Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Zidovudine

Generic name
Zidovudine
Brand name
ATC Code
J05AF01

Pharmacokinetics in children

The pharmacokinetics in infants from 5-6 months on are equal to adults.

After intravenous administration the following mean pharmacokinetic parameters were found:
t½: 1.5 hour
Cl: 30.9 ml/min/kg

In neonates younger than 14 days glucuronidation is reduced. This means that bioavailability and half-life are increased, and clearance is decreased. Pharmacokinetics seem equal to adults at 14 days after birth.

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

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Dosages

Treatment HIV infection
  • Oral
    • Duration of pregnancy Gestational age < 30 weeks
      [4]

      • Postnatal age 0-4 weeks: 4 mg/kg/day in 2 doses
        Postnatal age 4-8 weeks: 6 mg/kg/day in 2 doses
        Postnatal age > 8 weeks: 24 mg/kg/day in 2 doses

    • Duration of pregnancy Gestational age 30 weeks up to 35 weeks
      [4]

      • Postnatal age 0-2 weeks: 4 mg/kg/day in 2 doses
        Postnatal age 2-6 tweeks: 6 mg/kg/day in 2 doses
        Postnatal age > 6 weeks: 24 mg/kg/day in 2 doses

    • Duration of pregnancy Gestational age ≥ 35 weeks
      [4]

      • Postnatal age 0-4 weeks: 8 mg/kg/day in 2 doses
        Postnatal age > 4 weeks: 24 mg/kg/day in 2 doses

    • ≥ 1 month and 4 up to 9 kg
      [4]
      • 24 mg/kg/day in 2 doses.
    • ≥ 1 month and 9 up to 30 kg
      [4]
      • 18 mg/kg/day in 2 doses.
    • ≥ 1 month and ≥ 30 kg
      [4]
      • 600 mg/day in 2 doses.
  • Intravenous
    • Gestational age < 30 weeks
      [4]

      • Postnatal age 0-4 weeks:  3 mg/kg/day in 2 doses
        Postnatal age 4-8 weeks:  4.5 mg/kg/day in 2 doses
        Postnatal age > 8 weeks:  18 mg/kg/day in 2 doses

    • Gestational age 30 weeks up to 35 weeks
      [4]

      • Postnatal age 0-2 weeks:  3 mg/kg/day in 2 doses
        Postnatal age 2-6 weeks:  4.5 mg/kg/day in 2 doses
        Postnatal age > 6 weeks:  18 mg/kg/day in 2 doses

    • Gestational age ≥ 35 weeks
      [4]

      • Postnatal age 0-4 weeks:  6 mg/kg/day in 2 doses
        Postnatal age > 4 weeks:  18 mg/kg/day in 2 doses
Neonatal prophylaxis in an HIV-positive mother
  • Oral
    • Gestational age < 30 weeks
      [6]

      • Postnatal age 0 to 4 weeks: 4 mg/kg/day in 2 doses
        Postnatal age 4 to 8-10 weeks: 6 mg/kg/day in 2 doses
        Postnatal age ≥ 8 to 10 weeks: (increase dose only in confirmed HIV infection) 24 mg/kg/day in 2 doses

      • In neonates at high Risk of perinatal HIV transmission: In combination with lamivudine plus nevirapine of raltegravir

    • Gestational age 30 weeks up to 35 weeks
      [6]

      • Postnatal age 0 to 2 weeks: 4 mg/kg/day in 2 doses
        Postnatal age 2 to 6-8 weken: 6 mg/kg/day in 2 doses
        Postnatal age ≥ 6-8 weken:  (increase dose only for infants with confirmed HIV infection) 24 mg/kg/day in 2 doses

         

      • In neonates at high risk of perinatal HIV transmission: In combination with lamivudine plus nevirapine or raltegravir.

