Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Pantoprazole sodium in 0.9% sodium chloride injection is supplied as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic single-dose solution packaged in GALAXY container. The single-dose GALAXY plastic containers are available as follows: Code NDC Container Size Number of Containers/Carton 2G3571 NDC 0338-9644-12 GALAXY single-dose 100 mL 12 count of 40 mg/100 mL (0.4 mg/mL) GALAXY containers 2G3569 NDC 0338-9646-24 GALAXY single-dose 50 mL 24 count of 40 mg/50 mL (0.8 mg/mL) GALAXY containers 2G3581 NDC 0338-9648-12 GALAXY single-dose 100 mL 12 count of 80 mg/100 mL (0.8 mg/mL) GALAXY containers Storage and Handling Store frozen at or below -20°C /-4°F. Protect from light when stored frozen. Handle frozen product containers with care. Product containers may be fragile in the frozen state. Storage conditions for the thawed solution are described in another section of the prescribing information. [ see Dosage and Administration (2.3) ] .; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label NDC 0338-9644-12 40 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 40 mg/100 mL (0.4 mg/mL)* For Intravenous Infusion Only 100 mL Single-Dose GALAXY Container Discard Unused Portion Rx only Sterile *Each 100 mL contains: 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw. Do not refreeze the thawed solution. Thawed solution is expected to range from colorless to yellow over time. Do not add supplemental medication or additives. Baxter Logo Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation, Deerfield, IL 60015 USA Code 2G3571 PL 2040 Plastic Product of USA 07-34-00-1222 BAR CODE POSITION ONLY UPC-A XXXXXXXXXXXX Carton Label Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw. Do not refreeze the thawed solution. Handle frozen product containers with care. Product containers may be fragile in the frozen state. 40 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 40 mg/100 mL (0.4 mg/mL)* Contains 6 units of Single-Dose bags. Each bag contains 100 mL. Store frozen at or below -20°C /-4°F. Baxter Logo Rx only *FOR BAR CODE POSITION ONLY (01) 0000000000000 (10)XX000000 (21) 000000000000 (17)000000 NDC 0338-9644-12 Code 2G3571 *FOR BAR CODE POSITION ONLY (01) XXXXXXXXXXXXXX *Each 100 mL contains: 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Baxter Healthcare Corporation, Deerfield, IL 60015 USA PL 2040 Plastic 07-04-00-0582 Container Label NDC 0338-9646-24 40 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 40 mg/50 mL (0.8 mg/mL)* For Intravenous Infusion Only 50 mL Single-Dose GALAXY Container Discard Unused Portion Rx only Sterile *Each 50 mL contains: 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 77.5 mg histidine, USP; 450 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw. Do not refreeze the thawed solution. Thawed solution is expected to range from colorless to yellow over time. Do not add supplemental medication or additives. Baxter Logo Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation, Deerfield, IL 60015 USA Code 2G3569 PL 2040 Plastic Product of USA 07-34-00-1221 *BAR CODE FOR POSITION ONLY (1) XXXXXXXXXXXXXX Carton Label Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw. Do not refreeze the thawed solution. Handle frozen product containers with care. Product containers may be fragile in the frozen state. 