Corsodyl Mouthwash (original)

1. Name Of The Medicinal Product

Corsodyl Original Mouthwash

Corsodyl Mouthwash Original

2. Qualitative And Quantitative Composition

Chlorhexidine Digluconate 0.2% w/v

(equivalent to Chlorhexidine Digluconate Solution Ph Eur 1.0% v/v)

3. Pharmaceutical Form

Oromucosal solution

4. Clinical Particulars 4.1 Therapeutic Indications

Corsodyl Mouthwash is an antimicrobial solution which inhibits the formation of dental plaque.

It is indicated as an aid in the treatment and prevention of gingivitis and in the maintenance of oral hygiene, particularly in situations where toothbrushing cannot be adequately employed (eg following oral surgery, in mentally or physically handicapped patients).

It may also be used in a post-peridontal surgery or treatment* regimen to promote gingival healing.

*NB: Use as part of a post-periodontal treatment regimen has only been adequately studied over the short term and following standard root surface instrumentation.

It is useful in the management of aphthous ulceration and oral candidal infections (eg denture stomatitis and thrush).

4.2 Posology And Method Of Administration

Adults:

Thoroughly rinse the mouth for about one minute with 10 ml twice daily. In the dental surgery the patient should be instructed to rinse the mouth for one minute prior to treatment.

Corsodyl is incompatible with anionic agents which are usually present in conventional dentifrices. These should therefore be used before Corsodyl (rinsing the mouth between applications) or at a different time of day.

For the treatment of gingivitis a course of about one month is advisable although some variation in response is to be expected. In the case of aphthous ulceration and oral candidal infections treatment should be continued for 48 hours after clinical resolution. For the treatment of dental stomatitis the dentures should be cleansed and soaked in Corsodyl mouthwash for fifteen minutes twice daily.

Children and the Elderly:

The normal adult dose is appropriate for elderly patients and children of 12 years and over unless otherwise recommended by the dentist or the physician.

Children under 12 years of age should not use the product unless recommended by a healthcare professional.

Route of administration

External (oral) use. [This product is not intended to be swallowed].

4.3 Contraindications

Corsodyl is contraindicated for patients who have previously shown a hypersensitivity reaction to Chlorhexidine or to any of the excipients in the formulation. However, such reactions are extremely rare.

4.4 Special Warnings And Precautions For Use

For oral (external) use only. Do not swallow. Keep out of the eyes and ears.

If the mouthwash comes into contact with the eyes, wash out promptly and thoroughly with water.

In case of soreness, swelling or irritation of the mouth, stop using the product and consult a healthcare professional.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Chlorhexidine is incompatible with anionic agents.

4.6 Pregnancy And Lactation

There is no evidence of any adverse effects on the foetus arising from the use of Corsodyl during pregnancy or on infants during lactation. Therefore no special precautions are recommended.

4.7 Effects On Ability To Drive And Use Machines

None have been reported or are known.

4.8 Undesirable Effects

Discoloration: A superficial discoloration of the dorsum of the tongue may occur. This disappears after treatment is discontinued. Discoloration of the teeth and silicate or composite restorations may also occur. This stain is not permanent and can largely be prevented by reducing the consumption of tea, coffee and red wine and brushing with a conventional toothpaste daily before using the mouthwash or, in the case of dentures, cleaning with a conventional denture cleanser. However, in certain cases a professional prophylaxis (scaling and polishing) may be required to remove this stain completely. Stained anterior tooth-coloured restorations with poor margins or rough surfaces which are not adequately cleaned by professional prophylaxis may require replacement. Similarly where normal toothbrushing is not possible, for example with intermaxillary fixation, or with extensive orthodontic appliances, scaling and polishing may also be required once the underlying condition has been resolved.

Taste: Transient disturbance of taste sensation and a burning sensation of the tongue may occur on initial use of the mouthwash. These effects usually diminish with continued use.

Oral desquamation: In cases where oral desquamation occurs dilution of the mouthwash with an equal volume of tap water, freshly mixed, will often allow continued use of the mouthwash.

Parotid gland swelling: Very occasionally, swelling of the parotid glands during the use of chlorhexidine mouthrinses has been reported. In all cases spontaneous resolution has occurred on discontinuing treatment.

Irritative skin reactions: Irritative skin reactions to chlorhexidine preparations can occasionally occur.

Generalised reactions: Allergic reactions, hypersensitivity & anaphylaxis to chlorhexidine have also been reported but are extremely rare.

4.9 Overdose

This has not been reported.

Due to the alcohol content (7.0 % v/v) ingestion of large amounts by children requires attention. Seek medical advice for appropriate action.

Accidental ingestion: Chlorhexidine taken orally is poorly absorbed. Systemic effects are unlikely even if large volumes are ingested. However, gastric lavage may be advisable using milk, raw egg, gelatin or mild soap. Employ supportive measures as appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Chlorhexidine is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is active against a wide range of important oral pathogens and is therefore effective in the treatment of many common dental conditions.

5.2 Pharmacokinetic Properties

Because of its cationic nature, chlorhexidine binds strongly to skin, mucosa and tissues and is thus very poorly absorbed. No detectable blood levels have been found following oral use.

5.3 Preclinical Safety Data

No information further to that contained in other sections of the SPC is included.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Ethanol (96 per cent), Macrogolglycerol Hydroxystearate, Ponceau 4R (E124), Aniseed Flavouring Oil, Peppermint oil, Purified water.

6.2 Incompatibilities

Hypochlorite bleaches may cause brown stains to develop in fabrics that have previously been in contact with preparations containing chlorhexidine.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Oriented amber polyethylene terephthalate bottle with plastic screw cap made from white food grade polypropylene.

Each bottle contains 300 ml or 600 ml.

