Viral infections:

Indications for: RETROVIR CAPSULES

HIV-1 infection, in combination with other antiretroviral agents. Prevention of maternal-fetal HIV-1 transmission.

Adult Dosage:

≥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 Dosage:

<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).

Boxed Warning:

Hematological toxicity. Myopathy. Lactic acidosis and severe hepatomegaly with steatosis.

RETROVIR CAPSULES 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 Classification:

Nucleoside analogue (reverse transcriptase inhibitor).

RETROVIR CAPSULES 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.

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.

Generic Drug Availability:

YES

How Supplied:

Tabs—contact supplier; Caps—100; Syrup—240mL; IV (20mL/vial)—1, 5