40 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 40 mg/50 mL (0.8 mg/mL)* Contains 12 units of Single-Dose bags. Each bag contains 50 mL. Store frozen at or below -20°C /-4°F. Baxter Logo Rx only *FOR BAR CODE POSITION ONLY (01) 0000000000000 (10)XX000000 (21) 000000000000 (17)000000 NDC 0338-9646-24 Code 2G3571 *FOR BAR CODE POSITION ONLY (01) XXXXXXXXXXXXXX *Each 50 mL contains: 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 77.5 mg histidine, USP; 450 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Baxter Healthcare Corporation, Deerfield, IL 60015 USA PL 2040 Plastic 07-04-00-0581 Container Label NDC 0338-9648-12 80 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 80 mg/100 mL (0.8 mg/mL)* For Intravenous Infusion Only 100 mL Single-Dose GALAXY Container Discard Unused Portion Rx only Sterile *Each 100 mL contains: 80 mg of pantoprazole (equivalent to 90.2 mg of pantoprazole sodium USP); 2 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw. Do not refreeze the thawed solution. Thawed solution is expected to range from colorless to yellow over time. Do not add supplemental medication or additives. Baxter Logo Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation, Deerfield, IL 60015 USA Code 2G3581 PL 2040 Plastic Product of USA 07-34-00-1223 BAR CODE POSITION ONLY UPC-A XXXXXXXXXXXX Carton Label Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw. Do not refreeze the thawed solution. Handle frozen product containers with care. Product containers may be fragile in the frozen state. 80 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 80 mg/100 mL (0.8 mg/mL)* Contains 6 units of Single-Dose bags. Each bag contains 100 mL. Store frozen at or below -20°C /-4°F. Baxter Logo Rx only *FOR BAR CODE POSITION ONLY (01) 0000000000000 (10)XX000000 (21) 000000000000 (17)000000 NDC 0338-9648-12 Code 2G3581 *FOR BAR CODE POSITION ONLY (01) XXXXXXXXXXXXXX *Each 100 mL contains: 80 mg of pantoprazole (equivalent to 90.2 mg of pantoprazole sodium USP); 2 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Baxter Healthcare Corporation, Deerfield, IL 60015 USA PL 2040 Plastic 07-04-00-0583 Pantoprazole Representative Container Label 1 of 2 0338-9644-12 Pantoprazole Representative Container Label 2 of 2 0338-9644-12 Pantoprazole Representative Carton Label 1 of 2 0338-9644-12 Pantoprazole Representative Carton Label 2 of 2 0338-9644-12 Pantoprazole Representative Container Label 1 of 2 0338-9646-24 Pantoprazole Representative Container Label 2 of 2 0338-9646-24 Pantoprazole Representative Carton Label 1 of 2 0338-9646-24 Pantoprazole Representative Carton Label 2 of 2 0338-9646-24 Pantoprazole Representative Container Label 1 of 2 0338-9648-12 Pantoprazole Representative Container Label 2 of 2 0338-9648-12 Pantoprazole Representative Carton Label 1 of 2 0338-9648-12 Pantoprazole Representative Carton Label 2 of 2 0338-9648-12
- 16 HOW SUPPLIED/STORAGE AND HANDLING Pantoprazole sodium in 0.9% sodium chloride injection is supplied as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic single-dose solution packaged in GALAXY container. The single-dose GALAXY plastic containers are available as follows: Code NDC Container Size Number of Containers/Carton 2G3571 NDC 0338-9644-12 GALAXY single-dose 100 mL 12 count of 40 mg/100 mL (0.4 mg/mL) GALAXY containers 2G3569 NDC 0338-9646-24 GALAXY single-dose 50 mL 24 count of 40 mg/50 mL (0.8 mg/mL) GALAXY containers 2G3581 NDC 0338-9648-12 GALAXY single-dose 100 mL 12 count of 80 mg/100 mL (0.8 mg/mL) GALAXY containers Storage and Handling Store frozen at or below -20°C /-4°F. Protect from light when stored frozen. Handle frozen product containers with care. Product containers may be fragile in the frozen state. Storage conditions for the thawed solution are described in another section of the prescribing information. [ see Dosage and Administration (2.3) ] .
