TRADOREC XL® 100 mg, 200mg and 300mg prolonged-release tablets

1. Name Of The Medicinal Product

TRADOREC XL® 100 mg prolonged-release tablets

TRADOREC XL® 200 mg prolonged-release tablets

TRADOREC XL® 300 mg prolonged-release tablets

2. Qualitative And Quantitative Composition

One prolonged-release tablet contains 100mg, 200mg or 300mg tramadol hydrochloride

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Prolonged-release tablet.

White to off white, plain, bevelled edge, round biconvex tablet

4. Clinical Particulars 4.1 Therapeutic Indications

Treatment of moderate to severe pain.

4.2 Posology And Method Of Administration

The dosage should be adjusted according to the severity of pain and the response of the individual patient.

The tablets should be swallowed whole, with a sufficient quantity of liquid and not divided or chewed. The tablets can be taken with or without food.

Alternative tablet strengths of TRADOREC XL® are available. Where necessary, appropriate tablet strengths should be used to achieve the required dose.

TRADOREC XL® should be taken once every 24 hours as follows:

Adults and adolescents (12 years and over):

The starting dose is one 100 mg prolonged-release tablet once daily. The usual dose is one 200 mg prolonged-release tablet once daily, to be taken preferably in the evening. If this does not provide sufficient pain relief, the dosage can be increased in 100 mg dose increments to 300 mg or to a maximum of 400 mg once daily.

In general, the lowest effective analgesic dose should be chosen. A daily dose of 400mg of tramadol should not be exceeded except in special clinical cases.

TRADOREC XL® should not be used for a period longer than absolutely necessary. If continued pain treatment is necessary due to the nature and severity of the illness, careful regular surveillance should be carried out (including periods without treatment, if necessary) in order to determine the need for continued treatment.

Children (under 12):

TRADOREC XL® is not recommended for the treatment of children (under 12 years of age).

Elderly patients:

Dose adjustment in elderly patients (up to 75 years of age) without clinically relevant hepatic or renal impairment is normally not necessary. In patients over 75 years, the elimination half-life of tramadol may be prolonged. Use in these patients is not recommended.

Renal impairment, dialysis and hepatic impairment:

TRADOREC XL® is not recommended for patients with severe hepatic impairment or with severe renal impairment (creatinine clearance <10 ml/min, see section 4.3). Caution is advised in patients with moderate hepatic or moderate renal impairment (creatinine clearance <30 ml/min) (see section 4.5).

4.3 Contraindications

Known hypersensitivity to tramadol or to any of the excipients.

Acute intoxication or overdose with CNS depressants (alcohol, hypnotics, other opioid analgesics, etc.).

Patients receiving concomitant treatment with MAO inhibitors or who have been treated with MAO inhibitors during the past 2 weeks (see section 4.5).

Concomitant treatment with linezolid (see section 4.5).

Severe hepatic or severe renal impairment (creatinine clearance < 10ml/min).

Epilepsy not adequately controlled by treatment. (See section 4.4).

Tramadol must not be administered during breastfeeding if long-term treatment, i.e. more than 2 to 3 days, is necessary (see section 4.6).

4.4 Special Warnings And Precautions For Use

Consumption of alcohol is not recommended during treatment with tramadol. Concomitant treatment with carbamazepine is not recommended (see section 4.5).

Warnings:

Tramadol has a low potential for dependence. However, with long-term use, tolerance and psychological and/or physical dependence may develop. At therapeutic doses, withdrawal symptoms have been reported with a frequency of 1 in 8,000 while reports of dependence and abuse have been less frequent.

Because of the potential for dependence or withdrawal to occur, the clinical need for continued analgesia should be reviewed regularly. In patients with a tendency to drug abuse or dependence, tramadol should only be used for short periods under strict medical surveillance.

Tramadol is not suitable as a substitute in opioid dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms.

Respiratory depression or patient taking CNS depressants:

Caution is recommended with administration of tramadol in patients at risk for respiratory depression or receiving medicinal products likely to produce respiratory depression.

Precautions:

Tramadol should be used with caution in patients with head trauma, increased intracranial pressure, impairment of hepatic or renal function, in patients in shock, an altered state of consciousness (with no obvious cause), respiratory centre disorders or respiratory dysfunction.

There is an increased risk of seizures if the tramadol dose exceeds the maximum recommended daily dose (400 mg). Seizures have been reported at the therapeutic doses. Patients with controlled epilepsy or patients with a known risk of seizure should only be treated with tramadol in cases of absolute necessity. There is an increased risk of seizures in patients taking concomitant medications which lower the seizure threshold (see section 4.5).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant medication contraindicated during treatment with tramadol

Tramadol must not be used in combination with selective or nonselective MAO inhibitors. Serotonin Syndrome (diarrhoea, tachycardia, sweating, tremor, confusion and coma) may develop (see section 4.3).

Linezolid: Treatment experience with non-selective MAOI indicates a risk of development of Serotonin Syndrome: diarrhoea, tachycardia, sweating, tremor, confusion and coma.

Concomitant medication not recommended during treatment with tramadol

Mixed agonist-antagonists (buprenorphine, nalbuphine and pentazocine): Concomitant treatment with tramadol is not recommended because theoretically, this could reduce the analgesic effects of the pure agonist due to competitive blocking of receptors, resulting in the risk of occurrence of withdrawal symptoms.

