Topamax Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Topiramate

Indications/Uses

Monotherapy in patients w/ newly diagnosed epilepsy or for conversion to monotherapy in patients w/ epilepsy. Adjunctive therapy in patients w/ partial onset seizures or generalized tonic-clonic seizures, seizures associated w/ Lennox-Gastaut syndrome. Prophylaxis of migraine headache in adults.

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Dosage/Direction for Use

Adjunctive therapy epilepsy Adult Initially 25-50 mg nightly for 1 wk. Subsequently at wkly or bi-wkly intervals, increase dose to 25-50 (to 100) mg daily in 2 divided doses. Childn ≥2 yr Approx 5-9 mg/kg daily in 2 divided doses. Titrate at ≤25 mg (based on range of 1-3 mg/kg daily) nightly for the 1st wk. Subsequently at 1 or 2 wkly intervals, w/ increments of 1-3 mg/kg daily in 2 divided doses. Monotherapy epilepsy Adult Titrate at 25 mg nightly for 1 wk. Subsequently at 1 or 2 wkly intervals, increase dose by increments of 25 or 50 mg daily in 2 divided doses. Initial target dose: 100 mg daily. Max: 500 mg. Childn ≥2 yr Initially at 0.5-1 mg/kg daily nightly for the 1st wk. Subsequently at 1 or 2 wkly intervals, increase dose by increments of 0.5-1 mg/kg daily in 2 divided doses. Initial target dose: 3-6 mg/kg daily. Prophylaxis of migraine Initially 25 mg nightly for 1 wk, then increased at 25 mg daily increments at 1-wk intervals. Recommended total daily dose: 100 mg in 2 divided doses.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity.

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Special Precautions

Predisposition to or history of nephrolithiasis; ensure adequate hydration. Signs of suicidal ideation & behaviour. Acute myopia associated w/ secondary angle-closure glaucoma. Mood disturbance/depression. Serious skin reactions. Hyperammonemia & encephalopathy. Visual field defects. Monitor serum bicarbonate level. W/draw gradually. May affect ability to drive or operate machinery. Renal or hepatic impairment. Women of childbearing potential. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Somnolence, dizziness, fatigue, irritability, increased/decreased wt, decreased appetite, bradyphrenia, paresthesia, diplopia, nausea, nystagmus, lethargy, anorexia, rash, dysarthria, blurred vision, abnormal coordination or behavior, aggression, attention disturbance, memory impairment, diarrhea, constipation, nasopharyngitis, balance disorder, depression, anxiety, asthenia, dysgeusia, hypoesthesia, pyrexia, alopecia, insomnia, expressive language disorder.

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Drug Interactions

Decreased plasma conc by phenytoin & carbamazepine. Increased C_max & AUC w/ propranolol, hydrochlorothiazide. Increased AUC w/ diltiazem. Not to be used concomitantly w/ alcohol, CNS depressants. Possible decreased contraceptive efficacy & increased breakthrough bleeding w/ OCs. Monitor lithium levels. Increased risk of nephrolithiasis w/ other agents predisposing to nephrolithiasis. hyperammonemia w/ or w/o encephalopathy in concomitant use of valproic acid. Decreased prothrombin time/INR w/ vit K-antagonist anticoagulant medications.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Topamax detailed prescribing information

Storage

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Description

View Topamax description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Anticonvulsants / Antimigraine Preparations

ATC Classification

N03AX11 - topiramate ; Belongs to the class of other antiepileptics.

Regulatory Classification

Presentation/Packing

Form

Topamax tab 100 mg

Packing/Price

60's

Form

Topamax tab 25 mg

Packing/Price

60's

Form

Topamax tab 50 mg

Packing/Price

60's

Topamax

topiramate

Manufacturer:

Janssen

Distributor:

Zuellig Pharma