Amoxicillin Trihydrate Clavulanic Acid

Amoxicillin Trihydrate and Clavulanic Acid is a potent antibiotic combination product designed to overcome bacterial resistance mechanisms. This synergistic formulation consists of amoxicillin trihydrate, a broad-spectrum penicillin antibiotic, and clavulanic acid, a β-lactamase inhibitor that protects amoxicillin from enzymatic degradation. The combination ensures enhanced efficacy against a wide range of β-lactamase-producing bacteria.

The product is available in various pharmaceutical forms including powder for oral suspension, film-coated tablets, and injectable formulations. The powder form typically contains amoxicillin trihydrate equivalent to 250mg, 500mg, or 875mg amoxicillin and clavulanic acid as potassium salt in ratios of 4:1 or 2:1. The mixture demonstrates high purity levels with amoxicillin trihydrate content ≥95% and clavulanic acid potency maintained according to international pharmacopeial standards. The product shows excellent stability when stored in original packaging under recommended conditions.

Our manufacturing facility operates under strict Good Manufacturing Practice (GMP) guidelines and holds ISO 9001:2015 certification. The product complies with United States Pharmacopeia (USP), European Pharmacopoeia (EP), and British Pharmacopoeia (BP) standards. We hold CEP certification (Certificate of Suitability to the European Pharmacopoeia) for international market access, including European and Canadian markets. All batches undergo rigorous quality control testing and are accompanied by Certificate of Analysis, Material Safety Data Sheets, and relevant export documentation. Our quality assurance system includes comprehensive stability studies and regular environmental monitoring to ensure consistent product quality.

This combination product demonstrates broad-spectrum antibacterial activity against both Gram-positive and Gram-negative bacteria. The amoxicillin component inhibits bacterial cell wall synthesis, while clavulanic acid inhibits β-lactamase enzymes that would otherwise degrade amoxicillin. This synergistic action makes the product particularly effective against β-lactamase-producing resistant strains.

The primary applications include treatment of respiratory tract infections such as bronchitis, pneumonia, sinusitis, and otitis media. It is also effective for genitourinary infections including cystitis, pyelonephritis, and urethritis. The product finds application in skin and soft tissue infections such as cellulitis, abscesses, and wound infections. Additional uses include treatment of bone and joint infections, intra-abdominal infections, and prophylaxis in surgical procedures.

The product is available in various formulations suitable for different patient populations, with dosage adjustments recommended for patients with renal impairment. The combination therapy is particularly valuable in empirical treatment where resistant organisms are suspected, providing broader coverage than amoxicillin alone.