Zidovudine 300 MG Oral Tablet
1 INDICATIONS AND USAGE Zidovudine tablets, USP 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 tablets USP, 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 tablets 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 three 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 tablets in pregnant women for the prevention of maternal-fetal HIV-1 transmission include: • In most cases, zidovudine tablets 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 tablets 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 tablets 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.
Mylan Pharmaceuticals Inc.
ROUND WHITE M106
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16 HOW SUPPLIED/STORAGE AND HANDLING Zidovudine Tablets, USP are available containing 300 mg of zidovudine, USP. The 300 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M 106 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6106-91 bottles of 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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