Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 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 and impetigo.
Respiratory tract infections: Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, otitis media and externa, tonsillitis and quinsy.
Other infections caused by flucloxacillin-sensitive organisms: Osteomyelitis, urinary tract infection, enteritis, meningitis, endocarditis and 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 the age, weight and renal function of the patient, as well as on the severity of the infection.
Oral – 250mg four times a day.
In serious infections, the dosage may be doubled.
Osteomyelitis, endocarditis – Up to 8g daily, in divided doses six to eight hourly.
Surgical prophylaxis – 1 to 2g IV at induction of anaesthesia followed by 500mg six hourly IV, IM or orally for up to 72 hours.
2-10 years: 125mg four times daily.
Under 2 years: 62.5mg four times daily.
Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
In common with other penicillins, flucloxacillin usage in patients with renal impairment does not usually require dosage reduction. However, in the presence of severe renal failure (creatinine clearance <10ml/min) a reduction in dose or an extension of dose interval should be considered. 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. The maximum recommended dose in adults is 1 g every 8 to 12 hours.
Dose reduction in patients with reduced hepatic function is not necessary.
Oral: This medicine should be taken on an empty stomach. This means an hour before food or two hours after food.
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.
3 years: polypropylene containers.
2 years: blister strips.
Container: Do not store above 25°C. Store in the original container. Keep tightly closed.
Blister: Do not store above 25°C. Store in the original pack.
White polypropylene container with polyethylene lid: 14, 28, 100, 250, 500 and 1000 capsules.
Blister Strips: 14, 28 and 100 capsules.
The blister strips are packed in the carton along with the patient leaflet.
Or
Blister strips are packed in triple laminated bags along with a silica gel sachet and heat sealed. The bags are packed in the carton along with the patient leaflet.
Not all pack sizes may be marketed.
Nothing stated.
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