbic acid, aspartame, colloidal silicon dioxide, crospovidone, ferric oxide, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, sodium bicarbonate

Alavert Allergy Citrus Burst

anhydrous citric acid, aspartame, butylated hydroxyanisole, colloidal silicon dioxide, corn syrup solids, crospovidone, dextrin, ferric oxides, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified food starch, natural & artificial flavors, sodium bicarbonate

QUESTIONS OR COMMENTS?

call weekdays from 9 AM to 5 PM EST at 1-800-Alavert (1-800-252-8378)

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Alavert allergy Fresh Mint

Loratadine Orally Disintegrating Tablet, 10 mg, Antihistamine

30 Orally Disintegrating Tablets

Melts in your mouth!

Non-Drowsy* Allergy Relief

*When taken as directed. See Drug Facts Panel.

24 HOUR Relief of

Sneezing Runny Nose Itchy, Watery Eyes Itching of Nose & Throat

Compare to Claritin† & SAVE!

†Claritin is a registered trademark of Schering Corporation

Alavert Allergy provides 24 hours of allergy symptom relief without causing drowsiness when taken as directed (See Drug Facts Panel). It contains prescription strength loratadine.

Just one tablet a day relieves runny nose, sneezing and itchy, watery eyes. It is safe and effective for adults and children 6 years and over.

The Fresh Mint flavored tablet melts in your mouth. So convenient, it can be taken without water.

For most recent product information, visit www.Alavert.com

Wyeth

Distributed by:

Wyeth Consumer Healthcare

Madison, NJ 07940 U.S.A.

©2009 Wyeth

EACH TABLET IS BLISTER SEALED. DO NOT USE IF SEAL IS BROKEN.

For Ages 6+

Alavert allergy Bubble Gum Flavor

Loratadine Orally Disintegrating Tablet, 10 mg, Antihistamine

12 Orally Disintegrating Tablets

No Water Needed!

24 HOUR Non-Drowsy* Allergy Relief

*When taken as directed. See Drug Facts Panel.

Itching of Nose & Throat Itchy, Watery Eyes Sneezing Runny Nose

Alavert Allergy provides 24 hours of allergy symptom relief without causing drowsiness when taken as directed (See Drug Facts Panel). It contains prescription strength loratadine. Just one tablet a day relieves runny nose, sneezing and itchy, watery eyes. It is safe and effective for adults and children 6 years and over. The Bubble Gum flavored tablet melts in your mouth. So convenient, it can be taken without water. Visit our website at www.Alavert.com

Distributed by: Wyeth Consumer Healthcare, Madison, NJ 07940 U.S.A. ©2008 Wyeth

EACH TABLET IS BLISTER SEALED. DO NOT USE IF SEAL IS BROKEN.

For Ages 6+

Alavert allergy Citrus Burst

Loratadine Orally Disintegrating Tablet, 10 mg, Antihistamine

12 Orally Disintegrating Tablets

No Water Needed!

24 HOUR Non-Drowsy* Allergy Relief

*When taken as directed. See Drug Facts Panel.

Itching of Nose & Throat Itchy, Watery Eyes Sneezing Runny Nose

Alavert Allergy provides 24 hours of allergy symptom relief without causing drowsiness when taken as directed (See Drug Facts Panel). It contains prescription strength loratadine. Just one tablet a day relieves runny nose, sneezing and itchy, watery eyes. It is safe and effective for adults and children 6 years and over. The Citrus Burst flavored tablet melts in your mouth. So convenient, it can be taken without water. Visit our website at www.Alavert.com

Distributed by: Wyeth Consumer Healthcare, Madison, NJ 07940 U.S.A. ©2008 Wyeth

EACH TABLET IS BLISTER SEALED. DO NOT USE IF SEAL IS BROKEN.

