A proton pump inhibitor - It prevents the production of acid in the stomach
FDA Alerts
Special Alerts:
[UPDATE 12/11/2007] FDA informed healthcare professionals of the issuance of the Agency’s follow-up communication regarding its review of safety data for the drugs omeprazole (Prilosec) and esomeprazole (Nexium) that raised concerns about a potential increased risk of heart problems for patients treated with these drugs. The Agency conducted a comprehensive review of the data from two studies that were submitted to FDA. FDA continues to believe that long-term use of omeprazole or esomeprazole is not likely to be associated with an increased risk of heart problems and recommends that healthcare providers continue to prescribe and patients continue to use these products in the manner described in the labeling for the two products. See the “Update of Safety Review” for information regarding the two studies that were reviewed. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Omeprazole and http://www.fda.gov/cder/drug/early_comm/omeprazole_esomepazole_update.htm.
[Posted August 09, 2007] FDA issued an early communication about the ongoing review of new safety data for the proton pump inhibitors, omeprazole (Prilosec) and esomeprazole (Nexium). The new safety data was from two small long-term clinical studies in patients with severe gastroesophageal reflux disease (GERD). In both studies, patients were randomly assigned to receive treatment with a drug (either omeprazole or esomeprazole) or to have surgery to control their GERD.
The results from the study of omeprazole and analyses from an ongoing study of esomeprazole raised concerns that long-term use of omeprazole or esomeprazole may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery. After reviewing these and other data submitted by the company, FDA’s preliminary conclusion at this time, is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time.
Both drugs are used for the treatment of GERD, esophageal erosions and for maintenance of healing erosions of the esophagus. They are also used for the treatment of ulcers. Omeprazole is also sold over the counter for frequent heartburn. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Omeprazole and http://www.fda.gov/cder/drug/early_comm/omeprazole_esomeprazole.htm.
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.
Pathological Hypersecretory Conditions
Long-term treatment of pathologic GI hypersecretory conditions (e.g., Zollinger-Ellison syndrome, idiopathic gastric acid hypersecretion).
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.
Oral 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. Do not store the applesauce and esomeprazole mixture for future use.
Oral Suspension
Mix packet contents with 15 mL (1 tablespoon) of water and allow mixture to thicken for 2–3 minutes; within 30 minutes of preparation, stir and drink the mixture. If any mixture remains after drinking, add additional water, stir, and drink immediately.
NG or G Tube
Open capsule, empty intact granules into 60-mL catheter-tipped 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 granules have dissolved or disintegrated.
Open packet, empty intact granules into catheter-tipped syringe, and mix with 15 mL of water. Replace plunger and shake well; allow mixture to thicken for 2–3 minutes. Within 30 minutes of preparation, administer through NG or G tube; flush with additional water.
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
Available as esomeprazole magnesium and esomeprazole sodium; dosage expressed in terms of esomeprazole.
Pediatric Patients
GERD
GERD without Erosive Esophagitis
Oral
Children 1–11 years of age: 10 mg once daily for up to 8 weeks.
Adolescents 12–17 years of age: 20 or 40 mg once daily for up to 8 weeks.
Treatment of Erosive Esophagitis
Oral
Children 1–11 years of age weighing <20 kg: 10 mg once daily for 8 weeks.
Children 1–11 years of age weighing ≥20 kg: 10 or 20 mg once daily for 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.
Pathologic GI Hypersecretory Conditions
Oral
40 mg twice daily; adjust dosage to individual patient needs. Dosages up to 240 mg daily administered for 12 months.
Special Populations
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.
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