Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS), LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)
Zydus Pharmaceuticals USA Inc.
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
ABACAVIR AND LAMIVUDINE- ABACAVIR AND LAMIVUDINE TABLET, FILM COATED ZYDUS PHARMACEUTICALS USA INC. ---------- 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 Leggi il documento completo