Alavert ALLERGY 
loratadine  tablet, orally disintegrating Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-2620 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength loratadine (loratadine) loratadine 10 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE (off white) Score no score Shape ROUND ( beveled tablet) Size 14mm Flavor MINT Imprint Code A;24 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0573-2620-06 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2620-06) 2 0573-2620-12 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2620-12) 3 0573-2620-19 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 3 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2620-19) 4 0573-2620-30 5 BLISTER PACK In 1 CARTON contains a BLISTER PACK 4 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2620-30) 5 0573-2620-48 8 BLISTER PACK In 1 CARTON contains a BLISTER PACK 5 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2620-48) 6 0573-2620-02 1500 POUCH In 1 BOX contains a POUCH 6 1 TABLET In 1 POUCH This package is contained within the BOX (0573-2620-02) 7 0573-2620-65 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK 7 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2620-65)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021375 12/19/2002
Alavert ALLERGY 
loratadine  tablet, orally disintegrating Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-2621 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength loratadine (loratadine) loratadine 10 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color ORANGE (an orange flat faced tablet) Score no score Shape ROUND (beveled tablet) Size 14mm Flavor CITRUS (orange mint) Imprint Code A;24 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0573-2621-12 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2621-12) 2 0573-2621-18 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2621-18) 3 0573-2621-48 8 BLISTER PACK In 1 CARTON contains a BLISTER PACK 3 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2621-48) 4 0573-2621-65 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK 4 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2621-65) 5 0573-2621-72 12 BLISTER PACK In 1 CARTON contains a BLISTER PACK 5 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2621-72) 6 0573-2621-19 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 6 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2621-19)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021375 12/19/2002
Alavert ALLERGY 
loratadine  tablet, orally disintegrating Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-2623 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength loratadine (loratadine) loratadine 10 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color PINK (pink) Score no score Shape ROUND (beveled tablet) Size 14mm Flavor BUBBLE GUM (bubblegum flavor) Imprint Code A;24 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0573-2623-12 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2623-12)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021375 12/19/2002
Alavert ALLERGY 
loratadine  tablet, orally disintegrating Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-2624 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength loratadine (loratadine) loratadine 10 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color ORANGE (an orange flat faced tablet) Score no score Shape ROUND (beveled tablet) Size 14mm Flavor CITRUS (orange mint) Imprint Code A;24 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0573-2624-12 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2624-12)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021375 12/19/2002
Labeler - Pfizer Consumer Healthcare (828831730) Revised: 06/2010Pfizer Consumer Healthcare
More Alavert resources Alavert Side Effects (in more detail) Alavert Use in Pregnancy & Breastfeeding Alavert Drug Interactions Alavert Support Group 0 Reviews for Alavert - Add your own review/rating Alavert Syrup MedFacts Consumer Leaflet (Wolters Kluwer) Loratadine Monograph (AHFS DI) Loratadine Professional Patient Advice (Wolters Kluwer) Claritin Consumer Overview Claritin 24 Hour Allergy MedFacts Consumer Leaflet (Wolters Kluwer) Claritin Liqui-Gels MedFacts Consumer Leaflet (Wolters Kluwer) Compare Alavert with other medications Hay Fever Urticaria

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Gingimed

Dosage Form: oral liquid
ACTIVE INGREDIENT

STANNOUS FLUORIDE

INACTIVE INGREDIENTS

GLYCERIN, FLAVOR,XYLITOL

USE

APPROVED USES:  RELIEF OF DENTINAL HYPERSENSITIVITY.  CONTROL OF PERIO INFECTION.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS FOR USE

ADULTS AND CHILDREN 6 YEARS AND OLDER: RINSE EACH DAY AFTER USUAL BRUSHING AND FLOSSING OR MORE OFTEN IF YOUR DENTIST RECOMMENDS ADDITIONAL THERAPY BASED ON THE DIAGNOSIS.  PUSH DOWN ON PUMP TWICE OR POUR THE CONCENTRATED RINSE TO THE 1/8 FL. OX. MARK ON THE MIXING VIAL.  ADD WATER TO THE 1 OZ. LINE.  CLOSE TIGHTLY WITH SNAP-ON CAP AND SHAKE WELL.  THIS PREPARES A 0.1% STANNOUS FLUORIDE RINSE.  RINSE WITH ONE HALF OF THE SOLUTION FOR ONE MINUTE, EXPECTORATE (SPIT) AND REPEAT THE PROCEDURE WITH THE REMAINING HALF OF THE MIXTURE.  DO NOT SWALLOW AND DO NOT RINSE MOUTH.  RINSE MIXING VIAL WITH WATER AFTER EACH USE.

CHILDREN 6-12 YEARS: INSTRUCT AND SUPERVISE IN GOOD RINSING HABITS. (HELP TO MINIMIZE SWALLOWING)

CHILDREN UNDER 6: CONSULT A DENTIST.

