COMBIVIR Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
COMBIVIR is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
COMBIVIR, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection.
What should I know before taking it?
COMBIVIR is contraindicated in patients with a previous hypersensitivity reaction to lamivudine or zidovudine.
What important warnings are listed?
Zidovudine, a component of COMBIVIR (lamivudine and zidovudine) tablets, has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced Human Immunodeficiency Virus (HIV‑1) disease [see Warnings and Precautions (5.1)]. Prolonged use of zidovudine has been associated with symptomatic myopathy [see Warnings and Precautions (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 COMBIVIR). Discontinue COMBIVIR if clinical or laboratory findings suggestive of lactic acidosis or pronounced.
How is this medication usually taken?
COMBIVIR tablets contain 150 mg of lamivudine and 300 mg of zidovudine. The tablets are white, scored, film‑coated, modified capsule‑shaped tablets, debossed on both tablet faces, such that when broken in half, the full “GX FC3” code is present on both halves of the tablet (“GX” on one face and “FC3” on the opposite face of the tablet).
What side effects are listed?
The following adverse reactions are discussed in other sections of the labeling: •Hematologic toxicity, including neutropenia and anemia [see Boxed Warning, Warnings and Precautions (5.1)]. •Symptomatic myopathy [see Boxed Warning, Warnings and Precautions (5.2)]. •Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions (5.3)]. •Exacerbations of hepatitis B [see Boxed Warning, Warnings and Precautions (5.4)]. •Hepatic decompensation in patients co-infected with HIV‑1 and hepatitis C [see Warnings and Precautions (5.5)]. •Exacerbation of anemia in HIV‑1/HCV co-infected patients receiving ribavirin and zidovudine [see Warnings and Precautions.
What interactions are listed?
7 DRUG INTERACTIONS • Agents antagonistic with zidovudine: Concomitant use should be avoided. ( 7.1 ) • Hematologic/bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine. ( 7.1 ) • Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations; when possible, avoid chronic coadministration. ( 7.2 ) 7.1 Zidovudine Agents Antagonistic with Zidovudine Concomitant use of zidovudine with the following drugs should be avoided since an antagonistic relationship has been demonstrated in vitro: • Stavudine • Doxorubicine • Nucleoside analogues, e.g., ribavirin Hematologic/Bone Marrow Suppressive/Cytotoxic Agents Coadministration.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=16da660b-9981-4d24-a14a-94c7744fce4f
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.