Alcohol: Alcohol increases the sedative effect of opioid analgesics. The resulting drowsiness can be dangerous while driving or operating machinery. Alcoholic beverages and medicinal products containing alcohol should not be consumed during treatment with tramadol (see section 4.7).

Carbamazepine (enzyme inducer): Possibility of decreased plasma concentrations of tramadol and its pharmacologically active metabolite, resulting in reduction of the analgesic effect.

Naltrexone: Use of tramadol with naltrexone may reduce the analgesic effect. If necessary the analgesic dose can be increased.

Concomitant medication to be used with care during tramadol treatment

Other morphine derivatives (including antitussives and substitution treatments) benzodiazepines, barbiturates: Major risk of respiratory depression, can be fatal in case of overdose.

Other CNS depressants: Opioid analgesics, barbiturates, benzodiazepines, sedative antidepressants, sedative H1 antihistamines, anxiolytics other than benzodiazepines, hypnotics, neuroleptics, centrally acting antihypertensives, thalidomide, baclophene: Increased risk of central nervous system depression. The resulting impaired reaction time can make driving and operating machinery dangerous.

Selective serotonin re-uptake inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) and anti-depressants: Risk of convulsions and/or serotonin syndrome.

Medicinal products that reduce seizure threshold, notably tricyclic antidepressants (imipramines), selective serotonin re-uptake inhibitors (SSRIs), neuroleptic antidepressants (phenothiazine, butyrophenone), mefloquine, bupropion: Increased risk of convulsions.

Venlafaxine: Risk of convulsions and/or Serotonin Syndrome.

Caution should be exercised during concomitant treatment with tramadol and coumarin derivatives (e.g. warfarin) due to reports of increased INR and ecchymoses in some patients.

4.6 Pregnancy And Lactation

Pregnancy:

Tramadol should not be used during pregnancy unless clearly necessary. In humans, there is insufficient data available to appropriately assess the safety of tramadol use in pregnant women.

As with other opioid analgesics:

- Tramadol crosses the placental barrier.

- Chronic use of tramadol may induce – at any dosage – a withdrawal syndrome in newborns.

- At the end of pregnancy, high dosages, even for short-term treatment, may induce respiratory depression in the newborn.

Animal studies have not shown any teratogenic effects, but at high doses, foetotoxicity due to maternotoxicity appeared (see Section 5.3).

Lactation:

Tramadol and its metabolites have been detected in human breast milk in small amounts. An infant could ingest 0.1% of the single dose given to the mother. A single administration of tramadol does not usually require breastfeeding to be interrupted. If repeated administration is needed for several days, i.e. more than 2 to 3 days, breastfeeding should be suspended. If long-term treatment after birth is necessary, breastfeeding is contraindicated (see Section 4.3).

4.7 Effects On Ability To Drive And Use Machines

Tramadol may cause dizziness and/or drowsiness and has, even when used according to the directions, an influence on the ability to drive and use machines. This effect may occur at the beginning of treatment, and may be potentiated by alcohol and concomitant use of other CNS-depressants or antihistamines. If patients are affected they should be warned not to drive or operate machinery.

4.8 Undesirable Effects

The most commonly reported undesirable effects, nausea and dizziness, have been observed in more than 10% of patients.

Cardiac disorders

Uncommon (

Nervous system disorders

Very common (

Common (

Rare (

Respiratory depression may occur if the quantities administered greatly exceed the recommended doses and in the case of concomitant administration of other CNS depressant medicinal products. (See section 4.5).

Epileptiform seizures primarily occurred following administration of high doses of tramadol or following concomitant treatment with medicinal products that lower the seizure threshold or trigger seizures. (See sections 4.4 and 4.5).

Psychiatric disorders

Rare (

After the administration of tramadol, in rare cases, various psychiatric adverse events may occur, the nature and severity of which vary between patients (depending on the individual reactivity and the duration of treatment). Mood disorders (usually euphoria, occasionally dysphoria), changes in activity (usually reduced activity, occasionally an increase) and, altered cognitive and sensory capacities (for example the ability to make decisions, perception problems) may be observed. Dependence may occur.

Eye disorders

Rare (

Respiratory, thoracic and mediastinal disorders

An aggravation of asthma has been reported although a causal relationship was not confirmed.

Gastrointestinal disorders

Very common (

Common (

Uncommon (

Skin and subcutaneous tissue disorders

Common (

Uncommon (

Musculoskeletal and connective tissue disorders

Rare (

Hepatobiliary disorders

In some isolated cases, an increase in hepatic enzymes was reported during the therapeutic use of tramadol.

Renal and urinary disorders

Rare (

General disorders and administration site conditions

Rare (

4.9 Overdose

Symptoms

In tramadol intoxication, in principle, the same symptoms occur as for all other central acting analgesics (opioids). In particular, these include miosis, vomiting, cardiovascular collapse, loss of consciousness leading to coma, convulsions, respiratory depression leading to respiratory failure.

Treatment

General emergency measures are applicable: including maintenance of respiratory and cardiocirculatory functions.

