Healthy Inc > Blog > WHO-GMP antimalarial exporter Mumbai
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How to take artesunate amodiaquine?

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.

  • Why? High fat intake can interfere with the absorption and peak plasma concentration of Amodiaquine, potentially reducing its effectiveness.

  • 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).

  • 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:

  • Vomiting within 30 minutes: Re-administer the full dose immediately.

  • Vomiting between 30 and 60 minutes: Re-administer half the dose.

  • 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”

  • Amodiaquine Sensitivity: Some patients may experience a “drugged” feeling, dizziness, or intense itching (pruritus). This is often a reaction to the Amodiaquine component.

  • 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.

  • 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:

  • 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.

  • 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.

  • Dossier Support: We provide full WHO-standard CTD/eCTD Dossiers to support your firm’s registration for Global Fund and NGO tenders.

Artesunate Amodiaquine Tablets

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How to calculate IV artesunate for kids?

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.

  • Children < 20 kg: $3.0\text{ mg/kg}$ per dose.

  • 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

  1. Calculate Dose: $10\text{ kg} \times 3.0\text{ mg/kg} = 30\text{ mg}$.

  2. 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.

  • Dose 1: 0 Hours (Immediate).

  • Dose 2: 12 Hours later.

  • Dose 3: 24 Hours after the first dose.

  • 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”

  • The “1-Hour” Rule: Once reconstituted, the solution is chemically unstable. It must be used within 1 hour or discarded.

  • Slow Bolus Only: Administer as a slow IV bolus ($3\text{–}5$ minutes). It should never be given as a continuous IV drip.

  • 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:

  • 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.

  • Visual Aids: Include a waterproof Dosing Chart inside every outer carton. This reduces calculation errors for healthcare workers in high-pressure emergency wards.

  • 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.

Artesunate Tablets

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