Topamax

Topamax

topiramate

Manufacturer:

Johnson & Johnson
Concise Prescribing Info
Contents
Topiramate
Indications/Uses
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.
Dosage/Direction for Use
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.
Administration
May be taken with or without food: Tab: Swallow whole, do not chew/crush. Sprinkle Cap: Swallow whole or open the cap & sprinkle entire contents in 1 tsp of soft food. Swallow mixt immediately, do not store for future use.
Contraindications
Special Precautions
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. 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. Pregnancy & lactation. Childn <2 yr.
Adverse Reactions
Nasopharyngitis, decreased/increased wt, somnolence, dizziness, fatigue, irritability, 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, alopecia, expressive language disorder.
Drug Interactions
Decreased plasma conc w/ phenytoin & carbamazepine. May decrease the serum conc of digoxin. Do not use concomitantly w/ alcohol or other CNS depressants. Possible decrease in OC efficacy. Reduction in glyburide AUC. Increased risk of nephrolithiasis w/ agents predisposing to nephrolithiasis. Concomitant use w/ valproic acid has been associated w/ hyperammonemia w/ or w/o encephalopathy & hypothermia.
MIMS Class
ATC Classification
N03AX11 - topiramate ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Topamax tab 25 mg
Packing/Price
6 × 10's (Rp313,604/boks)
Form
Topamax sprinkle cap 25 mg
Packing/Price
60's (Rp364,655/pak)
Form
Topamax sprinkle cap 15 mg
Packing/Price
60's (Rp300,985/pak)
Form
Topamax tab 50 mg
Packing/Price
6 × 10's (Rp480,128/boks)
Form
Topamax tab 100 mg
Packing/Price
6 × 10's (Rp743,894/boks)
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