FOR HOME IRRIGATION: PREPARE 1 OZ. OF Gingimed RINSE AS DESCRIBED ABOVE.  POUR INTO IRRIGATOR RESIVOIR AND ADD 4 OZ. OF WATER.  MIX THOROUGHLY.  USE IRRIGATOR AS DESCRIBED

OTHER INFORMATION

THIS PRODUCT MAY CAUSE MINIMAL SURFACE DISCOLORATION ON THE TEETH, MAY BE PREVENTED BY ADEQUATE BRUSHING.

Warnings

IF MORE THAN AMOUNT DIRECTED FOR RINSING IS ACCIDENTALLY SWALLOWED, SEEK MEDICAL HELP FROM A POISON CONTROL CENTER.  DO NOT USE BEFORE MIXING WITH WATER.  USE AS DIRECTED BY A DENTAL PROFESSIONAL.  THIS IS A FLUORIDE TREATMENT RINSE, NOT A MOUTHWASH.

PACKAGE LABEL

ALCOHOL FREE PERIO TREATMENT.  Gingimed  0.63% STANNOUS FLUORIDE  READ DIRECTIONS THOROUGHLY.  MIX WITH WATER BEFORE USE. NOW CONTAINING XYLITOL

MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS, GRAVETTE, AR (479) 787-5168  WWW.MASSCODENTAL.NET

Gingimed 
stannous fluoride  liquid Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-210 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .71034 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor SPEARMINT (MINT) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-210-06 120 g In 1 BOTTLE, WITH APPLICATOR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Gingimed 
stannous fluoride  liquid Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-211 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .71034 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor GRAPE (CARIBBEAN ICE) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-211-06 120 g In 1 BOTTLE, WITH APPLICATOR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Gingimed 
stannous fluoride  liquid Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-212 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .71034 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor CINNAMON (CINNAMON) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-212-06 120 g In 1 BOTTLE, WITH APPLICATOR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Establishment Name Address ID/FEI Operations Massco Dental A Division of Dunacin Pharmaceuticals 008081858 manufacture Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals
More Gingimed resources Gingimed Use in Pregnancy & Breastfeeding Gingimed Support Group 3 Reviews for Gingimed - Add your own review/rating Compare Gingimed with other medications Prevention of Dental Caries

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Prevident 5000 Sensitive

sodium fluoride and potassium nitrate gel
Dosage Form: gel, dentifrice
Colgate®
PreviDent®5000 ppm

SENSITIVE

Rx ONLY

1.1% Sodium Fluoride, 5% Potassium Nitrate

Prescription Strength Toothpaste for Sensitive Teeth

Prevident 5000 Sensitive Description

Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.

Active Ingredients

Sodium fluoride 1.1% (w/w), Potassium nitrate 5%

Inactive Ingredients

water, hydrated silica, sorbitol, PEG-12, carrageenan, sodium lauryl sulfate, flavor, poloxamer 407, cocamidopropyl betaine, sodium saccharin, mica, sodium hydroxide, titanium dioxide, D&C yellow no. 10, FD&C blue no. 1

Prevident 5000 Sensitive - Clinical Pharmacology

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

Indications and Usage for Prevident 5000 Sensitive

A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 PreviDent® 5000 Sensitive brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Contraindications

Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.

Warnings

Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist or physician.

Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

Precautions General

Not for systemic treatment. DO NOT SWALLOW.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.

Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results.

Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.

Pregnancy Teratogenic Effects Pregnancy Category B

It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Nursing Mothers

It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

Geriatric Use

Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5

Adverse Reactions

Allergic reactions and other idiosyncrasies have been rarely reported.

Overdosage

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose (a thin ribbon) of PreviDent® 5000 Sensitive contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 575 mg fluoride.

Prevident 5000 Sensitive Dosage and Administration

Follow these instructions unless otherwise instructed by your dental professional:

Adults and children 12 years of age and older: Apply at least 1 inch strip of PreviDent® 5000 Sensitive onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or physician. How is Prevident 5000 Sensitive Supplied

3.4 FL OZ (100 mL) in plastic bottles. Mild Mint: NDC 0126-0070-61

STORAGE

Store at Controlled Room Temperature, 68-77°F (20-25°C)

REFERENCES American Dental Association, Accepted Dental Therapeutics Ed. 40 (Chicago, 1984): 405-407. H.R. Englander et al., JADA 75 (1967): 638-644. H.R. Englander et al., JADA 78 (1969): 783-787. H.R. Englander et al., JADA 83 (1971): 354-358. Data on file, Colgate Oral Pharmaceuticals.

