AL-Cefuroxime

What it is

AL-Cefuroxime is a semisynthetic cephalosporin prodrug which releases the active compound cefuroxime in the body to provide bactericidal activity. Cefuroxime has bactericidal activity against a wide range of common pathogens, including beta-lactamase producing strains. AL-Cefuroxime is available as 250 mg and 500 mg film coated tablets in blister packs.

Approved indications

AL-Cefuroxime is indicated for the treatment of mild to moderately severe infections in adults caused by sensitive bacteria. — Acute upper respiratory infections: otitis media, sinusitis, tonsillitis and pharyngitis — Acute exacerbations of chronic bronchitis, or acute bronchitis — Skin and skin structure infections, for example, furunculosis, pyoderma and impetigo — Acute uncomplicated gonococcal urethritis, and cervicitis due to non-penicillinase producing gonococci

Dosing overview

The usual course of therapy is 5 to 7 days for treatment of bronchitis, and 7 to 10 days for other infections. AL-Cefuroxime should be taken after a light meal for optimum absorption.

Key safety warnings

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. Before initiating therapy, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. 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. At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions. Antibiotic-associated pseudomembranous colitis has been reported with AL-Cefuroxime. 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 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.

Contraindications

AL-Cefuroxime is contraindicated in patients with known hypersensitivity to cephalosporin antibiotics or who have experienced a major allergy to penicillin (anaphylaxis, angioneurotic oedema, urticaria).

Regulatory history

AL-Cefuroxime 250 mg and 500 mg film coated tablet blister packs were first listed on the ARTG on 27 March 2017.