esomeprazole

ESOMEPRAZOLE

Manufacturer: Macleods Pharmaceuticals Limited

Score: 141.0

Quick Summary

Esomeprazole is a proton pump inhibitor used for the treatment of various conditions, including 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 is typically taken once daily, with or without food. Esomeprazole has been shown to be effective in healing and maintaining the healing of erosive esophagitis, as well as in reducing the risk of NSAID-associated gastric ulcers. However, it is not recommended for use in patients with certain conditions, such as severe liver impairment, and may interact with other medications. Special considerations are necessary for use in pediatric and geriatric patients, as well as in pregnant and nursing mothers.

Key Clinical Findings and Indications

Treatment of gastroesophageal reflux disease (GERD)
Healing and maintenance of healing of erosive esophagitis
Reducing the risk of NSAID-associated gastric ulcers
Treatment of pathological hypersecretory conditions

Important Safety Information

Warning

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

Contraindications

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

Adverse Reactions

Headache
Diarrhea
Nausea
Flatulence
Abdominal pain

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with severe liver impairment or those taking certain medications

GERD

Adult Dose

20 mg once daily for 4 weeks

Pediatric Dose

12 years to 17 years: 20 mg once daily for 4 weeks

Erosive esophagitis

Adult Dose

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

Pediatric Dose

12 years to 17 years: 20 mg or 40 mg once daily for 4 to 8 weeks

Special Population Considerations

Pregnancy

Esomeprazole is classified as a Category C drug, meaning that animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in pregnant women

Nursing Mothers

Esomeprazole is excreted in human milk, but the clinical significance of this is unknown

Pediatric Use

The safety and effectiveness of esomeprazole have been established in pediatric patients 12 years to 17 years of age for the treatment of GERD and erosive esophagitis

Geriatric Use

No overall differences in safety and efficacy were observed between the elderly and younger individuals, but greater sensitivity of some older individuals cannot be ruled out