Concise Prescribing Info
Monotherapy in adults & childn w/ newly diagnosed epilepsy. Adjunctive therapy in adults & childn <2 yr for refractory partial seizures w/ or w/o secondary generalization, seizures associated w/ Lennox-Gastaut syndrome & primary generalized tonic-clonic seizures. Treatment & prophylaxis of migraine headache in adults.
Dosage/Direction for Use
Adult Epilepsy 25 mg once daily for 1 wk, increased thereafter by increments of 25-50 mg at 1-2 wk intervals. Daily dose >25 mg should be taken in 2 divided doses. Adjunctive therapy: 200-400 mg, up to 800 mg daily. Monotherapy: 100-400 mg daily. Migraine 25 mg/day for 1st wk, & increased thereafter by increments of 25 mg. Dosage >25 mg should be taken in 2 divided doses. Usual dose: 100 mg. Childn 2-16 yr Epilepsy Adjunctive therapy: 25 mg nightly for the 1st wk, increased by increments of 1-3 mg/kg/day at 1-2 wk interval. Recommended dose: 5-9 mg/kg/day given in 2 doses, up to 30 mg/kg/day. Monotherapy: Childn ≥6 yr Initially 0.5-1 mg/kg at night for the 1st wk, increased by increments of 0.5-1 mg/kg/day at 1-2 wk intervals. Usual dose: 3-6 mg/kg/day in 2 divided doses. Patient w/ renal impairment: CrCl <70 mL/min/1.73 m2 ½ of adult dose. Patient undergoing hemodialysis ½ of daily dose in divided doses at the start & finish of the procedure.
May be taken with or without food: Swallow whole, do not chew/crush
Special Precautions
Acute myopia w/ secondary angle-closure glaucoma. Appropriate measures to reduce IOP. Decreased sweating & hyperthermia particularly in children. Correcting w/ alkali therapy may be appropriate for metabolic acidosis. Concomitant use w/ other drugs eg, carbonic anhydrase inhibitors & antimuscarinics. Monitor baseline & periodic serum bicarbonate levels during treatment. Avoid abrupt withdrawal. Adequate hydration is recommended. Renal or hepatic impairment. Pregnancy (Increased risk of developing cleft lip &/or palate in infants).
Adverse Reactions
Ataxia, impaired conc, confusion, dizziness, fatigue, paraesthesia, drowsiness, difficulties w/ memory or cognition; agitation, anxiety, nervousness, emotional lability (w/ mood disorders), depression. Abdominal pain, anorexia, asthenia, diplopia, leucopenia, nausea, nystagmus, insomnia, psychomotor retardation, impaired speech, altered taste, visual disturbances & wt loss.
Drug Interactions
Decreased plasma conc w/ phenytoin & carbamazepine. Potential to cause CNS depression & other cognitive &/or neuropsychiatric effects w/ alcohol & CNS depressants. Increased plasma clearance of estrogenic component w/ OCs. Increased risk of renal stone formation w/ other carbonic anhydrase inhibitors eg, acetazolamide or dichlorophenamide.
ATC Classification
N03AX11 - topiramate ; Belongs to the class of other antiepileptics.
Epimate-50 FC tab 50 mg
100's (P5,100/pack)
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