Description

Ampicillin & Cloxacillin Capsules

Healthy Inc is a specialized global supplier and exporter of advanced, synergistic beta-lactam antimicrobials. We provide high-purity Ampicillin (250 mg) & Cloxacillin (250 mg) Capsules, manufactured in WHO–GMP certified, completely dedicated penicillin oral solid dosage facilities. This “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 globally trusted empirical intervention for mixed respiratory, dermatological, and post-operative bacterial infections.

Product Overview

This formulation contains two highly complementary penicillins: Ampicillin (an extended-spectrum aminopenicillin) and Cloxacillin (a narrow-spectrum, highly beta-lactamase-resistant isoxazolyl penicillin).

The “Dual-Action Synergistic” Specialist:

• Mechanism 1 (Ampicillin – Broad Coverage): Ampicillin easily 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 excellent coverage against Streptococcus, Enterococcus, Haemophilus influenzae, and E. coli. However, it is highly susceptible to destruction by beta-lactamase enzymes.
• Mechanism 2 (Cloxacillin – The Staph Shield): Cloxacillin features a bulky chemical side chain that sterically hinders beta-lactamase enzymes from breaking its beta-lactam ring. It aggressively targets and destroys penicillinase-producing Staphylococcus aureus (MSSA), which would otherwise survive and neutralize the Ampicillin.
• The Empirical Advantage: In severe skin infections, wound infections, or neonatal sepsis, 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.

*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 for hospital/epidemic dispensing.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Hospital Distributors.

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): Capsules MUST be taken on an empty stomach (at least 30 minutes before or 2 hours after meals). Food heavily impairs the absorption of both Ampicillin and Cloxacillin, severely reducing peak blood concentrations.
• Standard Adult Dose: One capsule (250mg/250mg) every 6 hours (four times daily).
• 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: May alter normal gut flora, leading to antibiotic-associated diarrhea or, in severe cases, Clostridioides difficile-associated colitis (CDAC).
• The “Mononucleosis Rash”: Administering Ampicillin to patients with infectious mononucleosis (Epstein-Barr virus) causes a severe, generalized 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.