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Usual Dosing (Adults)

INDICATIONS AND USAGE
Teflaro™ (ceftaroline fosamil) is indicated for the treatment of patients with the following infections caused by susceptible isolates of the designated microorganisms.

Acute Bacterial Skin and Skin Structure Infections:
Teflaro is indicated for the treatment of 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:
Teflaro is indicated for the treatment of 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 (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

Usage:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Teflaro and other antibacterial drugs, Teflaro should be used to treat only ABSSSI or CABP that are proven or strongly suspected to be caused by susceptible bacteria. Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION
Recommended Dosage

The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over 1 hour in patients ≥ 18 years of age. The duration of therapy should be guided by the severity and site of infection and the patient's clinical and bacteriological progress.

The recommended dosage and administration by infection:
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Acute Bacterial Skin and Skin Structure Infection (ABSSSI):
600 mg q12h (infused over 1 hour) x 5-14 days

Community-Acquired Bacterial Pneumonia (CABP) :
600 mg q12h (infused over 1 hour) x 5-7 days
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Renal Dosing

dialysis Patients with Renal Impairment:
(Creatinine clearance (CrCl) estimated using the Cockcroft-Gault formula.)

CrCl> 50 mL/min:
No dosage adjustment necessary

> 30 to ≤ 50 mL/min:
400 mg IV (over 1 hour) every 12 hours

≥15 to ≤ 30 mL/min::
300 mg IV (over 1 hour) every 12 hours

Hemodialysis

dialysis End-stage renal disease, including hemodialysis:
200 mg IV (over 1 hour) every 12 hours

End-stage renal disease is defined as CrCl < 15 mL/min. Teflaro is hemodialyzable; thus Teflaro should be administered after hemodialysis on hemodialysis days.

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.
Ceftaroline