Adults
The recommended oral dose of ZIDOVIR is 600 mg/day in divided doses in combination with other antiretrovirals.
Pediatric Patients (6 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 capsules or tablets, children should be assessed for the ability to swallow capsules or tablets. If a child is unable to reliably swallow a zidovudine capsule or tablet, the zidovudine syrup formulation should be prescribed.
The recommended dosage in pediatric patients, 6 weeks of age and older and weighing ≥4 kg, is provided in Table 4. Zidovudine syrup should be used to provide accurate dosage when whole tablets or capsules are not appropriate.
Table 4: Recommended Pediatric Dosage of Zidovudine
Body Weight (kg) |
Total Daily Dose |
Dosage Regimen and Dose |
| b.i.d. |
t.i.d. |
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/m 2 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 the BSA.
Prevention of Maternal- Fetal HIV Transmission
The recommended dosing regimen for administration to pregnant women (>14 weeks of pregnancy) and their neonates is:
Maternal Dosing: 100 mg orally 5 times per day until the start of labor. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour, followed by a continuous I.V. 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.
Patients with Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin of <7.5 g/dL or reduction of >25% of baseline) and/or significant neutropenia (granulocyte count of <750 cells/mm 3 or reduction of >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed (see WARNINGS AND PRECAUTIONS). In patients who develop significant anemia, dose modification 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 hematological indices such as serum erythropoetin level and patient tolerance.
For patients experiencing pronounced anemia while receiving chronic co-administration of zidovudine and drugs such as fluconazole and valproic acid, zidovudine dose reduction may be considered.
Patients with Renal Impairment
End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours.
Patients with Hepatic Impairment
There are insufficient data to recommend dose adjustment of zidovudine in patients with mild to moderate impaired hepatic function or liver cirrhosis.
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