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 9BD, UK

8. Marketing Authorisation Number(S)

PL 0079/0313

9. Date Of First Authorisation/Renewal Of The Authorisation

10 February 1994

10. Date Of Revision Of The Text

March 2009

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Corsodyl 0.2% Mouthwash

1. Name Of The Medicinal Product

Corsodyl 0.2% Mouthwash

2. Qualitative And Quantitative Composition

Chlorhexidine Digluconate 0.2% w/v

(equivalent to Chlorhexidine Digluconate Solution 1.028% w/w)

Also contains macrogolglycerol hydroxystearate. For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oromucosal solution

A clear to slightly opalescent, transparent solution with an odour of peppermint.

4. Clinical Particulars 4.1 Therapeutic Indications

For inhibition of the formation of dental plaque.

As an aid in the treatment and prevention of gingivitis and in the maintenance of oral hygiene, particularly in situations where toothbrushing cannot be adequately employed (eg following oral surgery, in mentally or physically handicapped patients).

Also for use in a post-peridontal surgery or treatment* regimen to promote gingival healing.

*NB: Use as part of a post-periodontal treatment regimen has only been adequately studied over the short term and following standard root surface instrumentation.

It is useful in the management of aphthous ulceration and oral candidal infections (eg denture stomatitis and thrush).

4.2 Posology And Method Of Administration

Adults:

Thoroughly rinse the mouth for about one minute with 10 ml twice daily. In the dental surgery the patient should be instructed to rinse the mouth for one minute prior to treatment.

Corsodyl 0.2% Mouthwash is incompatible with anionic agents which are usually present in conventional dentifrices. These should therefore be used before Corsodyl 0.2% Mouthwash (rinsing the mouth between applications) or at a different time of day.

For the treatment of gingivitis a course of about one month is advisable although some variation in response is to be expected. In the case of aphthous ulceration and oral candidal infections treatment should be continued for 48 hours after clinical resolution. For the treatment of dental stomatitis the dentures should be cleansed and soaked in Corsodyl 0.2% Mouthwash for fifteen minutes twice daily.

Children and the Elderly:

The normal adult dose is appropriate for elderly patients and children of 12 years and over unless otherwise recommended by the dentist or the physician.

Children under 12 years of age should not use the product unless recommended by a healthcare professional.

Route of administration

Oromucosal use. [This product is not intended to be swallowed].

4.3 Contraindications

Corsodyl 0.2% Mouthwash is contraindicated for patients who have previously shown a hypersensitivity reaction to Chlorhexidine or to any of the excipients in the formulation. However, such reactions are extremely rare.

4.4 Special Warnings And Precautions For Use

For oromucosal use only. Do not swallow. Keep out of the eyes and ears.

If the mouthwash comes into contact with the eyes, wash out promptly and thoroughly with water.

In case of soreness, swelling or irritation of the mouth, stop using the product and consult a healthcare professional.

Macrogolglygerol hydroxystearate may cause skin reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Chlorhexidine is incompatible with anionic agents.

4.6 Pregnancy And Lactation

There is no evidence of any adverse effects on the foetus arising from the use of chlorhexidine digluconate during pregnancy or on infants during lactation. Therefore no special precautions are recommended.

4.7 Effects On Ability To Drive And Use Machines

None have been reported or are known.

4.8 Undesirable Effects

Discoloration: A superficial discoloration of the dorsum of the tongue may occur. This disappears after treatment is discontinued. Discoloration of the teeth and silicate or composite restorations may also occur. This stain is not permanent and can largely be prevented by reducing the consumption of tea, coffee and red wine and brushing with a conventional toothpaste daily before using the mouthwash, or, in the case of dentures, cleaning with a conventional denture cleaner. However, in certain cases a professional prophylaxis (scaling and polishing) may be required to remove this stain completely. Stained anterior tooth-coloured restorations with poor margins or rough surfaces which are not adequately cleaned by professional prophylaxis may require replacement. Similarly where normal toothbrushing is not possible, for example with intermaxillary fixation, or with extensive orthodontic appliances, scaling and polishing may also be required once the underlying condition has been resolved.

Taste: Transient disturbance of taste sensation and a burning sensation of the tongue may occur on initial use of the mouthwash. These effects usually diminish with continued use.

Oral desquamation: In cases where oral desquamation occurs dilution of the mouthwash with an equal volume of tap water, freshly mixed, will often allow continued use of the mouthwash.

Parotid gland swelling: Very occasionally, swelling of the parotid glands during the use of chlorhexidine mouthrinses has been reported. In all cases spontaneous resolution has occurred on discontinuing treatment.

Irritative skin reactions: Irritative skin reactions to chlorhexidine preparations can occasionally occur.

Generalised reactions: allergic reactions, hypersensitivity & anaphylaxis to chlorhexidine have also been reported but are extremely rare.

4.9 Overdose

This has not been reported.

Accidental ingestion: Chlorhexidine taken orally is poorly absorbed. Systemic effects are unlikely even if large volumes are ingested. However, gastric lavage may be advisable using milk, raw egg, gelatin or mild soap. Employ supportive measures as appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: anti-infectives and antiseptics for local oral treatment

ATC code: A01AB03

Corsodyl 0.2% Mouthwash contains 0.2% w/v chlorhexidine digluconate which is an antimicrobial preparation for external use. It is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is active against a wide range of important oral pathogens and is therefore effective in the treatment of many common dental conditions.

5.2 Pharmacokinetic Properties

Because of its cationic nature, chlorhexidine binds strongly to skin, mucosa and tissues and is thus very poorly absorbed. No detectable blood levels have been found following oral use.

5.3 Preclinical Safety Data

No information further to that contained in other sections of the SPC is included.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glycerol

Macrogolglycerol Hydroxystearate

Sorbitol liquid (non-crystallising)

Peppermint flavour

Purified water.

6.2 Incompatibilities

Hypochlorite bleaches may cause brown stains to develop in fabrics that have previously been in contact with preparations containing chlorhexidine.

6.3 Shelf Life

30 months.

Shelf-life after opening: 3 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Oriented amber polyethylene terephthalate bottle with plastic screw cap made from white food grade polypropylene.

Each bottle contains 300 ml or 600 ml.

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, U.K.

