ZIDOVUDINE = AZT = ZDV oral

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    Last updated: February 2025

     

    Prescription under medical supervision

     

    Therapeutic action

    • Antiretroviral, nucleoside reverse transcriptase inhibitor

    Indications

    • HIV infection, in combination with other antiretrovirals
    • Prevention of mother-to-child transmission (PMTCT) of HIV in neonates, alone or in combination with other antiretrovirals

    Forms and strengths

    • Single formulations:
      • 300 mg tablet
      • 50 mg/5 ml oral solution
    • Fixed-dose combinations with lamivudine (3TC):
      • 300 mg zidovudine/150 mg lamivudine breakable and dispersible tablet
      • 60 mg zidovudine/30 mg lamivudine breakable and dispersible tablet

    Dosage

    HIV infection, in combination with other antiretrovirals

    The daily dose is administered in 2 divided doses.

    • Child 1 month and over and adult:

     

    Weight

    Daily dose

    50 mg/5 ml oral sol.

    (10 mg/ml)

    300 mg tablet

    or  300 mg AZT/150 mg 3TC  tablet 

    60 mg AZT /30 mg 3TC

    tablet
    3 to < 6 kg 120 mg 6 ml x 2  – 1 tab x 2
    6 to < 10 kg  180 mg 9 ml x 2  – 1 ½ tab x 2
    10 to < 14 kg  240 mg 12 ml x 2  – 2 tab x 2
    14 to < 20 kg 300 mg 15 ml x 2 – 2 ½ tab x 2
    20 to < 25 kg  360 mg 18 ml x 2 – 3 tab x 2
    ≥ 25 kg 600 mg –

    1 tab x 2

    		 –

     

     

    PMTCT of HIV in neonates

     

    • Full term neonate:

    Follow national recommendations. For information (WHO simplified age-based dosage):

    • From birth to 6 weeks of age (from 0 to 42 days): 15 mg (1.5 ml) oral suspension 2 times daily

    Then, if indicated:

    • After 6 weeks and up to 12 weeks of age (from 43 to 84 days): 60 mg (6 ml) oral suspension 2 times daily
    • Preterm or low-birth weight neonate: seek specialist advice.

    Duration

    • HIV infection: depending on the efficacy and tolerance of AZT.
    • PMTCT: depending on the risk of acquiring HIV infection (for information):
      • High risk: 6 weeks (AZT combined with nevirapine). For breastfed children, this combined treatment may be extended for an additional 6 weeks. 
      • Low risk: 4 to 6 weeks (AZT alone), only for non-breastfed children.

    Contra-indications, adverse effects, precautions

    • Do not administer to patients with severe haematologic disorders (anaemia, neutropenia).
    • Administer with caution to:
      • patients with hepatic impairment or coinfection with hepatitis B or hepatitis C virus;
      • neonates with hyperbilirubinaemia or raised transaminases.
    • Reduce dosage in patients with severe renal or hepatic impairment.
    • May cause:
      • rash, gastrointestinal disturbances, myopathy;
      • haematologic disorders (monitor FBC), hepatic disorders (e.g. anorexia, nausea, general malaise, dark urine, pale stools, hepatomegaly, jaundice) and lactic acidosis.
    • Stop AZT in the event of:
      • severe anaemia or neutropenia. AZT may be resumed following recovery with reduced dosage and close surveillance. 
      • signs and symptoms of lactic acidosis (e.g. rapid or difficult breathing, anorexia, nausea, fatigue, weakness, myalgias). If lactic acidosis is confirmed, stop AZT permanently.
    • Avoid combination with ribavirin (increased risk of anaemia).
    • Use with caution and monitor combination with co-trimoxazole, dapsone, pyrimethamine (increased risk of haematotoxicity), fluconazole (increased AZT plasma concentrations).
    • Pregnancy: no contra-indication

    Remarks

    • AZT is also used for the treatment of HIV infection in neonates, in combination with other antiretrovirals. Check national recommendations.
    • Also comes in fixed-dose combinations with other antiretrovirals. For PMTCT, zidovudine is sometimes given as a fixed-dose combination of zidovudine/lamivudine/nevirapine.

     Storage

     
    –  Below 25 °C 
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