Neonatal Drug Therapy Manual

Zidovudine

Disclaimer: Official controlled document is the CHEO and Ottawa Hospital online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
AZT, Retrovir
Classification: 
Antiretroviral
Original Date: 
June 1996
Revised Date: 
June 2026
Indications: 
  • To reduce the risk of transmission of the HIV virus from an HIV positive mother to her baby. Administration to the baby is part of a defined protocol in which the mother has received antenatal combination antiretroviral therapy.
    • MONOTHERAPY:  if mother’s viral load is undetectable (HIV RNA level of < 50 copies/mL)2 and there are no events at delivery that increase risk of transmission, neonates are usually treated with prophylactic monotherapy, (oral zidovudine), for TWO weeks.  Discontinue prophylactic therapy at TWO weeks of age or therapy. No need to readjust dose with weight gain unless baby confirmed to be HIV positive. 
    • COMBINATION ANTIRETROVIRAL THERAPY: for any infant that does not meet the criteria for monotherapy after discussion with Pediatric ID or HIV expert.  Three antiretroviral agents are to be prescribed in combination for SIX weeks of therapy.  

Administration: 
  • PO
  • IV intermittent infusion: over 30 minutes
Dosage: 
Gestational Age (GA) Dose Duration
> 35 weeks PO: 4 mg/kg/dose q12h 4 - 6 weeks
IV: 3 mg/kg/dose q12h
 
> 30 to < 35 weeks PO: 2 mg/kg/dose q12h 2 weeks
IV: 1.5 mg/kg/dose q12h
Followed by:

PO: 3 mg/kg/dose q12h

4 weeks

 

IV: 2.3 mg/kg/dose q12h
 
< 30 weeks PO:2 mg/kg/dose q12h 4 weeks

IV: 1.5 mg/kg/dose q12h

 

Followed by:

PO: 3 mg/kg/dose q12h

2 weeks
IV: 2.3 mg/kg/dose q12h

 *** Zidovudine should be started as soon as possible after birth and no later than 2-6 hours after delivery

Side Effects: 
  • Endocrine and metabolic: lactic acidosis
  • Hematologic: anemia, neutropenia, thrombocytopenia, leukopenia
  • Hepatic: cholestatic hepatitis, hepatomegaly, elevated AST, LDH and ALP
Parameters to Monitor: 
  • CBC and differential (hemoglobin, absolute neutrophil count)
  • Liver transaminases (ALT, AST)
  • Lactic acid.
Reconstitution and Stability: 

IV intermittent infusion:

  • Zidovudine 10 mg/mL
    • Add 5 mL (50 mg) to 45 mL D5W
    • Final concentration: 1 mg/mL

TOH: 

  • Level 2 Hazardous Drug: consult the applicable corporate and nursing policies for drug handling, administration, and disposal
     
Compatibility: 

- Solutions Compatible: D5W and 0.9 % NaCl

- Y-site Compatible: acyclovir, dobutamine, dopamine, gentamicin, morphine, potassium chloride, SMOF, TPN, vancomycin

References: 

- Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Version Date: April 14, 2020 (Table 7).  Available at http://aidsinfo.nih.gov/ContenetFiles/PerinatalGL.pdf

-  Guidelines for the Prevention of Mother-to-Child HIV Transmission.  Information and Practice Guidance for Health Practitioners in Ontario.  Working with HIV-infected Women with Inadequate Control of HIV, and Women with Unknown HIV Status Who Present in Labor. Version Date: January 20, 2017

- Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Department of Health and Human Services. Accessed June 2026.

- NIOSH List of Hazardous Drugs in Healthcare Settings, 2024. DHHS (NIOSH) Publication Number 2025-103, December 2024

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