Ampicillin & Flucloxacillin Capsules

Healthy Inc is a specialized global supplier and exporter of advanced, synergistic beta-lactam antimicrobials. We provide high-purity Ampicillin (250 mg) & Flucloxacillin (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, LATAM, and Southeast Asia, serving as the gold-standard empirical intervention for mixed respiratory, dermatological, and post-operative infections.


Product Overview

This formulation contains two highly complementary penicillins: Ampicillin (an extended-spectrum aminopenicillin) and Flucloxacillin (a narrow-spectrum, 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. It provides excellent coverage against Streptococcus, Enterococcus, Haemophilus influenzae, and E. coli. However, it is easily destroyed by beta-lactamase enzymes.
  • Mechanism 2 (Flucloxacillin – The Staph Shield): Flucloxacillin features a bulky 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 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 lab cultures.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule, packed in specialized moisture-resistant Alu-Alu blister strips to preserve the highly hygroscopic Flucloxacillin salt.

Active IngredientStrength (Base Equivalent)Release Profile Function
Ampicillin Trihydrate USP/BP250 mgBroad-spectrum component for Gram-positive/negative systemic clearance.
Flucloxacillin Sodium BP/Ph.Eur.250 mgBeta-lactamase resistant component targeting Staphylococcal clearance.
ExcipientsMagnesium Stearate / Microcrystalline CelluloseLubricant / 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).


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Hospital Distributors.

HS Code3004.10.90 (Medicaments containing penicillins or derivatives thereof)
CAS Numbers7177-48-2 (Ampicillin Trihydrate) / 1847-24-1 (Flucloxacillin Sodium)
Dosage FormHard Gelatin Capsule
PackagingAlu-Alu Blisters (CRITICAL). Flucloxacillin sodium is extremely hygroscopic and will rapidly degrade if exposed to moisture.
StorageStore below 25°C in a dry place. Protect strictly from Light and Moisture.
CertificatesWHO-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 Flucloxacillin Sodium rapidly 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 or general surgery.
  • Gynecological & Pelvic Infections: Septic abortion, puerperal sepsis, and severe pelvic inflammatory disease (PID).

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 Flucloxacillin, 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.
  • Flucloxacillin-Induced Hepatotoxicity (CRITICAL): Flucloxacillin is uniquely associated with a risk of severe cholestatic jaundice and hepatitis. This risk increases significantly in older patients (over 55 years) and with prolonged treatment (exceeding 14 days). Hepatic function must be monitored during extended therapy.
  • 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.

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