Description
Amoxycillin & Cloxacillin Capsules
Healthy Inc is a specialized global supplier and exporter of advanced, synergistic beta-lactam antimicrobials. We provide high-purity Amoxycillin (250 mg) & Cloxacillin (250 mg) Capsules, manufactured in WHO–GMP certified, completely dedicated penicillin oral solid dosage facilities. This “High-Absorption Broad-Spectrum & Beta-Lactamase Resistant” combination is a massive-volume, high-priority export to surgical centers, primary care clinics, and government health ministries in Africa, the Middle East, and Southeast Asia, serving as the premium empirical intervention for mixed respiratory, dermatological, and post-operative bacterial infections.
Product Overview
This formulation contains two highly complementary penicillins: Amoxycillin (a highly bioavailable, extended-spectrum aminopenicillin) and Cloxacillin (a narrow-spectrum, highly beta-lactamase-resistant isoxazolyl penicillin).
The “High-Absorption Synergistic” Specialist:
- Mechanism 1 (Amoxycillin – Broad Coverage & High Bioavailability): Amoxycillin penetrates the outer membrane of Gram-negative bacteria via porin channels, binding to Penicillin-Binding Proteins (PBPs) to halt cell wall synthesis and induce bacterial lysis. It provides exceptional coverage against Streptococcus, Enterococcus, Haemophilus influenzae, and E. coli. Its primary clinical advantage over Ampicillin is its vastly superior gastrointestinal absorption, ensuring massive, reliable peak blood levels.
- Mechanism 2 (Cloxacillin – The Staph Shield): Because Amoxycillin is easily destroyed by beta-lactamase enzymes, Cloxacillin is paired with it to act as an unyielding chemical shield. Cloxacillin features a bulky side chain that sterically hinders these enzymes from breaking its beta-lactam ring. It aggressively targets and destroys penicillinase-producing Staphylococcus aureus (MSSA), neutralizing the primary threat to the Amoxycillin.
- The Empirical Advantage: In severe skin infections, infected surgical wounds, or deep respiratory exacerbations, it is often unclear if the pathogen is a Strep, a Gram-negative rod, or a Staph. This 500 mg FDC provides immediate, comprehensive empirical coverage against all three major threats simultaneously, halting tissue destruction while awaiting laboratory cultures.
Product Composition & Strength
We supply this product as a Hard Gelatin Capsule, packed in specialized moisture-resistant Alu-Alu or heavy-gauge Alu-PVC blister strips to preserve the highly hygroscopic Cloxacillin salt.
| Active Ingredient | Strength (Base Equivalent) | Release Profile Function |
|---|---|---|
| Amoxycillin Trihydrate USP/BP | 250 mg | Highly bioavailable broad-spectrum component for systemic clearance. |
| Cloxacillin Sodium USP/BP | 250 mg | Beta-lactamase resistant component targeting Staphylococcal clearance. |
| Excipients | Magnesium Stearate / Microcrystalline Cellulose | Lubricant / Diluent (Ensures rapid gastric dispersion and powder flow) |
*Pack Sizes: 10×10 Alu-Alu Blisters or 10×10 heavy-gauge Alu-PVC Blisters (Crucial for tropical export climates). Bulk Jars of 500/1000 also available.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Hospital Distributors.
| HS Code | 3004.10.90 (Medicaments containing penicillins or derivatives thereof) |
| CAS Numbers | 26787-78-0 (Amoxycillin Trihydrate) / 642-78-4 (Cloxacillin Sodium) |
| Dosage Form | Hard Gelatin Capsule |
| Packaging | Alu-Alu Blisters or High-Barrier Alu-PVC (CRITICAL). Cloxacillin sodium degrades rapidly if exposed to excessive environmental moisture. |
| Storage | Store below 25°C in a dry place. Protect strictly from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- 100% Dedicated Penicillin Isolation: Regulatory guidelines strictly mandate that penicillins be manufactured in completely isolated facilities to prevent fatal cross-contamination with other drug classes. Our combination capsules are processed in a segregated block with dedicated HVAC and air-filtration systems.
- Hygroscopic Environmental Control: Because Cloxacillin Sodium degrades in the presence of humidity, our encapsulation lines are rigorously controlled at Relative Humidity (RH) levels below 30%, guaranteeing absolute API stability and full therapeutic potency through the expiry date.
Therapeutic Indications (Human Use)
Indicated for the empirical treatment of severe, mixed bacterial infections:
- Skin and Soft Tissue Infections (SSTIs): Cellulitis, severe boils, abscesses, carbuncles, and infected surgical wounds where both Staph and Strep are suspected.
- Respiratory Tract Infections (RTIs): Bronchopneumonia, acute exacerbations of chronic bronchitis, and severe otitis media.
- Post-Operative Prophylaxis: Administered to prevent mixed infections following orthopedic, gynecological, or general surgery.
- Bone and Joint Infections: Osteomyelitis caused by susceptible organisms.
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Administration (TIMING): While Amoxycillin alone can be taken with food, the Cloxacillin component’s absorption is heavily impaired by food in the stomach. Therefore, these combination capsules are best taken on an empty stomach (at least 30 minutes before or 2 hours after meals) to ensure maximum absorption of the anti-staph component.
- Standard Adult Dose: One capsule (250mg/250mg) every 6 to 8 hours.
- Severe Infections: Dosing frequency or capsule volume may be increased under strict medical supervision depending on the severity of the infection.
Safety Warnings (CRITICAL):
- BLACK BOX WARNING (Anaphylaxis): Serious and fatal hypersensitivity reactions occur in patients allergic to penicillins. Strictly contraindicated in patients with a history of penicillin or cephalosporin allergy.
- Gastrointestinal Disruption: This combination is known to cause gastrointestinal upset, including nausea and diarrhea. If severe, persistent diarrhea occurs, Clostridioides difficile-associated colitis (CDAC) must be ruled out.
- The “Mononucleosis Rash”: Administering Amoxycillin to patients with infectious mononucleosis (Epstein-Barr virus) causes a severe, generalized erythematous maculopapular rash. It should not be used if viral mononucleosis is suspected.
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 Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Dedicated Penicillin Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement 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.










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