Emptying of the stomach by means of vomiting (patient to be conscious) or by means of pumping the stomach. Gastric lavage can be considered if the ingestion of overdose is very recent. This must not delay the (repeated) administration of activated charcoal to prevent the absorption of tramadol.The antidote for respiratory depression is naloxone. There is a risk of increased convulsions with the use of naloxone. In animal tests naloxone proved to be ineffective against convulsions. In that case diazepam should be administered intravenously.

Tramadol is only minimally removed from plasma using haemodialysis or haemofiltration. Therefore treatment of acute overdose of tramadol using haemodialysis or haemofiltration alone is not a suitable way of detoxification.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Analgesics, Other opioids

ATC code: N02A X02

Tramadol is a centrally acting analgesic. It is a pure non-selective µ, delta and k morphine receptor agonist with a higher affinity for µ receptors. Other mechanisms responsible for the product's analgesic effects include the inhibition of the neuronal re-uptake of noradrenalin and an increase in serotonin release.

Tramadol has an antitussive effect. Unlike morphine, broad ranges of analgesic tramadol doses do not have any respiratory depressant effect. Nor is there any effect on gastro-intestinal motility. The effects on the cardiovascular system tend to be slight. Tramadol has 1/10 to 1/6 the potency of morphine.

5.2 Pharmacokinetic Properties

Following oral administration of a single dose, TRADOREC XL® is almost completely absorbed (>90%).

The absolute bioavailability is approximately 70%, independent of food intake. The difference between the tramadol absorbed and the non-metabolised available tramadol is probably due to a weak first-pass effect. The first-pass effect following oral administration is a maximum of 30%.

Tramadol has a high tissue affinity (volume of distribution = 203 ± 40 litres). Approximately 20% is bound to plasma proteins.

Following single-dose administration of one 200 mg TRADOREC XL® prolonged- release tablet, in a fasted state, a mean maximum plasma concentration (Cmax) of 241 ± 62 ng/ml is reached after a median time (tmax) of 6.0 hours.

Tramadol crosses the blood-brain barrier and the placenta. Very small quantities of the active substance and its O-demethylated derivative have been found in breast milk (0.1% and 0.02% of the administered dose respectively).

The elimination half-life is approximately 6 hours, regardless of route of administration. The half life can be prolonged by a factor of approximately 1.4 in patients over 75 years of age.

In man, tramadol is extensively metabolised by N- and O-demethylation and by conjugation of the O-demethylation products with glucuronic acid. Only the O-desmethyltramadol metabolite is pharmacologically active. Considerable quantitative inter-individual differences have been observed between the other metabolites: 11 different metabolites have been identified to date in urine. Tests on animals showed that O-desmethyltramadol is more potent than the parent molecule by a factor of 2 to 4. Its half life (6 healthy volunteers) is 7.9 hours (range 5.4 to 9.6 hours), similar to that of tramadol.

The inhibition of cytochrome CYP3A4 and/or CYP2D6, the isozymes responsible for biotransformation of tramadol could modify the plasma concentration of tramadol or its active metabolite. To date, no clinically significant interactions have been observed. Tramadol and its metabolites are almost wholly excreted in urine. Cumulative urinary excretion accounts for 90% of the total radioactivity of the administered dose. The half-life may be slightly longer in the case of hepatic or renal impairment. In patients with liver cirrhosis, an elimination half-life of 13.3 ± 4.9 hours (tramadol) and 18.5 ± 9.4 hours (O-desmethyltramadol) has been observed, with one extreme case of elimination half-lives of 22.3 and 36 hours respectively. In renal insufficiency (creatinine clearance < 5 ml/min), elimination half-lives of 11 ± 3.2 and 16.9 ± 3 hours respectively have been observed, with one extreme case of 19.5 and 43.2 hours respectively. TRADOREC XL® presents a linear pharmacokinetic profile within the recommended therapeutic dosing regimen.

The relationship between serum concentration and analgesic effect is dose-dependent but varies considerably between individuals. A serum concentration of 100 ng/ml to 300 ng/ml is usually effective.

5.3 Preclinical Safety Data

Preclinical data reveal no special risk for clinical use based on acute toxicity, repeated dose toxicity, genotoxicity, carcinogenicity and reproductive toxicity studies. Animal studies have not shown any teratogenic effects, but at high doses, foetotoxicity due to maternotoxicity appeared.

In rats, doses of tramadol greater than or equal to 50 mg/kg/day caused toxic effects in pregnant animals and an increase in neonatal mortality. Retarded growth in the form of abnormal ossification and delayed vaginal and ocular opening were observed in the progeny. There was no change in the fertility of male animals. After higher doses (

In rabbits, toxic effects were revealed in the mothers and skeletal abnormalities in the progeny above doses of 125 mg/kg. Signs indicating a mutagenic effect were found in certain in vitro tests but in vivo studies did not show any such effects. Based on findings to date, tramadol can be regarded as non mutagenic.

Studies were conducted in rats and mice on the carcinogenic potential of tramadol hydrochloride. The study in rats did not show any indication of an increased frequency of tumours linked to the active ingredient. In the study on mice, an increased frequency of hepatocellular adenomas was observed in male animals (non significant dose-dependent increase above 15 mg/kg) and an increase in pulmonary tumours in females for all dosage groups (significant but non dose-dependent increase).

