Pantoprazole Sodium Dr
Generic Name: pantoprazole sodium dr
Brand Names:
Pantoprazole Sodium Dr
The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP, a PPI, is a substituted benzimidazole, 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridyl)methyl] sulfinyl]benzimidazole, sodium salt, sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S . 1.5 H 2O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium sesquihydrate, USP is a white to off-white powder.
Overview
The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP, a PPI, is a substituted benzimidazole, 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridyl)methyl] sulfinyl]benzimidazole, sodium salt, sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S . 1.5 H 2O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium sesquihydrate, USP is a white to off-white powder.
Uses
Pantoprazole Sodium Delayed-Release Tablets are indicated for: 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole Sodium Delayed-Release Tablet is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
Dosage
2.1 Recommended Dosing Schedule Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1. Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks* Children (5 years and older) ≥ 15 kg to < 40 kg ≥ 40 kg 20 mg Once daily for up to 8 weeks 40 mg Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once daily*** Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily ** * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered.
Side Effects
The following serious adverse reactions are described below and elsewhere in labeling: • Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)] • Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.3)] • Bone Fracture [see Warnings and Precautions (5.4)] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5)] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.6)] • Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.7)] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.8)] • Fundic Gland Polyps [see Warnings and Precautions (5.10)] 6.1 Clinical Trials Experience The adverse reaction profiles for Pantoprazole Sodium For Delayed-Release Oral Suspension and Pan...
Interactions
Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with pantoprazole sodium and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 4: Clinically Relevant Interactions Affecting Drugs Co-Administered with Pantoprazole Sodium and Interactions 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
5.1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with pantoprazole sodium 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 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). • Pantoprazole sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to any component of 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), Adverse Reactions ( 6)].
Storage
Storage Store pantoprazole sodium delayed-release tablets, USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Pantoprazole Sodium Dr used for?▼
Pantoprazole Sodium Delayed-Release Tablets are indicated for: 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole Sodium Delayed-Release Tablet is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
What are the side effects of Pantoprazole Sodium Dr?▼
The following serious adverse reactions are described below and elsewhere in labeling: • Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)] • Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.3)] • Bone Fracture [see Warnings and Precautions (5.4)] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5)] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.6)] • Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.7)] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.8)] • Fundic Gland Polyps [see Warnings and Precautions (5.10)] 6.1 Clinical Trials Experience The adverse reaction profiles for Pantoprazole Sodium For Delayed-Release Oral Suspension and Pan...
What are the important warnings for Pantoprazole Sodium Dr?▼
5.1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with pantoprazole sodium 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 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). • Pantoprazole sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to any component of 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), Adverse Reactions ( 6)].
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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.