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 | Artesunate 20 mg/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
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.