AHFS Class:

56:28.36 Proton-pump Inhibitors

Pantoprazole sodium is available as a lyophilized powder in single-dose vials containing pantoprazole 40 mg as the sodium salt with edetate disodium 1 mg and sodium hydroxide to adjust pH during manufacturing.²⁸⁵⁰; ³³⁵⁸

Pantoprazole sodium also is available as a lyophilized powder in single-dose vials containing pantoprazole 40 mg as the sodium salt with sodium hydroxide to adjust pH during manufacturing.³³⁵⁷

Reconstitute a 40-mg vial with 10 mL of sodium chloride 0.9% to a pantoprazole concentration of 4 mg/mL.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸ For intravenous infusion, 1 vial (40 mg) of the reconstituted drug solution may be diluted with 100 mL or 2 vials (80 mg) may be diluted with 80 mL of sodium chloride 0.9%, dextrose 5%, or Ringer’s injection, lactated to yield concentrations of about 0.4 or 0.8 mg/mL, respectively.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸

pH

The pH of the reconstituted solution ranges from 9 to 10.5²⁸⁵⁰; ³³⁵⁸ or from 9.5 to 11.5.³³⁵⁷

Equivalency

Pantoprazole sodium 45.1 mg provides 40 mg of pantoprazole.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸

Trade Name(s)

Protonix I.V.

Pantoprazole sodium injection reconstituted as directed to a pantoprazole concentration of 4 mg/mL may be administered by intravenous infusion over a period of at least 2 minutes.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸ The reconstituted solution also may be diluted in a compatible infusion solution to a pantoprazole concentration of about 0.4 or 0.8 mg/mL and administered by intravenous infusion over about 15 minutes.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸ Manufacturers state that pantoprazole sodium injection is only for intravenous infusion and that other parenteral routes of administration are not recommended.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸

The drug also has been administered as an intravenous bolus, followed by continuous intravenous infusion administered at a rate of 8 mg/hr.³³⁵⁹; ³³⁶⁰

Pantoprazole sodium injection should be administered intravenously through a dedicated intravenous line or Y-site.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸ The intravenous line used to administer the drug should be flushed with dextrose 5%, sodium chloride 0.9%, or Ringer’s injection, lactated prior to and following pantoprazole sodium administration.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸

Administration of pantoprazole sodium formulations containing edetate disodium has been associated with thrombophlebitis.²⁸⁵⁰; ³³⁵⁸

Caution should be used when formulations of pantoprazole sodium injection containing edetate disodium are co-administered intravenously with other drugs containing EDTA.²⁸⁵⁰; ³³⁵⁸ (See Stability.)

Intact vials of pantoprazole sodium should be stored at controlled room temperature and should be protected from light during storage.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸

After reconstitution as directed, pantoprazole sodium injection may be stored for up to 6 hours at room temperature before dilution or 24 hours at room temperature if administered without dilution.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸ Manufacturers note that the reconstituted²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸ and diluted solutions³³⁵⁷ should not be frozen.

After dilution in a compatible infusion solution, the drug must be used within 24 hours from the time of initial reconstitution when stored at room temperature.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸

Reconstituted and diluted solutions of pantoprazole sodium should be visually inspected for particulate matter and discoloration prior to and during administration.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸ Protection from light exposure is not required for reconstituted or diluted solutions.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸

Some formulations of pantoprazole sodium injection contain edetate disodium, the salt form of EDTA.²⁸⁵⁰; ³³⁵⁸ Edetate disodium may chelate metal ions (e.g., zinc), and therefore some formulations of pantoprazole sodium injection may not be compatible with products containing zinc.²⁸⁵⁰; ³³⁵⁸ Caution should be used when formulations of the drug containing edetate disodium are co-administered intravenously with other drugs containing EDTA.²⁸⁵⁰; ³³⁵⁸

Pantoprazole sodium admixtures prepared for infusion did not undergo discoloration over 24 hours at room temperature when exposed to light;²⁵⁰⁷ however, solutions have been noted to develop a slight yellow shade that is more apparent in more highly concentrated solutions over periods of up to 28 days.²⁸⁵¹ This color change did not appear to be associated with decomposition of the drug.²⁸⁵¹

pH Effects

The stability of pantoprazole in solution is pH dependent; the rate of degradation of the drug increases with decreasing pH.²⁸⁵⁰; ³³⁵⁷; ³³⁵⁸

Syringes

Pantoprazole sodium (Wyeth) reconstituted with sodium chloride 0.9% to a pantoprazole concentration of 4 mg/mL and stored in polypropylene syringes (Terumo) has been found to be physically and chemically stable for at least 96 hours at room temperature of 24°C when exposed to light and when refrigerated at 4°C.²⁶⁵⁶

Standardize 4 Safety

One or more standardized concentrations for this drug have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. (See Standardize 4 Safety in Users Guide.) Recommendations developed to date through this initiative are available at www.ashp.org/pharmacy-practice/standardize-4-safety-initiative.

Table 1: Standardize 4 Safety Continuous IV Infusion Standard Concentrations for Pantoprazole³⁶³⁵

Solution Compatibility

Drugs in Syringe Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

Additional Compatibility Information

In a simulated Y-site administration study, turbidity increased within 1 hour and pH decreased when pantoprazole sodium (Premier; presence or absence of edetate disodium not specified) at a pantoprazole concentration of 0.4 mg/mL in dextrose 5% was mixed with Normosol R at 21°C protected from light.³⁷¹⁹

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions September 12, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.