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label NDC 0338-9644-12 40 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 40 mg/100 mL (0.4 mg/mL)* For Intravenous Infusion Only 100 mL Single-Dose GALAXY Container Discard Unused Portion Rx only Sterile *Each 100 mL contains: 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw. Do not refreeze the thawed solution. Thawed solution is expected to range from colorless to yellow over time. Do not add supplemental medication or additives. Baxter Logo Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation, Deerfield, IL 60015 USA Code 2G3571 PL 2040 Plastic Product of USA 07-34-00-1222 BAR CODE POSITION ONLY UPC-A XXXXXXXXXXXX Carton Label Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw. Do not refreeze the thawed solution. Handle frozen product containers with care. Product containers may be fragile in the frozen state. 40 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 40 mg/100 mL (0.4 mg/mL)* Contains 6 units of Single-Dose bags. Each bag contains 100 mL. Store frozen at or below -20°C /-4°F. Baxter Logo Rx only *FOR BAR CODE POSITION ONLY (01) 0000000000000 (10)XX000000 (21) 000000000000 (17)000000 NDC 0338-9644-12 Code 2G3571 *FOR BAR CODE POSITION ONLY (01) XXXXXXXXXXXXXX *Each 100 mL contains: 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Baxter Healthcare Corporation, Deerfield, IL 60015 USA PL 2040 Plastic 07-04-00-0582 Container Label NDC 0338-9646-24 40 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 40 mg/50 mL (0.8 mg/mL)* For Intravenous Infusion Only 50 mL Single-Dose GALAXY Container Discard Unused Portion Rx only Sterile *Each 50 mL contains: 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 77.5 mg histidine, USP; 450 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw. Do not refreeze the thawed solution. Thawed solution is expected to range from colorless to yellow over time. Do not add supplemental medication or additives. Baxter Logo Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation, Deerfield, IL 60015 USA Code 2G3569 PL 2040 Plastic Product of USA 07-34-00-1221 *BAR CODE FOR POSITION ONLY (1) XXXXXXXXXXXXXX Carton Label Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw. Do not refreeze the thawed solution. Handle frozen product containers with care. Product containers may be fragile in the frozen state. 40 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 40 mg/50 mL (0.8 mg/mL)* Contains 12 units of Single-Dose bags. Each bag contains 50 mL. Store frozen at or below -20°C /-4°F. Baxter Logo Rx only *FOR BAR CODE POSITION ONLY (01) 0000000000000 (10)XX000000 (21) 000000000000 (17)000000 NDC 0338-9646-24 Code 2G3571 *FOR BAR CODE POSITION ONLY (01) XXXXXXXXXXXXXX *Each 50 mL contains: 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 77.5 mg histidine, USP; 450 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Baxter Healthcare Corporation, Deerfield, IL 60015 USA PL 2040 Plastic 07-04-00-0581 Container Label NDC 0338-9648-12 80 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 80 mg/100 mL (0.8 mg/mL)* For Intravenous Infusion Only 100 mL Single-Dose GALAXY Container Discard Unused Portion Rx only Sterile *Each 100 mL contains: 80 mg of pantoprazole (equivalent to 90.2 mg of pantoprazole sodium USP); 2 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw. Do not refreeze the thawed solution. Thawed solution is expected to range from colorless to yellow over time. Do not add supplemental medication or additives. Baxter Logo Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation, Deerfield, IL 60015 USA Code 2G3581 PL 2040 Plastic Product of USA 07-34-00-1223 BAR CODE POSITION ONLY UPC-A XXXXXXXXXXXX Carton Label Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw. Do not refreeze the thawed solution. Handle frozen product containers with care. Product containers may be fragile in the frozen state. 80 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 80 mg/100 mL (0.8 mg/mL)* Contains 6 units of Single-Dose bags. Each bag contains 100 mL. Store frozen at or below -20°C /-4°F. Baxter Logo Rx only *FOR BAR CODE POSITION ONLY (01) 0000000000000 (10)XX000000 (21) 000000000000 (17)000000 NDC 0338-9648-12 Code 2G3581 *FOR BAR CODE POSITION ONLY (01) XXXXXXXXXXXXXX *Each 100 mL contains: 80 mg of pantoprazole (equivalent to 90.2 mg of pantoprazole sodium USP); 2 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Baxter Healthcare Corporation, Deerfield, IL 60015 USA PL 2040 Plastic 07-04-00-0583 Pantoprazole Representative Container Label 1 of 2 0338-9644-12 Pantoprazole Representative Container Label 2 of 2 0338-9644-12 Pantoprazole Representative Carton Label 1 of 2 0338-9644-12 Pantoprazole Representative Carton Label 2 of 2 0338-9644-12 Pantoprazole Representative Container Label 1 of 2 0338-9646-24 Pantoprazole Representative Container Label 2 of 2 0338-9646-24 Pantoprazole Representative Carton Label 1 of 2 0338-9646-24 Pantoprazole Representative Carton Label 2 of 2 0338-9646-24 Pantoprazole Representative Container Label 1 of 2 0338-9648-12 Pantoprazole Representative Container Label 2 of 2 0338-9648-12 Pantoprazole Representative Carton Label 1 of 2 0338-9648-12 Pantoprazole Representative Carton Label 2 of 2 0338-9648-12
