8:12.28.92 Other Miscellaneous Antibacterials
Generic Name
Generic Name
Sulbactam sodium and durlobactam sodium is a copackaged product containing sulbactam sodium and durlobactam sodium in separate vials.3936 The components are packaged in a kit containing 1 clear single-dose vial containing the equivalent of sulbactam 1 g as a powder and 2 amber single-dose vials each containing the equivalent of durlobactam 0.5 g as a powder.3936 Vials also contain sodium hydroxide and hydrochloric acid for pH adjustment.3936
Each vial containing sulbactam sodium or durlobactam sodium must be reconstituted and further diluted together in a single infusion bag for intravenous infusion.3936 To prepare a dose of sulbactam sodium and durlobactam sodium for intravenous infusion, reconstitute each durlobactam 0.5 g vial with 2.5 mL of sterile water for injection and gently shake or invert 3 to 5 times to dissolve.3936 Each reconstituted vial contains durlobactam 0.5 g in 2.5 mL.3936 Next, reconstitute the vial containing sulbactam 1 g with 5 mL of sterile water for injection and gently shake or invert 3 to 5 times to dissolve.3936 The reconstituted vial contains sulbactam 1 g in 5 mL.3936 The reconstituted solutions must be further diluted within 1 hour of reconstitution.3936
To prepare the final diluted solution for intravenous infusion, use a syringe to transfer 2.5 mL from each vial of reconstituted durlobactam solution to a 100-mL infusion bag containing sodium chloride 0.9%, then transfer 5 mL of reconstituted sulbactam solution to the same infusion bag.3936 After adding the solutions to the infusion bag, the bag should be gently inverted to mix the solution.3936
Equivalency
Sulbactam sodium 1.1 g is equivalent to 1 g of sulbactam.3936
Durlobactam sodium 0.54 g is equivalent to 0.5 g of durlobactam.3936
Trade Name(s)
Xacduro
Sulbactam sodium and durlobactam sodium is administered by intravenous infusion over 3 hours.3936 Refrigerated solutions should be allowed to come to room temperature (15 to 30 minutes) prior to administration.3936
Intact vials of sulbactam sodium and durlobactam sodium should be stored at controlled cold temperature (2 to 8°C; brief exposure to 8 to 15°C permitted).3936 Reconstituted sulbactam sodium is a clear, colorless to slightly yellow solution.3936 Reconstituted durlobactam sodium is a clear, light yellow to orange solution.3936 Reconstituted solutions must be further diluted within 1 hour of reconstitution.3936
The manufacturer states final diluted solutions may be stored at 2 to 8°C for not more than 24 hours of reconstitution, including administration time.3936 The 3-hour infusion should be completed within 24 hours of reconstitution of the drugs.3936 Allow refrigerated solutions to come to room temperature (15 to 30 minutes) prior to administration.3936 Do not freeze.3936 Unused portions of solutions in vials or infusion bags should be discarded.3936
For a list of references cited in the text of this monograph, search the monograph titled References.