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Pradox

Pradox Dosage/Direction for Use

topiramate

Manufacturer:

Unison

Distributor:

Medline

Marketer:

B.Grimm Pharma
Full Prescribing Info
Dosage/Direction for Use
Oral: Note: Do not abruptly discontinue therapy; taper dosage gradually to prevent rebound effects. (In clinical trials, adult doses were withdrawn by decreasing in weekly intervals of 50-100 mg/day gradually over 2-8 weeks for seizure treatment, and by decreasing in weekly intervals by 25-50 mg/day for migraine prophylaxis.)
Epilepsy, monotherapy: Children ≥10 years and Adults: Partial onset seizure and primary generalized tonic-clonic seizure: Initial: 25 mg twice daily; may increase weekly by 50 mg/day up to 100 mg twice daily (week 4 dose); thereafter, may further increase weekly by 100 mg/day up to the recommended maximum of 200 mg twice daily.
Canadian labeling: Children ≥6 years and Adults: Initial: 25 mg once daily (in evening); may increase to 25 mg twice daily in weeks 2 or 3, and up to 50 mg twice daily by weeks 3 or 4; may further increase weekly in incre­ments of 50 mg/day up to recommended maximum of 200 mg twice daily.
Epilepsy, adjunctive therapy: Children 2-16 years: Partial onset seizure or seizure associated with Lennox­-Gastaut syndrome: Initial: 25 mg (1-3 mg/kg/day) once daily (in evening); may increase every 1-2 weeks in increments of 1-3 mg/kg/day up to the recom­mended maximum of 5-9 mg/kg/day in 2 divided doses.
Primary generalized tonic-clonic seizure: Use initial dose listed in the previous text for partial onset seizures, but use slower initial titration rate; titrate to the recommended maintenance dose of 6 mg/kg/day by the end of 8 weeks.
Canadian labeling: Initial: 25 mg (1-3 mg/kg/day) once daily (in evening); may increase every 1-2 weeks in increments of 1-3 mg/kg/day up to the recommended maximum of 5-9 mg/kg/day in two divided doses.
Adolescents ≥17 years and Adults: Partial onset seizures: Initial: 25 mg once or twice daily for 1 week; may increase weekly by 25-50 mg/day until response; usual maintenance dose: 100-200 mg twice daily. Doses >1600 mg/day have not been studied.
Primary generalized tonic-clonic seizures: Use initial dose as listed in the previous text for partial onset seizures, but use slower   initial titration rate; titrate upwards to rec­ommended dose by the end of a weeks; usual main­tenance dose: 200 mg twice daily. Doses >1600 mg/day have not been studied.
Canadian labeling: Initial: 25 mg once or twice daily; may increase weekly by 50 mg/day up to the recom­mended dose of 100-200 mg twice daily (maximum recommended dose: 800 mg/day; doses >400 mg/day have shown no additional benefit.
Migraine prophylaxis: Adults: Initial: 25 mg once daily (in evening); may increase weekly by 25 mg/day, up to the recommended dose of 100 mg/day given in 2 divided doses. Doses >100 mg/day have shown no additional benefit.
Cluster headache prophylaxis (unlabeled use): Adults: Initial: 25 mg/day, titrated at weekly intervals in 25 mg increments, up to 200 mg/day.
Neuropathic pain (unlabeled use): Adults: Initial: 25 mg/day, titrated at weekly intervals in 25-50 mg incre­ments to target dose of 400 mg daily in 2 divided doses.
Dosing adjustment in renal impairment: Clcr <70 mL/minute/1.73 m2: Administer 50% dose and titrate more slowly.
Hemodialysis: Supplemental dose may be needed during hemodialysis.
Dosing adjustment in hepatic impairment: Clearance may be reduced; however the manufacturer's labeling provides no specific dosing recommendations.
Administration:
Oral: May be administered without regard to meals.
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