TOPAMAX

Pays: Indonésie

Langue: indonésien

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

Unités en paquet:

DUS, 6 ALUBLISTER @ 10 TABLET

Date de l'autorisation:

2023-02-05

Résumé des caractéristiques du produit

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