Pantoprazole Sodium Injection
Generic Name: pantoprazole sodium injection
Brand Names:
Pantoprazole Sodium
11 DESCRIPTION The active ingredient in pantoprazole sodium for injection (pantoprazole sodium), 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 C 16 H 14 F 2 N 3 NaO 4 S, with a molecular weight of 405.4. The structural formula is: Pantoprazole sodium is a white or almost white powder and is racemic.
Overview
11 DESCRIPTION The active ingredient in pantoprazole sodium for injection (pantoprazole sodium), 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 C 16 H 14 F 2 N 3 NaO 4 S, with a molecular weight of 405.4. The structural formula is: Pantoprazole sodium is a white or almost white powder and is racemic.
Uses
1 INDICATIONS AND USAGE Pantoprazole sodium for injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of pantoprazole sodium for injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. Pediatric use information is approved for Pfizer Inc.'s PROTONIX® I.V. (pantoprazole sodium) for Injection. However, due to Pfizer Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
Dosage
2 DOSAGE AND ADMINISTRATION GERD and a History of EE Adults: The recommended dosage is 40 mg once daily by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes) for up to 10 days. ( 2.1 ) Discontinue as soon as the patient is able to receive oral treatment. Switch to an appropriate oral medication within 10 days of startingpantoprazole sodium for injection. ( 2.1 ) Pathological Hypersecretion Conditions, Including ZE Syndrome The recommended adult dosage is 80 mg every 12 hours by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes). ( 2.2 ) For information on how to adjust dosing for individual patient needs, see the full prescribing information.
Side Effects
6 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 )] Clostridioides 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 Precau...
Interactions
7 DRUG INTERACTIONS Table 3 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with pantoprazole sodium for injection and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 3: Clinically Relevant Interactions Affecting Drugs Co-Administered with Pantoprazole Sodium for 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.
Warnings
5 WARNINGS AND PRECAUTIONS Gastric Malignancy: In adults, symptomatic response to therapy with pantoprazole sodium for 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 pantoprazole sodium for injection. Assess the patient and remove the catheter if clinically indicated. ( 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. 4 CONTRAINDICATIONS Pantoprazole sodium for injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole.
Pregnancy
8.1 Pregnancy Risk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole sodium.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Pantoprazole sodium for injection is supplied in a single-dose vial as a white to off-white freeze-dried powder for reconstitution and dilution containing 40 mg of pantoprazole.
Frequently Asked Questions
What is Pantoprazole Sodium Injection used for?▼
1 INDICATIONS AND USAGE Pantoprazole sodium for injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of pantoprazole sodium for injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. Pediatric use information is approved for Pfizer Inc.'s PROTONIX® I.V. (pantoprazole sodium) for Injection. However, due to Pfizer Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
What are the side effects of Pantoprazole Sodium Injection?▼
6 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 )] Clostridioides 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 Precau...
Can I take Pantoprazole Sodium Injection during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole sodium.
What are the important warnings for Pantoprazole Sodium Injection?▼
5 WARNINGS AND PRECAUTIONS Gastric Malignancy: In adults, symptomatic response to therapy with pantoprazole sodium for 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 pantoprazole sodium for injection. Assess the patient and remove the catheter if clinically indicated. ( 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. 4 CONTRAINDICATIONS Pantoprazole sodium for injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.