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1. Indications And Usage Teflaro® Is A Cephalosporin Antibacterial Indicated In Adult And Pediatric Patients For The Treatment Of The Following Infection Caused By Designated Susceptible Bacteria: Acute Bacterial Skin And Skin Structure Infections (Absssi) In Adult And Pediatric Patients (At Least 34 Weeks Gestational Age And 12 Days Postnatal Age) ( 1.1 ) Community-Acquired Bacterial Pneumonia (Cabp) In Adult And Pediatric Patients 2 Months Of Age And Older ( 1.2 ) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Teflaro And Other Antibacterial Drugs, Teflaro Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Bacteria ( 1.3 ). ------- ---- --- --------- -Dosage And Administration---- --- ---------- Dosage Of Teflaro By Indication In Adult And Pediatric Patients ( 2.1 , 2.2 ) Indication Age Range Dosage Infusion Time Duration Acute Bacterial Skin And Skin Structure Infections (Absssi) 18 Years And Older 600 Mg Every 12 Hours 5 To 60 Minutes 5 To 14 Days ≥2 Years To < 18 Years (> 33 Kg) 400 Mg Every 8 Hours Or 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 *gestational Age 34 Weeks And Older And Postnatal Age 12 Days And Older Indication Age Range Dosage Infusion Time Duration Community Acquired Bacterial Pneumonia (Cabp) 18 Years And Older 600 Mg Every 12 Hours 5 To 60 Minutes 5 To 7 Days ≥2 Years To < 18 Years (> 33 Kg) 400 Mg Every 8 Hours Or 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 Dosage Adjustment Is Required In Adult Patients With Creatinine Clearance (Crcl) < 50 Ml/min And In End-Stage Renal Disease (Esrd) Including Hemodialysis ( 2.3 ). There Is Insufficient Information To Recommend A Dosage Regimen For Pediatric Patients With Crcl < 50 Ml/min/1.73 M 2 ( 2.3 ) 1.1 Acute Bacterial Skin And Skin Structure Infections Teflaro Is Indicated In Adult And Pediatric Patients (At Least 34 Weeks Gestational Age And 12 Days Postnatal Age) 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 [See Dosage And Administration ( 2.2 ) And Use In Specific Populations ( 8.4 )]. 1.2 Community-Acquired Bacterial Pneumonia Teflaro Is Indicated In Adult And Pediatric Patients 2 Months Of Age And Older 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. 1.3 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 Or Prevent Infections 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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