8. Marketing Authorisation Number(S)

PL 00079/0608

9. Date Of First Authorisation/Renewal Of The Authorisation

26/04/2007

10. Date Of Revision Of The Text

10/03/2010

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Aphthous Ulcer Medications

Definition of Aphthous Ulcer: These small sensitive painful craters in the mouth are common canker sores. There are many possible causes of apthous ulcers and frequently the cause is unknown. More...

Drugs associated with Aphthous Ulcer

The following drugs and medications are in some way related to, or used in the treatment of Aphthous Ulcer. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Aphthous UlcerAphthous Stomatitis (69 drugs in 2 topics) Learn more about Aphthous Ulcer

Medical Encyclopedia:

Mouth ulcersCanker soreCanker sore treatmentFever blisters and canker sores
Drug List:Anbesol-LiquidBenzo-JelCepacol-FizzlersDe-Sone-La-InjectionDent-O-KainFirst-Mouthwash-BlmOra-Film-StripsOrabaseOrajelOralonePediaderm-Ta-CreamSuper-Dent-Topical-Anesthetic-GelTopical-Anesthetic-Dental-GelTrianexZema-Pak-10-DayZilactin-B

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Topical astringents

Topical astringents are agents that cause skin cells or mucus membranes to contract or shrink, by precipitating proteins from their surface. When applied topically they dry, harden and protect the skin. They reduce bleeding from minor abrasions and are used to relieve skin irritations resulting from minor cuts, allergies, eczema, stretch marks, insect bites and so on. Topical astringents can be used in throat lozenges, mouthwash, creams, lotions, etc.

See also

Medical conditions associated with topical astringents:

Atopic Dermatitis Dermatological Disorders Drug List:

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Betadine Gargle & Mouthwash

1. Name Of The Medicinal Product

Betadine Gargle and Mouthwash.

2. Qualitative And Quantitative Composition

Povidone Iodine USP 1% w/v (equivalent to 0.1% w/v of available iodine).

3. Pharmaceutical Form

Solution.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of acute mucosal infections of the mouth and pharynx, for example gingivitis, and mouth ulcers. For oral hygiene prior to, during and after dental and oral surgery.

4.2 Posology And Method Of Administration

For oral administration, as a gargle and mouthwash. The product should not be swallowed. Adults and children over 6 years of age: Use undiluted or diluted with an equal volume of warm water. Gargle or rinse with up to 10ml for up to 30 seconds without swallowing. Repeat up to four times daily, for up to 14 consecutive days, or as directed.

4.3 Contraindications

Not for use in children under 6 years of age and in patients with a known or suspected iodine hypersensitivity. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).

4.4 Special Warnings And Precautions For Use

Regular use should be avoided as prolonged use may lead to the absorption of a significant amount of iodine. Do not use for more than 14 days. If sores or ulcers in the mouth do not heal within 14 days, seek medical or dental advice. Regular use should be avoided in patients on concurrent lithium therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Absorption of iodine from povidone iodine may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.

4.6 Pregnancy And Lactation

Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption of iodine on foetal thyroid function and development. The use of Betadine Gargle and Mouthwash in pregnant and lactating women should be limited to a single treatment session only.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Idiosyncratic mucosal irritation and hypersensitivity reactions may occur. Excessive absorption of iodine may produce systemic effects such as metabolic acidosis, hypernatraemia and impairment of renal function.

4.9 Overdose

Excessive iodine can produce goitre and hypothyroidism or hyperthyroidism. Acute overdose may result in symptoms of metallic taste in the mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling in the eyes, difficulty in breathing due to pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea. Metabolic acidosis, hypernatraemia and renal impairment may occur. Treatment: In the cases of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Betadine Gargle and Mouthwash contains povidone iodine, a complex of iodine which shows all the broad spectrum germicidal activity of elemental iodine. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue. Betadine Gargle and Mouthwash kills bacteria, viruses, fungi, spores and protozoa.

5.2 Pharmacokinetic Properties

The product is intended for topical application to the mouth and buccal cavity.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glycerol; menthol; methyl salicylate; ethanol 96%; saccharin sodium; purified water.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Store in a dry place below 25oC. Protect from light.

6.5 Nature And Contents Of Container

Amber soda-lime-silica glass bottle (USP Type III) fitted with an externally ribbed white urea cap, with a steran faced wad or with a wadless polypropylene cap containing 250ml of product.

6.6 Special Precautions For Disposal And Other Handling

This product should not be swallowed.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0006.

9. Date Of First Authorisation/Renewal Of The Authorisation

30th September 2005.

10. Date Of Revision Of The Text

September 2005.

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Mouth and throat products

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Topical mouth and throat products include agents such as antifungals, antiseptics, cough suppressants and saliva substitutes. They are used to treat conditions of the mouth and throat such as oral thrush, dry mouth, sore throat and tickly cough.

See also

Medical conditions associated with mouth and throat products:

Aphthous Stomatitis, Recurrent Aphthous Ulcer Cold Sores Cough Gastrointestinal Candidiasis Gingivitis Herpes Simplex Mucositis Nasal Congestion Oral and Dental Conditions Oral Thrush Pain Periodontitis Tonsillitis/Pharyngitis Xerostomia Drug List: Cepacol-Dual-Relief-Spray Neutrasal-Powder Mycelex-Troche Aphthasol Atridox Betasept-Liquid Bio-Statin-Powder Biopatch Calgon-Vesta Caphosol-Solution Cepacol-Sore-Throat-Lozenges Cetacaine-Liquid Chloraseptic-Lozenges Chlorostat Chlorostat-4 Denti-Care-Denti-Rinse Dyna-Hex Exactacain-Topical-Anesthetic-Spray First-Mouthwash-Blm Hibiclens-Liquid Hibistat Mycostatin Mycostatin-Pastilles Nilstat Peridex-Solution Periochip Periogard-Solution Perisol-Oral-Rinse Salivart-Spray Scrub-Care Spectrum-4 Vicks-Formula-44-Sore-Throat-Spray

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Eludril Mouthwash

1. Name Of The Medicinal Product

ELUDRIL mouthwash

2. Qualitative And Quantitative Composition

Actives :

Quantity :

Unit :

Chlorhexidine digluconate

0.100

% W/V

Chlorobutanol

0.500

% W/V

Each 1 ml contains chlorhexidine digluconate solution 0.005 ml (corresponding to 1 mg chlorhexidine digluconate).

