In the pharmaceutical industry, the Artesunate + Amodiaquine (AS+AQ) combination is a first-line Artemisinin-based Combination Therapy (ACT) for uncomplicated malaria. As a pharmacist and manufacturer, I view this Fixed-Dose Combination (FDC) as a highly effective tool, but its success depends on avoiding high-fat meals and adhering to a strict 3-day schedule.
At your WHO-GMP facility in Mumbai, ensuring that your marketplace listings clearly specify weight-based dosing is critical for pediatric safety and preventing drug resistance.
1. Standard 3-Day Dosage Schedule
The regimen is a simple once-daily dose for three consecutive days. To ensure efficacy, it should be taken at roughly the same time each day.
| Patient Weight | Typical Age | Daily Dose (ASAQ Tablets) | Duration |
| 4.5 to < 9 kg | 2–11 months | 1 tablet (25/67.5 mg) | 3 Days |
| 9 to < 18 kg | 1–5 years | 1 tablet (50/135 mg) | 3 Days |
| 18 to < 36 kg | 6–13 years | 1 tablet (100/270 mg) | 3 Days |
| $\ge$ 36 kg | $\ge$ 14 years | 2 tablets (100/270 mg) | 3 Days |
2. Administration: The “Fat-Free” Rule
Unlike many other antimalarials (like Coartem), Artesunate/Amodiaquine should NOT be taken with a high-fat meal.
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Why? High fat intake can interfere with the absorption and peak plasma concentration of Amodiaquine, potentially reducing its effectiveness.
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Pediatric Tip: For infants or children unable to swallow whole tablets, the tablet can be crushed and dispersed in a small amount of water or mixed with a non-fatty semi-solid food (like a small spoonful of fruit puree).
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Taste-Masking: Amodiaquine is notoriously bitter. Advise caregivers to offer sugar water or a small piece of fruit immediately after the dose to improve compliance.
3. The “Vomiting” Protocol
If a patient vomits shortly after taking the dose, the medication may not have been absorbed:
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Vomiting within 30 minutes: Re-administer the full dose immediately.
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Vomiting between 30 and 60 minutes: Re-administer half the dose.
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Persistent Vomiting: If the patient cannot keep any oral medication down, they must be transitioned to IV Artesunate for severe malaria management.
The Pharmacist’s “Technical Warning”
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Amodiaquine Sensitivity: Some patients may experience a “drugged” feeling, dizziness, or intense itching (pruritus). This is often a reaction to the Amodiaquine component.
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The “Step-Down” Role: ASAQ is also used as the oral completion therapy after a patient has been stabilized on IV/IM Artesunate for severe malaria.
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Resistance Awareness: This combination should not be used in regions where Amodiaquine resistance is widespread (e.g., parts of Southeast Asia).
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “Color-Coded” USP: On your marketplace, emphasize that your ASAQ blister packs are color-coded by weight band (e.g., Yellow for infants, Blue for adolescents, Red for adults). This is a mandatory requirement for WHO-standard supply chains to prevent dosing errors.
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Stability for Export: Amodiaquine Hydrochloride is slightly hygroscopic. To ensure a 36-month shelf life in Zone IVb tropical regions, Alu-Alu blister packaging is essential.
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Dossier Support: We provide full WHO-standard CTD/eCTD Dossiers to support your firm’s registration for Global Fund and NGO tenders.