FLUCIL

What it is

FLUCIL is the sodium salt of flucloxacillin, a member of the beta-lactamase-stable group of penicillins derived from the penicillin nucleus, 6-amino-penicillanic acid. The brand is registered on the ARTG in four variants: flucloxacillin 1g powder for injection, flucloxacillin 500mg powder for injection, flucloxacillin 125mg/5mL oral solution, and flucloxacillin 250mg/5mL oral solution.

Approved indications

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

Dosing overview

For adults by intramuscular injection, the usual dosage is 250mg every 6 hours. By intravenous injection or infusion, the usual dosage is 250mg to 1g every 6 hours. For intrapleural administration, 250mg once daily. For intra-articular administration, 250mg to 500mg once daily. Systemic doses may be doubled where necessary in severe infections. For children aged 2 to 10 years, the usual dosage is half the adult dose. For children under 2 years, the usual dosage is one quarter the adult dose. In severe infections the dosage may be increased.

Key safety warnings

FLUCIL can cause severe hepatitis and cholestatic jaundice, which may be protracted. This reaction is more frequent in older patients and those who take the drug for prolonged periods. Hepatitis reports have been more frequent with increasing age, particularly over 55 years of age, or following prolonged treatment lasting more than 14 days. Jaundice may appear several weeks after therapy and in some cases the course of the reaction has been protracted and lasted for several months. Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. Before commencing therapy with any beta-lactam antibiotic careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. Antibiotic-associated pseudomembranous colitis has been reported with many antibiotics including FLUCIL. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use, which may occur up to several weeks after cessation of antibiotic therapy. Severe cutaneous adverse reactions, 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, FLUCIL should be discontinued immediately and an alternative treatment should be considered. Caution is advised when FLUCIL 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. After co-administration of FLUCIL and paracetamol, close monitoring is recommended in order to detect the appearance of acid-base disorders, namely HAGMA.

Contraindications

FLUCIL should not be given to patients with a previous history of flucloxacillin sodium monohydrate-associated jaundice or hepatic dysfunction. FLUCIL should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (such as penicillins and cephalosporins). FLUCIL should not be used in the eye, either conjunctively or locally.

PBS listing

The powder for oral liquid 250mg strength (as sodium monohydrate) per 5mL is listed on the PBS with restriction and an ex-manufacturer price of A$9.10. The powder for oral liquid 125mg strength (as sodium monohydrate) per 5mL is also listed on the PBS with restriction and an ex-manufacturer price of A$6.45.

Regulatory history

FLUCIL was first approved on 14 June 1995. The 1g and 500mg powder for injection variants were first listed on the ARTG on 2003-01-09. The 125mg/5mL and 250mg/5mL oral solution variants were first listed on the ARTG on 2011-01-27. In November 2015, the PBAC recommended a change to listing of a proposed alternative pack size (10 vial) to maintain supply due to shortage of the 5 vial pack size.