Description

Moxifloxacin & Cefixime Film-Coated Tablets (400 mg / 400 mg)

Healthy Inc is a specialized global supplier and exporter of advanced anti-infective, pulmonology, and critical-care therapeutics. We provide ultra-high-purity, kinetically synchronized Moxifloxacin (as Hydrochloride) & Cefixime (as Trihydrate) Film-Coated Tablets (400 mg / 400 mg), manufactured in WHO–GMP certified, strictly segregated dedicated Cephalosporin oral solid dosage facilities. This “Dual-Mechanism Broad-Spectrum FDC” is a massive-volume, highly lucrative export to infectious disease centers, respiratory clinics, emergency hospital networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, heavy-duty intervention for Multi-Drug Resistant (MDR) Typhoid Fever, severe community-acquired pneumonia, and complicated intra-abdominal infections.

Product Overview

This highly advanced Fixed-Dose Combination masterfully synchronizes a 4th-generation respiratory fluoroquinolone with a heavy-hitting 3rd-generation cephalosporin. Together, they trap resistant bacteria in an inescapable, two-front biochemical war.

The “AMR-Eradication & Dual-Pathway” Specialist:

• Mechanism 1 (The Cell Wall Breacher – Cefixime): Cefixime acts as the outer-defense destroyer. It aggressively binds to Penicillin-Binding Proteins (PBPs) on the outside of the bacteria, completely halting the synthesis of peptidoglycan. This physically shatters the bacterial cell wall, causing the pathogen to swell, rupture, and die. It is exceptionally potent against Gram-negative bacteria.
• Mechanism 2 (The DNA Shredder – Moxifloxacin): While the cell wall is collapsing, Moxifloxacin easily penetrates into the bacteria and targets its genetic core. It specifically inhibits DNA gyrase and Topoisomerase IV—the enzymes required for bacterial DNA to uncoil and replicate. By locking these enzymes, it physically breaks the bacterial DNA strands. Moxifloxacin provides massive coverage against Gram-positive, Gram-negative, and “atypical” respiratory pathogens.
• The MDR Typhoid & Pneumonia Synergy: In emerging markets, Salmonella typhi (Typhoid) and Streptococcus pneumoniae are rapidly mutating to survive standard single-drug therapies. By attacking the cell wall and the DNA simultaneously, this FDC ensures absolute bacterial eradication before the pathogen has time to mutate, drastically lowering clinical failure rates in life-threatening infections.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the highly reactive antibiotic compounds.

*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict 7-to-14 day acute critical-care anti-infective dispensing regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Infectious Disease Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Dedicated Cephalosporin Block Segregation (CRITICAL COMPLIANCE): Cefixime is a Beta-Lactam antibiotic. It is highly illegal and dangerous to manufacture it in a general pharmaceutical facility due to the risk of severe anaphylactic cross-contamination. This formulation is manufactured in 100% physically isolated, dedicated Cephalosporin blocks. This features independent HVAC systems, separate air-handling units, and stringent negative-pressure controls, ensuring absolute regulatory compliance and patient safety.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly aggressive management of severe, drug-resistant bacterial infections:

• Multi-Drug Resistant (MDR) Typhoid Fever: First-line salvage therapy for severe Salmonella typhi infections that are resistant to standard fluoroquinolones or cephalosporins alone.
• Severe Community-Acquired Pneumonia (CAP): Broad-spectrum eradication of typical and atypical respiratory pathogens in high-risk patients.
• Complicated Intra-Abdominal Infections: Used off-label in severe mixed infections where aggressive dual-aerobic coverage is required.
• Complicated Urinary Tract Infections (cUTI): Treatment of severe, ascending pyelonephritis and highly resistant UTIs.

Dosage & Administration

Recommended Dosage (Strictly as per Infectious Disease Guidelines):

• Standard Adult Dosing: One tablet (400mg/400mg) taken orally once daily.
• Administration: Must be taken with a full glass of water. Can be taken with or without food.
• Antacid & Dairy Warning: Moxifloxacin binds heavily to calcium, magnesium, and iron. Tablets must not be taken within 2 to 4 hours of dairy products, antacids, or iron supplements, as this will completely block the antibiotic’s absorption into the blood.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Tendon Rupture & Neuropathy): Fluoroquinolones (Moxifloxacin) are associated with disabling and potentially irreversible serious adverse reactions, including spontaneous tendon rupture (especially the Achilles tendon), peripheral neuropathy, and severe central nervous system effects. Discontinue immediately at the first sign of tendon pain.
• QTc Prolongation & Fatal Arrhythmia: Moxifloxacin significantly prolongs the QT interval on an EKG. It is strictly contraindicated in patients with uncorrected hypokalemia or those taking Class IA or III antiarrhythmics, as it can trigger fatal Torsades de Pointes (cardiac arrest).
• Penicillin Cross-Reactivity (Anaphylaxis): Because Cefixime is a cephalosporin, it carries a 5-10% risk of severe cross-reactivity in patients with severe Penicillin allergies.
• Clostridioides difficile-Associated Diarrhea (CDAD): This heavy-duty FDC will completely wipe out the normal gut flora, significantly increasing the risk of severe, life-threatening pseudomembranous colitis.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Infectious Disease Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antibiotics and Dedicated Beta-Lactam Formulations. Whether you are looking for a reliable Government Tender Supplier for typhoid outbreak control in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.