STAPHYLEX

What it is

STAPHYLEX is a capsule containing flucloxacillin sodium monohydrate as the active ingredient, available in 250 mg and 500 mg strengths. Flucloxacillin sodium monohydrate is a narrow spectrum antibiotic belonging to the isoxazolyl group of semi-synthetic penicillins that is acid stable and penicillinase resistant.

Approved indications

— Treatment of confirmed or suspected staphylococcal and other Gram-positive coccal infections including pneumonia — Treatment of osteomyelitis — Treatment of skin and soft tissue and wound infections — Treatment of infected burns — Treatment of 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. As flucloxacillin sodium monohydrate is excreted to a large extent by the kidney, the dose or dose interval may need modification in patients with renal failure.

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). 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. Caution is advised when flucloxacillin sodium monohydrate is administered concomitantly with paracetamol due to the increased risk of high anion gap metabolic acidosis. Patients at high risk are in particular those with severe renal impairment, sepsis or malnutrition especially if the maximum daily doses of paracetamol are used. 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. Serious, and occasionally fatal, hypersensitivity (anaphylaxis) reactions 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. Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including flucloxacillin sodium monohydrate. 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

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

Regulatory history

STAPHYLEX 250 mg and 500 mg capsules were first listed on the Australian Register of Therapeutic Goods on 20 September 1991.