Pantoprazole Sodium In 0.9% Sodium Chloride
Generic Name: pantoprazole sodium in 0.9% sodium chloride
Brand Names:
Pantoprazole Sodium
11 DESCRIPTION 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.
Overview
11 DESCRIPTION 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.
Uses
1 INDICATIONS AND 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).
Dosage
2 DOSAGE AND 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.
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) ] • 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 a...
Interactions
7 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.
Warnings
5 WARNINGS AND 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. 4 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.
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.
Storage
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.
Frequently Asked Questions
What is Pantoprazole Sodium In 0.9% Sodium Chloride used for?▼
1 INDICATIONS AND 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).
What are the side effects of Pantoprazole Sodium In 0.9% Sodium Chloride?▼
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) ] • 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 a...
Can I take Pantoprazole Sodium In 0.9% Sodium Chloride 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.
What are the important warnings for Pantoprazole Sodium In 0.9% Sodium Chloride?▼
5 WARNINGS AND 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. 4 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.
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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.