Omeprazole for infusion is available as a powder in vials containing 40 mg of the drug as the sodium salt3408; 3409 or 40 mg of the drug as the base.3410 Each vial of the drug also contains disodium edetate and sodium hydroxide for pH adjustment.3408; 3409; 3410 Each 40-mg vial of omeprazole should be reconstituted with 5 mL of solution withdrawn from a 100-mL infusion bag or bottle of sodium chloride 0.9% or dextrose 5% and then mixed thoroughly until all of the powder has dissolved.3408; 3409; 3410 The reconstituted solution should then be transferred back into the same 100-mL infusion bag or bottle from which the solution used for reconstitution was withdrawn.3408; 3409; 3410
Omeprazole for injection is available as a powder in vials containing 40 mg of the drug as the sodium salt with an accompanying ampul containing 10 mL of solvent.3411 Each vial of the drug also contains sodium hydroxide.3411 The solvent contains citric acid monohydrate and polyethylene glycol 400 in water for injection.3411 Each 40-mg vial of omeprazole should be reconstituted only with 10 mL of the provided solvent; no other solvents should be used.3411
Equivalency
Omeprazole sodium 42.6 mg is equivalent to 40 mg of omeprazole.3408
pH
The pH of omeprazole (Azevedos) 0.4-mg/mL solution (reconstituted from omeprazole sodium) in dextrose 5% and sodium chloride 0.9% ranges from 8.9 to 9.5 and from 9.3 to 10.3, respectively.3408
The pH of omeprazole (Sandoz) 0.4-mg/mL solution (reconstituted from omeprazole sodium) in dextrose 5% or sodium chloride 0.9% ranges from 9 to 10.5.3409
The pH of a reconstituted solution of 40 mg of omeprazole (Sandoz) (reconstituted from omeprazole sodium) prepared with 10 mL of accompanying solvent is about 8.6.3411
Osmolality
The osmolality of omeprazole (Sandoz) 0.4-mg/mL solution (reconstituted from omeprazole sodium) in dextrose 5% or sodium chloride 0.9% is 297 or 282 mOsm/kg, respectively.3409
Omeprazole is administered by intravenous infusion3408; 3409; 3410 or by intravenous injection,3411 depending upon the product used.
After omeprazole for infusion is reconstituted and diluted to 100 mL with sodium chloride 0.9% or dextrose 5%, it should be administered as a 20- to 30-minute intravenous infusion.3408; 3409; 3410
After omeprazole for injection is reconstituted with the accompanying solvent, it should be administered as a slow intravenous injection over at least 2.5 minutes at a maximum rate of 4 mL/min.3411
Intact containers of omeprazole for infusion and omeprazole for injection (and accompanying solvent) generally should be stored at temperatures not exceeding 25°C in the outer carton to protect from light.3408; 3409; 3410; 3411
Stability of omeprazole solutions varies depending upon which product is used; specific product labeling should be consulted.3408; 3409; 3410; 3411
When stored at temperatures that do not exceed 25°C, omeprazole solutions for infusion are reportedly stable for 12 hours when prepared with sodium chloride 0.9%,3408; 3409 for 6 hours when prepared with dextrose 5%,3408; 3409 or for 6 hours in either solution;3410 when stored at 2 to 8°C, one product has been reported as stable for 24 hours in either solution.3409
Omeprazole for injection reconstituted with the accompanying solvent is stable for up to 4 hours when stored at temperatures below 25°C.3411
Light Effects
Intact containers of omeprazole, omeprazole sodium, and solvent, when provided, should be stored in their outer carton to protect from light.3408; 3409; 3410; 3411 At least one manufacturer states that vials may be exposed to normal indoor light outside of the box for up to 24 hours.3408
Reconstituted omeprazole (AstraZeneca) has been reported to develop an unacceptable discoloration indicating decomposition within 6 hours at room temperature when exposed to light.2507
For a list of references cited in the text of this monograph, search the monograph titled References.