Questions? Comments? Please Call 1-800-962-2345
www.colgateprofessional.com

PRINCIPAL DISPLAY PANEL 100 mL Bottle

NDC 0126-0070-61

Colgate®

PreviDent®
5000ppm

SENSITIVE
1.1% Sodium Fluoride
5% Potassium Nitrate

PRESCRIPTION STRENGTH
TOOTHPASTE FOR SENSITIVE TEETH

MILD MINT

3.4 FL OZ (100 mL)

Rx ONLY

P10000587

PREVIDENT  5000 SENSITIVE
sodium fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0126-0070 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (fluoride ion) Sodium fluoride 12.7 mg  in 1 mL Potassium nitrate (Potassium cation) Potassium nitrate 57.5 mg  in 1 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color GREEN Score      Shape Size Flavor PEPPERMINT Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0126-0070-61 100 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 07/06/2009
Labeler - Colgate-Palmolive Company (055002195) Revised: 07/2009Colgate-Palmolive Company More Prevident 5000 Sensitive resources Prevident 5000 Sensitive Side Effects (in more detail) Prevident 5000 Sensitive Use in Pregnancy & Breastfeeding 0 Reviews for Prevident 5000 Sensitive - Add your own review/rating Prevident 5000 Sensitive Concise Consumer Information (Cerner Multum) APF Gel Advanced Consumer (Micromedex) - Includes Dosage Information EtheDent Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Gel-Kam Rinse MedFacts Consumer Leaflet (Wolters Kluwer) Phos-Flur Cream MedFacts Consumer Leaflet (Wolters Kluwer) PreviDent 5000 Sensitive MedFacts Consumer Leaflet (Wolters Kluwer) Compare Prevident 5000 Sensitive with other medications Prevention of Dental Caries

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Kids Choice

Dosage Form: gel, dentifrice
ACTIVE INGREDIENT

Active Ingredient: Stannous Fluoride

INACTIVE INGREDIENTS

Glycerine, Hydroxy Ethyl Celluulose, Xylitol

USE

Aids in the prevention of dental decay.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS FOR USE

Adults and Children 12 years and Older: Use after regular brushing and flossing.  Place gel across length of toothbrush.  Brush Thoroughly.  Keep on teeth for 1 - 1 1/2 minutes and then expectorate (spit out).  Do not swallow.  Use once a day for cavity prevention.  Supervise children until capable of using without supervision.
Children 6-11 Years:  See directions above.  Adult supervision required.
Children Under 6: Consult a Dentist or Physician.

OTHER INFORMATION

This is a fluoride prevention treatment gel, not a toothpaste.  Read directions carefully before use.  This product may produce surface discoloration of the teeth.  Adequate toothbrushing may prevent discoloration.  Discoloration is not harmful or permanent and may be removed by a dental professional.  Do not freeze or expose to extreme heat.

QUESTIONS ? COMMENTS ?

Questions?? Comments??
Call 1-479-787-5168 M-F 9am to 5pm CST

Warnings

If more than amount used for brushing is accidentally swallowed, seek medical help from a poison control center.

PACKAGE LABEL

Brush on Therapy for Cavity Prevention - Doctor's Choice 0.4% Stannous Fluoride Gel
Manufactured by Massco Dental

Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-005 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .45103 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor BUBBLE GUM (BUBBLE GUM) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-005-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-006 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor CREME DE MENTHE (HINT OF MINT) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-006-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-007 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor LIME (LIMEAIDE) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-007-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-008 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor GRAPE (GRAPE) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-008-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-009 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor CHERRY (CHERRY) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-009-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-015 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor COTTON CANDY (COTTON CANDY) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-015-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Establishment Name Address ID/FEI Operations Massco Dental A Division of Dunacin Pharmaceuticals 008081858 manufacture Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals
More Kids Choice resources Kids Choice Use in Pregnancy & Breastfeeding Kids Choice Support Group 3 Reviews for Kids Choice - Add your own review/rating Compare Kids Choice with other medications Prevention of Dental Caries

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Boots NicAssist Ice Mint 4 mg Gum

1. Name Of The Medicinal Product

Nicorette Icy White 4 mg Gum

Boots NicAssist Ice Mint 4 mg Gum

2. Qualitative And Quantitative Composition

Chewing Gum containing 4 mg nicotine, as nicotine resinate.

For excipients, see 6.1.

