In the pharmaceutical industry, Artesunate is recognized as the most versatile artemisinin derivative. As a pharmacist and manufacturer, I can confirm that Artesunate can absolutely be given orally, but its application is strictly divided between treating uncomplicated malaria and completing the treatment of severe malaria.
At your WHO-GMP facility in Mumbai, where you likely manufacture the 50 mg and 200 mg tablets, it is critical to position this SKU correctly in your marketplace: oral Artesunate should not be used as a standalone treatment (monotherapy).
Primary Clinical Indications for Oral Use
Uncomplicated Malaria: Oral Artesunate is indicated for the treatment of uncomplicated P. falciparum malaria, but only when used as part of an Artemisinin-based Combination Therapy (ACT).
Step-Down Therapy: In cases of severe malaria, patients are started on IV/IM Artesunate. Once the patient is stable and able to swallow (usually after 24 hours), they must transition to a 3-day oral regimen to ensure complete parasite clearance.
Technical Dosing & Regimen (2026 Guidelines)
The standard oral dose is 4 mg/kg body weight, taken once daily for 3 days.
| Parameter | Standard Oral Protocol |
| Dose | 4 mg per kg of body weight |
| Duration | 3 days (monotherapy requires 7 days, but is discouraged) |
| Partner Drug | Mandatory. Common partners include Mefloquine or Sulfadoxine/Pyrimethamine (SP) |
The Pharmacist’s “Technical Warning”
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The Monotherapy Risk: Using oral Artesunate alone for only 3 days has a high failure rate (recrudescence) and directly contributes to global antimalarial resistance. Always advise B2B clients that it must be co-dispensed with a long-acting partner drug.
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Post-Artesunate Delayed Hemolysis (PADH): A critical technical note for your digital platforms—up to 37% of patients treated with Artesunate (especially after severe cases) may experience a drop in hemoglobin 1–3 weeks later. Advise weekly blood monitoring for 4 weeks post-treatment.
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Bioavailability: Oral Artesunate has lower bioavailability compared to IV, but it is rapidly converted in the liver to its active metabolite, Dihydroartemisinin (DHA).
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “FDC” Marketplace Strategy: On your multivendor marketplace, you should prioritize Fixed-Dose Combinations (FDCs) like Artesunate + Mefloquine. These are far more attractive to international health ministries because they prevent patients from skipping the partner drug.
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Stability for Export: Artesunate is highly sensitive to moisture and heat. For export to Zone IVb regions (Africa/SE Asia), Alu-Alu blister packaging is the non-negotiable industry standard to ensure a 36-month shelf life.
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Dossier Support: We provide full WHO-standard CTD/eCTD Dossiers to support your firm’s registration for international NGO tenders (UNICEF/Global Fund).