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Retrovir Dosage

Generic name: zidovudine
Dosage form: tablets, capsules and syrup

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Treatment of HIV-1 Infection

Adults: The recommended oral dose of RETROVIR is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of RETROVIR, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

Prescribers should calculate the appropriate dose of RETROVIR for each child based on body weight (kg) and should not exceed the recommended adult dose.

Before prescribing RETROVIR Capsules or Tablets, children should be assessed for the ability to swallow capsules or tablets. If a child is unable to reliably swallow a RETROVIR Capsule or Tablet, the RETROVIR Syrup formulation should be prescribed.

The recommended dosage in pediatric patients aged 4 weeks to <18 years and weighing ≥4 kg is provided in Table 1. RETROVIR Syrup should be used to provide accurate dosage when whole tablets or capsules are not appropriate.

Table 1. Recommended Pediatric Dosage of RETROVIR

Body Weight

(kg)

Total Daily Dose

Dosage Regimen and Dose

Twice Daily

Three Times Daily

 

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 RETROVIR can be based on body surface area (BSA) for each child. The recommended oral dose of RETROVIR is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.

Prevention of Maternal-Fetal HIV-1 Transmission

The recommended dosage 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 [see Clinical Studies(14.3)]. During labor and delivery, intravenous RETROVIR 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: Start neonatal dosing within 12 hours after birth and continue through 6 weeks of age. Neonates unable to receive oral dosing may be administered RETROVIR intravenously. See Table 2.

Table 2. Recommended Neonatal Dosages of RETROVIR

Route

Total Daily Dose

Dose and Dosage Regimen

Oral

8 mg/kg/day

2 mg/kg every 6 hours

IV

6 mg/kg/day

1.5 mg/kg infused over 30 minutes, every 6 hours

Patients With Severe Anemia and/or Neutropenia

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.

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 [see Clinical Pharmacology (12.3)].

Patients With Hepatic Impairment

There are insufficient data to recommend dose adjustment of RETROVIR in patients with mild to moderate impaired hepatic function or liver cirrhosis.

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