6. Pharmaceutical Particulars 6.1 List Of Excipients

Polyvinyl acetate, povidone, sodium laury sulphate and silica (Kollidon SR),

xanthan gum,

hydrogenated vegetable oil (Cotton seed oil),

magnesium stearate,

silica colloidal anhydrous,

Hydroxypropyl Distarch Phosphate – (E1442) (Contramid)

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Blisters: Do not store above 30°C.

HDPE Bottles: This medicinal product does not require any special storage conditions

6.5 Nature And Contents Of Container

TRADOREC XL 100 mg and 200mg:

PVC/PVDC blisters with Aluminium backing foil (containing 5, 10, 15, 20, 30, 50, 60 or 100 prolonged-release tablets) or

PVC/PE/PCTFE blisters with Aluminium backing foil (containing 5, 10, 15, 30, 60 or 100 prolonged-release tablets) or

HDPE Bottles containing 100 prolonged-release tablets

TRADOREC XL 300 mg:

PVC/PE/PCTFE blisters with Aluminium backing foil (containing 5, 10, 15, 20, 30, 50, 60 or 100 prolonged-release tablets) or

HDPE Bottles containing 100 prolonged–release tablets

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

LABOPHARM Europe Limited

5, The Seapoint Building

44 Clontarf Road Dublin 3,

IRELAND

8. Marketing Authorisation Number(S)

TRADOREC XL® 100 mg: PL 23232/0007

TRADOREC XL® 200 mg: PL 23232/0008

TRADOREC XL® 300 mg: PL 23232/0009

9. Date Of First Authorisation/Renewal Of The Authorisation

19 February 2010

10. Date Of Revision Of The Text

26 February 2010

LEGAL CATEGORY

POM

SPC.TRA.10.UK.3257.REN

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Urispas 200

Urispas 200mg Film-coated tablets

Flavoxate hydrochloride

Please read this leaflet carefully before you start to take your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

What is Urispas 200mg Film-coated Tablets?

Urispas 200mg Film-coated Tablets contain the active ingredient flavoxate hydrochloride.

Flavoxate hydrochloride is one of a group of drugs called antispasmodics which relieve or prevent muscle spasms including spasms of the urinary tract. Urispas has also been shown to relieve pain.

Urispas 200mg Film-coated Tablets also contain the ingredients lactose, sodium starch glycollate, povidone, talc, cellulose microcrystalline, magnesium stearate, hypromellose, macrogol, macrogol stearate and titanium dioxide (E171).

Each white, film coated tablet is embossed with 'F 200' and contains 200mg flavoxate hydrochloride.

The pack contains 90 tablets, which is enough for about 4 weeks treatment at the normal dose of one tablet three times a day.

The Marketing Authorisation holder is

Recordati Pharmaceuticals
Isis House
43 Station Rd
Henley on Thames
OXON
RG9 1AT
Tel: 01491 576336
What is Urispas 200mg Film-coated Tablets used for?

Urispas is used to treat conditions which cause muscle spasms of the urinary tract. These muscle spasms may be due to inflammation of the bladder, prostate gland or urethra (tube from bladder to outside). In addition, Urispas can be used to treat the symptoms which may occur as a result of surgery, cystoscopy or catheterisation such as painful urination, excessive urination at night and the inability to control urine flow.

If you have a urine infection as well, your doctor will probably also prescribe medicine to treat this at the same time.

When must Urispas not be used?

If you have a condition which causes a blockage of the stomach, bowel or urinary tract or if you suffer from bleeding from the stomach or bowel.

If you are allergic to Urispas 200mg Film-coated Tablets or any of the ingredients they contain.

In children under 12 years of age.

When should you be extra careful while taking Urispas 200mg Film-coated Tablets?

Make sure your doctor knows if you have, or suspects you have, the eye condition glaucoma.

This medicine may cause drowsiness, blurred vision or dizziness. If it does you should not operate a motor vehicle or machinery.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

May Urispas be used during pregnancy or while breast feeding?

Before starting treatment, tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. Your doctor will then decide whether you should take the medicine.

Many drugs pass into breast milk, therefore, if you are breast feeding, this medicine should be avoided. Your doctor will be able to discuss this with you.

How should Urispas 200mg Film-coated Tablets be taken?

Always take the tablets as your doctor tells you to. A normal dose is one tablet three times a day for as long as is required.

If you take too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.

If you forget to take your tablets:

Take the normal dose when you remember unless it is almost time for your next dose.

DO NOT TAKE A DOUBLE DOSE OF TABLETS TO MAKE UP FOR A MISSED DOSE.

What are the possible unwanted effects of Urispas 200mg Film-coated Tablets?

In addition to the beneficial effects of Urispas, it is possible that unwanted effects will occur during treatment such as:

feeling or being sick, dry mouth or diarrhoea. indigestion or difficulty swallowing. vertigo, headache, confusion (especially in the elderly), drowsiness, tiredness, dizziness or nervousness. allergic reaction such as rash, itching, skin redness, sneezing, difficulty in breathing and swelling of the throat. if any of these occur stop taking the tablets and see your doctor immediately. heart beat irregularities. disturbances to your vision or eye pain. painful urination. low white blood cell count.

If you are concerned about these or any other unwanted effects, talk to your doctor.

