Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95), ZIDOVUDINE (UNII: 4B9XT59T7S) (ZIDOVUDINE - UNII:4B9XT59T7S)
Preferred Pharmaceuticals Inc.
LAMIVUDINE
LAMIVUDINE 150 mg
ORAL
PRESCRIPTION DRUG
Lamivudine and zidovudine tablets, USP a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Lamivudine and zidovudine tablets, USP are contraindicated in patients with a previous hypersensitivity reaction to lamivudine or zidovudine. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine and zidovudine tablets 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 lamivudine or zidovudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data) . The APR uses the MACDP as the U.S. reference population for birth defects in the g
Lamivudine and zidovudine tablets, USP [150/300 mg], containing 150 mg lamivudine and 300 mg zidovudine, are white to off-white colored, oval, film coated tablets with "LZ" engraved on one side and breakline on other side. They are available as follows: 60 Tablets/Bottle (NDC 64380-707-03) Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
LAMIVUDINE AND ZIDOVUDINE- LAMIVUDINE AND ZIDOVUDINE TABLET PREFERRED PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LAMIVUDINE AND ZIDOVUDINE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMIVUDINE AND ZIDOVUDINE TABLETS, USP [150/300 MG ] LAMIVUDINE AND ZIDOVUDINE TABLETS, USP [150/300 MG] FOR ORAL USE. INITIAL U.S. APPROVAL: 1997 WARNING: HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, AND EXACERBATIONS OF HEPATITIS B _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • HEMATOLOGIC TOXICITY, INCLUDING NEUTROPENIA AND ANEMIA, HAVE BEEN ASSOCIATED WITH THE USE OF ZIDOVUDINE, A COMPONENT OF LAMIVUDINE AND ZIDOVUDINE TABLETS (5.1) • SYMPTOMATIC MYOPATHY ASSOCIATED WITH PROLONGED USE OF ZIDOVUDINE. (5.2) • LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES INCLUDING LAMIVUDINE AND ZIDOVUDINE (COMPONENTS OF LAMIVUDINE AND ZIDOVUDINE TABLETS). SUSPEND TREATMENT IF CLINICAL OR LABORATORY FINDINGS SUGGESTIVE OF LACTIC ACIDOSIS OR PRONOUNCED HEPATOTOXICITY OCCURS. (5.3) • 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 LAMIVUDINE AND ZIDOVUDINE TABLETS. MONITOR HEPATIC FUNCTION CLOSELY IN THESE PATIENTS AND, IF APPROPRIATE, INITIATE ANTI-HEPATITIS B TREATMENT. (5.4) INDICATIONS AND USAGE Lamivudine and Zidovudine tablets, USP a combination of 2 nucleoside analogue reverse transcriptase inhibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV - 1 infection. (1) DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS Tablets: Scored 150 mg lamivudine and 300 mg zidovudine (3) CONTRAINDICATIONS Lamivudine and zidovudine tablets, USP are contraindicated i Izlasiet visu dokumentu