Esomeprazole Magnesium

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

General Guidance

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

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