Topamax

Topiramate

Monotherapy in patients w/ newly diagnosed epilepsy or for conversion to monotherapy in patients w/ epilepsy. Adjunctive therapy for adult & childn (≥2 yr) w/ partial onset seizures or generalized tonic-clonic seizures. Adjunctive therapy in seizures associated w/ Lennox-Gastaut syndrome. Migraine headache prophylaxis in adults.

Epilepsy (monotherapy) Adult Initially 25 mg nightly for 1 wk. Increase dose by increments of 25-50 mg daily in 2 divided doses at 1-2 wk intervals. Recommended initial target dose: 100 mg daily. Max recommended daily dose: 500 mg. Childn ≥2 yr Initially 0.5-1 mg/kg nightly for the 1st wk. Increase dose by increments of 0.5-1 mg/kg daily in 2 divided doses at 1-2 wk intervals. Recommended initial target dose: 100-400 mg daily. Childn w/ recently diagnosed partial onset seizures have received doses of up to 500 mg daily. Epilepsy (adjunctive therapy) 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. Usual dose: 200-400 mg daily in 2 divided doses. Patient w/ renal impairment, CrCl <70 mL/min/1.73 m² ½ the usual adult dose. Childn ≥2 yr Initially 25 mg (or less, based on a range of 1-3 mg/kg daily) nightly for the 1st wk. The dosage may be increased at 1-2 wk intervals by increments of 1-3 mg/kg daily in 2 divided doses. Recommended total daily dose: 5-9 mg/kg daily as adjunctive therapy in 2 divided doses. Migraine headache prophylaxis Adult 25 mg nightly for 1 wk, may be increased in 25 mg daily increments at 1 wk intervals. Total daily dose: 100 mg in 2 divided doses.

May be taken with or without food: Tab: Swallow whole, do not break. Sprinkle Cap: Swallow whole or open the cap & sprinkle entire contents in 1 tsp of soft food. Swallow mixt immediately w/o chewing. Do not store for future use.

Hypersensitivity.

W/draw gradually to minimize potential for seizures or increase seizure frequency. Appropriate monitoring is recommended in situations where rapid w/drawal is medically required. Ensure adequate hydration. Increased incidence of mood disturbances & depression. Monitor for signs of suicidal ideation & behaviour & consider appropriate treatment. Discontinue use if SJS or TEN are suspected. Patients predisposed to nephrolithiasis. Discontinue in patients w/ acute myopia & secondary angle closure glaucoma; visual field defects. Reduce dose or discontinue (using dose tapering) if metabolic acidosis develops & persists. Consider hyperammonemic encephalopathy & measure ammonia levels in patients who develop unexplained lethargy. Consider dietary supplement or increased food intake in patients losing wt. May impair ability to drive & use machines. Moderate & severe renal impairment. Hepatic impairment. May cause fetal harm. Pregnancy & lactation. Childn <2 yr.

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

Decreased plasma conc w/ phenytoin & carbamazepine. May decrease the serum AUC of digoxin. Do not use concomitantly w/ alcohol or other CNS depressants. Possible decrease in OC efficacy. May increase systemic exposure of lithium. Reduced AUC of glyburide. May increase risk of nephrolithiasis w/ agents predisposing to nephrolithiasis. Concomitant use w/ valproic acid has been associated w/ hyperammonemia w/ or w/o encephalopathy & hypothermia. Decreased PT/INR when used concomitantly w/ vit K antagonist anticoagulants.

Anticonvulsants

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

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