"The U.S. Food and Drug Administration today approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary "...
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.
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
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 is described in Table 1.
Table 1: Dosage of Teflaro by Infection
|Infection||Dosage||Frequency||Infusion Time (hours)||Recommended Duration of Total Antimicrobial Treatment|
|Acute Bacterial Skin and Skin Structure Infection (ABSSSI)||600 mg||Every 12 hours||1||5-14 days|
|Community-Acquired Bacterial Pneumonia (CABP)||600 mg||Every 12 hours||1||5-7 days|
Patients with Renal Impairment
Table 2: Dosage of Teflaro in Patients with Renal
|Estimated CrCla (mL/min)||Recommended Dosage Regimen for Teflaro|
|> 50||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|
|a Creatinine clearance (CrCl) estimated using
the Cockcroft-Gault formula.
b End-stage renal disease is defined as CrCl < 15 mL/min.
c Teflaro is hemodialyzable; thus Teflaro should be administered after hemodialysis on hemodialysis days.
Preparation of Solutions
Aseptic technique must be followed in preparing the infusion solution. The contents of Teflaro vial should be constituted with 20 mL Sterile Water for Injection, USP; or 0.9% of sodium chloride injection (normal saline); or 5% of dextrose injection; or lactated ringer's injection. The preparation of Teflaro solutions is summarized in Table 3.
Table 3: Preparation of Teflaro for Intravenous Use
|Dosage Strength (mg)||Volume of Diluent To Be Added (mL)||Approximate Ceftaroline fosamil Concentration (mg/mL)||Amount to Be Withdrawn|
The constituted solution must be further diluted in range between 50 mL to 250 mL before infusion into patients. Use the same diluent for this further dilution, unless sterile water for injection was used earlier. If sterile water for injection was used earlier, then appropriate infusion solutions include: 0.9% Sodium Chloride Injection, USP (normal saline); 5% Dextrose Injection, USP; 2.5% Dextrose Injection, USP, and 0.45% Sodium Chloride Injection, USP; or Lactated Ringer's Injection, USP. The resulting solution should be administered over approximately 1 hour.
Constitution time is less than 2 minutes. Mix gently to constitute and check to see that the contents have dissolved completely. Parenteral drug products should be inspected visually for particulate matter prior to administration.
The color of Teflaro infusion solutions ranges from clear, light to dark yellow depending on the concentration and storage conditions. When stored as recommended, the product potency is not affected.
Studies have shown that the constituted solution in the infusion bag should be used within 6 hours when stored at room temperature or within 24 hours when stored under refrigeration at 2 to 8° C (36 to 46° F).
The compatibility of Teflaro with other drugs has not been established. Teflaro should not be mixed with or physically added to solutions containing other drugs.
Only for the 50 mL infusion bags dilution, see the instructions listed below.
Preparation of 600 mg of Teflaro dose in 50 mL
Withdraw 20 mL of diluent from the infusion bag. Proceed to inject entire content of the Teflaro vial into the bag to provide a total volume of 50 mL. The resultant concentration is approximately 12 mg/mL.
Preparation of 400 mg of Teflaro dose in 50 mL
Withdraw 20 mL of diluent from the infusion bag. Proceed to inject entire content of the Teflaro vial into the bag to provide a total volume of 50 mL. The resultant concentration is approximately 8 mg/mL.
Dosage Forms And Strengths
Teflaro is supplied in single-use, clear glass vials containing either 600 mg or 400 mg of sterile ceftaroline fosamil powder.
Storage And Handling
Teflaro (ceftaroline fosamil) for injection is supplied in single-use, clear glass vials containing:
600 mg - individual vial (NDC 0456-0600-01) and carton containing 10 vials (NDC 0456-0600-10)
400 mg - individual vial (NDC 0456-0400-01) and carton containing 10 vials (NDC 0456-0400-10)
Teflaro vials should be stored refrigerated at 2 to 8° C (36 to 46° F). Unrefrigerated, unreconstituted Teflaro can be stored at temperatures not exceeding 25°C (77°F) for no more than 7 days.
Distributed by: Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO 63045, USA. Manufactured by: Facta Farmaceutici S.p.A., Nucleo Industriale S. Atto–S. Nicolo a Tordino, 64020 Teramo, Italy. Revised: May 2013
Last reviewed on RxList: 6/17/2013
This monograph has been modified to include the generic and brand name in many instances.
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