Description
Artesunate & Mefloquine Tablet
Artesunate & Mefloquine Hydrochloride Tablets (ACT Combination)
Product Overview
This formulation operates as a “Dual-Phase Schizontocidal Eradication System.” It ensures patient safety and prevents the propagation of drug-resistant strains by combining a rapid-acting artemisinin derivative with an ultra-long-acting quinoline methanol partner.
Mechanism 1 (Rapid Free-Radical Generation – Artesunate): Artesunate physically reacts with intra-parasitic iron (heme) inside infected red blood cells. This chemically produces highly reactive free radicals that physically attack and destroy the parasite’s structural proteins and functional transport systems within hours.
Mechanism 2 (Food Vacuole Disruption – Mefloquine): Mefloquine physically targets the blood stages of the parasite. It chemically complexes with essential target lipids and physically disrupts the parasite’s food vacuole membrane, completely cutting off its ability to process hemoglobin and leading to cellular autolysis.
Mechanism 3 (Synchronized Clearance Matrix): Artesunate delivers the initial high-velocity physical clear-out of the parasite biomass, while Mefloquine chemically maintains a long therapeutic half-life (up to 14–21 days) to catch and eliminate any late-maturing or persistent merozoites.
Product Composition & Compliance Configurations
We supply this combination in both co-formulated Fixed-Dose Combination (FDC) single tablets and customized, color-coded co-blistered kits calibrated for adult and pediatric treatment regimens.
| Product Packaging Format | Active Ingredient Mix (per Dose) | Target Patient Cohort | Primary Clinical Function |
| Pediatric Compliance FDC | 25 mg Artesunate + 55 mg Mefloquine | Infants & Children (6 months to less than 7 years) | Micro-Dose Accuracy: Optimized for easy pediatric disintegration and ingestion. |
| Adolescent Strength FDC | 100 mg Artesunate + 220 mg Mefloquine | Youth & Teenagers (7 years to less than 14 years) | Intermediate Titration: Ensures balanced dosing without neuro-toxicity risks. |
| Adult Potency FDC / Kit | 100 mg + 220 mg (2 Tablets/Day for 3 days) or 200 mg + 440 mg | Adults & Children over 14 years | Full Strength Treatment: Maximizes biomass eradication in multi-drug resistant zones. |
Technical & Logistics Specifications
HS Code: 3004.90.99 (Medicaments acting on parasitic diseases / Anti-malarials)
CAS Numbers: 88495-63-0 (Artesunate) / 51773-92-3 (Mefloquine Hydrochloride)
Dosage Form: Oral Fixed-Dose Combination (FDC) Tablet or Co-packaged Blister Strips.
Packaging: 3-Day Compliance Blisters sealed inside high-barrier Alu-Alu (Cold-Form Foil) or thick PVC/PVDC matrices. Our specialized packaging systems physically prevent ambient moisture from degrading the sensitive artemisinin core, ensuring a 36-month shelf life in hot, humid Zone IVb tropical climates.
Manufacturing Authority & Compliance
Dehumidified Core Processing: Artesunate is highly physically sensitive to moisture-driven hydrolytic cleavage. We manage our entire blending, granulization, and compression lines within Class 10,000 cleanrooms maintained at strict relative humidity (RH less than 25%), eliminating raw chemical breakdown.
Precision Geometric Mixing: Mefloquine Hydrochloride must be perfectly balanced alongside Artesunate to avoid high localized concentrations that could trigger side effects. We employ Automated High-Speed V-Blenders, physically ensuring chemical uniformity across multi-million tablet batches.
Dissolution Kinetic Verification: Every export batch physically undergoes Automated Dissolution Profiling, chemically ensuring that both APIs dissolve rapidly inside the gastrointestinal tract to establish immediate systemic plasma levels during an acute malarial emergency.
Primary Indications
Tropical Medicine: First-line treatment of acute, uncomplicated malaria infections caused by Plasmodium falciparum, specifically in geographical zones presenting documented multi-drug resistance (such as Chloroquine, Sulfadoxine-Pyrimethamine, and Mepacrine resistance).
Institutional Deployment: Strategic stock for regional public health programs, national tenders, and military deployments in high-risk tropical zones.
Usage Instructions
The 3-Day Course: The medication must be administered physically once daily for 3 consecutive days.
Administration Guidelines: Swallow tablets physically whole with a full glass of water. It is physically ideal to take the dose with or immediately after a meal to chemically maximize the absorption of Mefloquine and reduce gastrointestinal irritation.
Vomiting Redose Protocol: If the patient physically vomits within 30 minutes of taking a dose, the entire daily dose must be chemically repeated. If vomiting occurs between 30 and 60 minutes, a half-dose must be re-administered.
Completion Mandate: Patients must complete the full 3-day treatment cycle, even if fever and clinical symptoms resolve on Day 2, to chemically prevent a parasitic recrudescence.
Safety Warning: CRITICAL HIGH-RESISTANCE ANTI-MALARIAL. For Confirmed Parasitic Diagnosis Only. Neuropsychiatric Note: Mefloquine can chemically interact with the central nervous system; monitor physically for acute anxiety, depression, restlessness, or confusion. Seizure Warning: Use with extreme physical caution in patients presenting a history of epilepsy or convulsive disorders. Contraindication: Do not use in patients with active depression, generalized anxiety disorder, schizophrenia, severe hepatic impairment, or known hypersensitivity to artemisinin or quinoline derivatives.
Global Export & Contract Manufacturing (CDMO Services)
Healthy Life Pharma Private Limited provides complete, internationally validated Third-Party Contract Manufacturing (CDMO) and private-label production for Artesunate & Mefloquine FDC Tablets and Kits. Whether you are bidding on a National Ministry of Health Tender in Southeast Asia, managing a public health pipeline in South America, or injecting premium inventory into an international B2B Pharmaceutical Marketplace, we supply all legally required registration dossiers (WHO-GMP, COPP, COA, Real-Time Stability Records, CTD Dossiers) for seamless global entry and fast customs clearance.
Commercial & Bulk Procurement Inquiries:
Corporate Head Office: Mumbai, Maharashtra, India
Primary Manufacturing Base: Boisar, Maharashtra, India
WhatsApp / Direct Call: +91 7710003340
Corporate Email: info@healthyinc.co.in
