Zinforo Special Precautions

Hypersensitivity reactions: Severe cutaneous adverse reactions (SCARs), 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.
Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients receiving therapy with beta-lactams. Before initiating therapy with ceftaroline fosamil, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, carbapenems or other beta-lactam agents. If an allergic reaction occurs, ceftaroline fosamil must be discontinued immediately and appropriate alternative therapy instituted.
Clostridium difficile-associated diarrhoea: Antibacterial-associated colitis and pseudomembranous colitis have been reported with nearly all anti-bacterial agents, including ceftaroline fosamil, 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 ceftaroline fosamil 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 levels (see Pharmacology: Toxicology: Preclinical safety data under Actions). Clinical study experience with ceftaroline fosamil in patients with pre-existing seizure disorders is limited. Therefore, ceftaroline fosamil 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 11.2% in the five pooled Phase 3 studies with administration every 12 hours (600 mg administered over 60 minutes every 12 hours) and 32.3% in a study in patients receiving ceftaroline fosamil every 8 hours (600 mg administered over 120 minutes every 8 hours). There was no evidence of haemolysis in any patient receiving ceftaroline fosamil who developed a positive DAGT.
Non-susceptible organisms: Superinfections may occur as with other antibacterial agents.
Limitations of the clinical data: There is no experience with ceftaroline in the treatment of CAP in the following patient groups: the immunocompromised, patients with severe sepsis/septic shock, severe underlying lung disease (e.g. cystic fibrosis, see Pharmacology: Pharmacokinetics under Actions), those with PORT Risk Class V, and/or CAP requiring ventilation at presentation, CAP due to methicillin-resistant S. aureus or patients requiring intensive care. Caution is advised when treating such patients.
There is no experience with ceftaroline in the treatment of cSSTI in the following patient groups: the immunocompromised, patients with severe sepsis/septic shock, necrotizing fasciitis, perirectal abscess and patients with third degree and extensive burns. There is limited experience in treating patients with diabetic foot infections. Caution is advised when treating such patients.
cSSTI caused by S. aureus with an MIC >1 mg/L to ceftaroline: There are limited clinical data for ceftaroline in treating cSSTI in adults caused by S. aureus with an MIC >1 mg/L to ceftaroline and there are no clinical data for treating S. aureus with an MIC = 2 mg/L to 4 mg/L to ceftaroline. Therefore, the recommended dosages of ceftaroline fosamil to treat cSSTI caused by S. aureus with an MIC >1 mg/L to ceftaroline are based on pharmacokinetic/pharmacodynamic modelling and simulation (see Dosage & Administration).
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. Dizziness may occur which may have an effect on ability to drive and use machines (see Adverse Reactions).
Use in Children: Paediatric patients < 2 months of age: There are limited clinical data in patients less than 2 months of age. Therefore the recommended dosage of ceftaroline fosamil shown in Table 10 for paediatric patients < 2 months of age is based on pharmacokinetic-pharmacodynamic modelling and simulation (see Dosage & Administration).