FELBAMATE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8)

Tilgjengelig fra:

Zydus Lifesciences Limited

INN (International Name):

FELBAMATE

Sammensetning:

FELBAMATE 400 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children. Felbamate is contraindicated in patients with known hypersensitivity to felbamate, its ingredients, or known sensitivity to other carbamates. It should not be used in patients with a history of any blood dyscrasia or hepa

Produkt oppsummering:

Felbamate Tablets USP, 400 mg are off-white to pale yellow colored, capsule shaped biconvex tablets, debossed with "10" and "53" separated by breakline on one side and plain on other and are supplied as: NDC 70771-1077-3 in bottles of 30 tablets NDC 70771-1077-9 in bottles of 90 tablets NDC 70771-1077-1 in bottles of 100 tablets NDC 70771-1077-5 in bottles of 500 tablets NDC 70771-1077-4 in cartons of 100 tablets (10 x 10 unit-dose) Felbamate Tablets USP, 600 mg are light pink to pink colored, capsule shaped biconvex tablets debossed with "10" and "54" separated by breakline on one side and plain on other and are supplied as: NDC 70771-1078-3 in bottles of 30 tablets NDC 70771-1078-9 in bottles of 90 tablets NDC 70771-1078-1 in bottles of 100 tablets NDC 70771-1078-8 in bottles of 180 tablets NDC 70771-1078-5 in bottles of 500 tablets NDC 70771-1078-4 in cartons of 100 tablets (10 x 10 unit-dose) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight container. Manufactured by: Cadila Healthcare Limited Matoda, Ahmedabad, India. Rev.: 06/17

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 10/2023
Document Id: 8ed3eb6a-7697-400c-ae6f-ff5387b71e0c
34391-3
Set id: efa55cb2-b625-4392-9ddb-0a8ad8ee58c4
Version: 5
Effective Time: 20231004
Zydus Lifesciences Limited

Preparatomtale

FELBAMATE- FELBAMATE TABLET
ZYDUS LIFESCIENCES LIMITED
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FELBAMATE TABLETS, USP
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1077-1
Felbamate tablets USP, 400 mg
100 Tablets
Rx only
NDC 70771-1078-1
Felbamate tablets USP, 600 mg
100 Tablets
Rx only
FELBAMATE
felbamate tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1077
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8)
FELBAMATE
400 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALUMINUM OXIDE (UNII: LMI26O6933)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
PRODUCT CHARACTERISTICS
COLOR
WHITE (OFF-WHITE TO PALE YELLOW COLOR)
SCORE
2 pieces
SHAPE
CAPSULE (CAPSULE)
SIZE
16mm
FLAVOR
IMPRINT CODE
10;53
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1077-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
08/15/2017
2
NDC:70771-
1077-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
08/15/2017
3
NDC:70771-
1077-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
08/15/2017
4
NDC:70771-
1077-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
08/15/2017
5
NDC:70771-
1077-4
10 in 1 CARTON
08/15/2017
5
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA208970
08/15/2017
FELBAMATE
felbamate tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1078
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
FELBAM