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Flucloxacillin 500mg Capsules (Prescription)

Flucloxacillin 500mg Capsules (Prescription)

Generic

Pharmaceutical Product
  • UK Prescription Only Medicine (POM) with one or more MHRA Marketing Authorisations for Flucloxacillin 500mg Capsules.
  • Manufactured in compliance with EU/UK Good Manufacturing Practice (GMP) for medicinal products.
  • Complies with relevant British Pharmacopoeia/European Pharmacopoeia specifications for flucloxacillin capsules.
  • Supplied through MHRA Registered pharmaceutical wholesalers and a GPhC Regulated pharmacy (Mirror Pharma) for professional prescribing in aesthetics and general practice.
Oral antibiotic \u2013 isoxazolyl penicillin capsules

Description

Flucloxacillin 500mg Capsules (Prescription) are beta-lactamase–resistant penicillin antibiotics (isoxazolyl penicillins) used to treat and prevent infections caused by susceptible Gram-positive organisms, including many staphylococci and streptococci. In the aesthetics setting, these capsules are used as prophylaxis of infection after cosmetic procedures, helping to reduce the risk of post-procedural bacterial complications where systemic antibiotic cover is clinically indicated. Each hard gelatin capsule contains 500mg flucloxacillin (as flucloxacillin sodium) and is a UK prescription-only medicine (POM), supplied via licensed aesthetics pharmacies such as Mirror Pharma.

Bnefits

  • Provides systemic antibacterial cover against many Gram-positive organisms, including β-lactamase–producing Staphylococcus aureus and streptococci.
  • Suitable for prophylaxis of infection following certain cosmetic and minor surgical procedures when clinically justified.
  • Oral capsule formulation allows convenient dosing in outpatient and day-case aesthetic practice.
  • Well-established antibiotic with extensive clinical experience and guideline support for skin, soft-tissue and respiratory infections.
  • 500mg strength is compatible with standard adult dosing regimens (e.g. 250–500mg four times daily), aiding simple prescription schedules.
  • Prescription-only status ensures use under medical supervision, supporting appropriate antimicrobial stewardship in aesthetics.
  • Generic product sourced from MHRA-licensed manufacturers ensures consistent quality and regulatory oversight.

Indications

  • Prophylaxis of infection after cosmetic procedures where flucloxacillin-sensitive organisms are a concern and systemic antibiotic prophylaxis is indicated by clinical judgement.
  • Treatment of skin and soft-tissue infections such as boils, abscesses, carbuncles, furunculosis, cellulitis, infected wounds and burns, impetigo and infected skin conditions (e.g. ulcers, eczema, acne) caused by susceptible organisms.
  • Treatment of respiratory tract infections including pneumonia, lung abscess, sinusitis, pharyngitis, tonsillitis, quinsy, empyema and otitis media/externa when caused by flucloxacillin-sensitive bacteria.
  • Treatment of other infections due to flucloxacillin-sensitive organisms, such as osteomyelitis, endocarditis, meningitis, enteritis, septicaemia and some urinary tract infections, where oral therapy is appropriate or used as step-down from parenteral treatment.
  • Prophylaxis during major surgery (e.g. cardiothoracic and orthopaedic procedures) when recommended by guidelines and where organisms are likely to be susceptible.

Composition

  • Active ingredient: 500mg flucloxacillin (as flucloxacillin sodium) per hard capsule.
  • Excipient with known effect: approximately 25mg sodium per capsule (exact content may vary slightly between manufacturers).
  • Typical capsule core excipients: magnesium stearate and other standard capsule fillers (e.g. microcrystalline cellulose).
  • Capsule shell components: gelatin, titanium dioxide (E171) and iron oxides (E172) for colour (exact colour scheme may vary by MA holder).
  • Printing ink (where used): shellac (E904), propylene glycol (E1520), titanium dioxide (E171), sodium hydroxide (E524), povidone and other standard ink 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.
  • Pharmacotherapeutic group: beta-lactam antibiotic, isoxazolyl penicillin (ATC code J01CF05).
  • Legal status (UK): Prescription Only Medicine (POM).

Packaging

  • Typically supplied in blister packs or securitainer bottles containing 28, 30, 50, 100 or other MA-approved pack sizes; aesthetic pharmacies commonly stock 28-capsule packs for short courses.
  • Outer carton or pharmacy label states product name, strength, legal category (POM), batch number, expiry date and storage conditions.
  • Hard gelatin capsules are usually blue/blue or similar colour depending on manufacturer, often overprinted with identification such as “fluc” and “500”.
  • Supplied to clinics and prescribers through licensed UK pharmaceutical wholesalers and specialist aesthetics pharmacies such as Mirror Pharma; not for general over-the-counter sale.