The content of chlorhexidine digluconate per ml when diluted as recommended is 0.22 mg/ml – 0.33 mg/ml.

Each ml contains 5 mg of chlorobutanol.

The content of chlorobutanol per ml when diluted as recommended is 1.11 mg/ml – 1.66 mg/ml.

Excipients:Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Mouthwash.

Clear colourless Oromucosal solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Eludril mouthwash is an antibacterial solution which inhibits dental plaque formation. It is indicated as an aid in the treatment and prevention of gingivitis, and in maintaining oral hygiene, particularly in situations where toothbrushing is difficult to carry out (eg following oral surgery or in physically or mentally-handicapped patients). It is valuable in the management of aphtous ulceration and oral candidal infections (eg denture stomatitis and thrush) and can be used as an adjuvant treatment for minor infections of the throat.

As a disinfectant solution for the cleansing of removable dentures.

4.2 Posology And Method Of Administration

Eludril is contraindicated in infants and children under six years of age: see section 4.3.

1. As a mouthwash, dilute 10 to 15 ml in the measuring-cup provided for this purpose and fill with lukewarm water to the upper line and use as a mouthwash or a gargle two or three times a day.

2. As a disinfectant for removable dentures, prepare a 1 in 3 dilution of Eludril with water. The dentures previously cleansed should be soaked in the solution for one hour.

Route of administration

Oromucosal use. (This product is not intended to be swallowed)

4.3 Contraindications

- Hypersensitivity to the active substances or to any of the excipients.

- Use in infants and children less than 6 years of age.

- Use with anionic agents (see section 4.5).

4.4 Special Warnings And Precautions For Use

Warnings

For oral use only

Do not swallow

Keep out of the eyes and ears. If the mouthwash comes into contact with the eyes or ears, wash out promptly and thoroughly with water.

Discoloration of the tongue, teeth and silicate or composite restorations may occur. This stain is not permanent and can largely be prevented by brushing with a conventional toothpaste daily before using the mouthwash or, in the case of dentures cleansing with a conventional cleanser: see sections 4.5, 4.8.

In case of soreness, swelling or irritation of the mouth, stop using the product and consult a healthcare professional: see section 4.8

This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E218) which may cause allergic reactions.

Precautions for use

Chlorhexidine is an irritant and should be used with caution. If there is evidence of irritation or aggravation of the condition, a doctor or dentist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Chlorhexidine is incompatible with anionic agents which are usually present in conventional toothpastes. Therefore, thorough rinsing of the mouth with water, after toothbrushing with toothpaste, should be done before using this medicine: see section 4.3. A short time should elapse between using the two products.

4.6 Pregnancy And Lactation

There is no evidence of any adverse effects in infants arising from the use of Eludril mouthwash during pregnancy or lactation.

Therefore no special precautions are recommended.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable Effects

Body System

Adverse Reactions (frequency not known)

Immune system disorders

Anaphylactic shock, anaphylactic reaction, hypersensitivity

Nervous system disorders

-Dysgeusia: transient disturbance of taste sensation

-Mucosal burning sensation: burning sensation of the tongue.

These effects may occur on initial use of the product and usually diminish with continued use.

Gastrointestinal disorders

-Tongue discoloration: Superficial discoloration of the dorsum of the tongue, reversible after discontinuing treatment: see section 4.4.

-Teeth discoloration: Discoloration of the teeth and silicate or composite restorations: see section 4.4.

-Parotid gland enlargement: swelling of the parotid glands reversible after discontinuing treatment.

- Oral desquamation: In cases where oral desquamation occurs dilution of 10ml of the mouthwash with water to the upper line of the measuring cup will often allow continued use of the mouthwash

4.9 Overdose

Overdose is not expected under normal conditions of use of this solution as a mouthwash (normal dilution conditions for 10 ml is 7.4 %v/v and for 15 ml is 11.1 %v/v.). However, due to the undiluted product alcohol content (33.25 % v/v) accidental ingestion of large amounts by children requires prompt medical attention for appropriate action.

Symptoms

Chlorhexidine when taken orally is poorly absorbed. Most patients will develop very few symptoms. Local effects like burning sensation in the mouth and throat may occur. Systemic effects are unlikely if large volumes are ingested. However, large amounts may cause digestive disorders (epigastric pain, diarrhoea) and if chlorhexidine passes into the general system, signs of neurological toxicity may develop.

Emergency procedures

- Do not attempt to empty the stomach

- Administration of milk, water to drink, raw egg, gelatin or mild soap may be advisable provided the airway can be protected.

- General supportive measures should be instituted as deemed necessary by the physician.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anti-infectives and antiseptics for local oral treatment.

ATC code: A01AB03.

CHLORHEXIDINE : broad-spectrum antibacterial (gram + and gram -) and anti-fungal product with extended bactericidal activity on buccal mucosa.

CHLOROBUTANOL: local anaesthetic providing a quick relief from pain, bacteriostatic reinforcing the activity of chlorhexidine.

5.2 Pharmacokinetic Properties

CHLORHEXIDINE:

Oral:Very weak systemic absorption, distribution mainly via liver and kidneys; little metabolism (no degradation of the molecule). Elimination mainly in faeces (99.5 % of the ingested dose).

Permucosal absorption: negligible. Distribution, metabolism and elimination same as oral route

CHLOROBUTANOL:

Systemic absorption after oral administration. Half-life of 9 to 10 days.

5.3 Preclinical Safety Data

No information further to that contained in other sections of the SPC is included.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Poloxamer

Alcohol

Sorbitol solution 70 % (crystallising)

Menthol

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Peppermint spirit

Purified Water

6.2 Incompatibilities

See section 4.5

6.3 Shelf Life

Unopened: 3 years

6.4 Special Precautions For Storage

Store away from light,

Store at a temperature of 25°C maximum.

