Advise patients that if toxicity develops, they may require transfusions or drug discontinuation. Mechanism of Action. Mechanism of Action: Zidovudine is a synthetic nucleoside analogue. The median age was 2.7 years (range: 6 weeks to 14 years), the mean baseline CD4+ cell count was 868 cells per mmThe utility of RETROVIR for the prevention of maternal-fetal HIV-1 transmission was demonstrated in a randomized, double-blind, placebo-controlled trial (ACTG 076) conducted in HIV-1-infected pregnant women with CD4+ cell counts of 200 to 1,818 cells per mmRETROVIR 100-mg capsules are supplied as white, opaque cap and body capsules containing 100 mg zidovudine per capsule. The incidence and severity of lipoatrophy are related to cumulative exposure.This fat loss, which is most evident in the face, limbs, and buttocks, may be only partially reversible and improvement may take months to years after switching to a non-zidovudine-containing regimen. (Symptomatic myopathy associated with prolonged use of zidovudine. Intracellularly, zidovudine is phosphorylated to its active 5′-triphosphate metabolite, zidovudine triphosphate (ZDV-TP). Neonates unable to receive oral dosing may be administered zidovudine intravenously. ©2017 the ViiV Healthcare group of companies or its licensor.Trademark is owned by or licensed to the ViiV Healthcare group of companies. Zidovudine Pharmacokinetic Parameters in Subjects with Severe Renal Table 9. Selected Clinical Adverse Reactions and Physical Findings (Greater than or Equal to 5% Frequency) in Pediatric Subjects in Trial ACTG 300Table 6. Patients should be regularly assessed for signs of lipoatrophy during therapy with zidovudine and other zidovudine-containing products, and if feasible, therapy should be switched to an alternative regimen if there is suspicion of lipoatrophy.The following adverse reactions are discussed in greater detail in other sections of the labeling:Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.The frequency and severity of adverse reactions associated with the use of RETROVIR are greater in patients with more advanced infection at the time of initiation of therapy.Selected laboratory abnormalities observed during a clinical trial of monotherapy with oral RETROVIR are shown in The adverse reactions reported during IV administration of RETROVIR injection are similar to those reported with oral administration; neutropenia and anemia were reported most frequently. The molecular formula is CZidovudine is a synthetic nucleoside analogue. Patients receiving interferon alfa with or without ribavirin and zidovudine should be closely monitored for treatment-associated toxicities, especially hepatic decompensation, neutropenia, and anemia.Discontinuation of zidovudine should be considered as medically appropriate. The most commonly reported adverse reactions were anemia (hemoglobin less than 9.0 g per dL) and neutropenia (less than 1,000 cells per mmThe following adverse reactions have been identified during post-approval use of RETROVIR. OFFERING INFORMATION ON HIV/AIDS These highlights do not include all the information needed to use RETROVIR safely and effectively. Patients recovered without permanent sequelae. A total of 471 symptomatic, HIV-1-infected therapy-naive pediatric subjects were enrolled in these 2 treatment arms. In adults, following oral administration, zidovudine is rapidly absorbed and extensively distributed, with peak serum concentrations occurring within 0.5 to 1.5 hours. The zidovudine AUC was similar when a single dose of zidovudine was administered with food.Although data are limited, methadone maintenance therapy in 5 pregnant women did not appear to alter zidovudine pharmacokinetics.Zidovudine is a synthetic nucleoside analogue.