Generic name: CEFTAROLINE FOSAMIL 400mg in 20mL
Dosage form: intravenous powder, for solution
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Recommended Dosage in Adult Patients
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.
||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|
2.2 Recommended Dosage in Pediatric Patients
The recommended dosage of Teflaro in pediatric patients is based on the age and weight of the child. Teflaro is administered every 8 hours by intravenous infusion over 5 to 60 minutes. The duration of therapy should be guided by the severity, site of infection and the patient's clinical and bacteriological progress.
The recommended dosage and administration by infection is described in Table 2.
|Indication||Age Range||Dosage and Frequency||Infusion time||Recommended Duration of Treatment|
|Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Community-Acquired Bacterial Pneumonia (CABP)
|2 months to < 2 years||8 mg/kg every 8 hours||5 to 60 minutes||5-14 days|
|≥ 2 years to < 18 years (≤ 33 kg)||12 mg/kg every 8 hours|
|≥ 2 years to < 18 years (> 33 kg)||400 mg every 8 hours
600 mg every 12 hours
Dosage Adjustments in Patients with Renal Impairment
Adults: No dosage adjustment is required in adult patients with CrCL > 50 mL/min. The dose in adult patients should be adjusted when creatinine clearance (CrCL) is ≤ 50 mL/min as shown below (see Table 3).
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.
|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,
|200 mg IV (over 5 to 60 minutes) every 12 hoursc|
Pediatrics: No dosage adjustment is required in pediatric patients with CrCL > 50 mL/min/1.73 m2, estimated using the Schwartz equation. There is insufficient information to recommend a dosage regimen for pediatric patients with CrCL < 50 mL/min/1.73 m2.
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 4.
* The recommended dosage of Teflaro is based on the age and weight of the child. See Table 2
|Volume of Diluent To Be Added
|Approximate Ceftaroline fosamil Concentration
|Amount to Be Withdrawn|
|400||20||20||Adults: Total Volume
Pediatric*: Volume based on age and weight
|600||20||30||Adults: Total Volume
Pediatric*: Volume based on age and weight
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.
Preparation of 600 mg of Teflaro dose in 50 mL infusion bag (for adult patients): 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 (for adult patients or pediatric patients weighing > 33 kg): 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.
Preparation of Teflaro dose in the infusion bag (for pediatric patients weighing ≤ 33 kg):The amount of solution withdrawn from the constituted Teflaro vial for pediatric patients weighing ≤ 33 kg for dilution in the infusion bag will vary according to the weight and age of the child. The infusion solution concentration for administration should not exceed 12 mg/ml ceftaroline fosamil.
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).