Dosage and Administration of Artesunate

 

Indications & Usage: Artesunate for Injection (Injectable artesunate) is introduced as a first line treatment and recommended by WHO for the initial treatment of severe malaria in adult as well as pediatric patients.

In order to treat severe malaria with injectable artesunate should always be followed by a full or complete treatment course of an apt oral antimalarial regimen.

Limitations of Use: The artesunate an anti-malaria medication does not treat the hypnozoite liver stage forms of Plasmodium and will therefore not prevent the relapses of malaria because of the Plasmodium vivax or Plasmodium ovale. Concomitant therapy with an antimalarial agent such as an 8-aminoquinoline drug is required for treating the severe malaria due to P. vivax or P. ovale.

 

Dosage Forms and Strengths: The injectable artesunate is available as the strength of 110 mg for Injection. It comes as a sterile white or almost white, fine crystalline powder in a clear glass single-dose vial for constitution.

 

Dosage and Administration: The recommended dosage and administration of Artesunate for Injection in adult and pediatric patients is 2.4 mg/kg administered, should be intravenously at 0 hours, 12 hours, and 24 hours, and thereafter, administered once daily until the patient is able to tolerate the oral antimalarial therapy. Administer constituted artesunate injection intravenously as a slow bolus over one minute to two minutes. Do not administer artesunate injection via continuous intravenous infusion. The artesunate injection should be administered with an antimalarial agent that is active against the hypnozoite liver stage forms of Plasmodium, such as an 8-aminoquinoline drug, to patients with the severe malaria due to P. vivax or P. ovale.

 

Preparation of Artesunate for Injection for Intravenous Administration: The Artesunate Injection needs to be constituted with the supplied diluent before administration. A diluent consisting of 12 mL of sterile 0.3 M pH 8.0 sodium phosphate buffer is provided with Artesunate for Injection.

To constitute artesunate injection, withdraw 11mL of this diluent through a needle and syringe and inject into the artesunate vial (when constituted the final concentration of artesunate is 10 mg/mL). Swirl gently (avoid shaking) for up to five to six minutes until the powder is completely dissolved and no visible particles remain.

The parenteral drug products need to be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit. It is not advised to administer the Artesunate for Injection in case particulate matter and/or discoloration is observed.

Following constitution, inject the constituted solution intravenously (through an established intravenous line or needle) as a slow bolus over one to two minutes. It is advised to discard the vial and also any unused portion of the medicine product following use.

 

Storage of the Constituted Solution: The constituted solution of Artesunate Injection should be administered within 1.5 hours of constitution with the supplied diluent.