Usage

  • Use only on the prescription of an appropriate prescriber (e.g. doctor, independent nurse prescriber); dosage and duration must be tailored to the indication, site of infection/procedure and patient factors.
  • Adults (including the elderly): typical dose is 250–500mg four times daily (every 6 hours). In severe infections, doses up to 1g four times daily may be used in line with the relevant Summary of Product Characteristics (SmPC).
  • For surgical or cosmetic prophylaxis, dosing regimens should follow local antimicrobial guidelines; for example, an intra-operative IV dose followed by 500mg orally every 6 hours for up to 72 hours in some protocols, if appropriate.
  • Capsules should be swallowed whole with a full glass of water; do not chew or crush.
  • Take on an empty stomach: at least 1 hour before food or 2 hours after meals, because food can reduce absorption.
  • Patients should avoid lying down immediately after taking a dose to reduce the risk of oesophageal irritation.
  • Continue treatment for the full prescribed course even if symptoms improve early, unless a prescriber advises stopping due to side effects or treatment change.
  • In patients with severe renal impairment, dose reduction and/or extended dosing intervals may be required; follow specialist guidance.
  • If a dose is missed, take it as soon as remembered unless it is almost time for the next dose; do not double dose to make up for a missed capsule.
  • Patients must be counselled on antimicrobial stewardship: use only when necessary, exactly as prescribed, and report any signs of hypersensitivity or severe adverse events promptly.

Contraindications

  • Known hypersensitivity to flucloxacillin, any other penicillin or any of the excipients.
  • History of severe immediate hypersensitivity reactions (e.g. anaphylaxis, angioedema, bronchospasm) to β-lactam antibiotics including cephalosporins, carbapenems or other penicillins.
  • Previous flucloxacillin-associated jaundice or hepatic dysfunction, particularly cholestatic hepatitis.
  • Caution or avoidance where there is a history of severe cutaneous adverse reactions (e.g. Stevens–Johnson syndrome, toxic epidermal necrolysis) associated with penicillins.
  • General contraindications and cautions to systemic penicillin use (e.g. certain severe renal or hepatic conditions) as outlined in the current SmPC and clinical guidelines.

Adverse Effects

  • Gastrointestinal: nausea, vomiting, diarrhoea, abdominal discomfort and indigestion; antibiotic-associated colitis including pseudomembranous colitis (presenting with severe, persistent or bloody diarrhoea).
  • Hypersensitivity reactions: skin rash, pruritus, urticaria; rare severe reactions including anaphylaxis, angioedema and bronchospasm.
  • Hepatic effects: cholestatic jaundice and hepatitis, which may be delayed and can occur up to several weeks after treatment has finished; risk is increased with prolonged treatment or in older adults.
  • Skin and mucosal reactions: erythema multiforme, Stevens–Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis (very rare but serious).
  • Haematological: eosinophilia, haemolytic anaemia, thrombocytopenia, neutropenia and other blood dyscrasias (usually reversible upon discontinuation).
  • Renal: interstitial nephritis and related renal impairment (rare).
  • Metabolic: high anion gap metabolic acidosis reported rarely when used with paracetamol in patients with risk factors (e.g. severe renal impairment).
  • Other: fever, arthralgia, serum sickness–like reactions; dyspnoea or chest discomfort associated with allergic reactions.
  • Oesophageal irritation or pain if taken without sufficient water or if the patient lies down immediately after dosing.

Storage Conditions

  • Store below 25°C in the original package to protect from moisture and light (follow specific storage statements on the dispensed pack).
  • Keep the container tightly closed when not in use.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date printed on the carton, bottle or blister strips.
  • Return any unused or expired capsules to a pharmacy for safe disposal; do not dispose of via wastewater or household rubbish.

Duration

Duration is determined by the clinical indication and prescriber; for prophylaxis after cosmetic procedures this is often a short course (e.g. a few days), while typical therapeutic courses for uncomplicated infections are 5\u20137 days and may extend to several weeks for deep or severe infections (e.g. osteomyelitis, endocarditis) under specialist supervision.

Onset

Symptomatic improvement in susceptible infections is usually observed within 24\u201372 hours of starting therapy, although full clinical resolution and prevention of post-procedural infection require completion of the prescribed course.

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