Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Nucleoside and Nucleotide Analogue Reverse Transcriptase Inhibitors (NRTIs)

Zidovudine

Last Updated: April 14, 2020; Last Reviewed: April 14, 2020

Zidovudine (ZDV, Retrovir)
Zidovudine (ZDV, Retrovir)
Formulations
Capsules: 100 mg
Syrup: 10 mg/mL
Concentrate for Injection or Intravenous Infusion: 10 mg/mL (Retrovir)

Generic Formulations:
  • 100 mg capsule
  • 100 mg/mL syrup
  • 300 mg tablet
Fixed-Dose Combination Tablets:
  • [Combivir and generic] Lamivudine 150 mg/zidovudine 300 mg (scored)
  • [Trizivir and generic] Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg
When using fixed-dose combination (FDC) tablets, refer to other sections of the Drug Appendix for information about the individual components of the FDC. See also Appendix A, Table 2. Antiretroviral Fixed-Dose Combination Tablets: Minimum Body Weights and Considerations for Use in Children and Adolescents

For additional information, see Drugs@FDA or DailyMed.
Dosing Recommendations Selected Adverse Events
Note: Zidovudine (ZDV) is frequently used in neonates to prevent perinatal transmission of HIV. See Antiretroviral Management of Newborns with Perinatal HIV Exposure or Perinatal HIV and Table 12 for information about using ZDV to prevent perinatal transmission.

Recommended Neonatal Dose for Treatment of HIV by Gestational Age at Birtha
Gestational Age at Birth Oral ZDV Dose
≥35 weeks Birth to Age 4 Weeks:
  • ZDV 4 mg/kg twice daily; or
  • Alternative simplified weight-band dosing
Simplified Weight-Band Dosing for Infants with a Gestational Age ≥35 Weeks at Birth:
Note: The doses in this table provide approximately ZDV 4 mg/kg orally twice daily from birth to age 4 weeks.
Weight Band Twice-Daily Volume of ZDV 10 mg/mL Syrup
2 kg to <3 kg 1 mL
3 kg to <4 kg 1.5 mL
4 kg to <5 kg 2 mL

Aged >4 Weeks:
  • ZDV 12 mg/kg twice daily
≥30 weeks to <35 weeks Birth to Age 2 Weeks:
  • ZDV 2 mg/kg orally twice daily
Aged 2 Weeks to 6 to 8 Weeks:
  • ZDV 3 mg/kg orally twice daily
Aged >6 Weeks to 8 Weeks:
  • ZDV 12 mg/kg orally twice daily
<30 weeks Birth to Age 4 Weeks:
  • ZDV 2 mg/kg orally twice daily
Aged 4 Weeks to 8 to 10 Weeks:
  • ZDV 3 mg/kg orally twice daily
Aged >8 Weeks to 10 Weeks:
  • ZDV 12 mg/kg orally twice daily
Note: For infants who are unable to tolerate oral agents, the intravenous dose should be 75% of the oral dose, but the dosing interval should remain the same.


Infant (Aged ≥35 Weeks Post-Conception and ≥4 Weeks Post-Delivery, Weighing ≥4 kg) and Child Dose

Weight-Based Dosing for Zidovudine 
Weight Twice-Daily Dosing
4 kg to <9 kg 12 mg/kg
9 kg to <30 kg 9 mg/kg
≥30 kg 300 mg

Alternative Body Surface Area Dosing
Oral:
  • ZDV 180 mg to 240 mg per m2 of body surface area every 12 hours
Child and Adolescent (Weighing ≥30 kg) and Adult Dose:
  • ZDV 300 mg twice daily
[Combivir and Generic] Lamivudine/Zidovudine
Child and Adolescent (Weighing ≥30 kg) and Adult Dose:
  • One tablet twice daily
[Trizivir and Generic] Abacavir/Lamivudine/Zidovudine
Child and Adolescent (Weighing ≥30 kg) and Adult Dose:
  • One tablet twice daily
  • Bone marrow suppression leading to anemia and neutropenia; macrocytosis with or without anemia
  • Nausea, vomiting, headache, insomnia, asthenia
  • Lactic acidosis/severe hepatomegaly with hepatic steatosis
  • Lipodystrophy and lipoatrophy
  • Myopathy (associated with prolonged use of ZDV) and myositis
Special Instructions
  • Give ZDV without regard to food.
  • If substantial granulocytopenia or anemia develops in patients who are receiving ZDV, it may be necessary to discontinue therapy until bone marrow recovery is observed. In this setting, some patients may require erythropoietin or filgrastim injections or transfusions of red blood cells.
  • Screen patients for hepatitis B virus (HBV) infection before using FDC products that contain lamivudine (3TC). Severe acute exacerbation of HBV infection can occur when 3TC is discontinued; therefore, hepatic function should be monitored for several months after patients with HBV infection stop taking 3TC.
Metabolism/Elimination
  • ZDV is eliminated primarily by hepatic metabolism. The major metabolite is ZDV glucuronide, which is renally excreted.
  • ZDV is phosphorylated intracellularly to active ZDV-triphosphate.
Zidovudine Dosing in Patients with Renal Impairment:
  • A dose adjustment is required for ZDV in patients with renal insufficiency.
Zidovudine Dosing in Patients with Hepatic Impairment:
  • The dose of ZDV may need to be reduced in patients with hepatic impairment.
  • Do not use FDC products (e.g., Combivir, Trizivir) in patients with creatinine clearance <50 mL/min, patients who are on dialysis, or patients who have impaired hepatic function.
a For premature infants who receive an HIV diagnosis, the time to change to the continuation dose varies with post-gestational age and clinical status of the infant.

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