FLUBICLOX

What it is

FLUBICLOX is a narrow spectrum antibiotic belonging to the isoxazolyl group of semi-synthetic penicillins. It is acid stable and penicillinase resistant. FLUBICLOX is a narrow spectrum antibiotic with considerable activity against penicillinase producing Staphylococcus aureus, penicillin sensitive Staphylococcus aureus, β-haemolytic streptococci (Streptococcus pyogenes), and Diplococcus pneumoniae. It is not active against Gram-negative bacilli, methicillin resistant Staphylococcus aureus (MRSA), nor Streptococcus faecalis.

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

The usual adult dose is 250 mg, 6 hourly. For children aged 2 to 10 years, the dose is 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 therapy. Reports have been more frequent with increasing age (particularly over 55 years of age) or following prolonged treatment (beyond 14 days). Jaundice may appear several weeks after therapy; in several cases, the course of the reactions has been protracted and lasted for several months. 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 should be discontinued immediately and an alternative treatment should be considered. Caution is advised when flucloxacillin 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. Antibiotic associated pseudomembranous colitis has been reported with flucloxacillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening.

Contraindications

FLUBICLOX is contraindicated for patients who are hypersensitive to beta-lactam antibiotics (such as penicillins and cephalosporins). FLUBICLOX is contraindicated for patients with a previous history of flucloxacillin associated jaundice or hepatic dysfunction. FLUBICLOX is contraindicated for use in the eye.

PBS listing

Information on PBS listing for FLUBICLOX is not available in the provided source documents.

Regulatory history

FLUBICLOX was first registered on the Australian Register of Therapeutic Goods on 20 September 1991. FLUBICLOX powder for injection products (500 mg and 1 g vials) were listed on 14 February 2003, and a 2 g vial formulation was listed on 23 May 2019.