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
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
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.
Disclaimer
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical
judgment. Neither GlobalRPh Inc. nor any other party involved in the
preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.PLEASE READ THE DISCLAIMER
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