    • Gestational age ≥ 35 weeks
      [6]

      • Postnatale leeftijd 0-4 weken: 8 mg/kg/dag in 2 doses.
        Postnatale leeftijd ≥ 4 weken: (increase dose only for infants with confirmed HIV infection) 24 mg/kg/dag in 2 doses.

      • In neonates at high risk of perinatal HIV transmission: In combination with lamivudine plus raltegravir of nevirapine

  • Intravenous
    • Gestational age < 30 weeks
      [6]

      • Postnatal age 0 to 4 weeks: 3 mg/kg/day in 2 doses
        Postnatal age 4 to 8 - 10 weeks: 4,5 mg/kg/day in 2 doses
        Postnatal age ≥ 8 - 10 weeks: (increase dose only for infants with confirmed HIV infection) 18 mg/kg/day in 2 doses

      • If oral administration is not possible

    • Gestational age 30 weeks up to 35 weeks
      [6]

      • Postnatal age 0 to 2 weeks: 3 mg/kg/day in 2 doses
        Postnatal age 2 to 6 - 8 weeks: 4,5 mg/kg/day in 2 doses
        Postnatal age ≥ 6-8 weeks: (increase dose only for infants with confirmed HIV infection) 18 mg/kg/day in 2 doses

      • If oral administration is not possible

    • Gestational age ≥ 35 weeks
      [6]

      • Postnatal age 0-4 weeks: 6 mg/kg/day in 2 doses Postnatal age ≥ 4 weeks: (increase dose only for infants with confirmed HIV infection) 18 mg/kg/day in 2 doses

      • If oral administration is not possible

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Adjustment not necessary
GFR 30-50 ml/min/1.73 m2
Adjustment not necessary
GFR 10-30 ml/min/1.73 m2
Adjustment not necessary
GFR < 10 ml/min/1.73 m2
Generalized recommendations cannot be given.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects

No information is present at this moment.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

  • Neonates with hyperbilirubinaemia who need treatment other than with light;
  • Neonates with elevated transaminase values of more than five times the upper limit of normal.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Administer before the nutrition if possible. In the event of substantial vomiting (i.e. not just a single mouthful:
< 15 minutes after taking: give a full new dose if the new-born is calm
15-30 minutes after taking: give a half dose
> 30 minutes after taking: Do not give a new dose: most of the medication has been absorbed.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB01
J05AB04
J05AB11
J05AB14
Protease inhibitors
J05AE10
J05AE03
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF10
J05AF05
Non-nucleoside reverse transcriptase inhibitors
J05AG01
Neuraminidase inhibitors
J05AH02
Antivirals for treatment of HIV infections, combinations
J05AR02
J05AR10
Other antivirals
J05AX12
J05AX08
ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS
J05AR02
J05AR10
Antivirals for treatment of HCV infections
J05AP57
J05AP08
J05AP55

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References

  1. CBO, Richtlijn Antiretrovirale therapie, www.cbo.nl, herziene versie december 2007
  2. NVK- Pediatrisch HIV overleg Nederland (PHON), Update landelijk HIV expositie protocol neonaten, inclusief follow-up pasgeborene en kind, www.nvk.nl, 05/03/2013
  3. GlaxoSmithKline BV, SPC Retrovir ( RVG 15118), www.cbg-meb.nl, Geraadpleegd 26 mei 2011, http://db.cbg-meb.nl/IB-teksten/h15118.pdf
  4. Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV, Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection - Zidovudine, Update 27 Jun 2024, https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/zidovudine?view=full
  5. PENTA Steering Commitee, PENTA 2009 guidelines for the use of antiretroviral therapy. , HIV Medicine, 2009, 10, 591-613
  6. Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV, Antiretroviral Management of Newborns with Perinatal HIV Exposure or HIV Infection - Zidovudine , www.clinicalinfo.hiv.gov, Rev 31 Jan 2023, https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/antiretroviral-management-newborns-perinatal-hiv-exposure-or-hiv-infection

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Changes

Changes