Amoxicillin & Potassium Clavulanate Tablets (Co-amoxiclav)
Healthy Inc is a specialized global supplier and exporter of advanced anti-infective, beta-lactam, and critical-care therapeutics. We provide ultra-high-purity, highly stabilized Amoxicillin & Potassium Clavulanate Film-Coated Tablets (625 mg / 1000 mg), manufactured in WHO–GMP certified, strictly dedicated Beta-Lactam isolation facilities. This “Beta-Lactamase Resistant Synergy” is a massive-volume, high-priority export to respiratory clinics, pediatric hospitals, primary care networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for severe, multi-drug resistant bacterial infections.
Product Overview
This highly advanced Fixed-Dose Combination (FDC) masterfully rescues the world’s most trusted penicillin (Amoxicillin) from bacterial resistance by pairing it with a brilliant “suicide inhibitor” (Clavulanic Acid).
The “Beta-Lactamase Shield & Pathogen Eradication” Specialist:
- Mechanism 1 (The Cell Wall Destroyer – Amoxicillin): Amoxicillin is a broad-spectrum penicillin. It aggressively binds to penicillin-binding proteins (PBPs) inside the bacteria, physically halting the cross-linking of the bacterial cell wall. Without a stable wall, the bacteria violently rupture and die (bactericidal action).
- Mechanism 2 (The Suicide Shield – Clavulanic Acid): Over decades, bacteria have evolved a defense mechanism—they secrete an enzyme called “Beta-Lactamase” that chomps up Amoxicillin before it can work. Clavulanic Acid is structurally similar to penicillin, but instead of attacking the cell wall, it acts as bait. The bacterial enzymes attack the Clavulanic Acid, which permanently and irreversibly binds to them (suicide inhibition). With the enzymes neutralized, the Amoxicillin is free to completely eradicate the resistant bacteria.
- The Global Resistance Standard: While plain Amoxicillin fails against many modern strains of staph, strep, and H. influenzae, the addition of Clavulanate forcefully restores its power, making this the undisputed gold standard for severe sinus, ear, lung, and bite wound infections globally.
Product Composition & Strength
We supply this product as a Precision-Blended Film-Coated Tablet, packed exclusively in highly secure, ultra-low moisture Alu-Alu blister strips (often containing integrated desiccants) to ensure the absolute stability of the incredibly hygroscopic Clavulanate salt.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Amoxicillin Trihydrate USP/Ph.Eur. Potassium Clavulanate USP/Ph.Eur. | 500 mg 125 mg (Total: 625 mg) | Standard Adult Dose: Therapy for moderate RTIs, dental infections, and skin infections. |
| Amoxicillin Trihydrate USP/Ph.Eur. Potassium Clavulanate USP/Ph.Eur. | 875 mg 125 mg (Total: 1000 mg) | High-Dose Adult Therapy: Aggressive intervention for severe pneumonia, severe sinus infections, and bite wounds. |
| Excipients | Microcrystalline Cellulose / Sodium Starch Glycolate / Colloidal Silicon Dioxide / Magnesium Stearate | Diluent / Superdisintegrant / Moisture Scavenger (Engineered for immediate gastric dissolution) |
*Pack Sizes: 1×6 or 1×10 Alu-Alu Blisters (Optimized specifically for strict 5-to-7 day acute antibiotic regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Hospital Procurement Boards, and Infectious Disease NGOs.
| HS Code | 3004.10.90 (Medicaments containing penicillins or derivatives thereof, with a penicillanic acid structure) |
| CAS Numbers | 61336-70-7 (Amoxicillin Trihydrate) / 61177-45-5 (Potassium Clavulanate) |
| Dosage Form | Film-Coated Tablet (Immediate Release) |
| Packaging | Alu-Alu Blisters (STRICTLY MANDATORY). Potassium Clavulanate degrades rapidly upon exposure to even trace humidity. Heavy-gauge Alu-Alu packaging is legally and clinically required to guarantee stability across Zone IVb tropical climates. |
| Storage | Store strictly below 25°C in a highly dry place. Protect from Light and Moisture. Do not remove from blister until immediately before use. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Dedicated Beta-Lactam Isolation (CRITICAL COMPLIANCE): Due to the severe risk of fatal anaphylactic reactions in penicillin-allergic patients, global regulatory bodies strictly forbid manufacturing penicillins on the same machinery as other drugs. Our Co-amoxiclav is produced in an entirely separate, self-contained Beta-Lactam block with dedicated HVAC and air-handling units, guaranteeing absolute safety and zero cross-contamination.
- Ultra-Low Humidity Control: Blending and compression of Clavulanate occur under extreme Relative Humidity (RH) controls (often below 20% RH) to prevent premature hydrolytic degradation of the API before it even reaches the blister pack.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of beta-lactamase-producing bacterial infections:
- Respiratory Tract Infections: Acute exacerbations of chronic bronchitis, community-acquired pneumonia, lobar pneumonia, and severe acute bacterial sinusitis.
- ENT Infections: Severe, recurrent otitis media (ear infections) and tonsillitis.
- Skin & Soft Tissue Infections: Cellulitis, animal/human bite wounds, and severe dental abscesses.
- Genitourinary Tract Infections: Cystitis, urethritis, and pyelonephritis.
Dosage & Administration
Recommended Dosage (Strictly as per Physician Guidelines):
- Standard Adult Dosing (625mg): One 625mg tablet taken every 12 hours (or every 8 hours for severe infections).
- High-Dose Adult Therapy (1000mg): One 1000mg tablet taken every 12 hours.
- Administration (THE MEALTIME RULE): To significantly increase the absorption of Clavulanate and to drastically minimize gastrointestinal intolerance, this medication MUST be taken at the absolute start of a meal.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX EQUIVALENT (Penicillin Anaphylaxis): Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving penicillin therapy. It is strictly contraindicated in patients with a history of severe allergic reactions to any penicillin or cephalosporin.
- Hepatotoxicity (Cholestatic Jaundice): Clavulanic acid has been strongly associated with hepatic dysfunction, including severe cholestatic jaundice and hepatitis. This risk is higher in elderly males and those on prolonged treatment (greater than 14 days). Liver function must be monitored if therapy is extended.
- Clostridioides difficile-Associated Diarrhea (CDAD): Co-amoxiclav profoundly alters the normal flora of the colon, frequently leading to overgrowth of C. difficile. Patients must be warned that if they develop severe, watery, or bloody diarrhea (even up to two months after stopping the drug), they must seek immediate emergency care.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antibiotic Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for pediatric infectious disease programs in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.