ARTESUNATE injectable
Therapeutic action
– Antimalarial
Indications
– Treatment of severe falciparum malaria
– Initial treatment of uncomplicated falciparum malaria, when persistent vomiting precludes oral therapy
Forms and strengths, route of administration
– Powder for injection, in 60 mg-vial, with one 1 ml-ampoule of 5% sodium bicarbonate and one 5 mlampoule of 0.9% sodium chloride, for slow IV injection (3 to 5 minutes) or slow IM injection
– Dissolve the powder in the entire volume of 5% sodium bicarbonate and shake the vial until the solution becomes clear. Then, add the 0.9% sodium chloride into the vial:
• 5 ml of 0.9% sodium chloride to obtain 6 ml of artesunate solution containing 10 mg/ml, for IV injection
• 2 ml of 0.9% sodium chloride to obtain 3 ml of artesunate solution containing 20 mg/ml, for IM injection
Dosage and duration
– Child under 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 at least 3 doses parenterally, then, if the patient can tolerate the oral route, change to an artemisinin-based combination (do not use the combination artesunate-mefloquine if the patient developed neurological signs during the acute phase).
Weight |
IV injection |
IM injection |
---|---|---|
< 3 kg |
1 ml |
0.5 ml* |
3 to < 4 kg |
1.2 ml |
0.6 ml* |
4 to < 5 kg |
1.5 ml |
0.8 ml* |
5 to < 6 kg |
2 ml |
1 ml |
6 to < 8 kg |
2.5 ml |
1.2 ml |
8 to < 10 kg |
3 ml |
1.5 ml |
10 to < 13 kg |
4 ml |
2 ml |
13 to < 15 kg |
4.5 ml |
2.5 ml |
15 to < 17 kg |
5 ml |
2.5 ml |
17 to < 20 kg |
6 ml |
3 ml |
20 to < 25 kg |
6 ml |
3 ml |
25 to < 29 kg** |
7 ml |
3.5 ml |
29 to < 33 kg |
8 ml |
4 ml |
33 to < 37 kg |
9 ml |
5 ml |
37 to < 41 kg |
10 ml |
5 ml |
41 to < 45 kg |
11 ml |
6 ml |
45 to < 50 kg |
12 ml |
6 ml |
50 to < 55 kg** |
13 ml |
7 ml |
55 to < 62 kg |
15 ml |
8 ml |
62 to < 67 kg |
16 ml |
8 ml |
67 to < 71 kg |
17 ml |
9 ml |
71 to < 76 kg |
18 ml |
9 ml |
76 to 81 kg** |
20 ml |
10 ml |
* Use a 1 ml syringe graduated in 0.01 ml when the dose required is less than 1 ml.
** For patients over 25 kg, a 2^{nd} vial must be prepared to obtain the volume needed, a 3^{rd} vial for patients over 50 kg and a 4^{th} vial for patients over 76 kg.
Contra-indications, adverse effects, precautions
– May cause: gastrointestinal disturbances, dizziness, headache, fever, muscle and joint pain, pruritus; rarely rash, QT interval prolongation, post-treatment haemolytic anaemia (especially in case of hyperparasitaemia and in young children).
– Pregnancy: no contra-indication
– 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.
– Do not use water for injection for:
• reconstitution (only use sodium bicarbonate);
• dilution (only use sodium chloride).
– Storage: below 25 °C - -
Once reconstituted, the solution must be used immediately.