CEPHALKEM

What it is

Cephalexin monohydrate is a semisynthetic cephalosporin antibiotic for oral administration. CEPHALKEM is available as 250 mg and 500 mg capsules.

Approved indications —

Respiratory tract infections caused by S. pneumoniae and group A beta-haemolytic streptococci — Bacterial sinusitis caused by streptococci, S. pneumoniae and S. aureus (methicillin-sensitive only) — Otitis media due to S. pneumoniae, staphylococci — Skin and soft-tissue infections caused by staphylococci and/or streptococci — Genitourinary tract infections, including acute prostatitis caused by E. coli, P. mirabilis, and Klebsiella sp.

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. In the therapy of otitis media, 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 of cephalexin should be administered for at least 10 days.

Key safety warnings

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, with a toxin produced by Clostridium difficile appearing to be the primary cause, and the severity of the colitis may range from mild to life threatening. There have been reports of neurotoxicity associated with cephalosporin treatment, with symptoms including encephalopathy, seizures and/or myoclonus, and 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

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

Regulatory history

CEPHALKEM was first listed on the ARTG on 2 October 2013, with both the 250 mg and 500 mg capsule formulations registered under licence category RE.