APO-CEPHALEXIN

What it is

APO-CEPHALEXIN is cefalexin monohydrate , available as capsules containing 250 mg or 500 mg of cefalexin . Cefalexin is a cephalosporin antibiotic that is bactericidal because of its inhibition of cell-wall synthesis .

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 . The usual adult dose is 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 .

Key safety warnings

Before instituting therapy, every attempt should be made to determine if the patient has had previous hypersensitivity reactions to the cephalosporins, penicillins, or other drugs, and the product 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, with a toxin produced by Clostridium difficile appearing to be the primary cause, and the severity 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 . There have been reports of neurotoxicity associated with cephalosporin treatment with symptoms including encephalopathy, seizures and/or myoclonus, with risk factors including 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, and when suspected, APO-CEPHALEXIN should be discontinued immediately .

Contraindications

APO-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

APO-CEPHALEXIN 250 mg capsule blister pack was first listed on the ARTG on 15 September 2000 . APO-CEPHALEXIN 500 mg capsule blister pack was first listed on the ARTG on 20 February 2007 .