TEFLARO SUMMARY
Teflaro is a sterile, semi-synthetic, broad-spectrum, prodrug antibacterial of cephalosporin class of beta-lactams.
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.
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NEWS HIGHLIGHTS
Published Studies Related to Teflaro (Ceftaroline Fosamil)
Ceftaroline fosamil versus ceftriaxone for the treatment of Asian patients with
community-acquired pneumonia: a randomised, controlled, double-blind, phase 3,
non-inferiority with nested superiority trial. [2015] Asian patients admitted to hospital with community-acquired pneumonia... INTERPRETATION: Ceftaroline fosamil 600 mg given every 12 h was superior to
Efficacy of ceftaroline fosamil for bacteremia associated with community-acquired
bacterial pneumonia. [2014] studies comparing treatment with ceftaroline fosamil versus ceftriaxone... CONCLUSIONS: In subjects with CABP-associated bacteremia, ceftaroline fosamil
Integrated analysis of FOCUS 1 and FOCUS 2: randomized, doubled-blinded,
multicenter phase 3 trials of the efficacy and safety of ceftaroline fosamil
versus ceftriaxone in patients with community-acquired pneumonia. [2010] Ceftriaxone in Hospitalized Patients (FOCUS) 1 and FOCUS 2... CONCLUSIONS: Ceftaroline was noninferior to ceftriaxone in the individual trials.
Assessment of ceftaroline fosamil in the treatment of community-acquired
bacterial pneumonia due to Streptococcus pneumoniae: insights from two randomized
trials. [2013] Ceftaroline fosamil resulted in higher cure rates than ceftriaxone in patients
with community-acquired bacterial pneumonia in 2 randomized trials (FOCUS 1 and
FOCUS 2). The present analysis examines the subgroup of patients with
Streptococcus pneumoniae infection to determine whether the apparent difference
in cure rates persists after adjusting for potential covariates...
Ceftaroline fosamil: a novel broad-spectrum cephalosporin with activity against
methicillin-resistant Staphylococcus aureus. [2011] CONCLUSIONS: These considerations should be part of the formulary review process;
Clinical Trials Related to Teflaro (Ceftaroline Fosamil)
Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus [Completed]
The purpose of this study is to determine whether ceftaroline is effective and safe for the
treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for
infection due to Methicillin-resistant Staphylococcus aureus (MRSA).
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP) [Completed]
This is a study of safety and effectiveness of ceftaroline fosamil in children with
Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP) [Completed]
This is a study of safety and effectiveness of ceftaroline fosamil in children with
Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.
Pharmacokinetics of Ceftaroline in Normal and Obese Subjects [Completed]
The purpose of this study is to characterize plasma and urinary concentrations of
ceftaroline following intravenous administration of a single dose of ceftaroline 600 mg in
healthy subjects who are normal weight, overweight, and obese.
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections [Completed]
This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil
in children with skin infections receiving antibiotic therapy in the hospital.
Reports of Suspected Teflaro (Ceftaroline Fosamil) Side Effects
OFF Label USE (3),
Medication Error (3),
Dyspnoea (3),
Pancytopenia (3),
Rash (3),
Product Label Issue (3),
Neutropenia (3),
Leukopenia (3),
Stridor (2),
Adverse Drug Reaction (2), more >>
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Page last updated: 2015-08-10
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