FLOPEN VIATRIS

What it is

FLOPEN VIATRIS contains flucloxacillin sodium monohydrate and is available as 250 mg or 500 mg capsules. 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, osteomyelitis, skin and soft tissue and wound infections, infected burns, cellulitis.

Dosing overview

The usual adult dose is 250 mg, six 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 sodium monohydrate therapy, with reports being 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 and in several cases the course has been protracted and lasted for several months. Caution is advised when flucloxacillin sodium monohydrate is administered concomitantly with paracetamol due to the increased risk of high anion gap metabolic acidosis, particularly in patients with severe renal impairment, sepsis or malnutrition, with close monitoring recommended to detect acid-base disorders including testing for urinary 5-oxoproline. Severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalised exanthematous pustulosis have been reported in patients taking beta-lactam antibiotics, and when suspected flucloxacillin sodium monohydrate should be discontinued immediately and alternative treatment considered. Serious and occasionally fatal hypersensitivity reactions have been reported in patients receiving beta-lactam antibiotics, and although more frequent following parenteral therapy, anaphylaxis has occurred in patients on oral therapy, with careful enquiry required concerning previous hypersensitivity reactions before commencing therapy. Antibiotic-associated pseudomembranous colitis has been reported with flucloxacillin sodium monohydrate, with a toxin produced by Clostridium difficile appearing to be the primary cause, and the severity ranging from mild to life threatening.

Contraindications

FLOPEN VIATRIS is contraindicated in patients who are hypersensitive to beta-lactam antibiotics including penicillins and cephalosporins. It is contraindicated in patients with a previous history of flucloxacillin sodium monohydrate-associated jaundice or hepatic dysfunction. Use in the eye is contraindicated.

PBS listing

FLOPEN VIATRIS 500 mg capsules are listed on the PBS with 3 items under streamlined restriction at an ex-manufacturer price of A$8.08. FLOPEN VIATRIS 250 mg capsules are listed on the PBS with 2 items under restriction at an ex-manufacturer price of A$3.86.

Regulatory history

FLOPEN VIATRIS 250 mg and 500 mg capsules were first listed on the ARTG on 21 July 2022.