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Retrovir Capsules Generic Name & Formulations
Legal Class
Rx
General Description
Zidovudine 100mg.
Pharmacological Class
Nucleoside analogue (reverse transcriptase inhibitor).
See Also
How Supplied
Tabs—contact supplier; Caps—100; Syrup—240mL; IV (20mL/vial)—1, 5
Manufacturer
Generic Availability
YES
Retrovir Capsules Indications
Indications
HIV-1 infection, in combination with other antiretroviral agents. Prevention of maternal-fetal HIV-1 transmission.
Retrovir Capsules Dosage and Administration
Adult
≥18yrs: 300mg twice daily. Renal impairment (CrCl <15mL/min) or on dialysis: 100mg every 6–8hrs. Prevention of maternal-fetal HIV or vertical transmission, severe anemia and/or neutropenia: see full labeling.
Children
<6wks and/or for vertical transmission: see full labeling. 4wks to <18yrs: (4 to <9kg): 24mg/kg/day (12mg/kg twice daily or 8mg/kg 3 times daily); (≥9 to <30kg): 18mg/kg/day (9mg/kg twice daily or 6mg/kg 3 times daily); (≥30kg): 600mg/day (300mg twice daily or 200mg 3 times daily). Alternative dosing based on BSA: 480mg/m2/day (240mg/m2 twice daily or 160mg/m2 3 times daily).
Retrovir Capsules Contraindications
Not Applicable
Retrovir Capsules Boxed Warnings
Boxed Warning
Hematological toxicity. Myopathy. Lactic acidosis and severe hepatomegaly with steatosis.
Retrovir Capsules Warnings/Precautions
Warnings/Precautions
Risk of hematologic toxicity/bone marrow suppression; monitor CBCs esp. in advanced HIV-1 disease; interrupt dose if anemia or neutropenia occurs. Myopathy/myositis with prolonged use. Suspend if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor for lipoatrophy; use alternatives if suspected. Severe renal impairment: reduce dose (see Adult). Hepatic impairment or cirrhosis: monitor for hematologic toxicity. Latex allergy (IV). Women. Obesity. Elderly. Pregnancy. Nursing mothers: not recommended.
Retrovir Capsules Pharmacokinetics
See Literature
Retrovir Capsules Interactions
Interactions
Avoid concomitant stavudine, doxorubicin, nucleoside analogues (eg, ribavirin). Increased hematologic toxicity with ganciclovir, interferon alpha, ribavirin, other bone marrow suppressants or cytotoxic drugs. Monitor for treatment-associated toxicities (eg, hepatic decompensation) with interferon alpha with or without ribavirin.
Retrovir Capsules Adverse Reactions
Adverse Reactions
Headache, malaise, nausea, vomiting, anorexia; neutropenia, anemia, myopathy, lactic acidosis, severe hepatomegaly with steatosis, immune reconstitution syndrome, pancreatitis, lipoatrophy. Children: also fever, cough.
Retrovir Capsules Clinical Trials
See Literature
Retrovir Capsules Note
Not Applicable
Retrovir Capsules Patient Counseling
See Literature
