- Complicated skin and soft tissue infections (cSSTI)
- Community-acquired pneumonia (CAP)
Ceftaroline Fosamil is indicated in neonates, infants, children, adolescents and adults.
Ceftaroline is a cephalosporin with activity against Gram-positive and Gram-negative bacteria. In vitro studies have shown that ceftaroline is bactericidal, due to inhibition of bacterial cell wall synthesis by binding to penicillin binding proteins (PBPs). Ceftaroline is also active against methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-nonsusceptible Streptococcus pneumoniae (PNSP) due to its affinity for the altered PBPs found in these organisms
Dosage in adults with normal renal function, creatinine clearance CrCl>50 ml/min:
| Indications | Posology (mg/infusion) |
nfusion time (minutes)/Frequency |
| Standard dosea:
Complicated skin and soft tissue infections (cSSTI) |
600 mg | 5-60b/every 12 hour |
| High doseb:
cSSTI confirmed or suspected to be caused by S. aureus with an MIC = 2 mg/L or 4 mg/L to ceftarolinec |
120/every 8 hours |
a. For patients with supranormal renal clearance receiving the standard dose, an infusion time of 60 minutes
may be preferable.
b. Infusion times of less than 60 minutes and high dose recommendations are based on pharmacokinetic and
pharmacodynamic analyses only.
c. For treatment of S. aureus for which the ceftaroline MIC is ≤1 mg/L, the standard dose is recommended.
Dosage in adults with normal renal function, creatinine clearance CrCl>50 ml/min:
| Indications | Posology (mg/infusion) |
nfusion time (minutes)/Frequency |
| Standard dosea:
Complicated skin and soft tissue infections (cSSTI) |
600 mg | 5-60b/every 12 hour |
| High doseb:
cSSTI confirmed or suspected to be caused by S. aureus with an MIC = 2 mg/L or 4 mg/L to ceftarolinec |
120/every 8 hours |
a. For patients with supranormal renal clearance receiving the standard dose, an infusion time of 60 minutes
may be preferable.
b. Infusion times of less than 60 minutes and high dose recommendations are based on pharmacokinetic and
pharmacodynamic analyses only.
c. For treatment of S. aureus for which the ceftaroline MIC is ≤1 mg/L, the standard dose is recommended.
The interaction potential of ceftaroline on drugs metabolised by P450 enzymes is expected to be low, since ceftaroline is not an inhibitor (CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4) nor an inducer (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP3A4/5) of P450 enzymes in vitro. Ceftaroline is not metabolised by P450 enzymes in vitro, so co-administered P450 inducers or inhibitors are unlikely to influence the pharmacokinetics of ceftaroline.
In vitro, ceftaroline is not transported by efflux transporters P-gp or BCRP. Ceftaroline does not inhibit P-gp, therefore an interaction with substrates, such as digoxin, is not expected. Ceftaroline is a weak inhibitor of BCRP, but the effect is too small to be clinically relevant. In vitro studies demonstrated that ceftaroline is not a substrate of, nor did it inhibit the renal uptake transporters OCT2, OAT1, and OAT3; drug-drug interactions with drugs that inhibit active renal secretion (e.g., probenecid) or with drugs that are substrates of these transporters would therefore not be expected.
- Hypersensitivity to the active substance or to any of its excipients.
- Hypersensitivity to the cephalosporin class of antibacterials.
- Immediate and severe hypersensitivity (e.g., anaphylactic reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or carbapenems).
Pregnancy: No clinical data on pregnancies are available for ceftaroline. Animal studies with ceftaroline fosamil do not indicate harmful effects with respect to fertility, pregnancy, parturition or postnatal development. Zinforo should not be used during pregnancy unless clearly necessary and only if the potential benefit outweighs the possible risk.
Lactation: It is not known whether ceftaroline is excreted in human milk, but because many beta-lactams are excreted in breast milk, women who are breast-feeding should be treated with Zinforo only if clearly indicated. Interruption of breast-feeding is recommended.