Country: United States
Language: English
Source: NLM (National Library of Medicine)
LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95), ZIDOVUDINE (UNII: 4B9XT59T7S) (ZIDOVUDINE - UNII:4B9XT59T7S)
Camber Pharmaceuticals, Inc.
LAMIVUDINE
LAMIVUDINE 150 mg
ORAL
PRESCRIPTION DRUG
Lamivudine and zidovudine tablets 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 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 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 populatio
Lamivudine and Zidovudine Tablets, USP containing 150 mg lamivudine and 300 mg zidovudine, are white, film coated, capsule shaped tablets debossed with 'H' and score line on one side and '2' on other side. They are available as follows: 60 Tablets/Bottle (NDC 31722-506-60) 500 Tablets/Bottle (NDC 31722-506-05) Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]
Abbreviated New Drug Application
LAMIVUDINE AND ZIDOVUDINE - LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED CAMBER PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LAMIVUDINE AND ZIDOVUDINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE AND ZIDOVUDINE TABLETS , 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, HAS 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 OCCUR. ( 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 TABLET. MONITOR HEPATIC FUNCTION CLOSELY IN THESE PATIENTS AND, IF APPROPRIATE, INITIATE ANTI- HEPATITIS B TREATMENT. ( 5.4) INDICATIONS AND USAGE Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogue reverse transcriptase inibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1) (1) DOSAGE AND ADMINISTRATION • Adults and Adolescents weighing greater than or equal to 30 kg: 1 tablet orally twice daily. ( 2.1) • Pediatrics weighing greater than or equal to 30 kg: 1 table Read the complete document