Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip, HA4 6QD, United Kingdom
Flucloxacillin Sodium is indicated for the treatment of infections due to sensitive Gram-positive organisms, including β-lactamase-producing staphylococci and streptococci.
Typical indications include:
Skin and soft tissue infections: Boils, Cellulitis, Infected burns, Abscesses, Infected skin conditions, e.g. ulcer, eczema, and acne, Protection for skin grafts, Carbuncles, Furunculosis, Infected wounds, Impetigo
Respiratory tract infections: Pneumonia, Lung abscess, Empyema, Sinusitis, Pharyngitis, Otitis media and externa, Tonsillitis, Quinsy
Other infections caused by Flucloxacillin-sensitive organisms: Osteomyelitis, Urinary tract infection, Enteritis, Meningitis, Endocarditis, Septicaemia
Flucloxacillin Sodium is also indicated for use as a prophylactic agent during major surgical procedures when appropriate; for example cardiothoracic and orthopaedic surgery.
Parenteral usage is indicated where oral dosage is inappropriate.
Consideration should be given to official local guidance (e.g. national recommendations) on the appropriate use of antibacterial agents.Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available.
The dosage depends on age, weight and renal function of the patient, as well as the severity of the infection.
Oral: 250mg four times daily.
In serious infections, the dosage may be doubled.
2-10 years: 125mg four times daily.
Under 2 years: 2.5ml (62.5mg) four times daily.
Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
In patients with renal insufficiency, excretion of flucloxacillin is slowed. In the presence of severe renal insufficiency (creatinine clearance <10 ml/min) a reduction in dose or an extension of dose interval should be considered. The maximum recommended dose in adults is 1g every 8 to 12 hours. Flucloxacillin is not significantly removed by dialysis and hence no supplementary dosages need to be administered either during, or at the end of the dialysis period
Dose reduction in patients with reduced hepatic function is not necessary.
Up to 8 g daily, in divided doses six to eight hourly
1 to 2 g IV at induction of anaesthesia followed by 500 mg six hourly IV, IM or orally for up to 72 hours.
Oral.
Flucloxacillin powder for oral solution should be taken at least 1 hour before or 2 hours after meals.
A full glass of water (250 ml) should be taken afterwards, to reduce the risk of oesophageal pain (see section 4.8). Patients should not lay down immediately after Flucloxacillin powder for oral solution intake.
With high doses (mainly parenteral) neurotoxicity may develop.
Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.
Flucloxacillin is not removed from the circulation by haemodialysis.
Unopened: 3 years.
After reconstitution or when the container is opened for the first time: 7 days.
Unopened bottle: Do not store above 25°C. Store in the original container. Keep the container tightly closed.
Reconstituted solution: Store at 2-8°C.
Nature: 150ml amber glass Beatson Clark container with polypropylene screw cap or 150ml high density polyethylene bottle with child resistant closure with expanded polyethylene wad: 100ml.
To reconstitute, add 58ml of water, replace the lid and shake the bottle well.
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