FLUCLOXACILLIN

What it is

Staphylex is a capsule containing 250 mg or 500 mg of flucloxacillin (as sodium monohydrate) as the active ingredient. Flucloxacillin sodium monohydrate is a narrow spectrum antibiotic belonging to the isoxazolyl group of semi-synthetic penicillins. It is acid stable and penicillinase resistant and is closely related to cloxacillin.

Approved indications

— Treatment of confirmed or suspected staphylococcal and other Gram-positive coccal infections including pneumonia, osteomyelitis, skin and soft tissue and wound infections, infected burns, cellulitis.

Dosing overview

Usual adult dose is 250 mg, 6 hourly. Children aged 2 to 10 years receive half the adult dose. In severe infections the dosage may be increased. The oral dose should be administered half to one hour before meals.

Key safety warnings

Hepatitis, predominantly of cholestatic jaundice, which may be protracted, has been reported with flucloxacillin sodium monohydrate therapy. Reports have been more frequent with increasing age (particularly over 55 years of age) or following prolonged treatment (beyond 14 days). During long-term treatments regular monitoring of hepatic function is recommended. Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics. When SCAR is suspected, flucloxacillin sodium monohydrate should be discontinued immediately and an alternative treatment should be considered. Caution is advised when flucloxacillin sodium monohydrate is administered concomitantly with paracetamol due to the increased risk of high anion gap metabolic acidosis (HAGMA). Patients at high risk for HAGMA are in particular those with severe renal impairment, sepsis or malnutrition especially if the maximum daily doses of paracetamol are used. Serious, and occasionally fatal, hypersensitivity (anaphylaxis) reactions have been reported in patients receiving beta-lactam antibiotics e.g. penicillins. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy.

Contraindications

Staphylex is contraindicated for patients who are hypersensitive to beta-lactam antibiotics (e.g. penicillins, cephalosporins). It is contraindicated in patients with a previous history of flucloxacillin sodium monohydrate associated jaundice/hepatic dysfunction. Use in the eye is contraindicated.

Regulatory history

Staphylex first received approval on 20 September 1991.