IBILEX

What it is

IBILEX is a semisynthetic cephalosporin antibiotic for oral administration. It is available as capsules containing cephalexin monohydrate equivalent to 250 mg or 500 mg cephalexin anhydrous.

Approved indications

IBILEX is indicated in the treatment of respiratory tract infections caused by Streptococcus pneumoniae and group A beta-haemolytic streptococci. — Bacterial sinusitis caused by streptococci, S. pneumoniae and methicillin-sensitive S. aureus. — Otitis media due to S. pneumoniae and staphylococci. — Skin and soft-tissue infections caused by staphylococci and/or streptococci. — Genitourinary tract infections, including acute prostatitis caused by Escherichia coli, Proteus mirabilis and Klebsiella species.

Dosing overview

The adult dosage ranges from 1 to 4 g daily in divided doses, with the usual adult dose being 250 mg every 6 hours. For streptococcal pharyngitis or tonsillitis, mild uncomplicated urinary tract infections, and skin and soft tissue infections, a dosage of 500 mg may be administered every 12 hours. The usual recommended daily dosage for children is 25 to 50 mg/kg in divided doses. For otitis media therapy in children, a dosage of 75 to 100 mg/kg/day in 4 divided doses is recommended. In the treatment of beta-haemolytic streptococcal infections, a therapeutic dosage should be administered for at least 10 days.

Key safety warnings

Before initiating therapy, every attempt should be made to determine if the patient has had previous hypersensitivity reactions to cephalosporins, penicillins or other drugs. IBILEX should be given cautiously to penicillin-sensitive patients. There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins, and patients have been reported to have had severe reactions including anaphylaxis to both drugs. Antibiotic-associated pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics including cephalosporins. 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 the 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. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms include encephalopathy, seizures and/or myoclonus. Risk factors include being elderly, renal impairment, central nervous system disorders and intravenous administration. 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.

Contraindications

IBILEX is contraindicated in patients with known allergy to the cephalosporin group of antibiotics or who have previously experienced a major allergy to penicillin.

PBS listing

IBILEX 250 mg capsules are listed on the PBS with 4 items available. The restriction type is unrestricted and streamlined. The ex-manufacturer price is A$2.50. IBILEX granules for oral suspension 250 mg per 5 mL (100 mL) are also listed with 2 PBS items available, unrestricted restriction type, and an ex-manufacturer price of A$2.60.

Regulatory history

IBILEX 500 mg capsules and IBILEX 250 mg capsules were first listed on the ARTG on 28 April 2000. Granules for oral suspension (IBILEX 125 mg per 5 mL and IBILEX 250 mg per 5 mL) were first listed on the ARTG on 26 March 2003.