ประเทศ: อินโดนีเซีย
ภาษา: อินโดนีเชีย
แหล่งที่มา: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 6 ALUBLISTER @ 10 TABLET
2023-02-05
1 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 : 03/02/2022 ID : EREG100061VR12100256 EREG100061VR12100257 EREG100061VR12100258 EREG100061VR12100259 EREG100061VR12100260 2 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 code: N03AX11. To อ่านเอกสารฉบับเต็ม