Overview
The active ingredient in pantoprazole sodium in 0.9% sodium chloride injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1 H -benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is: Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The thawed solution of pantoprazole sodium in 0.9% sodium chloride injection is in the pH range 9.0 to 10.5. Pantoprazole sodium in 0.9% sodium chloride injection is supplied for intravenous administration as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic 50 mL or 100 mL single-dose GALAXY container in following presentations: 40 mg/100 mL (0.4 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; 40 mg/50 mL (0.8 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 77.5 mg histidine, USP; 450 mg sodium chloride, USP; 80 mg/100 mL (0.8 mg/mL): containing 80 mg of pantoprazole (equivalent to 90.2 mg of pantoprazole sodium USP); 2 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; Sodium hydroxide and/or hydrochloric acid may be used to adjust pH. The solution is intended for intravenous use after thawing to room temperature. Thawed solution is expected to range from colorless to yellow over time. Pantoprazole Structural Formula
Indications & Usage
Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: • Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). ( 1.1 ) • Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. ( 1.2 ) 1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis Pantoprazole sodium in 0.9% sodium chloride injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE). Safety and efficacy of pantoprazole sodium in 0.9% sodium chloride injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated. 1.2 Pathological Hypersecretion Including Zollinger-Ellison Syndrome Pantoprazole sodium in 0.9% sodium chloride injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
Dosage & Administration
GERD Associated with EE ( 2.1 ) • The recommended adult dosage is 40 mg given once daily by intravenous infusion for 7 to 10 days. ( 2.1 ) Pathological Hypersecretion Conditions, Including ZE Syndrome ( 2.2 ): • The recommended adult dosage is 80 mg administered every 12 hours by intravenous infusion. For information on how to adjust dosing for individual patient needs, see the full prescribing information. Administration ( 2.3 ): • Only for intravenous infusion. • The intravenous infusion should be administered over 15 minutes. 2.1 Dosage for Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis The recommended adult dosage of pantoprazole sodium in 0.9% sodium chloride injection is 40 mg given once daily by intravenous infusion for 7 to 10 days. Discontinue treatment with pantoprazole sodium in 0.9% sodium chloride injection as soon as the patient is able to receive treatment with pantoprazole delayed-release tablets or oral suspension. Data on the safe and effective dosing for conditions other than those described [see Indications and Usage (1) ] such as life-threatening upper gastrointestinal bleeds, are not available. Pantoprazole sodium in 0.9% sodium chloride injection 40 mg once daily does not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions. 2.2 Dosage for Pathological Hypersecretion Including Zollinger-Ellison Syndrome The recommended adult dosage of pantoprazole sodium in 0.9% sodium chloride injection is 80 mg intravenously every 12 hours. The frequency of dosing can be adjusted to individual patient needs based on acid output measurements. In those patients who need a higher dosage, 80 mg intravenously every 8 hours is expected to maintain acid output below 10 mEq/h. Daily doses higher than 240 mg or administered for more than 6 days have not been studied [see Clinical Studies (14) ] . Transition from oral to intravenous and from intravenous to oral formulations of gastric acid inhibitors should be performed in such a manner to ensure continuity of effect of suppression of acid secretion. Patients with ZE Syndrome may be vulnerable to serious clinical complications of increased acid production even after a short period of loss of effective inhibition. 