3. Pharmaceutical Form

Medicated Chewing Gum

A square, coated, cr?me coloured piece of gum.

4. Clinical Particulars 4.1 Therapeutic Indications

Nicorette Icy White 4 mg Gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

Nicorette Icy White 4 mg Gum is indicated in pregnant and lactating women making a quit attempt.

4.2 Posology And Method Of Administration

Adults and Children over 12 years of age

Nicorette Icy White 4 mg Gum should be chewed slowly according to the instructions.

The strength of gum to be used will depend on the smoking habits of the individual. In general, if the patient smokes 20 or less cigarettes a day, 2 mg nicotine gum is indicated. If more that 20 cigarettes per day are smoked, 4 mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking.

Nicorette Icy White 4mg Gum should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur.

Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Gum and as soon as they are able, reduce the number of gums used until they have stopped completely.

Smokers aiming to reduce cigarettes should use Nicorette Icy White 4 mg Gum, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible.

As soon as they are ready smokers should aim to quit smoking completely.

Maximum daily dose: 15 pieces per day.

When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficulty discontinuing Nicorette Icy White 4mg Gum are recommended to contact their pharmacist or doctor for advice.

For those using the 4 mg gum, switching to the 2 mg gum may be helpful when stopping treatment or reducing the number of gums used each day.

The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Absorption of nicotine is through the buccal mucosa, any nicotine, which is swallowed being destroyed by the liver.

4.3 Contraindications

Hypersensitivity to nicotine or any component of the chewing gum.

Nicorette Icy White 4 mg Gum is contraindicated in children under the age of 12 years.

4.4 Special Warnings And Precautions For Use

Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.

Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Icy White 4 mg Gum presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette Icy White 4 mg Gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.

Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Renal or hepatic impairment: Nicorette Icy White 4 mg Gum should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotine gum should be disposed of with care.

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Icy White 4 mg Gum should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.

Excipients: Nicorette Icy White 4 mg Gum also contains butylated hydroxyl toluene (E321); this may cause irritation to the mucous membranes.

Denture warning: Smokers who wear dentures may experience difficulty in chewing Nicorette Icy White 4 mg Gum. The chewing gum may stick to, and may in rare cases damage dentures.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.

4.6 Pregnancy And Lactation

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. Ideally smoking cessation during pregnancy should be achieved without NRT. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the fetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but if this is not achievable Nicorette Icy White 4mg Gum may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the fetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.

Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.

Nicorette Icy White 4 mg Gum may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses Nicorette Icy White 4 mg Gum has not been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients occur during the first 3-4 weeks after start of treatment.

Excessive consumption of Nicorette Icy White 4 mg Gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at first, cause hiccupping.

Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation.

Those who are prone to indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4mg nicotine gum is used; slower chewing and the use of the 2mg nicotine gum (if necessary more frequently) will usually overcome this problem.

The chewing gum may stick to, and may in rare cases damage dentures.

Reported adverse events associated with Nicorette 2mg and 4mg gum include:

Body System

Incidence*

Reported adverse event

Nervous system disorders:

Very common:

Headache

 

Common:

Dizziness

Cardiac disorders:

Uncommon:

Palpitations

 

Very rare:

Reversible atrial fibrillation

Gastrointestinal disorders:

Very common:

Gastrointestinal discomfort, hiccups, nausea

 

Common:

Vomiting

Skin and subcutaneous tissue disorders:

Uncommon:

Erythema, urticaria

General disorders and administration site conditions:

Very common:

Sore mouth or throat, jaw-muscle ache

 

Rare:

Allergic reactions including angioedema

* Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Drugs used in nicotine dependence

ATC code: N07B A01

The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicorette 4 mg Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs. The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis.

The gum contains a number of ingredients that are recognized as having properties for removal of dental staining. Clinical studies have shown that the gum helps to improve tooth whiteness.

Increased appetite is a recognised symptom of nicotine withdrawal and post-cessation weight gain is common. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight following a quit attempt.

5.2 Pharmacokinetic Properties

Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5 – 7 minutes and reach a maximum about 30 minutes after the start of chewing. Blood levels are roughly proportional to the amount of nicotine chewed and have been shown never to exceed those obtained from smoking cigarettes.

5.3 Preclinical Safety Data

Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.

