Ceftaroline fosamil is available in vials containing 400 and 600 mg of anhydrous ceftaroline fosamil with L-arginine.2832
The 400- and 600-mg vials of ceftaroline fosamil should be reconstituted with 20 mL of sterile water for injection, sodium chloride 0.9%, dextrose 5%, or Ringer’s injection, lactated and mixed gently, yielding concentrations of 20 and 30 mg/mL, respectively.2832 The reconstituted solution must be further diluted in a suitable infusion solution prior to administration.2832 The same diluent should be used for both reconstitution and further dilution unless the drug was reconstituted with sterile water, in which case any compatible infusion solution should be used for further dilution.2832 (See Solution Compatibility.)
For adults and pediatric patients at least 2 years of age weighing more than 33 kg and requiring doses of 400 or 600 mg, the entire reconstituted contents of a 400- or 600-mg vial, respectively, must be diluted in 50 to 250 mL of a compatible infusion solution.2832 For adults requiring doses less than 400 mg (e.g., those with renal impairment requiring dosage adjustment), the appropriate volume of the reconstituted solution must be withdrawn from the vial and diluted in 50 to 250 mL of a compatible infusion solution.2832 For pediatric patients weighing 33 kg or less, the appropriate volume of the reconstituted solution must be withdrawn from the vial and diluted in a compatible infusion solution to yield an infusion solution with a ceftaroline fosamil concentration not exceeding 12 mg/mL.2832
The manufacturer recommends the following instructions specifically for the dilution of ceftaroline fosamil in 50-mL infusion bags: When ceftaroline fosamil is prepared for administration in a 50-mL infusion bag for adults, 20 mL of the diluent should be removed from the infusion bag prior to injecting the entire reconstituted contents of a 600-mg vial of the drug to yield an approximate concentration of 12 mg/mL.2832 When the drug is prepared for administration in a 50-mL infusion bag for adults or pediatric patients weighing more than 33 kg, 20 mL of the diluent should be removed from the infusion bag prior to injecting the entire reconstituted contents of a 400-mg vial of the drug to yield an approximate concentration of 8 mg/mL.2832 When the drug is prepared for administration in a 50-mL infusion bag for pediatric patients weighing 33 kg or less, the appropriate volume of the reconstituted solution should be withdrawn from the vial and transferred to an infusion bag to yield a concentration not exceeding 12 mg/mL.2832
pH
The reconstituted solution has a pH ranging from 4.8 to 6.5.2832
Trade Name(s)
Teflaro
Following dilution in a compatible infusion solution, ceftaroline fosamil is administered by intravenous infusion over 5 to 60 minutes in patients 2 months of age or older and over 30 to 60 minutes in patients less than 2 months of age.2832
Intact vials should be stored at controlled room temperature.2832 The powder is pale yellowish-white to light yellow in color.2832 After reconstitution, ceftaroline fosamil solution is clear and light to dark yellow in color.2832
For a list of references cited in the text of this monograph, search the monograph titled References.