6.5 Nature And Contents Of Container

Clear glass bottle with aluminium cap and a measuring cup.

Pack sizes: 90ml, 250ml and 500ml.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

PIERRE FABRE LIMITED

Hyde Abbey House

23 Hyde Street

Winchester

Hampshire

SO23 7DR

UNITED KINGDOM

8. Marketing Authorisation Number(S)

PL 00603/0012R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 9th August 1973

Date of last renewal: 16th April 2007

10. Date Of Revision Of The Text

27/01/2011

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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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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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Colyte with Flavor Packs Solution

Pronunciation: pol-ee-ETH-i-leen GLYE-kole/e-LECK-troe-lites
Generic Name: Polyethylene Glycol/Electrolytes
Brand Name: Examples include Colyte and Colyte with Flavor Packs
Colyte with Flavor Packs Solution is used for:

Cleaning out the bowel before surgery or other procedures. It may also be used for other conditions as determined by your doctor.

Colyte with Flavor Packs Solution is a laxative. It works by causing the colon to move contents along more quickly.

Do NOT use Colyte with Flavor Packs Solution if: you are allergic to any ingredient in Colyte with Flavor Packs Solution you have appendicitis or certain stomach or bowel problems (eg, blockage, retention, perforation, toxic inflammation, megacolon, ileus)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Colyte with Flavor Packs Solution:

Some medical conditions may interact with Colyte with Flavor Packs Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a throat (esophagus) disease, ulcerative colitis, heart disease (eg, irregular heartbeat, congestive heart failure), swallowing problems (eg, history of aspiration or regurgitation), impaired gag reflex, electrolyte imbalances (eg, high blood potassium levels), or rectal bleeding of unknown cause if you have a history of alcohol use

Some MEDICINES MAY INTERACT with Colyte with Flavor Packs Solution. However, no specific interactions with Colyte with Flavor Packs Solution are known at this time.

Ask your health care provider if Colyte with Flavor Packs Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Colyte with Flavor Packs Solution:

Use Colyte with Flavor Packs Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Your doctor will tell you when to start using Colyte with Flavor Packs Solution. Do not eat any solid foods for at least 2 hours before beginning Colyte with Flavor Packs Solution. It is preferred that you do not eat for 3 to 4 hours before beginning Colyte with Flavor Packs Solution. Drink only clear liquids and do not eat any solid foods from the time you start Colyte with Flavor Packs Solution until your procedure is complete. Before using Colyte with Flavor Packs Solution, fill the container with the amount of water indicated on the package label. Use lukewarm water to mix Colyte with Flavor Packs Solution to help the medicine dissolve faster. Shake well. Chilling Colyte with Flavor Packs Solution improves the taste. Do not add sugar, sweetening agents, or other additives to Colyte with Flavor Packs Solution. Some of these products come with a Flavor Pack. If this product comes with a Flavor Pack and you wish to use it, add the contents of the Flavor Pack into the bottle before you add the water. If you do not use the Flavor Pack, throw it away. Shake well before each use. Drink 8 ounces (240 mL) of Colyte with Flavor Packs Solution every 10 minutes until the stool is watery, clear, and free of all solid matter, or until the medicine is gone. At least 3 liters is usually required to produce the watery stool. It is best to drink all of Colyte with Flavor Packs Solution. Be sure to follow the instructions provided by your doctor. It is best to drink each portion quickly rather than sipping it. Rinsing your mouth with mouthwash after each glass of medicine may help get rid of the taste. Other medicines taken by mouth within 1 hour of taking Colyte with Flavor Packs Solution may not be absorbed or be effective. Contact your doctor or pharmacist with any concerns you might have about taking your other medicines. If you miss a dose of Colyte with Flavor Packs Solution, take it as soon as you remember. Continue to take it as directed by your doctor. Notify your doctor right away if you are unable to finish taking Colyte with Flavor Packs Solution before your test.

Ask your health care provider any questions you may have about how to use Colyte with Flavor Packs Solution.

Important safety information: The first bowel movement usually occurs about 1 hour after you begin drinking Colyte with Flavor Packs Solution. Keep all doctor and lab appointments while you are taking Colyte with Flavor Packs Solution. Use Colyte with Flavor Packs Solution with caution in patients who are unconscious or partially conscious because they may be at greater risk for vomiting and inhaling Colyte with Flavor Packs Solution. Use Colyte with Flavor Packs Solution with caution in the ELDERLY; they may be more sensitive to its effects. Colyte with Flavor Packs Solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Colyte with Flavor Packs Solution while you are pregnant. It is not known if Colyte with Flavor Packs Solution is found in breast milk. If you are or will be breast-feeding while you use Colyte with Flavor Packs Solution, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Colyte with Flavor Packs Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloating; nausea; rectal irritation; stomach fullness or cramps; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; hoarseness; muscle weakness; persistent or severe nausea and vomiting; severe bloating or abdominal swelling; severe stomach pain; slow or irregular heartbeat; vomiting of blood.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Colyte with Flavor Packs side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Colyte with Flavor Packs Solution:

Before mixing, store Colyte with Flavor Packs Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. After preparing the solution, store Colyte with Flavor Packs Solution in the refrigerator in a tightly closed container. Use within 48 hours. Discard any unused portion of Colyte with Flavor Packs Solution. Keep Colyte with Flavor Packs Solution out of the reach of children and away from pets.

General information: If you have any questions about Colyte with Flavor Packs Solution, please talk with your doctor, pharmacist, or other health care provider. Colyte with Flavor Packs Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Colyte with Flavor Packs Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Colyte with Flavor Packs resources Colyte with Flavor Packs Side Effects (in more detail) Colyte with Flavor Packs Use in Pregnancy & Breastfeeding Colyte with Flavor Packs Support Group 0 Reviews for Colyte with Flavor Packs - Add your own review/rating Compare Colyte with Flavor Packs with other medications Bowel Preparation Constipation, Chronic Gastrointestinal Decontamination

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Antabuse

Pronunciation: dye-SUL-fi-ram
Generic Name: Disulfiram
Brand Name: Antabuse

Antabuse must not be given to patients under the influence of alcohol or without their permission.