There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product, which have not been considered in other relevant sections of this Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Core Gum

Chewing gum base, containing butylated hydroxyl toluene (E321)

Xylitol

Peppermint oil

Sodium carbonate, anhydrous

Acesulfame Potassium

Levomenthol

Magnesium oxide, light

Quinoline yellow Al lake (E104)

Talc

Sub coating

Winterfresh

Hypromellose

Sucralose

Polysorbate 80

Purified water

Hard coating

Xylitol

Starch

Titanium dioxide (E171)

Winterfresh

Quinoline yellow Al lake (E104)

Carnauba wax

Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

2 Years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Blister packed strips each containing 6, 10 or 15 pieces supplied in packs of 10, 12, 15, 30, 105 and 210 pieces.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Dispose of Nicorette Gum sensibly.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0153

9. Date Of First Authorisation/Renewal Of The Authorisation

18/07/2006

10. Date Of Revision Of The Text

06 June 2011

Read More:

Trihexyphenidyl Hydrochloride

Class: Anticholinergic Agents
VA Class: AU350
CAS Number: 52-49-3

Introduction

Antimuscarinic antiparkinsonian agent.a b

Uses for Trihexyphenidyl Hydrochloride Parkinsonian Syndrome

Adjunctive treatment of all forms of parkinsonian syndrome.a b

May reduce the frequency and duration of oculogyric crises, salivation, spastic contractions, and dyskinesia, and relieve mental inertia and depression characteristic of all forms of parkinsonian syndrome.b

Drug-Induced Extrapyramidal Reactions

Control of extrapyramidal reactions induced by antipsychotic agents (e.g., phenothiazines, thioxanthenes).a b

Trihexyphenidyl Hydrochloride Dosage and Administration Administration Oral Administration

Administer orally before or after meals, depending on patient reaction.a b Administer before meals in patients with excessive xerostomia.a Administer after meals if nausea occurs.a

May be administered 3 times daily; if a fourth dose is required, administer at bedtime.b

Mint candies, chewing gum, water, or administration of a saliva substitute (e.g., Xero-lube) may relieve xerostomia that may accompany administration after meals.a b

Dosage

Available as trihexyphenidyl hydrochloride; dosage expressed in terms of the salt.a

Adjust dosage carefully according to individual requirements and response.b

Adults Parkinsonian Syndrome Oral

Initially, 1 mg on first day.a Dosages may be increased in 2-mg increments at 3- to 5-day intervals up to a maximum of 6–10 mg daily.a b

Postencephalitic patients: 12–15 mg daily may be required.a b

When trihexylphenidyl is used as an adjunct to levodopa, consider reducing levodopa and trihexyphenidyl dosages.a Generally, 3–6 mg daily of trihexyphenidyl hydrochloride is adequate.a

If trihexyphenidyl is replacing another antiparkisonian agent, increase trihexyphenidyl dose as needed while decreasing other drug dose until complete replacement is achieved.b

Drug-Induced Extrapyramidal Reactions Oral

Usual dosage: 5–15 mg total daily dosage.a b

Initially, 1 mg; if extrapyramidal reactions are not controlled within a few hours, progressively increase dosage until control is achieved. a b

Alternatively, to achieve a more rapid control, reduce dosage of the drug causing the reaction, then adjust the dosage of both drugs to attain the desired drug effect without extrapyramidal symptoms.b Once control of extrapyramidal reactions has been maintained for several days, dosage of trihexyphenidyl may be reduced or discontinued.b

Prescribing Limits Adults Parkinsonian Syndrome Oral

Maximum of 6–10 mg daily in most patients; postencephalitic patients may require 12–15 mg daily.a b

Special Populations Hepatic Impairment

No specific dosage recommendations at this time.a

Renal Impairment

No specific dosage recommendations at this time.a

Geriatric Patients

Patients ?60 years of age: Initiate with low dosage; titrate dosage gradually.a

Cautions for Trihexyphenidyl Hydrochloride Contraindications

Known hypersensitivity to trihexylphenidyl or any ingredient in the formulation.c

Warnings/Precautions Warnings Ophthalmic Effects

Possible increased ocular tension.a Possible precipitation of glaucoma in patients receiving prolonged therapy.a c

Use with caution in patients with glaucoma.a c

Periodic gonioscopic evaluation and intraocular pressure monitoring recommended.a b

General Precautions Tardive Dyskinesia

Antiparkinsonian agents do not alleviate symptoms of tardive dyskinesia and may aggravate these symptoms.a

