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Uses

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Gastroesophageal Reflux (GERD)

Short-term treatment of symptomatic GERD (e.g., heartburn) in patients without erosive esophagitis.

Short-term treatment of erosive esophagitis (diagnostically confirmed) in patients with GERD.

Maintain healing, symptom resolution, and decrease recurrence of erosive esophagitis.

IV as short-term (≤10 days) alternative to oral therapy in patients with a history of erosive esophagitis who are unable to continue taking the drug orally.

Duodenal Ulcer

Treatment of Helicobacter pylori infection and duodenal ulcer disease (active duodenal ulcer or history of duodenal ulcer in the past 5 years). Used in conjunction with amoxicillin and clarithromycin (triple therapy).

NSAIA-associated Ulcers

Reduction in the occurrence of gastric ulcers associated with chronic NSAIA therapy in patients at risk (i.e., ≥60 years of age and/or history of gastric ulcer). Effect on occurrence of duodenal ulcers not established.

Crohn’s Disease-associated Ulcers

Some evidence for use of proton-pump inhibitors (e.g., omeprazole) for gastric acid suppressive therapy as an adjunct in the management of upper GI Crohn’s disease†, including esophageal, gastroduodenal, and jejunoileal disease.

Dosage and Administration

Administration

Oral Administration

Administer orally at least 1 hour before a meal.

Antacids may be used concomitantly as needed for pain relief.

Capsules

Swallow capsules intact; do not chew or crush.

Alternatively, open capsule and mix contents with 1 tablespoon applesauce; swallow immediately without chewing. Applesauce should not be hot and should be soft enough to swallow without chewing.

NG Tube

Open capsule, empty intact granules into 60-mL syringe, and mix with 50 mL of water. Replace plunger and shake well for 15 seconds. Hold syringe with tip upright and check tip for remaining granules. Administer immediately through NG tube; flush with additional water. Do not administer if pellets have dissolved or disintegrated.

IV Administration

For solution compatibility information, see Compatibility under Stability.

Administer by slow direct IV injection or by IV infusion.

Flush the IV line with 0.9% sodium chloride, lactated Ringer’s, or 5% dextrose injection before and after administration.

Do not administer with any other drugs or diluents because of potential incompatibilities.

Reconstitution

For direct IV injection, reconstitute vial containing 20 or 40 mg of esomeprazole with 5 mL of 0.9% sodium chloride injection.

For IV infusion, reconstitute vial containing 20 or 40 mg of esomeprazole with 5 mL of 5% dextrose, 0.9% sodium chloride, or lactated Ringer’s injection. Dilute reconstituted solution prior to infusion.

Dilution

For IV infusion, dilute the reconstituted solution to a final volume of 50 mL with a compatible IV solution (see Compatibility under Stability).

Rate of Administration

Administer reconstituted solution by slow (over ≥3 minutes) direct IV injection.

Administer diluted solution by IV infusion over 10–30 minutes.

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Available as esomeprazole magnesium and esomeprazole sodium; dosage expressed in terms of esomeprazole.

Pediatric Patients

GERD

Oral

Adolescents 12–17 years of age: 20 or 40 mg once daily for up to 8 weeks.

Adults

GERD

GERD Without Erosive Esophagitis

Oral

20 mg once daily for 4 weeks; may give an additional 4 weeks of therapy. Chronic proton-pump inhibitor therapy may be appropriate.

Treatment of Erosive Esophagitis

Oral

20 or 40 mg once daily for 4–8 weeks; may give an additional 4–8 weeks of therapy.

IV

20 or 40 mg once daily for up to 10 days. Discontinue IV administration as soon as patient can resume oral esomeprazole therapy.

Maintenance of Healing of Erosive Esophagitis

Oral

20 mg once daily; not studied >6 months.

Duodenal Ulcer

Helicobacter pylori Infection and Duodenal Ulcer

Oral

Triple therapy: 40 mg once daily for 10 days in conjunction with amoxicillin and clarithromycin.

NSAIA-associated Ulcers

Prevention of Gastric Ulcers

Oral

20 or 40 mg once daily; not studied >6 months.

Special Populations

Dosage in Hepatic Impairment

Oral or IV dosage should not exceed 20 mg once daily in patients with severe (Child-Pugh class C) hepatic impairment. No dosage adjustment required for mild or moderate (Child-Pugh class A or B, respectively) hepatic impairment.