ARTESUNATE injectable

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    Last updated: June 2025

     

     

    Prescription under medical supervision
     

     

     

     
    This formulation requires a 2-step reconstitution/dilution of the injectable artesunate powder. Do not confuse with injectable artesunate requiring a 1-step reconstitution (see following page).

     

    Therapeutic action

    • Antimalarial

    Indications

    • Treatment of severe malaria
    • Initial treatment of uncomplicated malaria, when persistent vomiting precludes oral therapy

    Forms and strengths, route of administration

    • Powder for injection (artesunate), 60 mg vial, plus
    • Solvent: 5% sodium bicarbonate, 1 ml ampoule, plus
    • Diluent: 0.9% sodium chloride, 5 ml ampoule
    • Preparation :
      • For reconstitution (Step-1): add the 1 ml ampoule of 5% sodium bicarbonate into the vial. Shake the vial gently until the powder is dissolved and the solution is clear. 
      • For dilution (Step-2): 
        • For slow IV (3 to 5 minutes): add 5 ml of 0.9% sodium chloride into the vial to obtain 6 ml of solution containing 10 mg of artesunate per ml
        • For slow IM: add 2 ml of 0.9% sodium chloride into the vial to obtain 3 ml of solution containing 20 mg of artesunate per ml
    • NEVER ADMINISTER BY IV INFUSION. 

    Dosage and duration

    • Child under 6 kg: seek specialist advice.
    • Child 6 kg to < 20 kg: 3 mg/kg/dose
    • Child 20 kg and over and adult: 2.4 mg/kg/dose

     

    One dose on admission (H0) then 12 hours after admission (H12) then 24 hours after admission (H24) then, once daily.

    Administer for at least 24 hours (minimum 3 doses), then, if the patient can tolerate the oral route, change to a full 3-day course of an artemisinin-based combination (ACT). If not, continue parenteral treatment with one dose daily until the patient can tolerate the oral route (do not exceed 7 days of parenteral treatment). The first dose of ACT should be taken 8 to 12 hours after the last injection of artesunate.

     

    For information (WHO weight-based dosage):

    Weight

    Dose per injection (mg)

    Artesunate 10 mg/ml 
    solution for IV
    Dose per injection (ml)

    Artesunate 20 mg/ml 
    solution for IM
    Dose per injection (ml)

    Child 6 to < 20 kg

    6 to < 7 kg

    20 mg

    2 ml

    1 ml

    7 to < 11 kg

    30 mg

    3 ml

    2 ml

    11 to < 14 kg

    40 mg

    4 ml

    2 ml

    14 to < 17 kg

    50 mg

    5 ml

    3 ml

    17 to < 20 kg

    60 mg

    6 ml

    3 ml

    Child ≥ 20 kg and adult

    20 to < 26 kg

    60 mg

    6 ml

    3 ml

    26 to < 30 kg (a)Citation a.For patients over 26 kg, a 2nd vial must be prepared to obtain the volume needed, a 3rd vial for patients over 51 kg and a 4th vial for patients over 76 kg.

    70 mg

    7 ml

    4 ml

    30 to < 34 kg

    80 mg

    8 ml

    4 ml

    34 to < 38 kg

    90 mg

    9 ml

    5 ml

    38 to < 42 kg

    100 mg

    10 ml

    5 ml

    42 to < 46 kg

    110 mg

    11 ml

    6 ml

    46 to < 51 kg

    120 mg

    12 ml

    6 ml

    51 to < 55 kg(a)Citation a.For patients over 26 kg, a 2nd vial must be prepared to obtain the volume needed, a 3rd vial for patients over 51 kg and a 4th vial for patients over 76 kg.

    130 mg

    13 ml

    7 ml

    55 to < 59 kg

    150 mg

    14 ml

    7 ml

    59 to < 63 kg

    150 mg

    15 ml

    8 ml

    63 to < 67 kg

    160 mg

    16 ml

    8 ml

    67 to < 71 kg

    170 mg

    17 ml

    9 ml

    71 to < 76 kg

    180 mg

    18 ml

    9 ml

    76 to < 80 kg(a)Citation a.For patients over 26 kg, a 2nd vial must be prepared to obtain the volume needed, a 3rd vial for patients over 51 kg and a 4th vial for patients over 76 kg.

    190 mg

    19 ml

    10 ml

    80 to < 84 kg

    200 mg

    20 ml

    10 ml

    84 to < 88 kg

    210 mg

    21 ml

    11 ml 

     

     

    Contra-indications, adverse effects, precautions

    • May cause: gastrointestinal disturbances, dizziness, headache, fever, muscle and joint pain, pruritus; rarely rash, delayed haemolytic anaemia (appearing 2 to 3 weeks after treatment, especially in case of hyperparasitaemia and in young children).
    • Pregnancy and breast-feeding: no contra-indication
       

    Remarks

    • The solution should be clear, do not use if the solution is cloudy or if a precipitate is present.
    • Artesunate 60 mg 2-step formulation and artesunate 1-step formulation are bioequivalent and can be used interchangeably during the course of a treatment. For preparation, use only the solvent/diluent provided by the manufacturer for each formulation. However, to avoid confusion and reduce the risk of preparation errors, it is recommended to use only one formulation per patient per treatment course. 

       

    Storage

     
    – Below 30 °C 
    Once reconstituted, the solution must be used immediately.
    • a

      For patients over 26 kg, a 2nd vial must be prepared to obtain the volume needed, a 3rd vial for patients over 51 kg and a 4th vial for patients over 76 kg.