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Pantoprazole sodium delayed-release

PANTOPRAZOLE SODIUM DELAYED-RELEASE

Manufacturer: Lifestar Pharma LLC

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.