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Outline
What is the generic name?
ZIDOVUDINE
What is the Trade Name for ZIDOVUDINE?
Zidovudine
What are the Indications for ZIDOVUDINE?
- 1 INDICATIONS & USAGE Zidovudine capsules are 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 Zidovudine capsules , a nucleoside reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 1.2 Prevention of Maternal-Fetal HIV-1 Transmission Zidovudine capsules are 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: 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 capsules in pregnant women for the prevention of maternal-fetal HIV-1 transmission include: In most cases, zidovudine capsules 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 zidovudine capsules 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 zidovudine capsules 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.
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References: https://open.fda.gov/
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