ARTESUNATE injectable

Prescription under medical supervision


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
artesunate solution 10 mg/ml

IM injection
artesunate solution 20 mg/ml

< 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 2nd vial must be prepared to obtain the volume needed, a 3rd vial for patients over 50 kg and a 4th 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.