Source: FDA, National Drug Code (US) Revision Year: 2020
Artesunate for Injection is indicated for the initial treatment of severe malaria in adult and pediatric patients.
Treatment of severe malaria with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen [see Dosage and Administration (2.1)].
Limitations of Use:
Artesunate for Injection does not treat the hypnozoite liver stage forms of Plasmodium and will therefore not prevent relapses of malaria due to Plasmodium vivax or Plasmodium ovale. Concomitant therapy with an antimalarial agent such as an 8-aminoquinoline drug is necessary for the treatment of severe malaria due to P. vivax or P. ovale [see Dosage and Administration (2.1)].
The recommended dosage of Artesunate for Injection is 2.4 mg/kg administered intravenously at 0 hours, 12 hours, and 24 hours, and thereafter, administered once daily until the patient is able to tolerate oral antimalarial therapy.
Administer constituted Artesunate for Injection intravenously as a slow bolus over 1 minute to 2 minutes [see Dosage and Administration (2.2)]. Do NOT administer Artesunate for Injection via continuous intravenous infusion.
Administer Artesunate for Injection with an antimalarial agent that is active against the hypnozoite liver stage forms of Plasmodium, such as an 8-aminoquinoline drug, to patients with severe malaria due to P. vivax or P. ovale.
Artesunate for Injection must be constituted with the supplied diluent prior to 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 for Injection, withdraw 11 mL of this diluent with a needle and syringe and inject into the artesunate vial (when constituted the final concentration of artesunate is 10 mg/mL). Swirl gently (do not shake) for up to 5 to 6 minutes until the powder is fully dissolved and no visible particles remain.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Artesunate for Injection if particulate matter and/or discoloration is observed.
After constitution, inject the constituted solution intravenously (through an established intravenous line or needle) as a slow bolus over 1 to 2 minutes. Discard the vial and any unused portion of the drug product after use.
Administer the constituted solution within 1.5 hours of constitution with the supplied diluent.
Experience of acute overdose with artesunate is limited. A case of artesunate overdose has been documented in a 5-year-old child inadvertently administered rectal artesunate at a dose of 88 mg/kg/day (approximately 18 times the maximum recommended daily dose for Artesunate for Injection) for 4 days. Artesunate for Injection is not approved for rectal administration. The overdose was associated with pancytopenia, melena, seizures, multiorgan failure and death. Treatment of overdose should consist of general supportive measures.
Store vials of Artesunate for Injection and sterile diluent in the carton at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not freeze. Avoid exposure to heat. Keep protected from light. Do not use beyond the expiration date.
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