A proton pump inhibitor - It prevents the production of acid in the stomach
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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).
Short-term treatment of erosive esophagitis (endoscopically diagnosed) in patients with GERD.
Maintain healing and decrease recurrence of erosive esophagitis.
Short-term self-medication with omeprazolemagnesium for symptomatic relief of frequent (e.g., 2 or more days a week) heartburn in adults 18 years of age or older.
Duodenal Ulcer
Short-term treatment of active duodenal ulcer (endoscopically or radiographically confirmed).
Treatment ofHelicobacter pylori infection and duodenal ulcer disease. Used in conjunction with amoxicillin and clarithromycin (triple therapy) or clarithromycin (dual therapy); has been used in other multidrug regimens†.
Gastric Ulcer
Short-term treatment and symptomatic relief of active benign gastric ulcer.
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.
Pathologic GI Hypersecretory Conditions
Long-term treatment of Zollinger-Ellison syndrome, multiple endocrine adenomas, or systemic mastocytosis in adults.
Upper GI Bleeding
Used to decrease risk of upper GI bleeding in critically ill patients.
Dosage and Administration
Administration
Omeprazole is acid-labile. To avoid decomposition in acidic pH of the stomach, delayed-release capsules contain enteric-coated granules of the drug; the conventional immediate-release capsules and powder for oral suspension contain sodium bicarbonate to protect the drug.
Oral Administration
Capsules
Swallow intact with a glass of water at least 1 hour prior to a meal. Do not use with any other liquid. Do not open capsules or mix the contents with food.
Do not substitute two 20-mg capsules for one 40-mg capsule because the 20-mg and 40-mg capsules contain the same amount of sodium bicarbonate.
Delayed-release Capsules
Administer orally before a meal (preferably 30 minutes before eating)..
Swallow capsules intact; do not chew or crush.
Antacids may be used concomitantly as needed for pain relief.
Alternatively, open capsule and mix contents with 1 tablespoon applesauce; swallow immediately without chewing and with glass of cool water to ensure complete swallowing. Applesauce should not be hot and should be soft enough to swallow without chewing.
Delayed-release Tablets
Tablets for self-medication: swallow intact with a glass of water before breakfast; do not chew, crush, or crush in food.
Powder for Oral Suspension
Administer at least 1 hour prior to a meal.
Empty 20- or 40-mg single-dose packet for oral suspension into small cup containing 15–30 mL (1-2 tablespoons) of water, stir well, and swallow immediately. Rinse container with more water and swallow to ensure complete consumption of the dose. Do not mix with any other liquid or food.
Do not substitute two 20-mg packets for one 40-mg packet because the 20- and 40-mg powder for oral suspension packets contain the same amount of sodium bicarbonate.
May use antacids, antacid/alginic acid combinations, histamine H2-receptor antagonists, or histamine H2-receptor antagonist and antacid combinations for “breakthrough” symptoms, but efficacy of these preparations has not been established.
NG Tube
Reconstitute 20- or 40-mg single-dose packet for oral suspension with 20 mL of water, stir well, administer immediately through a NG or orogastric tube using appropriately sized syringe. Flush the tube with 20 mL of water after administration. Temporarily stop continuous enteral feeding via NG or orogastric tube for 3 hours before and 1 hour after administration.
Dosage
Available as omeprazole and omeprazole magnesium; dosage expressed in terms of omeprazole.
Pediatric Patients
Gastroesophageal Reflux
GERD.
Oral (Delayed-release Capsules)
Children >2 years of age: Children weighing <20 kg: 10 mg once daily. Those weighing ≥20 kg: 20 mg once daily. Administered for 4 weeks in one study.
Treatment of Erosive Esophagitis.
Oral (Delayed-release Capsules)
Children >2 years of age: Children weighing <20 kg: 10 mg daily. Those weighing ≥20 kg: 20 mg daily.
On a mg/kg basis, dosage of omeprazole required to heal erosive esophagitis is greater in children than that required in adults. In an uncontrolled open-label study, dosages required for healing were 0.7–3.5 mg/kg daily (maximum 80 mg daily) for 3–6 months; about 90% of children healed in the first 3 months, and about 5% required a second course of treatment. Dosage of 0.7 mg/kg daily resulted in healing in 44% of children; an additional 28% of the children studied required a dosage of 1.4 mg/kg daily for healing to occur.
