Epimate-50

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.

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 nightly 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 thereafter is about 5-9 mg/kg/day given in 2 divided doses, up to 30 mg/kg/day. Childn ≥6 yr Epilepsy Monotherapy: 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 Supplemental dose: 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

Hypersensitivity.

Adequate hydration is recommended. Mood disturbances &/or depression may occur. Increased risk of suicidal thoughts or behavior. Increased risk of renal stone formation in patients w/ predisposing risk factors to & w/ family history of nephrolithiasis & patients w/ hypercalciuria. Rare reports of acute myopia w/ secondary angle-closure glaucoma. Associated w/ metabolic acidosis. Monitor baseline & periodic serum bicarbonate levels during treatment. Gradually w/draw to minimize potential seizure or increased seizure frequency in patients w/ or w/o history of epilepsy/seizure. May cause dizziness, drowsiness, visual disturbances &/or blurred vision which may potentially affect ability to drive or operate machinery. Caution in patients w/ hepatic impairment. Increased risk of developing cleft lip &/or palate in infants born to women treated w/ topiramate during pregnancy. Should only be used during pregnancy if potential benefit outweighs potential risk. Not recommended during lactation.

Fatigue, decrease in wt, paresthesia, anorexia, somnolence & mood/behavior disturbances.

Decreased plasma conc w/ phenytoin & carbamazepine. Decreased plasma conc of digoxin & pioglitazone. Potential additive CNS depression & other cognitive &/or neuropsychiatric effects w/ CNS depressants. Increased plasma clearance of estrogenic component of OCs. Increased risk of renal stone formation w/ other carbonic anhydrase inhibitors eg, acetazolamide or dichlorphenamide. Reduced lithium exposure w/ topiramate 200 mg daily dose. Reduced systemic exposure of risperidone & glyburide. Increased plasma conc of metformin. Increased conc w/ hydrochlorothiazide.

Anticonvulsants / Antimigraine Preparations

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

Rx