How should Urispas 200mg Film-coated Tablets be stored?

Do not store above 30°C. In order to protect your medicine from light, keep the blister strips in the outer carton.

Keep this medicine out of the reach and sight of children.

This medicine must not be used after the expiry date printed on the pack. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to.

REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.

Further Information

You can get more information on Urispas 200mg Film-coated Tablets from your doctor or pharmacist.

Date of Preparation: April 2007

41894313 A

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Drug List: Aventyl Benicar Blocadren Botox Calan Calan-Sr-Controlled-Release-Tablets Catapres Catapres-Tts-Patches Corgard Covera-Hs-Sustained-Release-Tablets-Controlled-Onset Depakote Depakote-Er-Extended-Release-Tablets Depakote-Sprinkles Elavil Inderal Inderal-La-Sustained-Release-Capsules Innopran-Xl-Sustained-Release-Bead-Capsules Isoptin Isoptin-Sr-Controlled-Release-Tablets Kemstro Klonopin Klonopin-Wafer-Orally-Disintegrating-Tablets Lioresal Nardil Nimotop Norvasc Pamelor Prinivil Stavzor Tenormin Topamax Topamax-Sprinkle Topiragen Vanatrip Verelan-Sustained-Release-Pellet-Filled-Capsules Verelan-Pm-Sustained-Release-Capsules-Controlled-Onset Vitamin-B2 Zestril Zonegran

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Methylxanthines are bronchodilators used in the treatment of asthma and chronic obstructive pulmonary disease (COPD).

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In the US, Isosorbide (isosorbide mononitrate systemic) is a member of the drug class miscellaneous uncategorized agents.

US matches:

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Isosorbide (BAN, JAN, USAN) is known as Isosorbide in the US.

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Isosorbide Mononitrate is reported as an ingredient of Isosorbide in the following countries:

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International Drug Name Search

Glossary

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See also

Medical conditions associated with calcium channel blocking agents:

Angina Angina Pectoris Prophylaxis Arrhythmia Atrial Fibrillation Atrial Flutter Bipolar Disorder Cluster Headaches Coronary Artery Disease Heart Failure High Blood Pressure Hypertensive Emergency Hypertrophic Cardiomyopathy Idiopathic Hypertrophic Subaortic Stenosis Ischemic Stroke Migraine Prevention Nocturnal Leg Cramps Premature Labor Raynaud's Syndrome Subarachnoid Hemorrhage Supraventricular Tachycardia Drug List: Afeditab-Cr Diltia-Xt-24-Hour-Sustained-Release-Capsules Diltiazem-Hydrochloride-Sr Nimotop Adalat Cartia-Xt-24-Hour-Sustained-Release-Beads-Capsules Calan-Sr-Controlled-Release-Tablets Cardizem Isoptin-Sr-Controlled-Release-Tablets Nifediac-Cc Tiazac Verelan-Pm-Sustained-Release-Capsules-Controlled-Onset Diltiazem-Hydrochloride-Cd Procardia Adalat-Cc-Sustained-Release-Tablets Calan Cardizem-La-24-Hour-Extended-Release-Beads-Tablets Procardia-Xl-Sustained-Release-Tablets Isoptin Nifedical-Xl Cardizem-Cd-24-Hour-Sustained-Release-Beads-Capsules Norvasc Plendil Dynacirc-Cr-Extended-Release-Tablets Verelan-Sustained-Release-Pellet-Filled-Capsules Taztia-Xt-24-Hour-Extended-Release-Beads-Capsules Cardene Cardene-Iv Cardene-Sr-Sustained-Release-Capsules Cleviprex Covera-Hs-Sustained-Release-Tablets-Controlled-Onset Dilacor-Xr-24-Hour-Sustained-Release-Capsules Dilt-Xr-24-Hour-Sustained-Release-Capsules Diltiazem-Hydrochloride-Xr Diltiazem-Hydrochloride-Xt Diltzac Dynacirc Matzim-La Sular-Extended-Release-Tablets Vascor

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Hypomagnesemia Medications

Definition of Hypomagnesemia: Hypomagnesemia means low serum levels of magnesium. It may result from a number of conditions including chronicdiarrhea, chronic vomiting, hyperaldosteronism, celiac disease, and others.

Drugs associated with Hypomagnesemia

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

Learn more about Hypomagnesemia

Medical Encyclopedia:

Hypomagnesemia
Drug List: Chelated-Magnesium Chloromag Epsom-Salt Mag-64 Mag-200 Mag-Caps Mag-G Mag-Ox Mag-Ox-400 Mag-Sr-Sustained-Release-Tablets Mag-Delay Maggel Magonate Magonate-Natal Magtrate Mg-Plus-Protein Slow-Mag-Sustained-Release-Tablets Sulfamag Uro-Mag

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High Cholesterol, Familial Heterozygous Medications

Drugs associated with High Cholesterol, Familial Heterozygous

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

Drug List: Advicor Altocor Altoprev-Extended-Release-Tablets Choloxin Crestor Juvisync Lescol Lescol-Xl-Extended-Release-Tablets Lipitor Mevacor Pravachol Vytorin Zetia Zocor

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Vulvodynia Medications

Definition of Vulvodynia: Vulvodynia is described as chronic vulvar discomfort with complaints of burning and superficial irritation.