Maintenance of Healing of Erosive Esophagitis .
Oral (Delayed-release Capsules)
Children >2 years of age: Children weighing <20 kg: 10 mg daily. Those weighing≥20 kg: 20 mg daily. Maintenance therapy continued 2 years in one study. In an uncontrolled open-label study, maintenance dosages were half the dosages required for initial healing in 54% of children, while 46% required dosage increase (0.7–2.8 mg/kg daily) for all or part of the study.
Adults
GERD
GERD without Erosive Esophagitis
Oral (Capsules, Delayed-release Capsules; Powder for Oral Suspension)
20 mg once daily for up to 4 weeks.
Treatment of Erosive Esophagitis
Oral (Capsules, Delayed-release Capsules; Powder for Oral Suspension)
20 mg once daily until healing occurs (usually within 4–8 weeks); 40 mg once daily may be required. May give an additional 4 weeks of therapy (up to 12 weeks for a single course). If recurs, consider additional 4–8 weeks of therapy.
Maintenance of Healing of Erosive Esophagitis
Oral (Capsules, Delayed-release Capsules; Powder for Oral Suspension)
20 mg once daily. Chronic, lifelong therapy may be appropriate.
Self-medication for Frequent Heartburn
Oral (Delayed-release Tablets)
20 mg daily in the morning for 14 days. Do not exceed recommended dosage or duration; do not administer more than one course every 4 months. May relieve symptoms within 24 hours, but 1–4 days may be required for complete relief.
Duodenal Ulcer
Treatment of Active Duodenal Ulcer
Oral (Capsules, Delayed-release Capsules; Powder for Suspension)
20 mg once daily until healing occurs (usually within 2–4 weeks); an additional 4 weeks of therapy may be beneficial. Patients who responded poorly to H2-receptor antagonists may require up to 40 mg daily.
Treatment of Helicobacter pylori Infection and Duodenal Ulcer
Oral (Delayed-release Capsules)
Triple therapy: 20 mg twice daily (morning and evening) for 10 days in conjunction with amoxicillin and clarithromycin; additional omeprazole therapy of 20 mg once daily for 18 days recommended if active ulcer present initially.
Dual therapy: 40 mg once daily (in the morning) for 14 days in conjunction with clarithromycin; omeprazole 20 mg once daily for additional 14 days recommended if active ulcer present initially.
Gastric Ulcer
Treatment
Oral (Capsules, Delayed-release Capsules; Powder for Oral Suspension)
40 mg once daily for 4–8 weeks.
Pathologic GI Hypersecretory Conditions
Zollinger-Ellison Syndrome
Oral (Delayed-release Capsules)
60 mg once daily initially. Adjust dosage according to patient response and tolerance; continue therapy as long as necessary. Administer daily dosages >80 mg in divided doses. May require dosages of up to 360 mg daily (given in 3 divided doses).
Multiple Endocrine Adenomas
Oral (Delayed-release Capsules)
60 mg once daily initially. Adjust dosage according to patient response and tolerance; continue therapy as long as necessary. Administer daily dosages >80 mg in divided doses. May require dosages of up to 360 mg daily (given in 3 divided doses).
Systemic Mastocytosis
Oral (Delayed-release Capsules)
60 mg once daily initially. Adjust dosage according to patient response and tolerance; continue therapy as long as necessary. Administer daily dosages >80 mg in divided doses. May require dosages of up to 360 mg daily (given in 3 divided doses).
Upper GI Bleeding
Reduction of Risk of Upper GI Bleeding in Critically Ill Adults
Oral (Powder for Oral Suspension)
Initially, 40 mg followed by 40 mg after 6–8 hours on the first day, then 40 mg once daily for up to 14 days. Safety and efficacy for >14 days not established.
Special Populations
Hepatic Impairment
Consider dosage reduction, particularly in patients receiving long-term therapy for maintenance of healing of erosive esophagitis.
Asians
Consider dosage reduction, especially in patients receiving long-term therapy for maintenance of healing of erosive esophagitis.
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