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 16, 2019; Last Reviewed: April 16, 2019

Zidovudine (ZDV, Retrovir)
Zidovudine (ZDV, Retrovir)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Capsules: 100 mg
Tablets: 300 mg
Syrup: 10 mg/mL
Concentrate for Injection or Intravenous Infusion: 10 mg/mL

Generic Formulations:
  • Zidovudine capsules, tablets, syrup, and injection are approved by the Food and Drug Administration for manufacture and distribution in the United States.
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
Dosing Recommendations Selected Adverse Events
Note: Zidovudine 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 zidovudine to prevent perinatal transmission.

Recommended Neonatal Dose for Treatment of HIV by Gestational Age at Birtha
Gestational Age at Birth Oral Zidovudine Dose
≥35 weeks Birth to Age 4 Weeks:
  • Zidovudine 4 mg/kg orally 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 zidovudine 4 mg/kg orally twice daily from birth to age 4 weeks.
Weight Band Volume of Zidovudine 10 mg/mL Oral Syrup Twice Daily
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:
  • Zidovudine 12 mg/kg orally twice daily
≥30 weeks to <35 weeks Birth to Age 2 Weeks:
  • Zidovudine 2 mg/kg orally twice daily
Aged 2 Weeks to 6 to 8 Weeks:
  • Zidovudine 3 mg/kg orally twice daily
Aged >6 Weeks to 8 Weeks:
  • Zidovudine 12 mg/kg orally twice daily
<30 weeks Birth to Age 4 Weeks:
  • Zidovudine 2 mg/kg orally twice daily
Aged 4 Weeks to 8 to 10 Weeks:
  • Zidovudine 3 mg/kg orally twice daily
Aged >8 Weeks to 10 Weeks:
  • Zidovudine 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

Zidovudine Weight-Based Dosing
Body 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:
  • Zidovudine 180 mg to 240 mg per m2 of body surface area every 12 hours
Adolescent (Aged ≥18 Years) and Adult Dose:
  • Zidovudine 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 zidovudine) and myositis
Special Instructions
  • Give zidovudine without regard to food.
  • If substantial granulocytopenia or anemia develops in patients receiving zidovudine, 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.
  • When using fixed-dose combination (FDC) tablets that contain zidovudine, see other sections of the Drug Appendix for special instructions and additional information about the individual components of the FDC.
Metabolism/Elimination
  • Zidovudine is eliminated primarily by hepatic metabolism. The major metabolite is zidovudine glucuronide, which is renally excreted.
  • Zidovudine is phosphorylated intracellularly to active zidovudine-triphosphate.
Zidovudine Dosing in Patients with Renal Impairment:
  • A zidovudine dose adjustment is required in patients with renal insufficiency.
Zidovudine Dosing in Patients with Hepatic Impairment:
  • The dose of zidovudine 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 or in patients who are on dialysis or who have impaired hepatic function.
a For premature infants who are diagnosed with HIV infection, the time to change to the continuation dose varies with post-gestational age and clinical status of the infant.

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