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Dexlansoprazole

DEXLANSOPRAZOLE

Manufacturer: ENDO USA, Inc.

Score: 141.0

Quick Summary

Dexlansoprazole delayed release is a proton pump inhibitor used for the healing of all grades of erosive esophagitis, maintenance of healed erosive esophagitis, and treatment of symptomatic non-erosive gastroesophageal reflux disease. The recommended dosage is 30-60 mg once daily for up to 8 weeks. Important safety information includes contraindications for patients with known hypersensitivity to any component of the formulation and patients receiving rilpivirine-containing products. Adverse reactions may include diarrhea, abdominal pain, nausea, and vomiting. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Healing of all grades of erosive esophagitis
  • Maintenance of healed erosive esophagitis
  • Treatment of symptomatic non-erosive gastroesophageal reflux disease

Important Safety Information

Warning

Contraindicated in patients with known hypersensitivity to any component of the formulation and patients receiving rilpivirine-containing products

Contraindications

  • Patients with known hypersensitivity to any component of the formulation
  • Patients receiving rilpivirine-containing products

Adverse Reactions

  • Diarrhea
  • Abdominal pain
  • Nausea
  • Vomiting

Dosing Recommendations

General Guidance

Dose adjustment is recommended for patients with moderate hepatic impairment

Healing of erosive esophagitis

Adult Dose

60 mg once daily for up to 8 weeks

Pediatric Dose

30-60 mg once daily for up to 8 weeks (12-17 years old)

Maintenance of healed erosive esophagitis

Adult Dose

30 mg once daily for up to 6 months

Pediatric Dose

30 mg once daily for up to 16 weeks (12-17 years old)

Symptomatic non-erosive gastroesophageal reflux disease

Adult Dose

30 mg once daily for 4 weeks

Pediatric Dose

30 mg once daily for 4 weeks (12-17 years old)

Special Population Considerations

Pregnancy

  • There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk

Nursing Mothers

  • No data available

Pediatric Use

  • Approved for use in pediatric patients 12-17 years old
  • Not recommended for use in pediatric patients less than 2 years old

Geriatric Use

  • No overall differences in safety or effectiveness were observed between geriatric and younger patients

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