|
TOP
|
|
LAMIVUDINE and ZIDOVUDINE tablets, USP 150 mg/300 mg
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.
LAMIVUDINE and ZIDOVUDINE tablets, USP 150 mg/300 mg for oral use
Initial U.S. Approval: 1997
WARNING: RISK OF HEMATOLOGIC TOXICITY, MYOPATHY,
See full prescribing information for complete boxed warning.
Hematologic toxicity including neutropenia and anemia have been associated with the use of zidovudine, one of the components of lamivudine and zidovudine tablets. (5.1)
Symptomatic myopathy associated with prolonged use of zidovudine. (5.2)
Lactic acidosis and hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues including zidovudine. 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 tablets. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment. (5.4)
RECENT MAJOR CHANGES
Warnings and Precautions, Immune Reconstitution Syndrome (5.8) .............................(11/2011)
INDICATIONS AND USAGE
Lamivudine and zidovudine tablets, a combination of two nucleoside analogue reverse transcriptase inhibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
DOSAGE AND ADMINISTRATION
Adults and Adolescents weighing ≥ 30 kg: 1 tablet twice daily. (2.1)
Pediatrics: Dosage should be based on body weight not to exceed adult doses. (2.2)
Lamivudine and zidovudine tablets USP, a fixed-dose product, should not be prescribed for pediatric patients weighing less than 30 kg or patients requiring dosage adjustment, such as those with renal or hepatic impairment, or patients experiencing dose-limiting adverse reactions. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: Scored 150 mg lamivudine and 300 mg zidovudine (3)
CONTRAINDICATIONS
Lamivudine and zidovudine tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, Stevens-Johnson syndrome). (4)
WARNINGS AND PRECAUTIONS
|
|
