Product Description

Indications: Flupen is indicated for the treatment of infections caused by Gram-positive organisms, including penicillinase-producing staphylococci. It is used in skin and soft tissue infections such as boils, abscesses, carbuncles, infected ulcers, eczema, acne, furunculosis, cellulitis, infected wounds, burns, otitis media and externa, and impetigo. It is also effective in respiratory tract infections including pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, and quinsy. Additionally, it may be used for osteomyelitis, enteritis, endocarditis, urinary tract infections, meningitis, and septicemia caused by susceptible organisms. It is also used prophylactically during major surgical procedures such as cardiothoracic and orthopedic surgeries.

Pharmacology: Flucloxacillin is a bactericidal, isoxazolyl penicillin active mainly against Gram-positive bacteria, including penicillinase-producing strains. It inhibits bacterial cell wall synthesis by blocking the transpeptidase enzyme involved in peptidoglycan cross-linking, leading to cell wall weakening and bacterial lysis. It is resistant to degradation by penicillinase due to structural stability of its β-lactam ring.

Dosage & Administration: For oral use, adults are usually given 250 mg four times daily, which may be increased in severe infections. In serious conditions such as osteomyelitis or endocarditis, doses up to 8 g daily in divided doses may be required. Children aged 2–10 years receive half of the adult dose, while those under 2 years receive one-quarter of the adult dose. For parenteral use, adults may receive 250 mg four times daily via intramuscular injection or 250 mg to 1 g four times daily via intravenous route, administered slowly or by infusion. Higher doses may be required in severe infections.

Administration: Oral doses should be taken on an empty stomach, preferably 1 hour before meals for optimal absorption.

Interaction: Concomitant use with certain drugs may increase the plasma concentration of flucloxacillin and prolong its presence in the bloodstream.

Contraindications: Contraindicated in patients with known hypersensitivity to penicillins or any component of the formulation.

Side Effects: Common adverse effects include gastrointestinal disturbances such as nausea, vomiting, diarrhea, and dyspepsia. Other possible reactions include rash, urticaria, purpura, fever, interstitial nephritis, hepatitis, and cholestatic jaundice.

Pregnancy & Lactation: Classified as pregnancy category B. It should be used during pregnancy only if clearly needed. Flucloxacillin is excreted in breast milk, so caution is advised in breastfeeding mothers.

Precautions & Warnings: Use with caution in patients with hepatic dysfunction or those with a history of allergic conditions. Monitoring may be required in prolonged therapy.

Use in Special Populations: In patients with severe renal impairment (creatinine clearance <10 ml/min), dose adjustment or increased dosing interval may be necessary.

Therapeutic Class: Penicillinase-resistant penicillin antibiotic

Reconstitution: Flupen may be used via alternative routes in combination with systemic therapy. It can be administered intra-articularly (250–500 mg), intrapleurally (250 mg daily), or via nebulization (125–250 mg dissolved in sterile water) depending on clinical requirements.

Storage Conditions: Store in a cool, dry place away from light and heat. Keep out of reach of children.