Indicated for the treatment of community-acquired bacterial pneumonia (CABP) caused by the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.
Also indicated for the treatment of acute bacterial skin and skin structure infections caused by 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.
Contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class.
Information about hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be sought.
Clostridium difficile-associated diarrhea may occur.
Seroconversion from a negative to a positive direct Coombs’ test result occurrs in 10.8% of patients.
Serious adverse events occur in 7.5%) of patients receiving TEFLARO and treatment discontinuation due to adverse events occurs in 2.7%) of patients.
The most common adverse reactions occurring in >2% of patients with diarrhea, nausea, and rash.
There is minimal potential for drug-drug interactions between this drug and CYP450 substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; and drugs that may alter renal blood flow.
Excreted primarily by the kidney, care, and doses should be modified based on renal function.
Dosage adjustment is required in patients with moderate (CrCl >30 to ≤50 mL/min) or severe (CrCl ≥15 to ≤30 mL/min) renal impairment and in patients with end-stage renal disease (CrCl <15 mL/min).
Recommended β-lactam antibiotics for Community-Acquired Pneumonia in Immunocompetent Patients.
Recommended Dosage
The recommended dosage is 600 mg administered every 12 hours by intravenous (IV) infusion over 1 hour in patients ≥ 18 years of age.
For Acute Bacterial Skin and Skin Structure Infection 600 mg q 12 h
Community-Acquired Bacterial Pneumonia (CABP) 600 mg Every 12 hours
Patients with Renal Impairment
Dosage of Teflaro in patients with renal impairment:
>50cc/min No dosage adjustment necessary
> 30 to ≤ 50 400 mg IV (over 1 hour) every 12 hours
≥ 15 to ≤ 30 300 mg IV (over 1 hour) every 12 hours
End-stage renal disease, including hemodialysisb 200 mg IV (over 1 hour) every 12 hoursc
The drug is hemodialyzable and should be administered after hemodialysis on hemodialysis days.