Artesunate (Ridsunate) is an intravenous antimalarial drug indicated for the initial treatment of severe malaria in adults and children. As a semi-synthetic artemisinin derivative, it exerts its therapeutic effect by rapidly killing the asexual forms of Plasmodium in the blood stage.

Indications of Artesunate (Ridsunate)

Initial Treatment of Severe Malaria

Adult and pediatric patients: Used for the treatment of severe malaria caused by Plasmodium falciparum, Plasmodium malariae, etc. Intravenous administration must be initiated immediately after diagnosis.

Requirements for subsequent treatment: After intravenous administration, a complete course of oral antimalarial drugs (e.g., artemether-lumefantrine combination regimen) must be administered sequentially to ensure complete clearance of the parasites.

Usage Limitations

Ineffective against hypnozoites in the hepatic stage: It has no effect on the hypnozoites (dormant forms) of Plasmodium vivax and Plasmodium ovale in the hepatic stage. When treating these two types of malaria, it is necessary to combine with 8-aminoquinoline drugs (e.g., primaquine) to prevent recurrence.

Outside the scope of indications: Not suitable for the prevention of uncomplicated malaria or the treatment of Plasmodium strains that have developed drug resistance.

Specifications and Properties of Artesunate (Ridsunate)

Dosage Form and Content

Each single-dose vial contains 110mg of artesunate as a white to off-white crystalline powder, with a 12mL sterile sodium phosphate buffer diluent (pH 8.0) provided in the package.

The reconstituted solution is a colorless and clear liquid with a concentration of 10mg/mL, and must be used within 1.5 hours after reconstitution.

Packaging Information

Single-vial package: 1 vial of 110mg lyophilized powder + 1 vial of 12mL diluent.

Combination package: Contains 2 sets of lyophilized powder and diluent.

Chemical Properties

Chemical name: Butanedioic acid mono[(3R,5aS,6R,8aS,9R,10S,12R,12aR)-decahydro-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]-1,2-benzodioxepin-10-yl] ester.

Molecular formula and molecular weight: C₁₉H₂₈O₈, with a molecular weight of 384.43.

Solubility: Practically insoluble in water, slightly soluble in ethanol and isopropyl acetate.

Excipient Components

Active ingredient: Artesunate.

The diluent contains sodium dihydrogen phosphate, disodium hydrogen phosphate, and pH adjusters. The osmotic pressure of the reconstituted solution is 305–317mOsm/kg.

Storage Methods for Artesunate (Ridsunate)

Storage Conditions

Unreconstituted drug: Store in the original package away from light at 20–25°C (short-term storage at 15–30°C is allowed). Freezing or exposure to high temperatures is prohibited.

Reconstituted solution: Must be used immediately. If temporary storage is necessary, it should be refrigerated at 2–8°C and used within 1.5 hours.

Precautions

Avoid vigorous shaking during reconstitution; gently swirl until the powder is completely dissolved.

Before administration, check whether the solution is clear. If particles are present or discoloration occurs, the solution must be discarded.