Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Indicated for infections caused by susceptible Gram-positive and Gram-negative organisms, including Staphylococcus aureus (both methicillin-sensitive and resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.

Community-Acquired Bacterial Pneumonia (CABP): Indicated for pneumonia caused by susceptible Gram-positive and Gram-negative organisms, including Streptococcus pneumoniae (with or without concurrent bacteremia), Staphylococcus aureus, Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

Ceftaroline is a cephalosporin antibiotic with activity against both Gram-positive and Gram-negative bacteria. In vitro studies have demonstrated that ceftaroline exerts bactericidal action by inhibiting bacterial cell wall synthesis through binding to penicillin-binding proteins (PBPs). It is also effective against methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-nonsusceptible Streptococcus pneumoniae (PNSP) because of its strong affinity for the altered PBPs present in these organisms.

The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.

No clinical drug–drug interaction studies have been conducted with ceftaroline. However, the potential for interactions between ceftaroline and CYP450 substrates, inhibitors, or inducers is considered minimal. Likewise, interactions with drugs that undergo active renal secretion or with drugs that may alter renal blood flow are also expected to be minimal.

• Hypersensitivity to the active substance or any of its excipients.
• Known allergy to cephalosporin antibiotics.
• History of immediate and severe hypersensitivity reactions (e.g., anaphylaxis) to other beta-lactam antibiotics such as penicillins or carbapenems.

Common side effects of ceftaroline include diarrhea, nausea, vomiting, abdominal pain, headache, dizziness, rash, pruritus, increased transaminases, phlebitis, pyrexia, and infusion site reactions such as erythema, phlebitis, and pain. Uncommon side effects include anemia, leukopenia, thrombocytopenia, hypersensitivity or anaphylaxis, urticaria, Clostridium difficile colitis, prolonged prothrombin time, and increased blood creatinine. Eosinophilia has been reported rarely.

No clinical data are available regarding the use of ceftaroline during pregnancy. Animal studies with ceftaroline fosamil have not shown harmful effects on fertility, pregnancy, delivery, or postnatal development. However, ceftaroline should be used during pregnancy only when clearly necessary and only if the expected benefit outweighs the potential risk. It is not known whether ceftaroline is excreted in human breast milk. Since many beta-lactam antibiotics are excreted in breast milk, ceftaroline should be used in breastfeeding women only when clearly indicated. Temporary interruption of breastfeeding is recommended during treatment.

Serious hypersensitivity reactions, including anaphylaxis, have been reported with beta-lactam antibacterial agents, including ceftaroline. If such a reaction occurs, treatment with ceftaroline should be discontinued immediately. Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ceftaroline. Patients who develop diarrhea during treatment should be evaluated carefully.

Neurological adverse reactions have been reported in patients receiving cephalosporins, including ceftaroline. If neurological side effects occur, discontinuation of ceftaroline or appropriate dosage adjustment should be considered, especially in patients with renal impairment.

If anemia develops during or after treatment, a diagnostic evaluation for drug-induced hemolytic anemia should be performed, and discontinuation of ceftaroline should be considered.

Pediatric Use: The safety and effectiveness of ceftaroline for the treatment of ABSSSI have not been established in pediatric patients with a gestational age of less than 34 weeks and a postnatal age of less than 12 days. For the treatment of CABP, safety and effectiveness have not been established in pediatric patients below 2 months of age, as no data are available.

Renal Impairment: Dosage adjustment is required in adult patients with moderate renal impairment (CrCl >30 to ≤50 mL/min), severe renal impairment (CrCl ≥15 to ≤30 mL/min), and end-stage renal disease (ESRD, defined as CrCl <15 mL/min), including patients undergoing hemodialysis. There is insufficient information to recommend a dosage regimen for pediatric patients with CrCl <50 mL/min.

Hepatic Insufficiency: The pharmacokinetics of ceftaroline in patients with hepatic impairment have not been established. However, since ceftaroline does not appear to undergo significant hepatic metabolism, hepatic impairment is not expected to have a significant effect on its systemic clearance.

Overdose with ceftaroline has been reported in patients with renal impairment. Reported reactions have included neurological complications, including encephalopathy. In case of overdose, ceftaroline should be discontinued and appropriate supportive treatment should be provided.

Fifth-generation cephalosporin antibiotic.

Before reconstitution, Ceftaroline Fosamil powder for infusion should be stored below 30°C. After reconstitution, it should be used immediately. The diluted solution in the infusion bottle may be used within 6 hours if stored at room temperature, or within 24 hours if refrigerated at 2°C to 8°C. Protect from light and keep out of the reach of children.