Indications

Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by susceptible isolates of the following Gram positive and Gram negative microorganisms- Staphylococcus aureus (including methicillin-susceptible and resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae ... Read more Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by susceptible isolates of the following Gram positive and Gram negative microorganisms- Staphylococcus aureus (including methicillin-susceptible and resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae and Klebsiella oxytoca. Community-Acquired Bacterial Pneumonia (CABP) caused by susceptible isolates of the following Gram positive and Gram negative microorganisms- Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus, Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli.

Composition

Pharmacology

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 & Administration

The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress. Indications Age Range Dosage Infusion Time Duration Acute Bacterial Skin and Skin Structure Infections 18 years and older 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to <18 years (>33 kg) 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to <18 years (≤33kg) 12 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days 2 months to <2 years 8 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days 0 to <2 months 6 mg/kg every 8 hours 30 to 60 minutes 5 to 14 days Community Acquired Bacterial Pneumonia 18 years and older 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to <18 years (>33 kg) 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to <18 years (≤33kg) 12 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days 2 months to <2 years 8 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days

Contraindications

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).

Side Effects

The common side effects include diarrhea, nausea, vomiting, abdominal pain, headache, dizziness, rash, pruritus, increased transaminases, phlebitis, pyrexia and infusion site reactions (erythema, phlebitis, pain). The uncommon side effects are anemia, leucopenia, thrombocytopenia, hypersensitivity/anaphylaxis, urticaria, Clostridium difficile colitis, prolonged prothrombin time, increased blood creatinine; and rarely eosinophilia.

Pregnancy & Lactation

No clinical data on pregnancy is available for Ceftaroline. Animal studies with Ceftaroline fosamil do not indicate harmful effects with respect to fertility, pregnancy, parturition or postnatal development. Ceftaroline should not be used during pregnancy unless clearly necessary and only if the potential benefit outweighs the possible risk. 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 Ceftaroline only if clearly indicated. Interruption of breast-feeding is recommended.

Precautions & Warnings

Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs, including Ceftaroline. If a hypersensitivity reaction occurs, discontinue Ceftaroline. Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including Ceftaroline. Evaluate if diarrhea occurs. Neurological adverse reactions have been reported in patients treated with cephalosporins, including Ceftaroline. If neurological adverse reactions occur, consider discontinuing Ceftaroline or making appropriate dosage adjustments in patients with renal impairment. If anemia develops during or after therapy, a diagnostic workup for drug-induced hemolytic anemia should be performed and consideration given to discontinuation of Ceftaroline.

Therapeutic Class

Fifth generation Cephalosporins

Storage Conditions

Prior to reconstitution, do not store Ceftaroline Fosamil powder for infusion above 30°C and should be used immediately after reconstitution. The diluted solution in the infusion bottle should be used within 6 hours when stored at room temperature or within 24 hours when stored under refrigeration at 2° to 8°C Keep away from light and out of the reach of children.