Pradox 25/Pradox 50/Pradox 100: Dosing, Side Effect & Interaction

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

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 in adults & childn ≥2 yr w/ partial onset seizures or generalized tonic-clonic seizures, seizures associated w/ Lennox-Gastaut syndrome. Prophylaxis of migraine headache in adults.

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Dosage/Direction for Use

Adjunctive therapy epilepsy Adult Initially 25-50 mg nightly for 1 wk. Subsequently at wkly or bi-wkly intervals, increase dose by 25-50 (to 100) mg daily in 2 divided doses. Childn ≥2 yr Approx 5-9 mg/kg daily in 2 divided doses. Titrate at ≤25 mg (based on range of 1-3 mg/kg daily) nightly for 1st wk. Monotherapy epilepsy Adult Titrate at 25 mg nightly for 1 wk. Subsequently at 1 or 2 wkly intervals, increase dose by 25 or 50 mg daily increments in 2 divided doses. Initial target dose: 100 mg daily. Max: 500 mg. Childn ≥2 yr Initially at 0.5-1 mg/kg daily nightly for 1st wk. Subsequently at 1 or 2 wkly intervals, increase dose by 0.5-1 mg/kg daily increments in 2 divided doses. Initial target dose: 3-6 mg/kg daily. Prophylaxis of migraine Initially 25 mg nightly for 1 wk, then increased at 25 mg daily increments at 1-wk intervals. Recommended total daily dose: 100 mg in 2 divided doses.

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Overdosage

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Administration

May be taken with or without food: Do not break.

Contraindications

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

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Special Precautions

Discontinue use if SJS or TEN are suspected. Mood disturbances/depression; signs of suicidal ideation & behaviour. Serious skin reactions. Acute myopia associated w/ secondary angle-closure glaucoma; visual field defects. Hyperammonemia w/ or w/o encephalopathy. Predisposition to or history of nephrolithiasis; ensure adequate hydration. W/draw gradually. Monitor serum bicarbonate level. Consider dietary supplement or increased food intake in patients losing wt while on therapy. May affect ability to drive & use machines. Renal or hepatic impairment. Women of childbearing potential. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Leukopenia, lymphadenopathy, thrombocytopenia; hypersensitivity; hyperchloremic acidosis, hypokalemia, increased appetite; apathy, crying, distractibility, initial & middle insomnia, perseveration, sleep disorder, suicidal ideation, suicide attempt; circadian rhythm sleep disorder, grand mal convulsion, parosmia, poor quality sleep, syncope; increased lacrimation; sinus bradycardia, palpitations; orthostatic hypotension; nasal congestion, paranasal sinus hypersecretion; abdominal discomfort & pain, flatulence, glossodynia, pancreatitis; musculoskeletal stiffness; incontinence, micturition urgency; feeling abnormal, malaise, sluggishness.

Drug Interactions

Decreased plasma conc by phenytoin & carbamazepine. Possible decreased contraceptive efficacy & increased breakthrough bleeding w/ OCs. Decreased serum K w/ hydrochlorothiazide. Increased risk of nephrolithiasis w/ other agents predisposing to nephrolithiasis. Hyperammonemia w/ or w/o encephalopathy in concomitant use of valproic acid. Decreased prothrombin time/INR w/ vit K-antagonist anticoagulant medications. Monitor serum digoxin; lithium levels; metformin, pioglitazone, glyburide. Not to be used concomitantly w/ alcohol, CNS depressants.

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Storage

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Description

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Action

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MIMS Class

Anticonvulsants / Antimigraine Preparations

ATC Classification

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

Regulatory Classification

Presentation/Packing

Form

Pradox 100 FC tab 100 mg

Packing/Price

6 × 10's

Form

Pradox 25 FC tab 25 mg

Packing/Price

6 × 10's

Form

Pradox 50 FC tab 50 mg

Packing/Price

6 × 10's

Pradox 25/Pradox 50/Pradox 100

topiramate

Manufacturer:

Unison

Distributor:

Medispec