retrovir zidovudine 100 mg
1 INDICATIONS AND USAGE RETROVIR is a nucleoside analogue reverse transcriptase inhibitor indicated for: • Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. ( 1.1 ) • Prevention of maternal-fetal HIV-1 transmission. ( 1.2 ) 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 prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration ( 2.3 )]. The indication is based on a dosing regimen that included 3 components: 1. antepartum therapy of HIV‑1–infected mothers 2. intrapartum therapy of HIV‑1–infected mothers 3. post-partum therapy of HIV‑1–exposed neonate Points to consider prior to initiating RETROVIR in pregnant women for the prevention of maternal-fetal HIV-1 transmission include: • In most cases, RETROVIR for prevention of maternal-fetal HIV-1 transmission should be given in combination with other antiretroviral drugs. • Prevention of HIV-1 transmission in women who have received RETROVIR for a prolonged period before pregnancy has not been evaluated. • Because the fetus is most susceptible to the potential teratogenic effects of drugs during the first 10 weeks of gestation and the risks of therapy with RETROVIR during that period are not fully known, women in the first trimester of pregnancy who do not require immediate initiation of antiretroviral therapy for their own health may consider delaying use; this indication is based on use after 14 weeks’ gestation.
viiv healthcare company
CAPSULE WHITE Wellcome Y9C 100
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16 HOW SUPPLIED/STORAGE AND HANDLING RETROVIR 100-mg capsules are supplied as white, opaque cap and body capsules containing 100 mg
ZIDOVUDINE per capsule. Each capsule is printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body. The vial stoppers for RETROVIR injection contain dry natural rubber latex. Bottles of 100 (NDC 49702-211-20). Store at 15° to 25°C (59° to 77°F) and protect from moisture. RETROVIR oral solution is supplied as a colorless to pale yellow, strawberry-flavored solution containing 10 mg
ZIDOVUDINE in each mL. Bottle of 240 mL (NDC 49702-212-48) with child-resistant cap. Store at 15° to 25°C (59° to 77°F). RETROVIR injection, 10 mg
ZIDOVUDINE in each mL. 20‑mL Single‑use Vial (NDC 49702-213-01), Carton of 5 (NDC 49702-213-26). Store vials at 15° to 25°C (59° to 77°F) and protect from light.
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