Product Dossier

ZINNAT

Product Dossier for ZINNAT (cefuroxime, Aspen Pharmacare). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

Zinnat is a semisynthetic cephalosporin prodrug which releases the active compound cefuroxime in the body. Zinnat tablets are available in 125 mg and 250 mg strengths, each containing cefuroxime as axetil.

Approved indications

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 with Zinnat tablets is 5 to 7 days for treatment of bronchitis, and 7 to 10 days for other infections. Cefuroxime axetil 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, and 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. Antibiotic associated pseudomembranous colitis has been reported with cefuroxime axetil, 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. 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. 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.

Contraindications

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

PBS listing

Zinnat 250 mg tablets and 125 mg/5 mL oral suspension were recommended by PBAC in November 2015, including a new 20-tablet pack size for the 250 mg strength.

Regulatory history

Zinnat 125 mg and 250 mg tablets were first listed on the Australian Register of Therapeutic Goods on 24 February 1994. Oral suspension formulations (125 mg/5 mL and 250 mg/5 mL) were added to the register on 25 February 2002.