See related Apo-Topiramate tab information |
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Manufacturer |
Apotex |
Distributor |
Hong Kong: Hind Wing |
Contents |
Topiramate |
Indications |
Epilepsy: Monotherapy in patients w/ newly diagnosed epilepsy or for conversion to monotherapy in patients w/ epilepsy. Adjunctive therapy for adults & childn w/ partial onset seizures or generalized tonic-clonic seizures. Migraine: Prophylaxis of migraine headache. |
Dosage |
Adjunctive therapy epilepsy Adult Initially 25-50 mg nightly for 1 wk. Subsequently, at wkly or bi-wkly intervals, the dose should be increased by 25-50 (to 100) mg/day & taken in 2 divided doses. Childn ≥2 yr 5-9 mg/kg/day in 2 divided doses. Titration should begin at 1-3 mg/kg/day nightly for the 1st wk, thereafter increased at 1-2 wk intervals by increments of 1-3 mg/kg/day given in 2 divided doses. Monotherapy epilepsy Adult Initially 25 mg nightly for 1 wk, thereafter increased at 1-2 wk intervals by increments of 25-50 mg/day, given in 2 divided doses. Recommended initial target dose: 100 mg/day, max daily dose: 500 mg. Childn ≥2 yr Initially 0.5-1 mg/kg nightly for the 1st wk, thereafter increased at 1-2 wk intervals by increments of 0.5-1 mg/kg/day, given in 2 divided doses. Recommended initial target dose: 3-6 mg/kg/day. Prophylaxis of migraine headache Initially 25 mg nightly for 1 wk increased at 25 mg/day increments at 1 wk intervals. Recommended total daily dose: 100 mg/day in 2 divided doses. |
Administration |
May be taken with or without food |
Special Precautions |
Gradual w/drawal. Renal or hepatic impairment. |
Adverse Drug Reactions |
Somnolence, dizziness, nervousness, ataxia, fatigue, speech disorders/related speech problems, psychomotor slowing.
View ADR Monitoring Form |
Drug Interactions |
Phenytoin, carbamazepine, digoxin, OC, metformin.
View more drug interactions with Apo-Topiramate |
Pregnancy Category (US FDA) |
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). |
ATC Classification |
N03AX11 - topiramate ; Belongs to the class of other antiepileptics. |
Presentation/Packing |
Form |
Packing |
Photo |
Apo-Topiramate tablet |
Apo-Topiramate 25 mg x 100's |
Apo-Topiramate 100 mg x 100's |
Apo-Topiramate 200 mg x 100's |
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Manufacturer: |
Apotex |
Distributor: |
Hong Kong: Hind Wing |
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