Topamax

Topamax

topiramate

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
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.
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.
Administration
May be taken with or without food.
Contraindications
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.
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.
Drug Interactions
Decreased plasma conc by phenytoin & carbamazepine. Increased Cmax & 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.
MIMS Class
Anticonvulsants / Antimigraine Preparations
ATC Classification
N03AX11 - topiramate ; Belongs to the class of other antiepileptics.
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
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