ABACAVIR AND LAMIVUDINE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS), LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)

Beschikbaar vanaf:

Zydus Pharmaceuticals USA Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Abacavir and lamivudine is contraindicated in patients: - who have the HLA-B*5701 allele [see Warnings and Precautions (5.1)] . - with prior hypersensitivity reaction to abacavir [see Warnings and Precautions (5.1)] or lamivudine. - with moderate or severe hepatic impairment [see Use in Specific Populations (8.7)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir and lamivudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital

Product samenvatting:

Abacavir and lamivudine tablets, USP contain 600 mg of abacavir (equivalent to 702.00 mg abacavir sulfate, USP) and 300 mg of lamivudine, USP. Abacavir and Lamivudine Tablets USP, 600 mg/300 mg are light yellow to yellow, modified capsule shaped, coated tablets, debossed with "1049" on one side and plain on the other side and are supplied as: NDC 70710-1049-3 in bottle of 30 tablets with child-resistant closure NDC 70710-1049-9 in bottle of 90 tablets with child-resistant closure Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ABACAVIR AND LAMIVUDINE- ABACAVIR AND LAMIVUDINE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABACAVIR AND
LAMIVUDINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ABACAVIR
AND LAMIVUDINE TABLETS.
ABACAVIR AND LAMIVUDINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
WARNING: HYPERSENSITIVITY REACTIONS AND EXACERBATIONS OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HYPERSENSITIVITY REACTIONS
SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE OCCURRED
WITH ABACAVIR-
CONTAINING PRODUCTS. (5.1)
HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME. (5.1)
PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT A HIGHER RISK OF
EXPERIENCING A
HYPERSENSITIVITY REACTION TO ABACAVIR. (5.1)
ABACAVIR AND LAMIVUDINE IS CONTRAINDICATED IN PATIENTS WITH A PRIOR
HYPERSENSITIVITY
REACTION TO ABACAVIR AND IN HLA-B*5701-POSITIVE PATIENTS. (4)
DISCONTINUE ABACAVIR AND LAMIVUDINE AS SOON AS A HYPERSENSITIVITY
REACTION IS
SUSPECTED. REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE
ABACAVIR AND
LAMIVUDINE IF HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN OTHER
DIAGNOSES ARE
POSSIBLE. (5.1)
FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR AND LAMIVUDINE,
NEVER RESTART
ABACAVIR AND LAMIVUDINE OR ANY OTHER ABACAVIR-CONTAINING PRODUCT.
(5.1)
EXACERBATIONS OF HEPATITIS B
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN
PATIENTS WHO ARE
CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY
VIRUS (HIV-1)
AND HAVE DISCONTINUED LAMIVUDINE, A COMPONENT OF ABACAVIR AND
LAMIVUDINE.
MONITOR HEPATIC FUNCTION CLOSELY IN THESE PATIENTS AND, IF
APPROPRIATE, INITIATE ANTI-
HEPATITIS B TREATMENT. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Use with Interferon-and Ribavirin-Based
Regimens (previous 5.4)Removed
05/2019
INDICATIONS AND USAGE
Abacavir and lamivudine tablets, a combination of abacavir and
lamivudine, both n