CEFACLOR

What it is

KEFLOR CD is a pharmaceutically-modified form of the orally active cephalosporin, cefaclor monohydrate, and is a semisynthetic cephalosporin antibiotic for oral administration. Each KEFLOR CD modified release tablet contains 375 mg of cefaclor (as monohydrate) as the active ingredient. 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 KEFLOR CD is 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 of KEFLOR CD should be administered for at least 10 days.

Key safety warnings

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics. When SCAR is suspected, KEFLOR CD should be discontinued immediately and an alternative treatment should be considered. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions have been reported in patients on penicillin/cephalosporin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins/cephalosporins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including cefaclor. A toxin produced with 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 this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Risk factors for developing neurotoxicity with cephalosporin treatment 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 was first approved on 16 December 1997.