Zidovudine indications and usage

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Zidovudine
RETROVIR® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Indications And Usage

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.

Prevention of Maternal-Fetal HIV-1 Transmission

RETROVIR is indicated for the prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration (2.2)]. 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.[1]

References

  1. "RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) TABLET, FILM COATED RETROVIR (ZIDOVUDINE) SYRUP [VIIV HEALTHCARE COMPANY]". Retrieved 9 January 2014.

Adapted from the FDA Package Insert.