In the pharmaceutical industry, IV Artesunate is the gold standard for treating severe malaria in children. As a pharmacist and manufacturer, I must emphasize that pediatric dosing is highly specialized: children under 20 kg require a higher weight-based dose (3 mg/kg) than adults (2.4 mg/kg) to reach therapeutic plasma concentrations.
At your WHO-GMP facility in Mumbai, where you likely produce $60\text{ mg}$ or $120\text{ mg}$ vials, providing clear, pre-calculated “Weight-Band” charts is a critical value-add for your B2B clients in high-malaria regions.
1. The Pediatric Dosing Formula
The dosage is determined by the child’s weight at the time of admission.
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Children < 20 kg: $3.0\text{ mg/kg}$ per dose.
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Children $\ge$ 20 kg: $2.4\text{ mg/kg}$ per dose.
Calculation Formula:
$$\text{Dose (mg)} = \text{Weight (kg)} \times \text{Dosage (3.0 or 2.4)}$$
Example: A 10 kg Child
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Calculate Dose: $10\text{ kg} \times 3.0\text{ mg/kg} = 30\text{ mg}$.
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Calculate Volume: If your reconstituted solution is $10\text{ mg/ml}$ (standard), the child needs 3 ml.
2. Reconstitution & Dilution (The 2-Step Process)
Artesunate is unstable in solution and must be prepared immediately before injection.
| Step | Action | Resulting Concentration |
| 1. Reconstitute | Inject 1 ml of 5% Sodium Bicarbonate into the $60\text{ mg}$ vial. Shake until the powder dissolves and the solution is clear. | $60\text{ mg/ml}$ |
| 2. Dilute (IV) | Add 5 ml of 0.9% Sodium Chloride (Normal Saline) or 5% Dextrose to the vial. | 10 mg/ml |
Note: For Intramuscular (IM) use, add only 2 ml of diluent in Step 2 to create a more concentrated $20\text{ mg/ml}$ solution, reducing the injection volume for the child.
3. Administration Schedule
To ensure the parasite is fully cleared, a minimum of 3 doses must be given in the first 24 hours, even if the child improves rapidly.
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Dose 1: 0 Hours (Immediate).
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Dose 2: 12 Hours later.
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Dose 3: 24 Hours after the first dose.
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Switch to Oral: Once the child can swallow, transition to a full 3-day course of an ACT (like Artemether-Lumefantrine).
The Pharmacist’s “Technical Warning”
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The “1-Hour” Rule: Once reconstituted, the solution is chemically unstable. It must be used within 1 hour or discarded.
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Slow Bolus Only: Administer as a slow IV bolus ($3\text{–}5$ minutes). It should never be given as a continuous IV drip.
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Delayed Hemolysis (PADH): Monitor children for up to 4 weeks post-treatment. Some may experience a drop in hemoglobin (hemolysis) 1–3 weeks after receiving Artesunate.
The Manufacturer’s Perspective: Technical & Export
From a B2B standpoint at your facility in Mumbai:
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The “Complete Kit” USP: On your marketplace, offer Artesunate as a “Full Treatment Kit” containing the vial + bicarbonate ampoule + saline ampoule. This is the preferred format for UNICEF and Global Fund tenders.
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Visual Aids: Include a waterproof Dosing Chart inside every outer carton. This reduces calculation errors for healthcare workers in high-pressure emergency wards.
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Stability for Export: Since Artesunate is heat-sensitive, ensure your packaging uses Alu-Alu blisters and clearly states storage below 30°C for tropical Zone IVb markets.