Zidovudine

What it is and how it works

Mechanism of Action Zidovudine is an antiretroviral agent .

Mechanism class: Nucleoside Reverse Transcriptase Inhibitors

Indications

Zidovudine oral solution 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. Treatment of HIV-1 Zidovudine oral solution, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Prevention of Maternal-Fetal HIV-1 Transmission Zidovudine oral solution is indicated for the prevention of maternal-fetal HIV-1 transmission . The indication is based on a dosing regimen that included 3 components: antepartum therapy of HIV-1-infected mothers intrapartum therapy of HIV-1-infected mothers post-partum therapy of HIV-1-exposed neonate Points to consider prior to initiating zidovudine oral solution in pregnant women for the prevention of maternal-fetal HIV-1 transmission include: In most cases, zidovudine oral solution for prevention of maternal-fetal HIV-1 transmission should be given in combination with other antiretroviral drugs.

Dosage and administration (summary)

Treatment of HIV-1 infection: Adults: Recommended oral dosage is 300 mg twice a day with other antiretroviral agents. 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. Patients with severe anemia and/or neutropenia: Dosage interruption may be necessary. Renal impairment: Recommended oral dosage in hemodialysis or peritoneal dialysis or in patients with creatinine clearance (CrCl) less than 15 mL per minute is 100 mg every 6 to 8 hours.

Contraindications

Zidovudine oral solution 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 formulation. Hypersensitivity to zidovudine or any of the components (e.g., anaphylaxis, Stevens-Johnson syndrome).

Warnings and precautions

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.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to zidovudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.

Storage and supply

Zidovudine Oral Solution USP, 10 mg/mL is (colorless to pale yellow, strawberry-flavored) containing 10 mg zidovudine in each (mL). Bottle of 240 mL NDC 65862-048-24 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

Source: Zidovudine (Zidovudine) — US FDA prescribing information, 2025-02-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.