2.3 Preparation and Administration Instructions Only for intravenous infusion over 15 minutes; other parenteral routes of administration and infusion rates are not recommended. Fifteen Minute Infusion 1. Thaw frozen container at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. 2. No further dilution is necessary. 3. Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired. 4. Do not add supplementary medication. 5. Inspect thawed pantoprazole sodium in 0.9% sodium chloride solution visually for particulate matter prior to and during administration. Thawed solution is expected to range from colorless to yellow over time.. 6. Administer intravenously over a period of approximately 15 minutes. Storage Thawed solution is stable for 21 days under refrigeration 2-8°C (36 - 46°F) or 48 hours at room temperature 20-25°C (68 - 77°F). Protect from light when stored under refrigeration. Do not refreeze the thawed solution. 2.4 Compatibility Information • Administer pantoprazole sodium in 0.9% sodium chloride injection intravenously through a dedicated line or through a Y-site. • Flush the intravenous line before and after administration of pantoprazole sodium in 0.9% sodium chloride injection with either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer’s Injection, USP. • When administered through a Y-site, pantoprazole sodium in 0.9% sodium chloride injection is compatible with the following solutions: 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer’s Injection, USP. • Midazolam HCl has been shown to be incompatible with Y-site administration of pantoprazole sodium injection • Pantoprazole sodium injection may not be compatible with products containing zinc [see Warnings and Precautions (5.3) ]. • When pantoprazole sodium in 0.9% sodium chloride injection is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.
Warnings & Precautions
• Gastric Malignancy : In adults, symptomatic response to therapy with pantoprazole sodium in 0.9% sodium chloride injection does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) • Injection Site Reactions : Thrombophlebitis is associated with the administration of intravenous pantoprazole. ( 5.2 ) • Potential Exacerbation of Zinc Deficiency : Consider zinc supplementation in patients who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously. ( 5.3 ) • Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. ( 5.4 ) • Clostridium difficile- Associated Diarrhea : PPI therapy may be associated with increased risk. ( 5.5 ) • Bone Fracture : Long term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. ( 5.6 ) • Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.7 ) • Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue pantoprazole sodium in 0.9% sodium chloride injection and refer to specialist for evaluation. ( 5.8 ) • Hepatic Effects : Elevations of transaminases observed. ( 5.9 ) • Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged treatment with PPIs. ( 5.10 ) • Fundic Gland Polyps : Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. ( 5.11 ) 5.1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with pantoprazole sodium in 0.9% sodium chloride injection does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy. 5.2 Injection Site Reactions Thrombophlebitis was associated with the administration of pantoprazole sodium injection. 5.3 Potential for Exacerbation of Zinc Deficiency Pantoprazole sodium in 0.9% sodium chloride injection contains edetate disodium (the salt form of EDTA), a chelator of metal ions including zinc. Therefore, zinc supplementation should be considered in patients treated with pantoprazole sodium in 0.9% sodium chloride injection who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously [see Dosage and Administration (2.4) ] . 5.4 Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). Discontinue pantoprazole sodium in 0.9% sodium chloride injection and evaluate patients with suspected acute TIN [see Contraindications (4) ] . 5.5 Clostridium difficile- Associated Diarrhea Published observational studies suggest that PPI therapy like pantoprazole sodium in 0.9% sodium chloride injection may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2) ]. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. 5.6 Bone Fracture Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2.1 , 2.2) , Adverse Reactions (6) ] . 5.7 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions, including erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs [see Adverse Reactions (6.2) ]. Discontinue pantoprazole sodium in 0.9% sodium chloride injection at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 5.8 Cutaneous and Systemic Lupus Erythematosus Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including pantoprazole sodium. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematous cases were CLE. The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement. Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported. Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving pantoprazole sodium in 0.9% sodium chloride injection, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations. 5.9 Hepatic Effects Mild, transient transaminase elevations have been observed in clinical studies. The clinical significance of this finding in a large population of subjects administered pantoprazole sodium injection is unknown [see Adverse Reactions (6) ]. 5.10 Hypomagnesemia and Mineral Metabolism Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, and in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see Adverse Reactions (6.2) ] . Consider monitoring magnesium and calcium levels prior to initiation of pantoprazole sodium in 0.9% sodium chloride injection and periodically while on treatment in patients with a preexisting risk of hypocalcemia (e.g., hypoparathyroidism). Supplement with magnesium and/or calcium as necessary. If hypocalcemia is refractory to treatment, consider discontinuing the PPI. 5.11 Fundic Gland Polyps PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated. 5.12 Interference with Investigations for Neuroendocrine Tumors Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Healthcare providers should temporarily stop pantoprazole sodium injection treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary [see Clinical Pharmacology (12.2) ] . 5.13 Interference with Urine Screen for THC Pantoprazole sodium may produce false-positive urine screen for THC (tetrahydrocannabinol) [see Drug Interactions (7) ]. 5.14 Concomitant Use of Pantoprazole in 0.9% Sodium Injection with Methotrexate Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients [see Drug Interactions (7) ].
Contraindications
• Pantoprazole sodium in 0.9% sodium chloride injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2 , 5.4 ), Adverse Reactions (6) ] . • Proton pump inhibitors (PPIs), including pantoprazole sodium in 0.9% sodium chloride injection, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7) ] . • Patients with a known hypersensitivity to any component of the formulation or to substituted benzimidazoles. (4) • Patients receiving rilpivirine-containing products. ( 4 , 7 )
Adverse Reactions
The following serious adverse reactions are described below and elsewhere in labeling: • Injection Site Reactions [see Warnings and Precautions (5.2) ] • Potential for Exacerbation of Zinc Deficiency [see Warnings and Precautions (5.3) ] • Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.4) ] • Clostridium difficile- Associated Diarrhea [see Warnings and Precautions (5.5) ] • Bone Fracture [see Warnings and Precautions (5.6) ] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.7) ] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.8) ] • Hepatic Effects [see Warnings and Precautions (5.9) ] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.10) ] • Fundic Gland Polyps [see Warnings and Precautions (5.11) ] Most common adverse reactions (>2%) are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Worldwide, approximately 80,500 patients have been treated with pantoprazole in clinical trials involving various dosages and duration of treatment. Gastroesophageal Reflux Disease (GERD) Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral pantoprazole sodium (20 mg or 40 mg), 299 patients on an H2-receptor antagonist, 46 patients on another PPI, and 82 patients on placebo. The most frequently occurring adverse reactions are listed in Table 1 . The number of patients treated in comparative studies with pantoprazole sodium injection is limited; however, the adverse reactions seen were similar to those seen in the oral studies. Thrombophlebitis was the only new adverse reaction identified with pantoprazole sodium injection. Table 1. Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of > 2% Oral Pantoprazole Sodium (n=1473) % Comparators (n=345) % Placebo (n=82) % Headache 12.2 12.8 8.5 Diarrhea 8.8 9.6 4.9 Nausea 7.0 5.2 9.8 Abdominal pain 6.2 4.1 6.1 Vomiting 4.3 3.5 2.4 Flatulence 3.9 2.9 3.7 Dizziness 3.0 2.9 1.2 Arthralgia 2.8 1.4 1.2 Additional adverse reactions that were reported for oral pantoprazole sodium in US clinical trials with a frequency of ≤2% are listed below by body system: Body as a Whole: allergic reaction, fever, photosensitivity reaction, facial edema, thrombophlebitis (I.V. only) Gastrointestinal: constipation, dry mouth, hepatitis Hematologic: leukopenia (reported in ex-US clinical trials only), thrombocytopenia Metabolic/Nutritional: elevated CPK (creatine phosphokinase), generalized edema, elevated triglycerides, liver function tests abnormal Musculoskeletal: myalgia Nervous: depression, vertigo Skin and Appendages: urticaria, rash, pruritus Special Senses: blurred vision Zollinger-Ellison (ZE) Syndrome In clinical studies of ZE Syndrome, adverse reactions reported in 35 patients administered pantoprazole sodium injection doses of 80 mg to 240 mg per day for up to 2 years were similar to those reported in adult patients with GERD. