Amodiaquine Hydrochloride Tablets

Amodiaquine Tablets

Amodiaquine Hydrochloride Tablets USP 100 mg
Each Uncoated Tablet Contains:
Amodiaquine Hydrochloride USP
eq. To Amodiaquine 100 mg

Amodiaquine Hydrochloride Tablets USP 200 mg
Each Uncoated Tablet contains
Amodiaquine Hydrochloride USP
Eq. To Amodiaquine 200 mg

Amodiaquine Hydrochloride Tablets USP 600 mg
Each Uncoated Tablet Contains:
Amodiaquine Hydrochloride USP
eq. To Amodiaquine 600 mg

Usage: – Treat to malaria

Category: – Antimalarial drugs

Therapeutic category: – Antimalarial,

SKU: Amodiaquine Tablets Categories: , , , , , , Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Description

Amodiaquine Tablets (67.5mg / 200mg)

Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc

1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Amodiaquine Tablets in India. This 4-aminoquinoline antimalarial is a critical component of Artemisinin-based Combination Therapy (ACT), specifically paired with Artesunate (AS+AQ). We produce both the pediatric (67.5mg) and adult (200mg) strengths. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and African health tenders.

2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Amodiaquine Tablets | | Generic Name | Amodiaquine Hydrochloride USP / BP / IP | | Strength | 67.5mg (Base) / 153.1mg (Base) / 200mg (Base) | | Dosage Form | Film Coated Tablet / Dispersible Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Antimalarial | | Shelf Life | 36 Months | | Packaging | 1×3 Blister / 1×6 Strip / 1000s Bulk Jar |

3. Manufacturing Amodiaquine Tablets We divide our operations to ensure specialized focus.

  • The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Amodiaquine is naturally very bitter. To prevent children from rejecting the medication, we use Advanced Taste-Masking Technology. We apply a specialized polymer coating that prevents the drug from interacting with taste buds in the mouth but dissolves instantly once it reaches the stomach. This significantly improves compliance rates in pediatric malaria programs.

  • The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Amodiaquine Tablets. We are experts in supplying “Co-Blistered” packs (where Amodiaquine is packed alongside Artesunate) to creating complete AS+AQ therapy kits for national tenders in West and Central Africa.

4. Quality Assurance We test every batch rigorously.

  • Dissolution: We test how the tablet releases the drug. Fast release is essential for high bioavailability.

  • Friability: We ensure the tablets are durable enough to survive rough transport conditions on rural roads without turning to dust.

  • Assay: We confirm the precise content of Amodiaquine Base to ensure effective parasite clearance.

5. Why Use Amodiaquine Tablets? It is a long-acting partner drug in ACT.

  • Mechanism: Like Chloroquine, it interferes with the parasite’s ability to digest hemoglobin. It causes toxic heme to build up inside the parasite, killing it.

  • Effect: When used with Artesunate, Artesunate kills the parasites quickly, while Amodiaquine stays in the blood longer to kill any remaining survivors.

Key Indications:

  • Uncomplicated Malaria: Treatment of P. falciparum malaria (Standard of Care in many West African nations).

  • Seasonal Malaria Chemoprevention (SMC): Used in combination with SP (Sulfadoxine-Pyrimethamine) to prevent malaria in children during rainy seasons.

6. Export and Regulatory Support We provide complete documentation for registration.

  • Dossier: We offer CTD and ACTD formats.

  • Certificates: We supply the Free Sale Certificate (FSC) and COPP.

  • Logistics: We ship via FOB Mumbai or CIF.

7. Frequently Asked Questions

  • Q: Who manufactures Amodiaquine Tablets?A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

  • Q: Is this the same as Chloroquine?A: It is in the same family, but Amodiaquine is often effective against strains of malaria that are resistant to Chloroquine.

  • Q: Can you supply the Artesunate combination?A: Yes, we can supply Amodiaquine and Artesunate either as loose tablets or co-packed in the same blister.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

  • Standard Dosage: 10 mg/kg body weight once daily for 3 days.

  • Combination: Almost always taken with Artesunate (4 mg/kg/day).

  • Administration: Can be crushed and mixed with water for infants.

9. Side Effects and Precautions

  • Common Side Effects: Fatigue, weakness, nausea, and abdominal pain.

  • Neutropenia: Prolonged use (prophylaxis) is generally avoided due to the risk of agranulocytosis (low white blood cells) and liver toxicity. It is safe for the standard 3-day treatment course.

  • Movement Disorders: Rare reports of involuntary movements (extrapyramidal symptoms).

10. Storage Instructions

  • Store below 30°C in a dry place.

  • Protect from light.

  • Keep out of reach of children.

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