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Description of Retrovir
RETROVIR is the brand name for zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against HIV-1. The chemical name of zidovudine is 3′-azido-3′-deoxythymidine; it has the following structural formula: Zidovudine is a white to beige, odorless, crystalline solid with a molecular weight of 267.24 and a solubility of 20.1 mg per mL in water at 25°C. The molecular formula is C 10 H 13 N 5 O 4 . RETROVIR capsules are for oral administration. Each capsule contains 1...
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Uses of Retrovir
RETROVIR is a nucleoside analogue reverse transcriptase inhibitor indicated for: • Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. • Prevention of maternal-fetal HIV-1 transmission. 1.1 Treatment of HIV-1 RETROVIR, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 1.2 Prevention of Maternal-Fetal HIV-1 Transmission RETROVIR is indicated for the ...
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Available dosage forms and strengths
• RETROVIR capsules 100 mg (white, opaque cap and body) containing 100 mg zidovudine and printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body. • RETROVIR oral solution (colorless to pale yellow, strawberry‑flavored) containing 10 mg zidovudine in each mL. • RETROVIR injection is a clear, nearly colorless, sterile aqueous solution with a pH of approximately 5.5. Each vial contains 200 mg of zidovudine in 20 mL solution (10 mg per mL). • Capsules: 100 mg • Oral Solution: 10 mg p...
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How should you take Retrovir
• Treatment of HIV-1 infection: Adults: Recommended oral dosage is 300 mg twice a day with other antiretroviral agents. For patients who are unable to take the oral formulations, the recommended intravenous dose is 1 mg per kg infused over 1 hour every 4 hours. Pediatric patients (aged 4 weeks to less than 18 years): Dosage should be calculated based on body weight not to exceed adult dose. • Prevention of maternal-fetal HIV-1 transmission: Specific dosage instructions for mother and infant. • Patie...
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Precautions and contraindications for Retrovir
RETROVIR is contraindicated in patients who have had a potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the formulations. Hypersensitivity to zidovudine or any of the components (e.g., anaphylaxis, Stevens-Johnson syndrome).
In case of overdosage
Acute overdoses of zidovudine have been reported in pediatric patients and adults. These involved exposures up to 50 grams. No specific symptoms or signs have been identified following acute overdosage with zidovudine apart from those listed as adverse events such as fatigue, headache, vomiting, and occasional reports of hematological disturbances. Patients recovered without permanent sequelae. Hemodialysis and peritoneal dialysis appear to have a negligible effect on the removal of zidovudine whil...
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Warnings and Cautions
• See boxed warning for information about the following: hematologic toxicity, myopathy, and lactic acidosis and severe hepatomegaly. ( 5.1 , 5.2 , 5.3 ) • Exacerbation of anemia has been reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine. Coadministration of ribavirin and zidovudine is not advised. • Hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with/without ribavirin. Di...
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Drug interactions
• Avoid use with stavudine. • Avoid use with doxorubicin. • Bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine. 7.1 Antiretroviral Agents Stavudine Concomitant use of zidovudine with stavudine should be avoided since an antagonistic relationship has been demonstrated in vitro. Nucleoside Analogues Affecting DNA Replication Some nucleoside analogues affecting DNA replication, such as ribavirin, antagonize the in vitro antiviral activity of RETROVIR against H...
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Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RETROVIR during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for zidovudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital...
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Notice: This medical information is provided to help you better understand this medical condition or process and may contain information about medication often used as part of a treatment plan prescribed by a doctor. It is not intended to be used as either a diagnosis or recommendation for treatment of your medical situation. If you are unwell, concerned about your physical or mental state, or are experiencing symptoms, you should speak with your doctor or primary health care provider. If you are in medical distress, please contact emergency services (such as 911).
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