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Hypersensitivity reactions: As with all beta-lactam antibacterials, serious and occasionally fatal hypersensitivity reactions are possible (see Contraindications and Adverse Reactions).
Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterials may also be hypersensitive to ceftaroline fosamil. Before initiating therapy with ZINFORO, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibacterials. If a patient developed an immediate and severe hypersensitivity (e.g. anaphylactic reaction) previously to any type of beta-lactam antibacterial, ceftaroline fosamil shoul dnot be administered (see Contraindications).
If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken.
Clostridium difficile-associated diarrhoea: Antibacterial-associated colitis and pseudomembranous colitis have been reported with nearly all anti-bacterial agents, including ZINFORO, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftaroline fosamil (see Adverse Reactions). In such circumstance, the discontinuation of therapy with ZINFORO and the use of supportive measures together with the administration of specific treatment for Clostridium difficile should be considered.
Patients with pre-existing seizure disorder: As with other cephalosporins, seizures have occurred in ceftaroline toxicology studies at 7-25 times human Cmax levels (see Pharmacology: Toxicology: Preclinical safety data under Actions). Clinical study experience with ceftaroline in patients with pre-existing seizure disorders is limited. Therefore, ZINFORO should be used with caution in this patient population.
Direct antiglobulin test (Coombs test) seroconversion: The development of a positive direct antiglobulin test (DAGT) may occur during treatment with cephalosporins. The incidence of DAGT seroconversion in patients receiving ceftaroline fosamil was 10.7% in the pooled Phase 3 studies. There was no evidence of haemolysis in any patient receiving ceftaroline fosamil who developed a positive DAGT.
Patients with renal impairment: Clinical study experience with ceftaroline in patients with severe renal impairment and ESRD is limited. Therefore, use of ZINFORO is not recommended in these patient populations (see Pharmacology: Pharmacokinetics under Actions).
Non-susceptible organisms: Superinfections may occur as with other antibacterial agents.
Effects on ability to drive and to use machines: Undesirable effects e.g. dizziness may occur and this may have an effect on the ability to drive and use of machines (see Adverse Reactions).