Drugs associated with Vulvodynia

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

Drug List: Aventyl Carbatrol-Sustained-Release-Capsules Effexor-Xr-Extended-Release-Capsules Elavil Epitol Fanatrex Gabarone Lexapro Neurontin Norpramin Pamelor Prozac Prozac-Weekly-Delayed-Release-Capsules Rapiflux Tegretol Tegretol-Xr-Sustained-Release-Tablets Topamax Topamax-Sprinkle Topiragen Vanatrip

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Seizure Prevention (Seizure Prophylaxis) Medications

Drugs associated with Seizure Prevention

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

Drug List: Depacon Depakene Diamox Diamox-Sequels-Sustained-Release-Capsules Diastat-Gel Diastat-Acudial-Gel Diastat-Pediatric Diazepam-Intensol-Concentrate Epsom-Salt Klonopin Klonopin-Wafer-Orally-Disintegrating-Tablets Lamictal Lamictal-Cd Lamictal-Odt-Orally-Disintegrating-Tablets Lamictal-Xr-Extended-Release-Tablets Mesantoin Paradione Peganone Sabril Stavzor Sulfamag Topamax Topamax-Sprinkle Topiragen Tranxene Tranxene-Sd-Sustained-Release-Tablets Tranxene-T-Tab Tridione Valium Valrelease

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Atrial Fibrillation Medications

Definition of Atrial Fibrillation:

A condition where there is disorganised electrical conduction in the atria, resulting in ineffective pumping of blood into the ventricle.

Acronym: AF

Drugs associated with Atrial Fibrillation

The following drugs and medications are in some way related to, or used in the treatment of Atrial Fibrillation. 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 Atrial FibrillationPrevention of Thromboembolism in Atrial Fibrillation (24 drugs) Learn more about Atrial Fibrillation

Medical Encyclopedia:

Atrial fibrillation/flutter

Harvard Health Guide:

Symptoms and treatment for Atrial Fibrillation
Drug List:Betapace-AfBreviblocCardizemCardizem-Cd-24-Hour-Sustained-Release-Beads-CapsulesCardizem-La-24-Hour-Extended-Release-Beads-TabletsCartia-Xt-24-Hour-Sustained-Release-Beads-CapsulesCatapresCoregCoreg-Cr-Extended-Release-CapsulesCorvertDigitekDilacor-Xr-24-Hour-Sustained-Release-CapsulesDilt-Xr-24-Hour-Sustained-Release-CapsulesDiltia-Xt-24-Hour-Sustained-Release-CapsulesDiltiazem-Hydrochloride-CdDiltiazem-Hydrochloride-SrDiltiazem-Hydrochloride-XrDiltiazem-Hydrochloride-XtDiltzacLanoxicapsLanoxinLopressorMatzim-LaMetoprolol-Succinate-ErMultaqRythmolRythmol-Sr-Sustained-Release-CapsulesSotalol-Hydrochloride-AfTambocorTiazacToprolXarelto

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Dibenzazepine anticonvulsants

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.

Anticonvulsants are drugs that prevent or reduce the severity and frequency of seizures in various types of epilepsy. The different types of anticonvulsants may act on different receptors in the brain and have different modes of action.

Two mechanisms that appear to be important in anticonvulsants are enhancement of GABA action and inhibition of sodium channel activity. Other mechanisms are inhibition of calcium channels and glutamate receptors.

See also

Medical conditions associated with dibenzazepine anticonvulsants:

AnxietyBipolar DisorderDiabetic Nerve DamageDystoniaEpilepsyLennox-Gastaut SyndromePeripheral NeuropathyReflex Sympathetic Dystrophy SyndromeSchizoaffective DisorderSeizuresTrigeminal NeuralgiaVulvodynia Drug List:BanzelTegretol-Xr-Sustained-Release-TabletsCarbatrol-Sustained-Release-CapsulesEpitolTrileptalTegretolEquetro

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Urinary Incontinence Medications

Definition of Urinary Incontinence:

Incontinence is the inability to control the passage of urine. This can range from an occasional leakage of urine, to a complete inability to hold any urine.

The three main types of urinary incontinence are:

Stress incontinence -- occurs during certain activities like coughing, sneezing, laughing, or exercise.

Stress incontinence is a bladder storage problem in which the strength of the muscles (urethral sphincter) that help control urination is reduced. The sphincter is not able to prevent urine flow when there is increased pressure from the abdomen.

Stress incontinence may occur as a result of weakened pelvic muscles that support the bladder and urethra or because of a malfunction of the urethral sphincter.

Treatment for stress incontinence may include behavioral changes, medication, pelvic floor muscle training or surgery.

Urge incontinence -- involves a strong, sudden need to urinate followed by instant bladder contraction and involuntary loss of urine. You don't have enough time between when you recognize the need to urinate and when you actually do urinate.

In most cases of urge incontinence, no specific cause can be identified.Although urge incontinence may occur in anyone at any age, it is more common in women and the elderly.

Treatment for urge incontinence may include medication, retraining, and surgery.

Mixed incontinence -- contains components of both stress and urge incontinence.

