8:12.07.08 Carbapenems
Generic Name
Generic Name
Generic Name
The fixed combination of imipenem-cilastatin sodium-relebactam is available as a powder for injection in single-dose vials containing 1.25 g (imipenem 500 mg [as the monohydrate], cilastatin 500 mg [as the sodium salt], relebactam 250 mg [as the monohydrate]) along with sodium bicarbonate 20 mg to adjust the pH.3505
To prepare the fixed combination for administration, infusion bags containing 100 mL of a compatible diluent should be used; if an infusion bag containing 100 mL of a compatible diluent is not available, 100 mL of a compatible diluent may be transferred into an empty infusion bag.3505 Twenty mL (as two 10-mL aliquots) of the compatible diluent should be removed from the infusion bag.3505 The contents of one 1.25-g vial should be reconstituted initially with one 10-mL aliquot of the compatible diluent (withdrawn from the infusion bag) and the vial should be shaken well.3505 The resulting suspension should then be transferred into the infusion bag containing the remaining 80 mL of diluent.3505 The second 10-mL aliquot of the compatible diluent should then be added to the vial and shaken well to ensure complete transfer of any remaining vial contents; the resulting suspension should be transferred to the infusion bag to total 100 mL and the infusion bag should be agitated until the infusion solution is clear.3505
The manufacturer’s instructions for preparing various doses of imipenem-cilastatin-relebactam from the infusion solution are as follows:3505
For 1.25 g (imipenem 500 mg, cilastatin 500 mg, relebactam 250 mg), do not remove any volume from the prepared infusion bag; the solution delivers a 1.25-g dose in 100 mL.
For 1 g (imipenem 400, cilastatin 400 mg, relebactam 200 mg), remove and discard 20 mL from the prepared infusion bag; the remaining solution (i.e., 80 mL) delivers a 1-g dose.
For 0.75 g (imipenem 300 mg, cilastatin 300 mg, relebactam 150 mg), remove and discard 40 mL from the prepared infusion bag; the remaining solution (i.e., 60 mL) delivers a 0.75-g dose.
For 0.5 g (imipenem 200 mg, cilastatin 200 mg, relebactam 100 mg), remove and discard 60 mL from the prepared infusion bag; the remaining solution (i.e., 40 mL) delivers a 0.5-g dose.
Equivalency
In imipenem-cilastatin sodium-relebactam, cilastatin sodium 531 mg is equivalent to 500 mg of cilastatin.3505
pH
Diluted solutions of imipenem-cilastatin-relebactam for infusion have a pH ranging from 6.5 to 7.6.3505
Sodium Content
Each 1.25-g vial of this fixed combination contains 37.5 mg (1.6 mEq) of sodium.3505
Trade Name(s)
Recarbrio
Imipenem-cilastatin sodium-relebactam is administered by intravenous infusion over 30 minutes after reconstitution and dilution.3505
Imipenem-cilastatin sodium-relebactam is a white to light yellow lyophilized powder that forms a clear, colorless to yellow solution upon reconstitution and dilution; variations in color within this range do not affect the potency of the product.3505 Intact vials of imipenem-cilastatin sodium-relebactam should be stored at controlled room temperature.3505
Diluted solutions of imipenem-cilastatin-relebactam for infusion should be visually inspected for particulate matter and discoloration prior to administration.3505 Solutions that are discolored and those in which visible particles are observed should be discarded.3505
The diluted solution for infusion is stable for 2 hours at room temperature up to 30°C or for 24 hours at 2 to 8°C.3505
Freezing Solutions
The manufacturer states that solution of imipenem-cilastatin sodium-relebactam should not be frozen.3505
For a list of references cited in the text of this monograph, search the monograph titled References.