TOPIRAMATE tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)

Disponible desde:

Zydus Lifesciences Limited

Designación común internacional (DCI):

TOPIRAMATE

Composición:

TOPIRAMATE 25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Topiramate tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. Topiramate tablets and topiramate capsules are indicated as adjunctive therapy for  for the treatment of partial-onset seizures,  primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. Topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-f

Resumen del producto:

Topiramate Tablets, USP Topiramate Tablets USP, 25 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 16" on one side and plain on the other side and are supplied as follows: NDC 65841-647-14 in bottle of 60 tablets NDC 65841-647-16 in bottle of 90 tablets NDC 65841-647-01 in bottle of 100 tablets NDC 65841-647-05 in bottle of 500 tablets Topiramate Tablets USP, 50 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 15" on one side and plain on the other side and are supplied as follows: NDC 65841-648-14 in bottle of 60 tablets NDC 65841-648-16 in bottle of 90 tablets NDC 65841-648-01 in bottle of 100 tablets NDC 65841-648-05 in bottle of 500 tablets Topiramate Tablets USP, 100 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 14" on one side and plain on the other side and are supplied as follows: NDC 65841-649-14 in bottle of 60 tablets NDC 65841-649-16 in bottle of 90 tablets NDC 65841-649-01 in bottle of 100 tablets NDC 65841-649-05 in bottle of 500 tablets Topiramate Tablets USP, 200 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 13" on one side and plain on the other side and are supplied as follows: NDC 65841-650-14 in bottle of 60 tablets NDC 65841-650-16 in bottle of 90 tablets NDC 65841-650-01 in bottle of 100 tablets NDC 65841-650-05 in bottle of 500 tablets Topiramate Capsules, USP Topiramate Capsules USP, 15 mg are white to off-white pellets filled in size '2' empty hard gelatin capsules with white opaque cap imprinted with "ZA63" and white opaque body imprinted with "15 mg" in black ink and are supplied as follows: NDC 65841-651-14 in bottle of 60 capsules NDC 65841-651-16 in bottle of 90 capsules NDC 65841-651-01 in bottle of 100 capsules NDC 65841-651-05 in bottle of 500 capsules NDC 65841-651-10 in bottle of 1000 capsules Topiramate Capsules USP, 25 mg are white to off-white pellets filled in size '1' empty hard gelatin capsules with white opaque cap imprinted with "ZA64" and white opaque body imprinted with "25 mg" in black ink and are supplied as follows: NDC 65841-652-17 in bottle of 28 capsules NDC 65841-652-14 in bottle of 60 capsules NDC 65841-652-16 in bottle of 90 capsules NDC 65841-652-01 in bottle of 100 capsules NDC 65841-652-05 in bottle of 500 capsules NDC 65841-652-10 in bottle of 1000 capsules Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 9/2023
Document Id: 8a989029-e6a6-4b52-a927-8007642f32e4
34391-3
Set id: 57016639-89fe-43ad-89c4-5e7a756dddec
Version: 8
Effective Time: 20230927
Zydus Lifesciences Limited

Ficha técnica

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
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TOPIRAMATE TABLETS AND TOPIRAMATE CAPSULES
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-647-14 in bottle of 60 tablets
Topiramate Tablets USP, 25 mg
60 tablets
Rx only
NDC 65841-648-14 in bottle of 60 tablets
Topiramate Tablets USP, 50 mg
60 tablets
Rx only
NDC 65841-649-14 in bottle of 60 tablets
Topiramate Tablets USP, 100 mg
60 tablets
Rx only
NDC 65841-650-14 in bottle of 60 tablets
Topiramate Tablets USP, 200 mg
60 tablets
Rx only
TOPIRAMATE
topiramate tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-647
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
TOPIRAMATE
25 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
IMPRINT CODE
Z D;16
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-647-
14
60 in 1 BOTTLE; Type 0: Not a Combination
Product
03/27/2009
2
NDC:65841-647-
16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
03/27/2009
3
NDC:65841-647-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
03/27/2009
4
NDC:65841-647-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
03/27/2009
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA078235
03/27/2009
TOPIRAMATE
topiramate tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG