Flucloxacillin 125mg/5ml, 100ml Solution POM (Sugar Free Powder for Oral Solution)

Misc (Generics)

Pharmaceutical Product

Oral antibiotic solution (sugar-free)

UK Prescription Only Medicine (POM) with a valid Marketing Authorisation for Flucloxacillin 125mg/5ml Sugar Free Powder for Oral Solution.
Manufactured under EU/UK Good Manufacturing Practice (GMP) for medicinal products.
Conforms to relevant British Pharmacopoeia/European Pharmacopoeia quality standards for flucloxacillin oral preparations.
Supplied through MHRA Registered pharmaceutical wholesalers and distributors for professional use only.

UK Prescription Only Medicine (POM) with a valid Marketing Authorisation for Flucloxacillin 125mg/5ml Sugar Free Powder for Oral Solution.
Manufactured under EU/UK Good Manufacturing Practice (GMP) for medicinal products.
Conforms to relevant British Pharmacopoeia/European Pharmacopoeia quality standards for flucloxacillin oral preparations.
Supplied through MHRA Registered pharmaceutical wholesalers and distributors for professional use only.

Oral antibiotic solution (sugar-free)

Description

Flucloxacillin 125mg/5ml, 100ml Solution POM is a sugar-free powder for oral solution that, after reconstitution, provides 100ml of oral suspension containing 125mg flucloxacillin per 5ml (as flucloxacillin sodium). Flucloxacillin is a beta-lactamase-resistant isoxazolyl penicillin antibiotic active mainly against Gram-positive organisms, including many β-lactamase–producing staphylococci and streptococci. This presentation is primarily used in children and adults who require a liquid formulation for the treatment of susceptible skin, soft-tissue and respiratory tract infections, and other infections caused by flucloxacillin-sensitive organisms.

Bnefits

Provides 125mg flucloxacillin per 5ml in a sugar-free oral solution suitable for patients who need to avoid sucrose.
Convenient liquid formulation for paediatric patients and adults who cannot swallow capsules or tablets.
Effective against many Gram-positive organisms, including β-lactamase–producing Staphylococcus aureus and streptococci.
Licensed for a wide range of common community and hospital infections (e.g. skin, soft-tissue and respiratory infections).
Powder-for-oral-solution format with defined reconstitution instructions to ensure consistent dosing.
Classified as Prescription Only Medicine (POM) under MHRA regulation, ensuring quality and safety oversight.

Indications

Skin and soft-tissue infections such as boils, abscesses, carbuncles, furunculosis, cellulitis, infected burns, infected wounds and impetigo.
Infected skin conditions including ulcers, eczema and acne, and for protection of skin grafts when organisms are susceptible.
Respiratory tract infections including pneumonia, lung abscess, sinusitis, tonsillitis, pharyngitis, quinsy, empyema and otitis media/externa.
Other infections caused by flucloxacillin-sensitive organisms, such as osteomyelitis, septicaemia, enteritis, meningitis, endocarditis and certain urinary tract infections, where oral therapy is appropriate or used as step-down from parenteral treatment.
Use according to official local guidelines on the appropriate use of antibacterial agents.

Composition

Active ingredient: flucloxacillin sodium monohydrate equivalent to 125mg flucloxacillin per 5ml of reconstituted oral solution.
Sodium (excipients with known effect): approximately 17mg per 5ml (classified as essentially sodium-free at the patient-information level for 125mg/5ml strength).
Excipients (sugar-free formulation): sodium citrate anhydrous, citric acid monohydrate, disodium edetate, sodium benzoate, xanthan gum, saccharin sodium, colloidal anhydrous silica, sorbitol (E420), menthol flavour, lemon flavour, strawberry flavour.
Preservative: sodium benzoate 5mg per 5ml (may increase risk of jaundice in newborns up to 4 weeks of age).

Formulation

Pharmaceutical form: sugar-free powder for oral solution.
Appearance (before reconstitution): free-flowing white granular powder with a slight lemon odour.
Appearance (after reconstitution): opaque off-white oral solution with lemon flavour and odour.
Strength: 125mg flucloxacillin per 5ml of reconstituted solution.
Route of administration: oral.
Pharmacotherapeutic group: beta-lactamase–resistant penicillin (isoxazolyl penicillin), ATC code J01CF05.

Packaging

Supplied as powder in a 150ml natural high-density polyethylene (HDPE) bottle with tamper-evident and/or child-resistant (CRC) cap.
After reconstitution with potable water, the final volume is 100ml of oral solution (125mg/5ml).
Bottle may be supplied in an aluminium pouch for extended shelf-life prior to reconstitution in some presentations.
Pack size: 1 x 100ml bottle (POM), suitable for typical short-course therapy.
Measurement device included with most presentations (5ml spoon or oral dosing syringe with bottle-neck adaptor) to aid accurate dosing.

Usage

Reconstitution (for the pharmacist or healthcare professional): add the recommended volume of potable water (typically 87ml for the 125mg/5ml strength), then shake until all powder is fully dispersed to make 100ml of solution.
Shake the bottle well before each dose to ensure uniform suspension of the active ingredient.
Administer by mouth using the supplied measuring spoon or oral syringe for accuracy.
Typical adult dosage (including the elderly): 250mg four times daily (10ml of the 125mg/5ml solution four times a day). In severe infections, higher doses may be used as directed by a prescriber.
Typical paediatric dosage: children 2–10 years: 125mg four times daily (5ml four times a day); children under 2 years: 62.5mg four times daily (2.5ml four times a day). Use only under medical supervision.
Take doses on an empty stomach: at least 1 hour before or 2 hours after meals to optimise absorption.
After each dose, swallow with or followed by a full glass of water (about 250ml) and avoid lying down immediately afterwards to reduce the risk of oesophageal irritation or pain.
Use for the full prescribed course even if symptoms improve earlier; do not stop treatment without medical advice.
Dose adjustment and close monitoring are required in severe renal impairment (e.g. maximum in adults often limited to 1g every 8–12 hours).
Not generally recommended for premature infants or babies under 4 weeks old without specialist advice.

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 (including penicillins, cephalosporins, carbapenems).
Previous flucloxacillin-associated jaundice or hepatic dysfunction.
Use in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should be assessed carefully due to sorbitol content.
General contraindications to systemic penicillin therapy according to current clinical guidelines.

Adverse Effects

Common: mild gastrointestinal disturbance including nausea, vomiting, diarrhoea, abdominal discomfort, heartburn or indigestion.
Uncommon: skin rash, pruritus, urticaria (hives), purpura or other mild hypersensitivity reactions.
Very rare but serious: anaphylactic shock, angioedema, severe cutaneous adverse reactions such as Stevens–Johnson syndrome, toxic epidermal necrolysis, and acute generalised exanthematous pustulosis (AGEP).
Hepatic: cholestatic jaundice and hepatitis, sometimes delayed for up to 2 months after treatment has finished; can be prolonged and occasionally severe or fatal, particularly in older patients or those with underlying disease.
Haematological: eosinophilia, neutropenia (including agranulocytosis), thrombocytopenia, haemolytic anaemia and other blood count abnormalities (usually reversible on discontinuation).
Renal: interstitial nephritis and related renal dysfunction (rare).
Gastrointestinal: antibiotic-associated colitis, including pseudomembranous colitis, presenting with severe or persistent diarrhoea.
Metabolic: very rare cases of high anion gap metabolic acidosis when used concomitantly with paracetamol in the presence of risk factors.
Electrolytes: hypokalaemia (low potassium), especially with high doses or in those with additional risk factors or on potassium-lowering diuretics.
Other: oesophageal pain and related symptoms (difficulty swallowing, chest or throat pain) if not taken with adequate fluids or when lying down soon after dosing.

Storage Conditions

Unreconstituted powder: store below 25°C in a dry place in the original container (and aluminium pouch if supplied) to protect from moisture and light.
Reconstituted oral solution: store in a refrigerator at 2–8°C and keep the bottle tightly closed.
Discard any unused reconstituted solution 7 days after preparation, even if some remains in the bottle.
Keep out of the sight and reach of children.
Do not use after the expiry date printed on the bottle/carton; return expired or unused medicine to a pharmacy for safe disposal.

Duration

Duration depends on indication, severity and clinical response; commonly 5\u20137 days for uncomplicated community infections, but significantly longer courses (e.g. several weeks) may be required for osteomyelitis, endocarditis or other deep-seated infections as directed by a specialist.

Onset

Clinical improvement in susceptible infections is typically observed within 24\u201372 hours of starting appropriate therapy; complete resolution requires continuation for the full prescribed course.