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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use RETROVIR safely and effectively. See full prescribing information for RETROVIR.
RETROVIR® (zidovudine) Tablets, Capsules, and Syrup
Initial U.S. Approval: 1987 |
WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS
See full prescribing information for complete boxed warning.
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Hematologic toxicity including neutropenia and severe anemia have been associated with the use of zidovudine. (5.1)
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Symptomatic myopathy associated with prolonged use of zidovudine. (5.2)
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Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues including RETROVIR. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur. (5.3)
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RECENT MAJOR CHANGES
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Dosage and Administration, Pediatric Patients (2.1)
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September 2008
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INDICATIONS AND USAGE
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RETROVIR is a nucleoside analogue reverse transcriptase inhibitor indicated for:
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Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. (1.1)
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Prevention of maternal-fetal HIV-1 transmission. (1.2)
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DOSAGE AND ADMINISTRATION
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