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: May 22, 2018; Last Reviewed: May 22, 2018

Zidovudine (ZDV, AZT, Retrovir)
Zidovudine (ZDV, AZT, 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 plus zidovudine 300 mg (scored)
  • [Trizivir] Abacavir 300 mg plus lamivudine 150 mg plus zidovudine 300 mg
Dosing Recommendations Selected Adverse Events
Note: 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 (Weeks) at Birtha
Gestational Age at Birth Oral Zidovudine Dose
≥35 Weeks Birth to Age 4 Weeks:
  • 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 4 mg/kg orally twice daily from birth to age 4 weeks.
Weight Band Volume 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:
  • 12 mg/kg orally twice daily
≥30 to <35 Weeks Birth to Age 2 Weeks:
  • 2 mg/kg orally twice daily
Aged 2 Weeks to 6 to 8 Weeks:
  • 3 mg/kg orally twice daily
Aged >6 to 8 Weeks:
  • 12 mg/kg orally twice daily
<30 Weeks Birth to Age 4 Weeks:
  • 2 mg/kg orally twice daily
Aged 4 Weeks to 8 to 10 Weeks:
  • 3 mg/kg orally twice daily
Aged >8 to 10 Weeks:
  • 12 mg/kg orally twice daily
a For premature infants who are diagnosed with HIV, the time to change the dose to continuation dose varies with postgestational age and clinical status of the neonate (see the Special Issues for Neonates section below).

Note: For infants who are unable to tolerate oral agents, the intravenous (IV) 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: 180–240 mg/m2 body surface area every 12 hours
Adolescent (Aged ≥18 Years) and Adult Dose:
  • 300 mg twice daily
[Combivir and Generic] Lamivudine plus Zidovudine
Adolescent (Weighing ≥30 kg) and Adult Dose:
  • 1 tablet twice daily
[Trizivir] Abacavir plus Lamivudine plus Zidovudine
Adolescent (Weighing ≥40 kg) and Adult Dose:
  • 1 tablet twice daily
  • Bone marrow suppression: macrocytosis with or without anemia, neutropenia
  • 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.
  • For infants unable to tolerate oral agents, the intravenous (IV) dose should be 75% of the oral dose, but the dosing interval should remain the same.
  • 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
  • Metabolized primarily in the liver to zidovudine glucuronide, which is renally excreted.
  • Zidovudine is phosphorylated intracellularly to active zidovudine-triphosphate.
Zidovudine Dosing in Patients with Renal Impairment:
  • Dose adjustment is required in renal insufficiency.
Zidovudine Dosing in Patients with Hepatic Impairment:
  • Dose 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.

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