Pradox: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Topiramate

Indications/Uses

Monotherapy or adjunctive therapy for partial onset seizures & primary generalized tonic-clonic seizures. Adjunctive treatment of seizures associated w/ Lennox-Gastaut syndrome. Prophylaxis of migraine headache.

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Dosage/Direction for Use

Migraine prophylaxis Adult Initially 25 mg once daily (in the evening), may be increased wkly by 25 mg/day. Recommended dose: 100 mg/day given in 2 divided doses. Epilepsy (adjunctive therapy) Adult including the elderly Initially 25-50 mg nightly for 1 wk. Subsequently at wkly or bi-wkly intervals, increase dose to 25-50 (to 100) mg/day in 2 divided doses. Usual daily dose: 200-400 mg in 2 divided doses. Childn ≥2 yr Approx 5-9 mg/kg/day in 2 divided doses. Titrate starting at 25 mg (or less, based on a range of 1-3 mg/kg/day) nightly for the 1st wk. Increase at 1 or 2 wkly intervals, by increments of 1-3 mg/kg/day in 2 divided doses. Monotherapy epilepsy Adult Titrate at 25 mg nightly for 1 wk. Subsequently at 1 or 2 wkly intervals, increase dose by increments of 25 or 50 mg/day in 2 divided doses. Max: 400 mg/day.

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Women in childbearing yr not using effective contraception (migraine prophylaxis only).

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Special Precautions

Do not abruptly discontinue therapy. Taper dose gradually to prevent rebound effects. Ensure adequate hydration. Monitor for signs/symptoms of depression & suicidal tendencies. Discontinue use if acute myopia & secondary angle closure glaucoma occurs; visual field defects independent of elevated IOP. Evaluate serum bicarbonate level & potential complications of chronic acidosis. Cognitive dysfunction, psychiatric disturbances & sedation may occur. May affect ability to drive or use machinery. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Somnolence; dizziness, fatigue, nervousness, irritability, paresthesias, diplopia, abnormal coordination, nausea, nystagmus, lethargy, anorexia, dysarthria, blurred vision, decreased appetite, memory impairment.

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Drug Interactions

May inhibit CYP2C19 & induce CYP3A4 substrates. Increase effect/toxicity of alcohol, phenytoin & valproic acid. Decrease contraceptive efficacy & increase breakthrough bleeding of OCs. Ketogenic diet may increase the possibility of acidosis &/or kidney stones.

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Storage

View Pradox storage conditions for details to ensure optimal shelf-life.

Action

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MIMS Class

Anticonvulsants / Antimigraine Preparations

ATC Classification

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

Thai FDA Category

Presentation/Packing

Form

Pradox FC tab 100 mg

Packing/Price

6 × 10's

Form

Pradox FC tab 25 mg

Packing/Price

10 × 10's;6 × 10's

Form

Pradox FC tab 50 mg

Packing/Price

6 × 10's

Pradox

topiramate

Manufacturer:

Unison

Distributor:

Medline

Marketer:

B.Grimm Pharma