Država: Indonezija
Jezik: indonezijski
Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TOPIRAMATE
SOHO INDUSTRI PHARMASI - Indonesia
TOPIRAMATE
100 MG
TABLET
DUS, 6 ALUBLISTER @ 10 TABLET
CILAG AG - Switzerland
2020-03-31
1 CCDS 05Oct20 v.23 ID Topamax Tab + SC PI TOPAMAX ® topiramate NAME OF THE MEDICINAL PRODUCT TRADEMARK TOPAMAX ® INTERNATIONAL NONPROPRIETARY NAME Topiramate DOSAGE FORMS AND STRENGTHS Film-coated tablet Sprinkle capsule 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” on one side and “50” on the other. Each tablet contains 50 mg of topiramate. 100 MG TABLET Round, yellow tablet imprinted with “TOP” on one side and “100” on the other. Each tablet contains 100 mg of topiramate. SPRINKLE CAPSULES 15 MG CAPSULE Small, white to off-white spheres in a gelatin capsule consisting of a white body with a clear or natural cap, printed in black ink with “TOP” on the cap and “15 mg” on the body. Each capsule contains 15 mg of topiramate. 25 MG CAPSULE Small, white to off-white spheres in a gelatin capsule consisting of a white body with a clear or natural cap, printed in black ink with “TOP” on the cap and “25 mg” on the body. Each capsule contains 25 mg of topiramate. For excipients, see _List of Excipients._ PHARMACOLOGICAL PROPERTIES Topiramate is designated chemically as 2,3:4,5-bis-_O_-(1-methylethylidene)-ß-D-fructopyranose sulfamate. The empirical formula is C 12 H 21 NO 8 S. The molecular weight is 339.36. The structural formula is: DISETUJUI OLEH BPOM: 26/04/2021 ID REG: EREG10006112100032- EREG10006112100036 2 CCDS 05Oct20 v.23 ID Topamax Tab + SC PI Topiramate is a white crystalline powder having a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: other antiepileptics, ATC Pročitajte cijeli dokument