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Esomeprazole Magnesium

ESOMEPRAZOLE MAGNESIUM

Manufacturer: NorthStar Rx LLC

Score: 141.0

Quick Summary

Esomeprazole Magnesium is a proton pump inhibitor used for the treatment of various conditions such as gastroesophageal reflux disease (GERD), erosive esophagitis, and pathological hypersecretory conditions. It works by reducing the amount of acid produced in the stomach. The drug is available in delayed-release capsules and should be taken at least one hour before meals. The recommended dosage varies depending on the condition being treated, and patients should follow the dosing instructions carefully to minimize the risk of adverse reactions.

Key Clinical Findings and Indications

  • Treatment of gastroesophageal reflux disease (GERD)
  • Healing of erosive esophagitis
  • Pathological hypersecretory conditions
  • Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence

Important Safety Information

Warning

Esomeprazole Magnesium may increase the risk of osteoporosis-related fractures, Clostridium difficile-associated diarrhea, and hypomagnesemia

Contraindications

  • Hypersensitivity to esomeprazole or any component of the formulation
  • Concomitant use with rilpivirine-containing products

Adverse Reactions

  • Headache
  • Diarrhea
  • Nausea
  • Abdominal pain
  • Constipation
  • Dry mouth

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with severe liver impairment or renal impairment

Healing of erosive esophagitis

Adult Dose

20 mg or 40 mg once daily for 4 to 8 weeks

Pediatric Dose

1 year to 11 years: 10 mg or 20 mg once daily for up to 8 weeks; 12 years to 17 years: 20 mg or 40 mg once daily for 4 to 8 weeks

Treatment of symptomatic GERD

Adult Dose

20 mg once daily for 4 weeks

Pediatric Dose

1 year to 11 years: 10 mg once daily for up to 8 weeks; 12 years to 17 years: 20 mg once daily for 4 weeks

Special Population Considerations

Pregnancy

  • Esomeprazole Magnesium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • There are no adequate and well-controlled studies in pregnant women

Nursing Mothers

  • Esomeprazole Magnesium may be present in human milk
  • Caution should be exercised when administering Esomeprazole Magnesium to nursing mothers

Pediatric Use

  • The safety and effectiveness of Esomeprazole Magnesium have been established in pediatric patients 1 year to 17 years of age
  • Use of Esomeprazole Magnesium in pediatric patients less than 1 year of age is not recommended

Geriatric Use

  • Of the total number of patients who received Esomeprazole Magnesium in clinical trials, 1459 were 65 to 74 years of age and 354 patients were 75 years of age and older
  • No overall differences in safety and efficacy were observed between the elderly and younger individuals

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