Description

Cefuroxime Axetil Film-Coated Tablets (250 mg / 500 mg)

Healthy Inc is a specialized global supplier and exporter of advanced anti-infectives, respiratory medicine, and targeted cephalosporin therapeutics. We provide ultra-high-purity, kinetically optimized Cefuroxime Axetil Tablets (250 mg / 500 mg), manufactured in WHO–GMP certified, dedicated Beta-Lactam high-containment facilities. This “2nd-Generation Cephalosporin & Beta-Lactamase Stable Antibiotic” is a massive-volume, premium export to ENT clinics, pulmonary centers, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for severe Lower Respiratory Tract Infections (LRTI), Acute Otitis Media, and Lyme Disease.

Product Overview

This formulation operates as a structural executioner of pathogenic bacteria. It is an orally active prodrug that is rapidly hydrolyzed in the intestinal mucosa and blood to release Cefuroxime, a powerful agent that shatters the protective architecture of the bacterial cell.

The “Beta-Lactamase Stable & Amorphous Matrix” Specialist:

• Mechanism 1 (The Cell Wall Rupture): Cefuroxime binds with high affinity to Penicillin-Binding Proteins (PBPs) located on the inner membrane of the bacterial cell wall. This prevents the final transpeptidation step of peptidoglycan synthesis. Without a stable cell wall, the osmotic pressure causes the bacteria to physically explode (Lysis).
• Mechanism 2 (Resistance to Beta-Lactamases): Unlike older penicillins, Citalopram possesses a high degree of stability against many Beta-Lactamase enzymes produced by bacteria like H. influenzae and S. aureus. This makes it a devastatingly effective “Shield-Breaker” for infections that fail standard first-line therapy.
• Mechanism 3 (The Axetil Prodrug Strategy): Cefuroxime itself is not absorbed in the gut. By esterifying it into the Axetil form, the molecule becomes lipophilic, allowing it to glide through the intestinal lining. Once inside the body, esterases rip off the axetil group, unleashing the active antibiotic payload exactly where it is needed.

Product Composition & Strength

We supply this product as a Precision-Blended, Amorphous Solid Dispersion Tablet, packed exclusively in secure, moisture-resistant Alu-Alu blister strips to ensure the stability of the hygroscopic prodrug.

*Pack Sizes: 1×6, 1×10, or 10×10 Alu-Alu Blisters (Optimized specifically for strict 5-to-10 day acute curative regimens).

Technical & Logistics Specifications

Manufacturing Authority

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

• Dedicated Beta-Lactam Containment (CRITICAL COMPLIANCE): Cross-contamination with Beta-Lactams can trigger fatal anaphylaxis in sensitive patients. Our facility utilizes Strictly Isolated Dedicated Lines with separate HVAC systems and airlocks. Furthermore, we utilize Dehumidified Processing (RH < 30%) to protect the amorphous API. We provide global buyers with a safe, bioequivalent product that delivers the exact “Original Brand” performance.

Therapeutic Indications

• Respiratory Tract Infections: Acute Bronchitis, Community-Acquired Pneumonia (CAP), and Sinusitis.
• Ear, Nose, and Throat: Acute Otitis Media, Pharyngitis, and Tonsillitis.
• Lyme Disease: First-line therapy for early-stage Borrelia burgdorferi infection.
• Skin and Soft Tissue: Impetigo and cellulitis caused by susceptible bacteria.

Dosage & Administration

• Standard Adult Dosing: 250 mg to 500 mg taken twice daily (BID) for 7 to 10 days.
• The “Full Stomach” Mandate (CRITICAL): Cefuroxime Axetil MUST be taken after food. Absorption is significantly enhanced in the presence of a meal. Taking this on an empty stomach results in therapeutic failure.
• The No-Crush Warning: The film coating is essential to mask the intensely bitter taste of the API. If crushed, the taste is intolerable and may lead to vomiting in pediatric patients.

Safety Warnings (CRITICAL):

• Penicillin Cross-Sensitivity: Use with extreme caution in patients with a history of penicillin allergy (10% cross-reactivity risk for anaphylaxis).
• C. Difficile-Associated Diarrhea: Like all broad-spectrum antibiotics, it can cause severe, potentially fatal pseudomembranous colitis.
• Antacid Interaction: Drugs that reduce stomach acid (PPIs, H2 blockers) will violently decrease the absorption of Cefuroxime Axetil. Avoid concurrent use.

Global Export & Contract Manufacturing Services

Healthy Inc is a premier Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-end Cephalosporins. Whether you are a Government Tender Supplier for respiratory health in Africa or a B2B Pharma Marketplace partner in Latin America, we ensure secure, WHO-GMP compliant delivery.