Drugs associated with Urinary Incontinence

The following drugs and medications are in some way related to, or used in the treatment of Urinary Incontinence. 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 Urinary IncontinenceOveractive Bladder (18 drugs) Learn more about Urinary Incontinence

Medical Encyclopedia:

Urinary incontinence

Harvard Health Guide:

Symptoms and treatment for Urinary Incontinence
Drug List:A-SpazAnaspazAzo-CranberryBotoxColidrops-DropsCymbaltaCystospazDetrolDetrol-La-Extended-Release-CapsulesDitropanDitropan-Xl-Extended-Release-TabletsEd-SpazElavilEnablexGelniqueHyomaxHyomax-DtHyomax-FtHyomax-SlHyomax-SrHyospazHyosyne-DropsIb-Stat-SprayLevbid-Extended-Release-TabletsLevsinLevsin-SlLevsinex-Extended-Release-CapsulesLevsinex-SrNulev-Orally-Disintegrating-TabletsOxytrolSancturaSanctura-Xr-Extended-Release-CapsulesSpasdel-DropsSymax-Duotab-Controlled-Release-TabletsSymax-Fastabs-Orally-Disintegrating-TabletsSymax-SlSymax-Sr-Extended-Release-TabletsToviazUrispasUrotrolVanatripVesicare

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Revascularization Procedures, Prophylaxis Medications

Drugs associated with Revascularization Procedures, Prophylaxis

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

Drug List: Arthritis-Pain Arthritis-Pain-Formula Ascriptin Ascriptin-Maximum-Strength Aspergum-Gum Aspir-81 Aspir-Low Aspirin-Buffered Aspirin-Lite-Coat Aspirin-Low-Dose Aspiritab Bayer Bayer-Plus Bayer-Low-Adult-Strength-Controlled-Release-Tablets Bayer-Aspirin-With-Calcium Buffered-Aspirin Bufferin Bufferin-Arthritis-Strength Bufferin-Extra-Strength Easprin Ecotrin-Delayed-Release-Tablets Ecotrin-Adult-Low-Strength Ecotrin-Maximum-Strength Empirin Fasprin Genacote Halfprin Litecoat-Aspirin Medi-Seltzer-Effervescent-Tablets Norwich-Aspirin Pravachol Pravigard_Pac St-Joseph-Aspirin-Adult-Ec St-Joseph-Aspirin-Adult-Chewable St-Joseph-81-Mg-Adult-Chewable-Tablets Stanback-Analgesic Tri-Buffered-Aspirin Ysp-Aspirin Zorprin-Controlled-Release-Tablets

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Statins

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.

Statins, also known as HMG-CoA reductase inhibitors, inhibit HMG-CoA reductase (3-hydroxy-3-methylglutaryl coenzyme A reductase) an enzyme involved in the synthesis of cholesterol especially in the liver. Decreased cholesterol production leads to an increase in the number of LDL (low density lipoprotein) membrane receptors, which increases clearance of LDL cholesterol from circulation.

Statins are used to treat hyperlipidemia and are the most effective drugs in lowering LDL cholesterol.

See also

Medical conditions associated with statins:

Atherosclerosis Cardiovascular Risk Reduction High Cholesterol High Cholesterol, Familial Heterozygous High Cholesterol, Familial Homozygous Hyperlipoproteinemia Hyperlipoproteinemia Type IIa, Elevated LDL Hyperlipoproteinemia Type IIb, Elevated LDL VLDL Hyperlipoproteinemia Type III, Elevated beta-VLDL IDL Hyperlipoproteinemia Type IV, Elevated VLDL Ischemic Stroke, Prophylaxis Myocardial Infarction, Prophylaxis Prevention of Cardiovascular Disease Revascularization Procedures, Prophylaxis Rheumatoid Arthritis Drug List: Altoprev-Extended-Release-Tablets Lescol Pravachol Lipitor Mevacor Crestor Livalo Zocor Altocor Baycol Lescol-Xl-Extended-Release-Tablets

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Aseptic Necrosis Medications

Definition of Aseptic Necrosis: Aseptic necrosis is bone death caused by poor blood supply to the area. It is most common in the hip, knee, and shoulder.

Drugs associated with Aseptic Necrosis

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

Drug List: A-G-Profen Actiprofen Addaprin Advil Advil-Liqui-Gels Aflaxen Aleve All-Day-Pain-Relief All-Day-Relief Anaprox Anaprox-Ds Arthritis-Pain Aspergum-Gum Aspirin-Lite-Coat Aspiritab Bayer Bayer-Plus Bayer-Aspirin-With-Calcium Buffered-Aspirin Bufferin Bufferin-Arthritis-Strength Bufferin-Extra-Strength Cataflam Comfort-Pac-With-Naproxen Easprin Ec-Naprosyn-Enteric-Coated-Tablets Ecotrin-Delayed-Release-Tablets Ecotrin-Adult-Low-Strength Ecotrin-Maximum-Strength Empirin Fasprin Fosamax Genacote Genpril Halfprin Haltran Ibu Ibu-200 Leader-Naproxen-Sodium Litecoat-Aspirin Medi-Seltzer-Effervescent-Tablets Midol-Extended-Relief Midol-Ib Motrin Motrin-Ib Naprelan-Sustained-Release-Tablets Naprosyn Norwich-Aspirin Nuprin Q-Profen Stanback-Analgesic Tri-Buffered-Aspirin Voltaren Voltaren-Xr-Extended-Release-Tablets Ysp-Aspirin Zorprin-Controlled-Release-Tablets

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Lo-Hist 12 12-Hour Sustained-Release Tablets

Pronunciation: brome-fen-EER-a-meen
Generic Name: Brompheniramine
Brand Name: Examples include Lodrane 12 Hour and Lo-Hist 12
Lo-Hist 12 12-Hour Sustained-Release Tablets are used for:

Treating and preventing symptoms of hay fever, other allergies, and colds. It may also be used for other conditions as determined by your doctor.

