Toramig 25/Toramig 50/Toramig 100

Monotherapy in adults, adolescents & childn >6 yr w/ partial seizures w/ or w/o secondary generalized seizures, & primary generalized tonic-clonic seizures. Adjunctive therapy 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.

Monotherapy of epilepsy Adult Initially 25 mg nightly for 1 wk, then increased at 1- or 2-wk intervals by 25 mg or 50 mg daily increments in 2 divided doses. Initial target dose: 100-200 mg daily in 2 divided doses. Max daily dose: 500 mg in 2 divided doses (up to 1,000 mg in some patients w/ refractory forms of epilepsy). Childn >6 yr Initially 0.5-1 mg/kg nightly for 1st wk, then increased at 1- or 2-wk intervals by  0.5-1 mg/kg daily increments in 2 divided doses. Initial target dose: 100 mg daily depending on clinical response. Adjunctive therapy of 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, then increased at wkly or bi-wkly intervals by 25-50 daily increments in 2 divided doses. Usual daily dose: 200-400 mg in 2 divided doses. Childn ≥2 yr Total daily dose: 5-9 mg/kg in 2 divided doses. Initially ≤25 mg nightly for 1st wk, then increased at 1- or 2-wk intervals by 1-3 mg/kg daily increments in 2 divided doses. Migraine Adult Total daily dose: 100 mg daily in 2 divided doses. Initially 25 mg nightly for 1 wk, then increased at 1-wk interval by 25 mg daily increments. Renal impairment CrCl ≤70 mL/min ½ of usual starting & maintenance dose, ESRD Supplemental dose equal to ½ daily dose on hemodialysis days, administered in divided doses at the beginning & completion of hemodialysis.

May be taken with or without food.

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

Discontinue use if acute myopia & secondary angle closure glaucoma occur; SJS or TEN is suspected. Consider discontinuation if visual defects occur at any time during treatment. Not intended for acute treatment of migraine headache. Increased seizure frequency or onset of new types of seizures; oligohydrosis; increased incidence of mood disturbances & depression; nephrolithiasis; hyperchloremic, non-anion gap, metabolic acidosis (ie, decreased serum bicarbonate below the normal reference range in absence of resp alkalosis); cognitive impairment; hyperammonemia w/ or w/o encephalopathy. Monitor patients for signs of suicidal ideation & behavior; wt loss. Minor or moderate influence on ability to drive & use machines. Renal impairment (CrCl ≤70 mL/min). Moderate to severe hepatic impairment. Perform pregnancy testing before treatment initiation & highly effective contraceptive method is advised in women of childbearing potential. Pregnancy & lactation. Not recommended for treatment of prevention of migraine in childn.

Nasopharyngitis; depression; paresthesia, somnolence, dizziness; nausea, diarrhea; fatigue; decreased wt. Anemia; hypersensitivity; anorexia, decreased appetite; bradyphrenia, insomnia, expressive language disorder, anxiety, confusional state, disorientation, aggression, altered & depressed mood, agitation, mood swings, anger, abnormal behavior; disturbance in attention, memory & mental impairment, amnesia, cognitive & balance disorder, impaired psychomotor skills, convulsion, abnormal coordination, tremor, lethargy, hypoesthesia, nystagmus, dysgeusia, dysarthria, intention tremor, sedation; blurred vision, diplopia, visual disturbance; vertigo, tinnitus, ear pain; dyspnea, epistaxis, nasal congestion, rhinorrhea, cough; vomiting, constipation, upper abdominal pain, dyspepsia, abdominal pain & discomfort, dry mouth, stomach discomfort, oral paraesthesia, gastritis; alopecia, rash, pruritus; arthralgia, muscle spasms & twitching, myalgia, muscular weakness, musculoskeletal chest pain; nephrolithiasis, pollakiuria, dysuria; pyrexia, asthenia, irritability, gait disturbance, abnormal feeling, malaise; increased wt.

May increase plasma conc of phenytoin. May interfere w/ CYP2C19 substrates eg, diazepam, imipramin, moclobemide, proguanil, omeprazole. Decreased plasma conc w/ phenytoin & carbamazepine. Decreased serum AUC of digoxin; diltiazem. Not recommended to be concomitantly used w/ alcohol or other CNS depressants. Risk of decreased plasma conc resulting in loss of efficacy w/ St. John's wort. Possible decreased contraceptive efficacy & increased breakthrough bleeding w/ combined OCs. Reduced systemic exposure of lithium; risperidone. Increased C_max & AUC w/ hydrochlorothiazide. Increased C_max & AUC_0-12h of metformin. Reduced oral plasma clearance w/ metformin. Decreased C_max,ss & AUC_τ,ss of pioglitazone. Reduced AUC₂₄ of glibenclamide. Risk of nephrolithiasis may be increased w/ other agents predisposing to nephrolithiasis. Hyperammonemia w/ or w/o encephalopathy & hypothermia w/ valproic acid. Decreased prothrombin time/INR w/ warfarin.

Anticonvulsants

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

Rx