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INDICATIONS AND USAGE
COMBIVIR, a combination of two nucleoside analogue reverse transcriptase inhibitors, is 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.
Pediatrics: Dosage should be based on body weight not to exceed adult doses.
COMBIVIR, 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.
DOSAGE FORMS AND STRENGTHS
Tablets: Scored 150 mg lamivudine and 300 mg zidovudine
COMBIVIR Tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, Stevens-Johnson syndrome).
WARNINGS AND PRECAUTIONS
Hematologic toxicity/bone marrow suppression including neutropenia and anemia have been associated with the use of zidovudine, one of the components of COMBIVIR.
Symptomatic myopathy associated with prolonged use of zidovudine.
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.
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 COMBIVIR. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment.
COMBIVIR should not be administered with other lamivudine- or zidovudine-containing products or emtricitabine-containing products.
Hepatic decompensation, some fatal, has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with/without ribavirin. Discontinue COMBIVIR as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both.
Exacerbation of anemia has been reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine. Co-administration of ribavirin and zidovudine is not advised.
Pancreatitis: Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue treatment as clinically appropriate.
Immune reconstitution syndrome (5.8) and redistribution/accumulation of body fat (5.9) have been reported in patients treated with combination antiretroviral therapy.
Most commonly reported adverse reactions (incidence greater than or equal to 15%) in adult and pediatric HIV-1 clinical studies of combination lamivudine and zidovudine were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough.
Concomitant use with the following drugs should be avoided: stavudine, zalcitabine, doxorubicin
Bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine.
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