Χώρα: Σιγκαπούρη
Γλώσσα: Αγγλικά
Πηγή: HSA (Health Sciences Authority)
TOPIRAMATE
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
N03AX11
50 mg
TABLET, FILM COATED
TOPIRAMATE 50 mg
ORAL
Prescription Only
CILAG AG
ACTIVE
1998-03-24
PRODUCT NAME TOPAMAX ® (topiramate) DOSAGE FORMS AND STRENGTHS FILM-COATED TABLETS The tablets are debossed, engraved or embossed. 25 MG TABLET Round, white tablet imprinted with “TOP” on one side and “25” on the other. Each tablet contains 25 mg of topiramate. 50 MG TABLET Round, light yellow tablet imprinted with “TOP” or “TOPAMAX” on one side and “50” on the other. Each tablet contains 50 mg of topiramate. 100 MG TABLET Round, yellow tablet imprinted with “TOP” or “TOPAMAX” on one side and “100” on the other. Each tablet contains 100 mg of topiramate. For excipients, see _List of Excipients_. CLINICAL INFORMATION INDICATIONS EPILEPSY TOPAMAX ® is indicated as monotherapy for adults and children with partial onset seizures and generalized seizures, including tonic-clonic seizures. TOPAMAX ® is indicated as adjunctive therapy for adults and children with partial onset seizures or generalized tonic-clonic seizures and seizures associated with Lennox Gastaut syndrome. MIGRAINE TOPAMAX ® is also indicated for adults for the prophylaxis of migraine headache. The usefulness of TOPAMAX ® in the acute treatment of migraine headache has not been studied. DOSAGE AND ADMINISTRATION DOSAGE For optimal seizure control in both adults and children, it is recommended that therapy be initiated at a low dose followed by titration to an effective dose. _EPILEPSY _ _– ADJUNCTIVE THERAPY _ ADULTS Therapy should begin at 25 to 50 mg nightly for one week. Subsequently, at weekly or bi-weekly intervals, the dose should be increased by 25 to 50 mg/day and taken in two divided doses. Dose ti Διαβάστε το πλήρες έγγραφο
PRODUCT NAME TOPAMAX ® (topiramate) DOSAGE FORMS AND STRENGTHS FILM-COATED TABLETS The tablets are debossed, engraved or embossed. 25 MG TABLET Round, white tablet imprinted with “TOP” on one side and “25” on the other. Each tablet contains 25 mg of topiramate. 50 MG TABLET Round, light yellow tablet imprinted with “TOP” or “TOPAMAX” on one side and “50” on the other. Each tablet contains 50 mg of topiramate. 100 MG TABLET Round, yellow tablet imprinted with “TOP” or “TOPAMAX” on one side and “100” on the other. Each tablet contains 100 mg of topiramate. For excipients, see _List of Excipients_ . CLINICAL INFORMATION INDICATIONS EPILEPSY TOPAMAX ® is indicated as monotherapy for adults and children with partial onset seizures and generalized seizures, including tonic-clonic seizures. TOPAMAX ® is indicated as adjunctive therapy for adults and children with partial onset seizures or generalized tonic-clonic seizures and seizures associated with Lennox Gastaut syndrome. MIGRAINE TOPAMAX ® is also indicated for adults for the prophylaxis of migraine headache. The usefulness of TOPAMAX ® in the acute treatment of migraine headache has not been studied. DOSAGE AND ADMINISTRATION DOSAGE For optimal seizure control in both adults and children, it is recommended that therapy be initiated at a low dose followed by titration to an effective dose. _EPILEPSY – ADJUNCTIVE THERAPY_ • ADULTS Therapy should begin at 25 to 50 mg nightly for one week. Subsequently, at weekly or bi-weekly intervals, the dose should be increased by 25 to 50 mg/day and taken in two divided doses. Dose titration should be guided by clinical outcome. Some patients may achieve efficacy with once-a- day dosing. In clinical trials as adjunctive therapy, 200 mg was effective and was the lowest dosage studied. This is therefore considered the minimum effective dose. The usual daily dose is 200 to 400 mg in two divided doses. Individual patients have received doses as high as 1600 mg/day. These dosing recommendations Διαβάστε το πλήρες έγγραφο