Antabuse is used for:

Treating alcoholism.

Antabuse is an alcohol-abuse deterrent. It works by blocking the breakdown of alcohol, causing unpleasant side effects (eg, vomiting, upset stomach) when even a small amount of alcohol is consumed.

Do NOT use Antabuse if: you are allergic to any ingredient in Antabuse or other similar medicines you are under the influence of alcohol you have severe heart disease, a blockage of your heart arteries, or a mental disorder (eg, psychosis) you are taking metronidazole or an alcohol-containing medicine (eg, certain HIV protease inhibitors [eg, amprenavir], cough syrups, other liquid medicines)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Antabuse:

Some medical conditions may interact with Antabuse. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances (eg, latex rubber) if you have brain damage, diabetes, heart or lung disease, mental or mood problems (eg, depression), an underactive thyroid, seizures, or liver or kidney problems

Some MEDICINES MAY INTERACT with Antabuse. Tell your health care provider if you are taking any other medicines, especially any of the following:

Alcohol-containing medicines (eg, certain HIV protease inhibitors [eg, amprenavir], cough syrups, other liquid medicines) or metronidazole because the risk of severe side effects may be increased Anticoagulants (eg, warfarin), benzodiazepines (eg, diazepam), isoniazid, or phenytoin because side effects may be increased by Antabuse

This may not be a complete list of all interactions that may occur. Ask your health care provider if Antabuse may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Antabuse:

Use Antabuse as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Antabuse may be taken with or without food. Antabuse may be swallowed whole, chewed, or crushed and mixed with food. Do not take the first dose of Antabuse for at least 12 hours after drinking alcohol. If you miss a dose of Antabuse, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Antabuse.

Important safety information: Antabuse may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Antabuse. Using Antabuse alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Avoid all alcohol including alcohol found in sauces, vinegar, mouthwash, liquid medicines, lotions, after shave, or backrub products. A reaction to alcohol may cause flushing, nausea, thirst, abdominal pain, chest pain, dizziness, vomiting, fast breathing, fast heartbeat, fainting, difficulty breathing, or confusion. Use caution when using topical products containing alcohol, such as cologne or perfume. Before using alcohol-containing products on the skin, test the product by applying some to a small area of the skin. If no redness, itching, headache, or nausea occurs after 1 or 2 hours, you should be able to use the product. You may have a reaction if you drink alcohol or use a product that contains alcohol for 2 weeks after your last dose of Antabuse. Notify your doctor immediately if you experience yellowing of the skin or eyes, dark urine, weakness, tiredness, loss of appetite, or nausea and vomiting. These may be signs of a liver problem. Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Antabuse. Carry an identification card at all times that says you are taking Antabuse. LAB TESTS, including liver function tests and complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments. Use Antabuse with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Antabuse during pregnancy. It is unknown if Antabuse is excreted in breast milk. Do not breast-feed while taking Antabuse. Possible side effects of Antabuse:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; headache; metallic or garlic taste in mouth.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; changes in color vision; dark urine; loss of appetite; mental or mood problems; nausea; numbness or tingling of the arms or legs; seizures; tiredness; vomiting; weakness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Antabuse side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Antabuse:

Store Antabuse at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Antabuse out of the reach of children and away from pets.

General information: If you have any questions about Antabuse, please talk with your doctor, pharmacist, or other health care provider. Antabuse is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Antabuse. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Antabuse resources Antabuse Side Effects (in more detail) Antabuse Use in Pregnancy & Breastfeeding Drug Images Antabuse Drug Interactions Antabuse Support Group 17 Reviews for Antabuse - Add your own review/rating Antabuse Prescribing Information (FDA) Antabuse Consumer Overview Antabuse Monograph (AHFS DI) Antabuse Advanced Consumer (Micromedex) - Includes Dosage Information Disulfiram Prescribing Information (FDA) Disulfiram Professional Patient Advice (Wolters Kluwer) Compare Antabuse with other medications Alcohol Dependence

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Striant

Generic Name: testosterone buccal system (tes TOSS ter one)
Brand Names: Striant

What is testosterone buccal system?

Testosterone is a naturally occurring "male" sex hormone necessary for many processes in the body.

Testosterone buccal system is used to treat men with low testosterone levels.

Testosterone buccal system may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about testosterone buccal system? Notify your doctor if you experience nausea; vomiting; swelling of the ankles; changes in skin color; too frequent or prolonged erections; breathing disturbances, including those associated with sleep; yellowing of the skin or eyes; dark colored urine; or problems with urination. Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

What should I discuss with my healthcare provider before using testosterone buccal system? Do not use testosterone buccal system if you have cancer of the breast or prostate. Testosterone may worsen some cancers of these types.

Before using testosterone buccal system, tell your doctor if you have

had a previous allergic reaction to testosterone;

diabetes;

sleep apnea (brief periods of not breathing during sleep) or if you have risk factors for sleep apnea (e.g., obesity, chronic lung disease);

difficulty with urination due to enlargement of the prostate;

heart disease; or

liver disease or kidney disease.

You may not be able to use testosterone buccal system, or you may need a dosage adjustment or special monitoring if you have any of the conditions listed above.

Testosterone buccal system is not approved for use by women and must not be used by women. Testosterone buccal system is in the FDA pregnancy category X. This means that testosterone is known to cause birth defects in an unborn baby. Do not use testosterone buccal system if you are pregnant or could become pregnant during treatment. Testosterone buccal system is not approved for use by women and must not be used by women. It is not known whether testosterone from the buccal system will pass into breast milk.Do not use testosterone buccal system if you are breast-feeding a baby. Men over 65 years of age that use testosterone buccal system may be at increased risk for the development of prostatic enlargement or cancer. You may not be able to use buccal system testosterone, or you may require a lower dose or special monitoring. How should I use testosterone buccal system?

