ARTESUNATE injectable

Prescription under medical supervision


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, 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. NEVER ADMINISTER BY IV INFUSION.

– 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 parenterally at least 24 hours (3 doses), then, if the patient can tolerate the oral route, change to a complete 3-day course of an artemisinin-based combination. If not, continue parenteral treatment once daily until the patient can change to oral route (without exceeding 7 days of parenteral treatment).

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, delayed haemolytic anaemia (appearing 2 to 3 weeks after treatment, 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 30 °C - 
Once reconstituted, the solution must be used immediately.