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Pantoprazole Sodium

PANTOPRAZOLE SODIUM

Manufacturer: REMEDYREPACK INC.

Score: 141.0

Quick Summary

Pantoprazole sodium is a proton pump inhibitor (PPI) used for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD), maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions, including Zollinger-Ellison syndrome. The recommended dosage is 40 mg once daily for up to 8 weeks in adults and children 5 years and older. Important safety information includes contraindications for patients with known hypersensitivity to any component of the formulation, warnings for acute interstitial nephritis, Clostridium difficile-associated diarrhea, and bone fracture, as well as potential interactions with other drugs. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Short-term treatment of erosive esophagitis associated with GERD
  • Maintenance of healing of erosive esophagitis
  • Pathological hypersecretory conditions, including Zollinger-Ellison syndrome

Important Safety Information

Warning

Contraindicated in patients with known hypersensitivity to any component of the formulation

Contraindications

  • Known hypersensitivity to any component of the formulation

Adverse Reactions

  • Headache
  • Diarrhea
  • Nausea
  • Abdominal pain
  • Vomiting
  • Flatulence
  • Dizziness
  • Arthralgia

Dosing Recommendations

General Guidance

No dosage adjustment is recommended based on age, but dose adjustments may be necessary for patients with severe renal impairment or hepatic impairment

Short-term treatment of erosive esophagitis 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 15-17 years old

Maintenance of healing of erosive esophagitis

Adult Dose

40 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Pantoprazole should be used during pregnancy only if clearly needed

Nursing Mothers

  • Pantoprazole and its metabolites are excreted in human milk, and a decision should be made whether to discontinue nursing or discontinue the drug

Pediatric Use

  • The safety and effectiveness of pantoprazole for short-term treatment of erosive esophagitis associated with GERD have been established in pediatric patients 1 year through 16 years of age

Geriatric Use

  • In short-term US clinical trials, erosive esophagitis healing rates in elderly patients were similar to those found in patients under the age of 65