TOPAMAX

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

TOPIRAMATE

제공처:

SOHO INDUSTRI PHARMASI - Indonesia

INN (국제 이름):

TOPIRAMATE

복용량:

100 MG

약제 형태:

TABLET

패키지 단위:

DUS, 6 ALUBLISTER @ 10 TABLET

Manufactured by:

CILAG AG - Switzerland

승인 날짜:

2020-03-31

제품 특성 요약

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