Esomeprazole sodium is available as a lyophilized powder or cake in single-dose vials containing the equivalent of esomeprazole 20 or 40 mg as the sodium salt with edetate disodium 1.5 mg and sodium hydroxide to adjust pH.3988; 3989 For direct intravenous injection, reconstitute either size vial with 5 mL of sodium chloride 0.9%.3988; 3989
For intravenous infusion, reconstitute the 20- or 40-mg vial with 5 mL of sodium chloride 0.9%; Ringers injection, lactated; or dextrose 5%, and then dilute the reconstituted solution to 50 mL with additional infusion solution to yield a solution containing esomeprazole 0.4 or 0.8 mg/mL, respectively.2053; 3988; 3989
To prepare an 80-mg dose for intravenous infusion as a loading dose or continuous infusion for certain indications, reconstitute two 40-mg vials each with 5 mL of sodium chloride 0.9% and then dilute the contents of both vials in 100 mL of sodium chloride 0.9%.3988
Equivalency
Esomeprazole sodium 21.3 or 42.5 mg is equivalent to 20 or 40 mg of esomeprazole.3988; 3989
pH
Reconstituted solutions have a pH ranging from 9 to 11.3988; 3989
Trade Name(s)
NexIUM I.V.
Esomeprazole sodium may be administered by direct intravenous injection over at least 3 minutes, by intravenous infusion over 10 to 30 minutes, or by continuous intravenous infusion.3988 The line should be flushed with sodium chloride 0.9%; Ringers injection, lactated; or dextrose 5% both before and after intravenous administration.3988 The manufacturers state that esomeprazole sodium should not be administered concomitantly with any other drugs through the same intravenous site and/or tubing.3988; 3989
Esomeprazole sodium is a white to off-white powder.3988 Intact vials should be stored at controlled room temperature in the original carton and protected from light.3988
Solutions diluted in sodium chloride 0.9% or Ringer's injection, lactated should be stored at room temperature and administered within 12 hours of preparation.3988 Solutions diluted in dextrose 5% should be stored at room temperature and administered within 6 hours of preparation.3988 Any unused portions should be discarded.3988
pH Effects
The stability of esomeprazole sodium in solution is strongly dependent on pH.3988 The stability of the drug decreases with decreasing pH.3988
For a list of references cited in the text of this monograph, search the monograph titled References.