Topamax

Topamax

topiramate

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Concise Prescribing Info
Contents
Topiramate
Indications/Uses
Monotherapy for newly diagnosed epilepsy or conversion to monotherapy in patients w/ epilepsy. Adjunctive therapy in partial onset or generalized tonic-clonic seizures; seizures associated w/ Lennox Gaustat syndrome. Migraine prophylaxis.
Dosage/Direction for Use
Adult Epilepsy (adjunctive therapy) Initially, 25-50 mg nightly for 1 wk. Increase dose by 25-50 (up to 100) mg/day in 2 divided doses, at wkly or bi-wkly intervals. Usual daily dose: 200-400 mg/day, in 2 divided doses. Max: 1,600 mg/day. Epilepsy (monotherapy) Initially, 25 mg nightly for 1 wk. Increase dose by 25-50 mg/day in 2 divided doses, at wkly or bi-wkly intervals. Recommended initial target dose: 100 mg/day. Max: 500 mg/day (up to 1,000 mg/day for patients w/ refractory forms of epilepsy). Migraine prophylaxis Recommended daily dose: 100 mg/day in 2 divided doses. Initially, 25 mg nightly for 1 wk. Increase dose by 25 mg/day at wkly intervals. May give total dose 200 mg/day. Childn ≥2 yr Epilepsy (adjunctive therapy) Recommended dose: Approx 5-9 mg/kg/day in 2 divided doses. Initially, ≤25 mg (based on 1-3 mg/kg/day range) nightly for 1st wk. Increase dose by 1-3 mg/kg/day, in 2 divided doses at wkly or bi-wkly intervals. Epilepsy (monotherapy) Initially, 0.5-1 mg/kg nightly for 1st wk. Increase dose by 0.5-1 g/kg/day in 2 divided doses at wkly or b-wkly intervals. Initial target dose range: 100-400 mg/day. Max: 500 mg/day (recently diagnosed partial onset seizure). Renal impairment ½ of the daily dose in hemodialysis days, in divided doses at the beginning & completion of hemodialysis.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Gradually w/draw treatment to minimize seizure potential or increased seizure frequency. Oligohidrosis, anhidrosis & hyperthermia may occur; ensure adequate hydration to reduce risk of nephrolithiasis. May increase incidence of mood disturbances & depression, & suicidal thoughts or behavior. May cause acute myopia syndrome associated w/ secondary angle closure glaucoma, including acute onset of decreased visual acuity &/or ocular pain; ophth finding may include myopia, anterior chamber shallowing, ocular hyperemia & increased IOP, w/ or w/o mydriasis; may be associated w/ supraciliary effusion resulting in anterior displacement of the lens & iris, w/ secondary angle closure glaucoma. May cause visual field defects independent of elevated IOP. May cause hyperchloremic, non-anion gap metabolic acidosis; recommend appropriate evaluation eg, serum bicarbonate levels during treatment; reduce dose or discontinue treatment (using dose tapering) if metabolic acidosis persists. Consider using dietary supplement or increasing food intake during treatment if patient loses wt. May impair ability to drive or operate machinery. Renal impairment; may increase risk of renal stone formation & associated signs & symptoms eg, renal colic, renal or flank pain. Hepatic impairment. Pregnancy & lactation.
Adverse Reactions
Somnolence, dizziness, fatigue, irritability, wt decrease, bradyphrenia, paresthesias, diplopia, abnormal coordination, nausea, nystagmus, lethargy, anorexia, dysarthria, blurred vision, decreased appetite, memory impairment, diarrhea, disturbance in attention, aggression, rash, abnormal behavior, balance disorder, constipation, depression, anxiety, asthenia, dysgeusia, hypoesthesia, pyrexia, alopecia, insomnia & expressive language disorder. Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Drug Interactions
Decreased AUC of digoxin. Possible decreased contraceptive efficacy of & increased breakthrough bleeding w/ combination OCs. Reduced lithium systemic exposure w/ topiramate 200 mg/day; increased systemic exposure w/ topiramate up to 600 mg/day. Increased AUC & Cmax, & decreased serum K w/ hydrochlorothiazide. Reduced oral plasma clearance w/ metformin; decreased AUC & Cmax of pioglitazone active metabolite; reduced AUC of glyburide & reduced systemic exposure of glyburide active metabolites; monitor patient for adequate control of diabetes. Increased risk of nephrolithiasis in concomitant use w/ other agents predisposing to nephrolithiasis. May cause hyperammonemia w/ or w/o encephalopathy, & hypothermia w/ valproic acid. Increased Cmax & AUC of nortriptylline metabolite. Increased AUC of haloperidol reduced metabolite. Increased Cmax of propranolol & increased Cmax & AUC of topiramate w/ concomitant use. Decreased AUC of diltiazem & increased AUC of topiramate w/ concomitant use. Increased AUC of flunarizine.
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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