Classes
DEA Class; Rx
Common Brand Names; Combivir, 3tc/zdv
- HIV, ART Combos
Description
Combination of 2 nucleoside reverse transcriptase inhibitors (NRTIs)
Used for HIV infection in combination with other antiretroviral agents
Black Box Warnings for hematologic toxicity, myopathy, lactic acidosis, severe hepatomegaly with steatosis, and exacerbations of hepatitis B upon treatment discontinuation
Indications
Indicated for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents.
Contraindications
Hypersensitivity
Patients requiring separate lamivudine or zidovudine dose reduction
Adverse Effects
- Headache (35%)
- Nausea (33%)
- Malaise & fatigue (27%)
- Cough (18%)
- Diarrhea (18%)
- Vomiting (13%)
- Musculoskeletal pain (12%)
- Neuropathy (12%)
- Insomnia & other sleep disorders (11%)
- Anorexia &/or decreased appetite (10%)
- Dizziness (10%)
- Fever or chills (10%)
- Abdominal pain (9%)
- Depressive disorders (9%)
- Skin rashes (9%)
- Myalgia (8%)
- Neutropenia (7.2% )
- Abdominal cramps (6%)
- Arthralgia (5%)
- Dyspepsia (5%)
- Anemia (2.9% )
Warnings
Risk of immune reconstitution syndrome
Zidovudine use has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV-1 disease; use with caution in patients who have bone marrow compromise evidenced by granulocyte count < 1,000 cells per mm³ or hemoglobin < 9.5 g/dL; frequent blood counts strongly recommended in patients with advanced HIV-1 disease; periodic blood counts recommended for other HIV-1-infected patients; if anemia or neutropenia develops, dosage interruption may be needed
Myopathy and myositis, with pathological changes similar to that produced by HIV-1 disease associated with prolonged use of zidovudine
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analogues, including lamivudine and zidovudine (components of the combination product) and other antiretrovirals reported; a majority of these cases have been in women; female sex and obesity may be risk factors for the development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analogues; suspend treatment in patients who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations)
Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine; monitor patients closely with both clinical and laboratory follow-up for at least several months after stopping treatment
Emergence of hepatitis B virus variants associated with resistance to lamivudine reported in HIV-1-infected subjects who received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus
Concomitant administration with other products containing lamivudine or zidovudine not recommended
Pregnancy and Lactation
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to therapy during pregnancy
The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection
Maximum Dosage
Lamivudine 300 mg/day PO and zidovudine 600 mg/day PO.
Lamivudine 300 mg/day PO and zidovudine 600 mg/day PO.
>= 30 kg: Lamivudine 300 mg/day PO and zidovudine 600 mg/day PO.
< 30 kg: Combination product not recommended.
>= 30 kg: Lamivudine 300 mg/day PO and zidovudine 600 mg/day PO.
< 30 kg: Combination product not recommended.
Combination product not recommended.
Combination product not recommended.
How supplied
Lamivudine/zidovudine
tablet
- 150mg/300mg