Use testosterone buccal system exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

To use the testosterone buccal system (Striant):

Hold one buccal system with the flat side on your fingertip. Place the curved side onto your gum, as high as possible above the left or right incisor tooth. Hold your finger on the outside of your lip over the system for 30 seconds to ensure the system is attached to the gum. If the system sticks to the cheek and not the gum, this is acceptable.

The buccal system should remain in place for 12 hours. To remove the system, move it slightly toward the back or front of the mouth then slide it toward the teeth from removal. With each new application, rotate to alternate sides of the mouth. This avoids scratching the gum. Check to see that the system is in place after eating, drinking, brushing the teeth, or using mouthwash.

As the buccal system absorbs moisture from the mouth, it will begin to soften and will mold to the shape of the gum. The system does not dissolve completely, but will remain in place. It will not move until you remove it.

If a buccal system falls off before 8 hours of use, remove it and replace it with a new system in the same place.

Change the buccal system and alternate sides of the mouth 12 hours after application of the original system. If a buccal system falls off after 8 hours but before 12 hours of use, remove the system and replace it with a new system above the opposite incisor. This will serve as the second dose for the day.

Do not chew or swallow the testosterone buccal system.

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

Your doctor may want to perform tests to monitor the amount of testosterone in the body, liver function, prostate function, cholesterol levels, or other factors during treatment with testosterone buccal system.

It is important to use testosterone buccal system regularly to get the most benefit.

Dispose of all used systems properly, out of the reach of children and pets.

Store testosterone buccal system at room temperature away from moisture and heat. What happens if I miss a dose?

Apply the next system as soon as you remember. Do not use two doses simultaneously, unless otherwise directed by your doctor.

What happens if I overdose? An overdose of testosterone buccal system is not likely to threaten life. If you do suspect an overdose, or if a system has been ingested, call an emergency room or poison control center for advice. What should I avoid while using testosterone buccal system?

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

Testosterone buccal system side effects If you experience any of the following serious side effects, stop using testosterone buccal system and seek emergency medical attention or contact your doctor immediately:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

nausea or vomiting;

changes in skin color;

swelling of the ankles or legs;

breathing disturbances, including those associated with sleep;

too frequent or prolonged erections;

liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue); or

dark colored urine or problems with urination.

Other, less serious side effects may be more likely to occur. Continue to use testosterone buccal system and talk to your doctor if you experience

irritation or changes in the gum at the system application site;

bitter or unusual taste in the mouth;

headache;

emotional changes;

increased blood pressure;

decreased interest in sex;

changes in blood cholesterol or number of red blood cells (detected by blood tests);

prostate changes or difficulty urinating;

enlarged, swollen or tender breasts; or

acne.

Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect testosterone buccal system?

Before using testosterone buccal system, tell your doctor if you are taking any of the following medicines:

warfarin (Coumadin);

insulin or an oral diabetes medication such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), repaglinide (Prandin), rosiglitazone (Avandia), pioglitazone (Actos), and others;

propranolol (Inderal, Inderal LA, others); or

a corticosteroid such as hydrocortisone (Cortef, Hydrocortone, Solu-Cortef), dexamethasone (Decadron, Hexadrol others), methylprednisolone (Depo-Medrol, Medrol, Solu-Medrol), prednisolone (Prelone, Pediapred), prednisone (Deltasone, Orasone, others), and others.

You may not be able to use testosterone buccal system, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with testosterone buccal system. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Striant resources Striant Side Effects (in more detail)Striant Use in Pregnancy & BreastfeedingDrug ImagesStriant Drug InteractionsStriant Support Group0 Reviews for Striant - Add your own review/rating Striant MedFacts Consumer Leaflet (Wolters Kluwer) Striant Advanced Consumer (Micromedex) - Includes Dosage Information Striant Consumer Overview Striant Prescribing Information (FDA) Testosterone Monograph (AHFS DI) Testosterone Prescribing Information (FDA) Testosterone Professional Patient Advice (Wolters Kluwer) AndroGel Prescribing Information (FDA) AndroGel Gel MedFacts Consumer Leaflet (Wolters Kluwer) Androderm Advanced Consumer (Micromedex) - Includes Dosage Information Androderm Patch MedFacts Consumer Leaflet (Wolters Kluwer) Androderm Prescribing Information (FDA) Androgel Consumer Overview Androgel Advanced Consumer (Micromedex) - Includes Dosage Information Axiron Prescribing Information (FDA) Axiron Consumer Overview Axiron Solution MedFacts Consumer Leaflet (Wolters Kluwer) Delatestryl Prescribing Information (FDA) Delatestryl MedFacts Consumer Leaflet (Wolters Kluwer) Depo-Testosterone Prescribing Information (FDA) Depo-Testosterone MedFacts Consumer Leaflet (Wolters Kluwer) Fortesta Gel MedFacts Consumer Leaflet (Wolters Kluwer) Fortesta Consumer Overview Testim Prescribing Information (FDA) Testim Gel MedFacts Consumer Leaflet (Wolters Kluwer) Testosterone Cypionate Prescribing Information (FDA) Testosterone Enanthate Prescribing Information (FDA) Compare Striant with other medications Hypogonadism, Male Where can I get more information? Your pharmacist has additional information about testosterone buccal system written for health professionals that you may read.

See also: Striant side effects (in more detail)

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HalfLytely Solution

Pronunciation: POL-ee-ETH-i-leen GLYE-kol/e-LECK-troe-lites/bis-AK-oh-dil
Generic Name: Polyethylene Glycol/Electrolytes
Brand Name: HalfLytely and Bisacodyl Tablet Bowel Prep Kit
HalfLytely Solution is used for:

Cleaning out the bowel before certain medical procedures (eg, colonoscopy). It may also be used for other conditions as determined by your doctor.

HalfLytely Solution is a combination of 2 laxatives. The solution works by changing the amounts of water and electrolytes in the intestines. The tablet works by causing the colon to move contents along more quickly.

