pms-Topiramate

pms-Topiramate

topiramate

Manufacturer:

Pharmascience

Distributor:

T-BOMA
Concise Prescribing Info
Contents
Topiramate
Indications/Uses
Monotherapy for the management of patients (adults & childn ≥6 yr) w/ newly diagnosed epilepsy. Adjunctive therapy for the management of patients (adults & childn ≥2 yr) w/ epilepsy who are not satisfactorily controlled w/ conventional therapy. Prophylaxis of migraine headache.
Dosage/Direction for Use
Epilepsy monotherapy Adult & childn ≥6 yr Initial target dose: 100 mg/day in 2 divided doses, may be increased at wkly intervals in increments of 50 mg/day to a max of 400 mg/day. Titration rate to 100 mg/day: Wk 1: 25 mg evening dose; wk 2-3: 25 mg morning dose, 25 mg evening dose; wk 3-4: 50 mg morning dose, 50 mg evening dose. Adjunctive therapy for epilepsy Adult ≥17 yr Initially 50 mg/day in 2 divided doses, may be increased by 50 mg/day at wkly intervals. Maintenance: 200-400 mg/day in 2 divided doses. Max: 800 mg/day. Childn 2-16 yr Initially 25 mg (or less based on a range of 1-3 mg/kg/day) nightly for the 1st wk, increase at 1- or 2-wk intervals by increments of 1-3 mg/kg/day administered in 2 divided doses. Maintenance: Approx 5-9 mg/kg/day in 2 divided doses. Migraine prophylaxis Adult 100 mg/day in 2 divided doses. Titration rate to 100 mg/day: Wk 1: 25 mg evening dose; wk 2: 25 mg morning dose, 25 mg evening dose; wk 3: 25 mg morning dose, 50 mg evening dose; wk 4: 50 mg morning dose, 50 mg evening dose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Migraine prophylaxis: Women of childbearing potential not using an effective method of contraception. Pregnancy.
Special Precautions
Should be gradually withdrawn to minimize potential for seizures or increased seizure frequency. Risk of oligohidrosis, anhidrosis & hyperthermia; hyperchloremic, non-anion gap, metabolic acidosis; CNS effects eg, psychomotor slowing, difficulty w/ concentration & speech or language problems, somnolence or fatigue, mood disturbances including irritability & depression; paresthesia; acute myopia associated w/ secondary angle closure glaucoma; visual field defects; serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis); occurrence of kidney stones. Monitor patients for signs of suicidal ideation & behaviour. Hyperammonemia w/ or w/o encephalopathy in monotherapy or in concomitant w/ valproic acid or other antiepileptic medications. Hypothermia w/ valproic acid. Decreases in serum K w/ hydrochlorothiazide. Dietary supplement or increased food intake may be considered if patient is losing wt while on medication. Patients w/ renal &/or hepatic impairment; patients undergoing hemodialysis. Pregnancy (for epilepsy indication) & lactation. Can cause fetal harm when administered to pregnant woman. Not indicated in childn <2 yr. Elderly >65 yr.
Adverse Reactions
Paresthesia, fatigue, headache, somnolence, upper resp tract infection, anorexia, wt decrease. Adults: Dizziness, depression, nausea, ataxia, speech disorders & related speech problems, psychomotor slowing, nystagmus. Childn: Difficulty w/ concentration/attention, fever, nervousness, difficulty w/ memory, aggressive reaction.
Drug Interactions
Decreased conc w/ phenytoin, carbamazepine, valproic acid, lamotrigine. Risk of hypothermia or encephalopathy (w/ or w/o hyperammonemia) w/ valproic acid. Potential to increase conc of phenytoin; metformin; pioglitazone. Potential increase in conc w/ hydrochlorothiazide. Decreased serum AUC of digoxin. Should not be used concomitantly w/ alcohol or other CNS depressants. Possibility of decreased efficacy of OCs & increased breakthrough bleeding. Decreases in serum K w/ hydrochlorothiazide. Reduced systemic exposure of glyburide; risperidone; diltiazem. Increased systemic exposure of lithium. Changes in conc of amitriptyline. Decreased prothrombin time/INR responses w/ vit K-antagonist anticoagulants. Potential to increase risk of nephrolithiasis w/ other agents predisposing to nephrolithiasis eg, carbonic anhydrase inhibitors.
MIMS Class
Anticonvulsants
ATC Classification
N03AX11 - topiramate ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
pms-Topiramate tab 100 mg
Packing/Price
100's
Form
pms-Topiramate tab 25 mg
Packing/Price
100's
Form
pms-Topiramate tab 50 mg
Packing/Price
100's
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