Cardiovascular Effects

Possible tachycardia;a use with caution and carefully monitor patients with cardiac disease or hypertension.a c

GU Effects

Possible urinary hesitancy and retention;a c use with caution and carefully monitor patients with prostatic hypertrophy or obstructive disease of the GU tract.a c

CNS Effects

Possible mental confusion, disorientation, agitation, hallucinations, and psychotic-like symptoms.a

GI Effects

Possible decreased intestinal mobility and paralytic ileus; use with caution in patients with obstructive diseases of the GI tract.a

Specific Populations Pregnancy

Category C.d

Geriatric Use

Possibility exists of greater sensitivity to the drug in some geriatric individuals.a

Hepatic Impairment

Use with caution; careful monitoring recommended.a

Renal Impairment

Use with caution; careful monitoring recommended.a

Common Adverse Effects

Dry mouth, blurred vision, dizziness, nausea, nervousness.a

Interactions for Trihexyphenidyl Hydrochloride Specific Drugs

Drug

Interaction

Anticholinergic agents

Increased risk of adverse anticholinergic effectsc

Trihexyphenidyl Hydrochloride Pharmacokinetics Absorption

Rapidly absorbed from the GI tract following oral administration.b

Onset

Following oral adminstration, onset of action occurs within 1 hour.b

Duration

6–12 hours.b

Elimination Elimination Route

Excreted principally in urine, probably as unchanged drug.b

Stability Storage Oral Elixir

20–25°C.e Do not freeze.e

Tablets

20–25°C.a

ActionsActions

Exhibits atropine-like action and exerts antispasmodic effects on parasympathetic-innervated peripheral structures, including smooth muscle.a b

Exact mechanism of action in parkinsonian syndrome not understood; may result from blockade of efferent impulses and from central inhibition of cerebral motor centers.b

Competitively inhibits acetylcholine or other cholinergic stimuli at autonomic effectors innervated by postganglionic nerves.c

Exhibits weak mydriatic, antisialagogue, and cardiovagal blocking effects.b

Advice to Patients

Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.a

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.a

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a

Importance of informing patients of other important precautionary information.a (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Trihexyphenidyl Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Elixir

2 mg/5 mL*

Trihexyphenidyl Hydrochloride Elixir

Mikart, Pharmaceutical Associates, Pharmaceutical Ventures

Tablets

2 mg*

Trihexyphenidyl Hydrochloride Tablets

URL, Vintage, Watson, West-Ward

5 mg*

Trihexyphenidyl Hydrochloride Tablets

URL, Vintage, Watson, West-Ward

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Trihexyphenidyl HCl 0.4MG/ML Elixir (PHARMACEUTICAL ASSOCIATES): 473/$30.99 or 1419/$79.97

Trihexyphenidyl HCl 2MG Tablets (WATSON LABS): 90/$22.99 or 180/$39.97

Trihexyphenidyl HCl 5MG Tablets (WEST-WARD): 180/$65.99 or 280/$95.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. Watson Laboratories Inc. trihexyphenidyl hydrochloride tablets, USP. prescribing information. Corona, CA; 2005 May.

b. AHFS drug information 2006. McEvoy GK, ed. Trihexyphenidyl. Bethesda, MD: American Society of Health-System Pharmacists; 2006:1256.

c. AHFS drug information 2006. McEvoy GK, ed. Antimuscarinics/Antispasmodics General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2006:1257-64].

d. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation, 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:1628

e. Pharmaceutical Associates, Inc. Trihexyphenidyl HCl elixir prescribing information. Greenville, SC; 2002 May.

More Trihexyphenidyl Hydrochloride resources Trihexyphenidyl Hydrochloride Side Effects (in more detail)Trihexyphenidyl Hydrochloride Use in Pregnancy & BreastfeedingDrug ImagesTrihexyphenidyl Hydrochloride Drug InteractionsTrihexyphenidyl Hydrochloride Support Group4 Reviews for Trihexyphenidyl Hydrochloride - Add your own review/rating Trihexyphenidyl MedFacts Consumer Leaflet (Wolters Kluwer) Trihexyphenidyl Prescribing Information (FDA) Artane Advanced Consumer (Micromedex) - Includes Dosage Information Artane Concise Consumer Information (Cerner Multum) Compare Trihexyphenidyl Hydrochloride with other medications Cerebral SpasticityExtrapyramidal ReactionParkinson's Disease

Read More:

Trihexyphenidyl Hydrochloride

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