Logo
Flucloxacillin 500mg Capsules x28

Flucloxacillin 500mg Capsules x28

Generic

Pharmaceutical Product
  • UK Prescription Only Medicine (POM) licensed by the MHRA via one or more Marketing Authorisation holders for flucloxacillin 500mg capsules.
  • Manufactured under EU/UK Good Manufacturing Practice (GMP) for medicinal products.
  • Meets BP/Ph. Eur. quality standards for flucloxacillin capsules where specified by MA documentation.
  • Pack presentations and pricing referenced in NHS Drug Tariff (e.g. 28 Capsule pack in Part VIIIA).
Oral antibiotic \u2013 isoxazolyl penicillin capsules

Description

Flucloxacillin 500mg Capsules x28 is a UK prescription-only generic antibiotic product containing flucloxacillin (as flucloxacillin sodium), an isoxazolyl penicillin active mainly against Gram-positive organisms. Each hard gelatin capsule contains 500mg flucloxacillin and is used in the treatment of infections caused by flucloxacillin-sensitive bacteria, particularly β-lactamase–producing staphylococci and streptococci. Typical indications include skin and soft-tissue infections (such as boils, abscesses, cellulitis, infected wounds, impetigo), respiratory infections (pneumonia, lung abscess, sinusitis, otitis media, tonsillitis, pharyngitis) and other susceptible infections as directed by a prescriber. The pack size of 28 capsules is suitable for standard short courses in adults when dosed four times daily.

Bnefits

  • Broad activity against many Gram-positive organisms, including β-lactamase–producing Staphylococcus aureus.
  • Useful in a wide range of skin, soft-tissue and respiratory infections when pathogens are susceptible.
  • Oral capsule formulation allows convenient outpatient treatment compared with parenteral therapy.
  • 500mg strength facilitates standard adult dosing regimens (e.g. 250–500mg four times daily).
  • Well-established penicillin-class antibiotic with extensive clinical experience and guideline support.
  • Generic UK product, normally cost-effective compared with branded alternatives.

Indications

  • Skin and soft-tissue infections: boils, abscesses, carbuncles, furunculosis, cellulitis, infected burns, infected wounds, impetigo, infected skin conditions (e.g. ulcers, eczema, acne) and prophylaxis in skin grafts.
  • Respiratory tract infections: pneumonia, lung abscess, sinusitis, tonsillitis, quinsy, pharyngitis, empyema, otitis media and otitis externa.
  • Other infections caused by flucloxacillin-sensitive organisms, such as some urinary tract infections, osteomyelitis, endocarditis and infections of the small intestine and meninges, where oral therapy is considered appropriate or as step-down from parenteral treatment.
  • Use should follow local/national antibiotic guidance and culture/susceptibility results where available.

Composition

  • Active ingredient: flucloxacillin sodium equivalent to 500mg flucloxacillin per hard capsule.
  • Typical capsule excipients (may vary slightly by MA holder): magnesium stearate, microcrystalline cellulose and/or other standard capsule fillers.
  • Capsule shell: gelatin, titanium dioxide (E171), and iron oxides (E172) to provide capsule colouring.
  • Printing ink (if present on capsule): shellac (E904), propylene glycol (E1520), titanium dioxide (E171), sodium hydroxide (E524), povidone and related excipients.

Formulation

  • Pharmaceutical form: hard gelatin capsule containing a white to off-white powder.
  • Strength: 500mg flucloxacillin (as flucloxacillin sodium) per capsule.
  • Route of administration: oral.
  • Legal category: Prescription Only Medicine (POM) in the UK.
  • Pharmacotherapeutic group: Beta-lactam antibiotic – isoxazolyl penicillin.

Packaging

  • Pack size: 28 capsules (commonly supplied as blisters or securitainer; configuration may vary by manufacturer).
  • Outer carton printed with product name, strength, legal category (POM), batch number, expiry date and storage conditions.
  • Blister packs or securitainer labelled with strength and batch details, containing hard capsules with 500 marking where branded (e.g. Floxapen/Floxapen generics).

Usage

  • Use exactly as prescribed by a healthcare professional; the exact dose and duration depend on the type and severity of infection, age, weight and renal function.
  • Typical adult dose: 250–500mg four times daily (every 6 hours). In severe infections, higher doses may be used (e.g. up to 1g QDS) as per prescribing information.
  • Capsules should be taken on an empty stomach: at least 1 hour before or 2 hours after meals, as food can reduce absorption.
  • Swallow each capsule whole with a full glass of water (around 250ml) to reduce the risk of oesophageal irritation or pain.
  • Patients should avoid lying down immediately after taking a dose to help prevent oesophageal irritation.
  • Continue treatment for the full prescribed course even if symptoms improve early, unless a doctor advises stopping due to side effects.
  • If a dose is missed, take it as soon as remembered unless it is almost time for the next dose; do not double up doses.
  • Seek medical advice if symptoms worsen, do not improve, or new symptoms appear during treatment.
  • Dose adjustments and careful monitoring are required in patients with significant renal impairment; this must be guided by a prescriber.

Contraindications

  • Known hypersensitivity to flucloxacillin, any other penicillin or any of the excipients.
  • History of severe immediate hypersensitivity reactions (e.g. anaphylaxis) to β-lactam antibiotics (penicillins, cephalosporins, carbapenems).
  • Previous history of flucloxacillin-associated jaundice or hepatic dysfunction.
  • General contraindications to systemic penicillin therapy as per current prescribing information.

Adverse Effects

  • Common: gastrointestinal disturbance such as nausea, vomiting, diarrhoea and abdominal discomfort.
  • Skin reactions: rash, pruritus, urticaria; maculopapular or morbilliform rashes.
  • Hypersensitivity reactions: angioedema, bronchospasm, anaphylaxis (rare but potentially life-threatening).
  • Hepatic effects: cholestatic jaundice and hepatitis, which may be delayed and can occur up to several weeks after treatment has finished; elderly and prolonged high-dose therapy are higher risk groups.
  • Haematological effects: eosinophilia, haemolytic anaemia, thrombocytopenia and other blood dyscrasias (usually reversible on stopping).
  • Renal effects: interstitial nephritis (rare).
  • Gastrointestinal: antibiotic-associated colitis including pseudomembranous colitis (presenting with severe, persistent or bloody diarrhoea).
  • Other: fever, arthralgia, serum sickness–like reactions, Stevens–Johnson syndrome, toxic epidermal necrolysis and other severe cutaneous adverse reactions (very rare).

Storage Conditions

  • Store below 25°C (or as specified on the individual pack) in the original package to protect from moisture and light.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date printed on the carton and blister/securitainer.
  • Do not store in the bathroom or near sinks; keep in a dry place.
  • Return any unused or expired capsules to a pharmacy for safe disposal; do not dispose of via wastewater or household rubbish.

Duration

Varies with indication and clinical response; common courses in adults are typically 5\u20137 days for uncomplicated infections, but may be longer (e.g. several weeks) for conditions such as osteomyelitis or endocarditis, guided by specialist advice.

Onset

Symptomatic improvement in susceptible infections is often seen within 24\u201372 hours of starting appropriate therapy; full resolution requires completion of the prescribed course.

Browse more Pharmaceutical Product

Top Treatments

Top Cities in the UK