Do NOT use HalfLytely Solution if: you are allergic to any ingredient in HalfLytely Solution you have appendicitis; severe stomach pain; severe constipation; stomach, intestinal, or rectal bleeding; or certain stomach or bowel problems (eg, blockage, problems with the contents of your stomach emptying, opening or hole in the wall of your stomach or bowel, certain types of inflammation, very enlarged bowel) you cannot swallow the tablet whole you will be having abdominal surgery

Contact your doctor or health care provider right away if any of these apply to you.

Before using HalfLytely Solution:

Some medical conditions may interact with HalfLytely Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a throat (esophagus) disease, reflux problems (GERD), stomach or bowel problems (eg, ulcerative colitis), swallowing problems (eg, history of aspiration or regurgitation), problems with your gag reflex, electrolyte problems (eg, low blood potassium, sodium, calcium, or magnesium levels), kidney problems, or rectal bleeding of unknown cause if you have nausea, vomiting, or undiagnosed stomach pain if you have a history of heart problems (eg, irregular heartbeat, congestive heart failure, angina) or a recent heart attack if you have a history of seizures, alcohol use, or you are currently in withdrawal from alcohol or certain other substances (eg, benzodiazepines)

Some MEDICINES MAY INTERACT with HalfLytely Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Tricyclic antidepressants (eg, amitriptyline) because the risk of seizures may be increased Angiotensin converting enzyme (ACE) inhibitors (eg, lisinopril), angiotensin receptor blockers (ARBs) (eg, losartan), diuretics (eg, furosemide, hydrochlorothiazide), or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen) because they may increase the risk of HalfLytely Solution's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if HalfLytely Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use HalfLytely Solution:

Use HalfLytely Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

HalfLytely Solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get HalfLytely Solution refilled. For best results, do not eat solid food or drink milk on the day that you use HalfLytely Solution. Drink only clear liquids and do not eat any solid foods from the time you start HalfLytely Solution until your procedure is complete. Some of these products come with a Flavor Pack. If this product comes with a Flavor Pack and you wish to use it, add the contents of the Flavor Pack into the bottle before you add the water. If you do not use the Flavor Pack, throw it away. To mix the solution, fill the container with the amount of water indicated on the package label. Use lukewarm water to mix HalfLytely Solution to help the medicine dissolve faster. Shake well. Chilling HalfLytely Solution improves the taste. Do not add sugar, sweetening agents, or other additives to HalfLytely Solution. To use the bisacodyl tablet - Swallow the tablet with water unless your doctor instructs you otherwise. Swallow the tablet whole. Do not break, crush, or chew before swallowing. Do not take an antacid within 1 hour before you take the tablet. The first bowel movement should occur about 1 to 6 hours after you take the tablet. Wait until a bowel movement occurs (or a maximum of 6 hours) and then begin drinking the solution, unless your doctor has given you different instructions. To use the polyethylene glycol/electrolytes solution - Shake well before each use. Unless your doctor has given you different instructions, drink 8 ounces (240 mL) of the solution every 10 minutes until it is completely gone. It is best to drink each portion quickly rather than sipping it. Rinsing your mouth with mouthwash after each glass of medicine may help get rid of the taste. Other medicines taken by mouth within 1 hour of the start of the solution may not be absorbed or be effective. Contact your doctor or pharmacist with any concerns you might have about taking your other medicines. If you miss a dose of HalfLytely Solution, take it as soon as you remember. Continue to take it as directed by your doctor. Notify your doctor right away if you are unable to finish taking HalfLytely Solution before your test.

Ask your health care provider any questions you may have about how to use HalfLytely Solution.

Important safety information: The first bowel movement usually occurs about 1 hour after you begin drinking HalfLytely Solution. If you experience stomach discomfort, pain, or bloating, you may need to stop the solution for a short time or allow a longer time between doses. Check with your doctor or pharmacist for more information. Notify your doctor right away if you are unable to finish taking HalfLytely Solution before your test. Keep all doctor and lab appointments while you are taking HalfLytely Solution. Do not drink large amounts of water during or after preparation for colonoscopy. Discuss any questions or concerns with your doctor. Do not take other laxatives while you are using HalfLytely Solution. Discuss any questions with your doctor or pharmacist. Use HalfLytely Solution with caution in patients who are unconscious or partially conscious because they may be at greater risk for vomiting and inhaling HalfLytely Solution. Use HalfLytely Solution with caution in the ELDERLY; they may be more sensitive to its effects. HalfLytely Solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using HalfLytely Solution while you are pregnant. It is not known if HalfLytely Solution is found in breast milk. If you are or will be breast-feeding while you use HalfLytely Solution, check with your doctor. Discuss any possible risks to your baby. Possible side effects of HalfLytely Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloating; lightheadedness; nausea; rectal irritation; stomach fullness, cramps, or discomfort; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; chest pain; confusion; decreased urination; fainting; muscle weakness or cramping; persistent or severe nausea or vomiting; rectal bleeding; seizures; severe bloating or abdominal swelling; severe stomach pain; slow or irregular heartbeat; symptoms of dehydration (eg, very dry mouth or eyes, increased thirst, fast heartbeat, dizziness, headache); vomiting of blood.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: HalfLytely side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of HalfLytely Solution:

Store the tablet and the powder for solution (before mixing) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. After mixing the solution, store it in the refrigerator in a tightly closed container. Use the solution within 48 hours. Discard any unused portion of HalfLytely Solution. Keep HalfLytely Solution out of the reach of children and away from pets.

General information: If you have any questions about HalfLytely Solution, please talk with your doctor, pharmacist, or other health care provider. HalfLytely Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about HalfLytely Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More HalfLytely resources HalfLytely Side Effects (in more detail) HalfLytely Use in Pregnancy & Breastfeeding HalfLytely Drug Interactions HalfLytely Support Group 2 Reviews for HalfLytely - Add your own review/rating Compare HalfLytely with other medications Bowel Preparation

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HalfLytely Solution

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