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of oral pantoprazole sodium and pantoprazole sodium injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are listed below by body system: General Disorders and Administration Conditions : asthenia, fatigue, malaise Immune System Disorders : anaphylaxis (including anaphylactic shock), systemic lupus erythematosus Investigations : weight changes Skin and Subcutaneous Tissue Disorders : severe dermatologic reactions (some fatal), including erythema multiforme, SJS/TEN, DRESS, AGEP, angioedema (Quincke’s edema) and cutaneous lupus erythematosus Musculoskeletal Disorders : rhabdomyolysis, bone fracture Renal and Genitourinary Disorders : acute tubulointerstitial nephritis, erectile dysfunction Hepatobiliary Disorders : hepatocellular damage leading to jaundice and hepatic failure Psychiatric Disorder : hallucinations, confusion, insomnia, somnolence Metabolism and Nutritional Disorders: hyponatremia, hypomagnesemia, hypocalcemia, hypokalemia, hyponatremia Infections and Infestations : Clostridium difficile associated diarrhea Hematologic : pancytopenia, agranulocytosis Nervous : ageusia, dysgeusia Gastrointestinal Disorders : fundic gland polyps
Drug Interactions
Table 2 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with pantoprazole sodium injection and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 2. Clinically Relevant Interactions Affecting Drugs Co-Administered with Pantoprazole Sodium in 0.9% Sodium Chloride Injection and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with pantoprazole may reduce antiviral effect and promote the development of drug resistance. • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with pantoprazole may increase toxicity of the antiretroviral drugs. • There are other antiretroviral drugs which do not result in clinically relevant interactions with pantoprazole. Intervention: Rilpivirine-containing products : Concomitant use with pantoprazole sodium in 0.9% sodium chloride injection is contraindicated [see Contraindications (4) ] . See prescribing information. Atazanavir : See prescribing information for atazanavir for dosing information. Nelfinavir : Avoid concomitant use with pantoprazole sodium in 0.9% sodium chloride injection See prescribing information for nelfinavir. Saquinavir : See the prescribing information for saquinavir and monitor for potential saquinavir toxicities. Other antiretrovirals : See prescribing information. Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin. Clopidogrel Clinical Impact: Concomitant administration of pantoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition [see Clinical Pharmacology (12.3) ]. Intervention: No dose adjustment of clopidogrel is necessary when administered with an approved dose of pantoprazole sodium in 0.9% sodium chloride injection. Methotrexate Clinical Impact: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warnings and Precautions (5.14) ] . Intervention: A temporary withdrawal of pantoprazole sodium in 0.9% sodium chloride injection may be considered in some patients receiving high-dose methotrexate. Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of pantoprazole sodium in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH [see Clinical Pharmacology (12.3) ] . The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving pantoprazole sodium injection and MMF. Use pantoprazole sodium in 0.9% sodium chloride injection with caution in transplant patients receiving MMF. See the prescribing information for other drugs dependent on gastric pH for absorption. Interactions with Investigations of Neuroendocrine Tumors Clinical Impact: CgA levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors [see Warnings and Precautions (5.12) , Clinical Pharmacology (12.2) ] . Intervention: Temporarily stop pantoprazole sodium in 0.9% sodium chloride injection treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary. False Positive Urine Tests for THC Clinical Impact: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs [see Warnings and Precautions (5.13) ] . Intervention: An alternative confirmatory method should be considered to verify positive results. See the full prescribing information for a list of clinically important drug interactions. ( 7 )
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