Epamate TEVA

Topiramate

Monotherapy for adults, adolescents & childn >6 yr w/ partial seizures w/ or w/o secondary generalised seizures, & primary generalised tonic-clonic seizures. Adjunct in adults, adolescents & childn ≥2 yr w/ partial onset seizures w/ or w/o secondary generalization or primary generalized tonic-clonic seizures & for seizures associated w/ Lennox-Gastaut syndrome. Prophylaxis of migraine headache in adults after careful evaluation of possible alternative treatment options.

Epilepsy Adult Begin titration at 25 mg nightly for 1 wk, then increase dose at 1- or 2-wk interval by increments of 25 or 50 mg daily in 2 divided doses. Initial target dose: 100-200 mg daily in 2 divided doses. Max dose: 500 mg daily in 2 divided doses. Patients w/ refractory forms of epilepsy 1,000 mg daily. Childn >6 yr Initially 0.5-1 mg/kg nightly for 1st wk, then increase dose at 1- or 2-wk interval by increments of 0.5-1 mg/kg daily in 2 divided doses. Initial target dose range: 100 mg daily depending on clinical response (about 2 mg/kg daily in childn 6-16 yr). Adjunctive therapy in epilepsy (partial onset seizures w/ or w/o secondary generalization, primary generalized tonic-clonic seizures, or seizures associated w/ Lennox-Gastaut syndrome Adult Initially 25-50 mg nightly for 1 wk. Subsequently, increase by 25-50 mg daily in 2 divided doses at wkly or bi-wkly intervals. Usual daily dose: 200-400 mg in 2 divided doses. Childn ≥2 yr Total dose: 5-9 mg/kg daily in 2 divided doses. Begin titration at 25 mg (or less, based on range 1-3 mg/kg daily) nightly for 1st wk. Then increase dose at 1- or 2-wk interval by increments of 1-3 mg/kg daily in 2 divided doses. Alternatively, 30 mg/kg daily. Migraine Adult Recommended total dose: 100 mg daily in 2 divided doses. Begin titration at 25 mg nightly for 1 wk, then increase in increments of 25 mg daily at 1-wk interval. Total daily dose: 200 mg. Renal impairment ½ of usual starting & maintenance dose. End-stage renal function Supplemental dose equal to ½ of daily dose on hemodialysis days.

May be taken with or without food: Swallow whole, do not crush/break/chew.

Hypersensitivity. Migraine prophylaxis in pregnancy & women of childbearing potential not using effective methods of contraception.

Allergy to peanuts or soya. Discontinue treatment if acute myopia & secondary angle closure glaucoma occur. Consider discontinuation if visual defects occur at any time during treatment. Reduce dose or discontinue treatment if metabolic acidosis develops & persists. Increased seizure frequency or onset of new types of seizures; oligohydrosis; increased incidence of mood disturbances & depression; suicidal ideation & behaviour; nephrolithiasis; hyperchloremic, non-anion gap, metabolic acidosis (ie, decreased serum bicarbonate below normal reference range in absence of resp alkalosis); cognitive impairment. History of eye disorders. Patients w/ conditions or therapies predisposing metabolic acidosis eg, renal disease, severe resp disorders, status epilepticus, diarrhoea, surgery, ketogenic diet. Ensure adequate hydration. Monitor for signs of suicidal ideation & behaviour; wt loss. Measure serum bicarbonate level if signs & symptoms indicative of metabolic acidosis are present. May affect ability to drive & use machines. Renal impairment (CrCl ≤60 mL/min). Moderate to severe hepatic impairment. Perform pregnancy testing before treatment initiation in women of childbearing potential. Avoid sudden discontinuation of antiepileptic drug therapy during pregnancy & in women of childbearing potential. May cause fetal harm & growth restriction. Risk of congenital malformations. Lactation. Decreased sweating & rise in body temp in young childn exposed to high ambient temp. Childn (not recommended for treatment or prevention of migraine).

Decreased wt; paraesthesia, somnolence, dizziness; nausea, diarrhoea; nasopharyngitis; fatigue; depression. Increased wt; anaemia; attention disturbance, memory & mental impairment, amnesia, cognitive disorder, impaired psychomotor skills, convulsion, abnormal coordination, tremor, lethargy, hypoaesthesia, nystagmus, dysgeusia, balance disorder, dysarthria, intention tremor, sedation; blurred vision, diplopia, visual disturbance; vertigo, tinnitus, ear pain; dyspnoea, epistaxis, nasal congestion, rhinorrhoea, cough; vomiting, constipation, upper abdominal pain, dyspepsia; abdominal pain & discomfort; dry mouth, stomach discomfort, oral paraesthesia, gastritis; nephrolithiasis, pollakiuria, dysuria; alopecia, rash, pruritus; arthralgia, muscle spasms, myalgia, muscle twitching, muscular weakness, musculoskeletal chest pain; anorexia, decreased appetite; pyrexia, asthenia, irritability, gait disturbance, feeling abnormal, malaise; hypersensitivity; bradyphrenia, insomnia, expressive language disorder, anxiety, confusional state, disorientation, aggression, altered mood, agitation, mood swings, depressed mood, anger, abnormal behaviour. SJS, erythema multiforme, Raynaud's phenomenon. TEN.

Increased plasma conc of phenytoin. Concomitant use w/ diazepam, imipramine, moclobemide, proguanil, omeprazole; alcohol or other CNS depressants. Decreased plasma conc w/ phenytoin & carbamazepine. Decreased AUC of digoxin. Decreased plasma conc w/ St. John's wort (Hypericum perforatum). Possibility of decreased contraceptive efficacy & increased breakthrough bleeding w/ combined OCs. Reduced systemic exposure of lithium; risperidone. Increased C_max & AUC w/ hydrochlorothiazide. Reduced oral plasma clearance w/ metformin. Decreased C_max,ss & AUC_t,ss of pioglitazone. Reduced AUC₂₄ of glyburide. Increased risk of nephrolithiasis w/ other agents predisposing to nephrolithiasis. Hyperammonemia w/ or w/o encephalopathy & hypothermia w/ valproic acid. Increased C_max & AUC of propranolol. Increased AUC w/ diltiazem.

Anticonvulsants / Antimigraine Preparations

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

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