ZIDOVUDINE- zidovudine tablet
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including zidovudine tablets and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [see Warnings and Precautions ( 5.3 )] .
1 INDICATIONS AND USAGE
Zidovudine tablets, USP a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Zidovudine tablets, USP are 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:
- 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 in pregnant women for the prevention of maternal-fetal HIV-1 transmission include:
- In most cases, zidovudine 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 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 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.
Adults: The recommended oral dose of zidovudine is 600 mg/day in divided doses in combination with other antiretroviral agents.
Pediatric Patients (4 weeks to <18 years of age): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a zidovudine tablet, the zidovudine syrup formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine Syrup should be used to provide accurate dosage when whole tablets are not appropriate.
|Body Weight (kg)||Total Daily Dose||Dosage Regimen and Dose|
|4 to <9||24 mg/kg/day||12 mg/kg||8 mg/kg|
|≥9 to <30||18 mg/kg/day||9 mg/kg||6 mg/kg|
|≥30||600 mg/day||300 mg||200 mg|
Alternatively, dosing for zidovudine can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine is 480 mg/m 2 /day in divided doses (240 mg/m2 twice daily or 160 mg/m 2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.
The recommended dosage regimen for administration to pregnant women (>14 weeks of pregnancy) and their neonate is:
Maternal Dosing: 100 mg orally 5 times per day until the start of labor [see Clinical Studies ( 14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.
Neonatal Dosing: 2 mg/kg orally every 6 hours starting within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered zidovudine intravenously at 1.5 mg/kg, infused over 30 minutes, every 6 hours.
Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions ( 5.1)]. In patients who develop significant anemia, dose interruption does not necessarily eliminate the need for transfusion. If marrow recovery occurs following dose interruption, resumption in dose may be appropriate using adjunctive measures such as epoetin alfa at recommended doses, depending on hematologic indices such as serum erythropoetin level and patient tolerance.
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