Pantoprazole sodium delayed-release

PANTOPRAZOLE SODIUM DELAYED-RELEASE

Manufacturer: Preferred Pharmaceuticals Inc.

Score: 141.0

Quick Summary

Pantoprazole sodium delayed-release is a proton pump inhibitor (PPI) used for the short-term treatment of erosive esophagitis (EE) associated with gastroesophageal reflux disease (GERD), maintenance of healing of EE, and pathological hypersecretory conditions including Zollinger-Ellison syndrome. The recommended dosage is 40 mg once daily for up to 8 weeks for adults and children 5 years and older. Pantoprazole sodium is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole and in patients receiving rilpivirine-containing products. Common adverse reactions include headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.

Key Clinical Findings and Indications

Short-term treatment of erosive esophagitis (EE) associated with gastroesophageal reflux disease (GERD)
Maintenance of healing of EE
Pathological hypersecretory conditions including Zollinger-Ellison syndrome

Important Safety Information

Warning

Pantoprazole sodium is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole and in patients receiving rilpivirine-containing products.

Contraindications

Known hypersensitivity to any component of the formulation or any substituted benzimidazole
Patients receiving rilpivirine-containing products

Adverse Reactions

Headache
Diarrhea
Nausea
Abdominal pain
Vomiting
Flatulence
Dizziness
Arthralgia

Dosing Recommendations

General Guidance

No dose adjustment is needed for patients with mild to moderate hepatic impairment or renal impairment.

Short-term treatment of EE associated with GERD

Adult Dose

40 mg once daily for up to 8 weeks

Pediatric Dose

20 mg once daily for up to 8 weeks for children 5-14 years old, 40 mg once daily for up to 8 weeks for children 15 years and older

Maintenance of healing of EE

Adult Dose

40 mg once daily

Pediatric Dose

Not established

Pathological hypersecretory conditions including Zollinger-Ellison syndrome

Adult Dose

40 mg twice daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Pantoprazole sodium is not recommended for use in pregnancy unless the benefits outweigh the risks.

Nursing Mothers

Pantoprazole sodium is excreted in human milk, but the clinical significance is unknown.

Pediatric Use

Pantoprazole sodium is approved for use in pediatric patients 5 years and older for the short-term treatment of EE associated with GERD.

Geriatric Use

No dose adjustment is needed for geriatric patients.

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