Lo-Hist 12 12-Hour Sustained-Release Tablets are an antihistamine. It works by blocking the action of histamine, a chemical released during allergic reactions.

Do NOT use Lo-Hist 12 12-Hour Sustained-Release Tablets if: you are allergic to any ingredient in Lo-Hist 12 12-Hour Sustained-Release Tablets you are breast-feeding you have narrow-angle glaucoma, or a peptic or stomach ulcer you are unable to urinate or you are having an asthma attack you are taking sodium oxybate (GHB) or you have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the past 14 days

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

Before using Lo-Hist 12 12-Hour Sustained-Release Tablets:

Some medical conditions may interact with Lo-Hist 12 12-Hour Sustained-Release Tablets. 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 an enlarged prostate, difficulty urinating or severe constipation if you have an overactive thyroid, asthma, increased pressure in the eyes, glaucoma, heart disease, or high blood pressure

Some MEDICINES MAY INTERACT with Lo-Hist 12 12-Hour Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Barbiturates (eg, phenobarbital), MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because the risk of severe drowsiness may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lo-Hist 12 12-Hour Sustained-Release Tablets 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 Lo-Hist 12 12-Hour Sustained-Release Tablets:

Use Lo-Hist 12 12-Hour Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Lo-Hist 12 12-Hour Sustained-Release Tablets may be taken with food if it upsets your stomach. Swallow whole. Do not break, crush, or chew before swallowing. If you miss a dose of Lo-Hist 12 12-Hour Sustained-Release Tablets, 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 Lo-Hist 12 12-Hour Sustained-Release Tablets.

Important safety information: Lo-Hist 12 12-Hour Sustained-Release Tablets may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Lo-Hist 12 12-Hour Sustained-Release Tablets. Using Lo-Hist 12 12-Hour Sustained-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Lo-Hist 12 12-Hour Sustained-Release Tablets. Lo-Hist 12 12-Hour Sustained-Release Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants. Risk of side effects may be increased with high doses or prolonged use. Do NOT exceed the recommended dose or take Lo-Hist 12 12-Hour Sustained-Release Tablets for longer than prescribed without checking with your doctor. Use Lo-Hist 12 12-Hour Sustained-Release Tablets with caution in the ELDERLY because they may be more sensitive to its effects, especially dizziness, drowsiness, dry mouth, and trouble urinating. Use Lo-Hist 12 12-Hour Sustained-Release Tablets with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed. Lo-Hist 12 12-Hour Sustained-Release Tablets may interfere with results of some lab tests, including allergy skin tests. Inform lab attendants that you are taking Lo-Hist 12 12-Hour Sustained-Release Tablets. PREGNANCY and BREAST-FEEDING: It is unknown if Lo-Hist 12 12-Hour Sustained-Release Tablets can cause harm to the fetus. If you become pregnant while taking Lo-Hist 12 12-Hour Sustained-Release Tablets, discuss with your doctor the benefits and risks of using Lo-Hist 12 12-Hour Sustained-Release Tablets during pregnancy. It is unknown if Lo-Hist 12 12-Hour Sustained-Release Tablets are excreted in breast milk. Do not breast-feed while taking Lo-Hist 12 12-Hour Sustained-Release Tablets. Possible side effects of Lo-Hist 12 12-Hour Sustained-Release Tablets:

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:

Dizziness; drowsiness; dry mouth, throat, and nose; thickening of mucus in nose or throat.

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); fast or irregular heartbeat; fever; mental or mood changes; shortness of breath; sore throat; unusual bleeding or bruising; unusual tiredness or weakness.

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: Lo-Hist2 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. Symptoms may include bizarre behavior; constipation; enlarged pupils; excitement; flushing; hallucinations; seizures; severe dizziness; severe drowsiness.

Proper storage of Lo-Hist 12 12-Hour Sustained-Release Tablets:

Store Lo-Hist 12 12-Hour Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Lo-Hist 12 12-Hour Sustained-Release Tablets out of the reach of children and away from pets.

General information: If you have any questions about Lo-Hist 12 12-Hour Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider. Lo-Hist 12 12-Hour Sustained-Release Tablets are 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 Lo-Hist 12 12-Hour Sustained-Release Tablets. 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 Lo-Hist 12 resources Lo-Hist 12 Side Effects (in more detail) Lo-Hist 12 Use in Pregnancy & Breastfeeding Lo-Hist 12 Drug Interactions Lo-Hist 12 Support Group 0 Reviews for Lo-Hist2 - Add your own review/rating Compare Lo-Hist 12 with other medications Allergic Reactions Cold Symptoms Hay Fever Urticaria

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Lo-Hist 12 12-Hour Sustained-Release Tablets

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