Flucloxacillin Capsules

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Flucloxacillin capsules contain flucloxacillin sodium as the active ingredient, along with specific excipients that vary slightly by manufacturer but typically include a lubricant, a glidant, and sodium.

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Description

Flucloxacillin Capsules

Healthy Inc is a specialized global supplier and exporter of essential anti-infectives and advanced beta-lactam therapeutics. We provide high-purity, highly bioavailable Flucloxacillin Capsules (250 mg / 500 mg), manufactured in WHO–GMP certified, strictly dedicated and segregated beta-lactam oral solid dosage facilities. This “Beta-Lactamase-Resistant Isoxazolyl Penicillin” is a massive-volume, essential export to infectious disease hospitals, surgical/burn wards, dermatology clinics, and government health ministries in Africa, LATAM, the Middle East, and Southeast Asia, serving as the definitive first-line intervention for severe Staphylococcal skin and soft-tissue infections.


Product Overview

This formulation contains Flucloxacillin Sodium, a highly targeted narrow-spectrum penicillin engineered specifically to survive the defensive enzymes produced by resistant bacteria.

The “Anti-Staphylococcal & Wound Care” Specialist:

  • Mechanism 1 (The Beta-Lactamase Shield): Many dangerous bacteria (specifically Staphylococcus aureus) produce an enzyme called beta-lactamase, which acts like molecular scissors to cut and destroy standard penicillins (like Amoxicillin). Flucloxacillin possesses a bulky chemical side-chain that physically blocks these “scissors.” This allows the drug to remain fully intact and lethal against bacteria that would easily survive older antibiotics.
  • Mechanism 2 (Cell Wall Destruction): Once it bypasses the bacterial defenses, Flucloxacillin violently binds to specific Penicillin-Binding Proteins (PBPs) located inside the bacterial cell wall. This halts peptidoglycan cross-linking, compromising the structural integrity of the bacterium and causing rapid cell lysis (death).
  • The Skin & Soft Tissue Gold Standard: Because the vast majority of severe skin infections (boils, cellulitis, infected surgical incisions) are caused by Staph and Strep bacteria, Flucloxacillin is globally recognized as the supreme empirical choice for dermatological and wound-care infections.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule, packed in highly secure, moisture-resistant Alu-Alu or heavy-gauge Alu-PVC blister strips to ensure the highly sensitive beta-lactam ring remains stable across high-humidity tropical climates.

Active Ingredient Strength Primary Clinical Use
Flucloxacillin Sodium BP/Ph.Eur. 250 mg (Equivalent to Flucloxacillin Base) Standard pediatric dosing and treatment of mild-to-moderate impetigo or localized boils.
Flucloxacillin Sodium BP/Ph.Eur. 500 mg (Equivalent to Flucloxacillin Base) Standard Adult Dose for severe cellulitis, infected wounds, and bone infections.
Excipients Magnesium Stearate / Colloidal Silicon Dioxide Lubricant / Glidant (Ensures uniform powder flow and rapid gastric dispersion)

*Pack Sizes: 10×10 Blisters (Optimized for standard 5-to-14 day acute infectious disease and post-surgical dispensing protocols).


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Hospital Procurement Boards, and Surgical Networks.

HS Code 3004.10.90 (Medicaments containing penicillins or derivatives thereof, with a penicillanic acid structure)
CAS Number 1847-24-1 (Flucloxacillin Sodium)
Dosage Form Hard Gelatin Capsule
Packaging Alu-Alu or Alu-PVC Blisters (CRITICAL). Flucloxacillin is highly prone to hydrolytic degradation. Strict moisture barriers are mandatory to prevent loss of antibiotic potency.
Storage Store strictly below 25°C in a dry place. Protect 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.

  • Segregated Beta-Lactam Containment (CRITICAL REGULATORY COMPLIANCE): Cross-contamination of penicillin into non-penicillin drugs can cause fatal anaphylaxis in allergic patients. Our Flucloxacillin capsules are manufactured in a 100% dedicated, isolated beta-lactam facility with independent HVAC systems, separate staff entrances, and closed-loop powder handling, satisfying the absolute strictest global health ministry audits.
  • Dissolution Integrity: Because it is an acute, life-saving antibiotic, reaching peak serum concentrations quickly is non-negotiable. Our strict HPLC dissolution profiling guarantees rapid gastric release to flood the bloodstream and target tissues with the API.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of beta-lactamase producing Staphylococcal infections:

  • Skin and Soft Tissue Infections (SSTI): Treatment of severe cellulitis, impetigo, carbuncles, furunculosis (boils), and infected post-operative/surgical wounds or burns.
  • Bone & Joint Infections: Highly effective as adjunctive oral step-down therapy for Staphylococcal osteomyelitis and septic arthritis.
  • Respiratory Tract Infections (RTI): Treatment of staphylococcal pneumonia and lung abscesses.
  • Endocarditis: Used in specific regimens for staphylococcal endocarditis (often as an oral continuation after IV therapy).

Dosage & Administration

Recommended Dosage (Strictly as per Physician/Infectious Disease Guidelines):

  • Administration (EMPTY STOMACH RULE IS CRITICAL): The absorption of Flucloxacillin is massively and negatively impacted by the presence of food in the stomach. These capsules MUST be taken on an empty stomach, at least 1 hour before or 2 hours after a meal. Failure to do so will result in sub-therapeutic blood levels and clinical failure.
  • Standard Adult Dosing: 250 mg to 500 mg taken four times a day (QID) or every 6 hours. Severe infections (like osteomyelitis) may require up to 8000 mg daily in divided doses.
  • Treatment Duration: Must complete the full prescribed course even if symptoms resolve early, to prevent the emergence of multidrug-resistant bacteria.

Safety Warnings (CRITICAL):

  • Penicillin Allergy (BLACK BOX EQUIVALENT): Strictly contraindicated in patients with a history of hypersensitivity to any penicillin or cephalosporin. Administration can trigger immediate, fatal anaphylactic shock.
  • Hepatic Toxicity & Cholestatic Jaundice: Flucloxacillin is infamous for causing severe hepatic injury, particularly cholestatic jaundice and hepatitis. The risk increases exponentially in older patients (over 55) and those taking the drug for longer than 14 days. Note: Hepatic events may occur up to 2 months after the treatment has finished.
  • Renal Impairment: Because the drug is primarily excreted by the kidneys, dosing intervals must be extended in patients with severe renal failure to prevent toxic accumulation.

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 Essential Antibiotic Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Surgical Hospital Supplier for wound management programs in Africa or a B2B Pharma Marketplace partner for Southeast Asia, 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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