KEFLOR

What it is

KEFLOR CD is a modified release tablet containing 375 mg of cefaclor (as monohydrate). It is a pharmaceutically modified form of the orally active cephalosporin cefaclor monohydrate and is a semisynthetic cephalosporin antibiotic for oral administration. KEFLOR CD differs from other available products containing cefaclor in its rate of dissolution, producing a lower peak serum concentration but retaining sustained measurable serum concentrations, which provides the advantage of twice daily dosing.

Approved indications

KEFLOR CD is indicated for the treatment of the following types of infections caused by susceptible organisms, in adults and children aged 12 years or older: — Acute bronchitis and acute exacerbations of chronic bronchitis — Upper respiratory infections, including pharyngitis, tonsillitis and acute bacterial sinusitis — Community-acquired pneumonia of mild to moderate severity (excluding atypical pneumonia) — Symptomatic lower urinary tract infections, including cystitis — Skin and skin structure infections

Dosing overview

KEFLOR CD can be taken with or without food; however, absorption is enhanced when administered with food. The tablets should not be cut, crushed or chewed. For acute bacterial sinusitis, KEFLOR CD should be taken for 10 days. In the treatment of infections caused by S. pyogenes (group A streptococci), a therapeutic dosage should be administered for at least 10 days.

Key safety warnings

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. When severe cutaneous adverse reactions are suspected, KEFLOR CD should be discontinued immediately and an alternative treatment should be considered. In penicillin-sensitive patients, cephalosporin antibiotics should be administered cautiously. There is clinical and laboratory evidence of partial cross-allergenicity of the penicillins and cephalosporins, and serious and occasionally fatal hypersensitivity reactions including anaphylaxis have been reported in patients on penicillin/cephalosporin therapy. Antibiotic-associated pseudomembranous colitis has been reported with cefaclor, with a toxin produced by Clostridium difficile appearing to be the primary cause. The severity may range from mild to life threatening, and this diagnosis should be considered in patients who develop diarrhoea or colitis in association with antibiotic use, which may occur up to several weeks after cessation of therapy. There have been reports of neurotoxicity associated with cephalosporin treatment, with symptoms including encephalopathy, seizures and myoclonus. Risk factors for developing neurotoxicity include being elderly, renal impairment, central nervous system disorders and intravenous administration.

Contraindications

KEFLOR CD is contraindicated in patients with known allergy to the cephalosporin group of antibiotics or who have previously experienced a major allergy to penicillin, or any of the excipients.

Regulatory history

KEFLOR CD (cefaclor 375 mg sustained release tablet) was first listed on the ARTG on 19 February 1997. The first approval date was 16 December 1997.