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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 5 to 60 minutes 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 Indication
|Indication||Dosage||Frequency||Infusion Time||Recommended Duration of Treatment|
|Acute Bacterial Skin and Skin Structure Infection (ABSSSI)||600 mg||Every 12 hours||5 to 60 minutes||5-14 days|
|Community-Acquired Bacterial Pneumonia (CABP)||600 mg||Every 12 hours||5 to 60 minutes||5-7 days|
Dosage Adjustments In Patients With Renal Impairment
Table 2: Dosage of Teflaro
in Patients with Renal Impairment
|Estimated CrCla (mL/min)||Recommended Dosage Regimen for Teflaro|
|> 50||No dosage adjustment necessary|
|> 30 to ≤ 50||400 mg IV (over 5 to 60 minutes) every 12 hours|
|≥ 15 to ≤ 30||300 mg IV (over 5 to 60 minutes) every 12 hours|
|End-stage renal disease, including hemodialysisb||200 mg IV (over 5 to 60 minutes) every 12 hoursc|
|a Creatinine clearance (CrCl) estimated using the
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 Teflaro For Administration
Constitution of Teflaro Powder for Injection
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. Constitution time is less than 2 minutes. Mix gently to constitute and check to see that the contents have dissolved completely. 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|
Dilution of the Constituted Solution of Teflaro
The constituted solution must be further diluted in a range between 50 mL to 250 mL before intravenous infusion into patients. Use the same diluent used for constitution of the powder 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.
Dilution of the Constituted Solution of Teflaro in the 50 mL Infusion Bags Only
Preparation of 600 mg of Teflaro dose in 50 mL infusion bag: 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 infusion bag: 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.
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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Storage Of Constituted Solutions
Stability in Baxter® Mini-Bag Plus™
Solutions of Teflaro in concentrations ranging from 4 to 12 mg/mL in Baxter Mini-Bag Plus containers with 0.9% Sodium Chloride Injection may be stored for up to 6 hours at room temperature or for up to 24 hours at 2°C to 8°C (36°F to 46°F). Stability testing in the Baxter Mini-Bag Plus has solely been conducted on 50 mL and 100 mL containers (0.9% Sodium Chloride Injection).
Stability in Infusion Bag
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.
Dosage Forms And Strengths
For Injection: Teflaro is supplied as 600 mg or 400 mg of sterile ceftaroline fosamil powder in single-use, 20 mL clear glass vials. The powder is constituted and further diluted for intravenous injection.
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)
Unreconstituted Teflaro vials should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Distributed by: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC. Manufactured by: Facta Farmaceutici S.p.A. Nucleo Industriale S. Atto–S. Nicoḷ a Tordino 64020 Teramo, Italy. Revised: Aug 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/15/2015
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