Duodenal Ulcer (adults)

PRILOSEC (omeprazole) is indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

PRILOSEC (omeprazole) in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.

PRILOSEC (omeprazole) in combination with clarithromycin is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies and DOSAGE AND ADMINISTRATION].

Among patients who fail therapy, PRILOSEC (omeprazole) with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted. [See Microbiology section], and the clarithromycin package insert, Microbiology section.)

Gastric Ulcer (adults)

PRILOSEC (omeprazole) is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer in adults. [See Clinical Studies]

Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients)

Symptomatic GERD

PRILOSEC (omeprazole) is indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults.

Erosive Esophagitis

PRILOSEC (omeprazole) is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults. [See Clinical Studies]

The efficacy of PRILOSEC (omeprazole) used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of omeprazole may be considered.

Maintenance of Healing of Erosive Esophagitis (adults and pediatric patients)

PRILOSEC (omeprazole) is indicated to maintain healing of erosive esophagitis in pediatric patients and adults.

Controlled studies do not extend beyond 12 months. [See Clinical Studies]

Pathological Hypersecretory Conditions (adults)

PRILOSEC (omeprazole) is indicated for the long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

PRILOSEC (omeprazole) Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with PRILOSEC (omeprazole) .

Patients should be informed that the PRILOSEC (omeprazole) Delayed-Release Capsule should be swallowed whole.

For patients unable to swallow an intact capsule, alternative administration options are available.

Short-Term Treatment of Active Duodenal Ulcer

The recommended adult oral dose of PRILOSEC (omeprazole) is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

Triple Therapy (PRILOSEC (omeprazole) /clarithromycin/amoxicillin)

The recommended adult oral regimen is PRILOSEC (omeprazole) 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of PRILOSEC (omeprazole) 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy (PRILOSEC (omeprazole) /clarithromycin)

The recommended adult oral regimen is PRILOSEC (omeprazole) 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of PRILOSEC (omeprazole) 20 mg once daily is recommended for ulcer healing and symptom relief.

Gastric Ulcer

The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

Gastroesophageal Reflux Disease (GERD)

The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

Maintenance of Healing of Erosive Esophagitis

The recommended adult oral dose is 20 mg daily. [See Clinical Studies]

Pathological Hypersecretory Conditions

The dosage of PRILOSEC (omeprazole) in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with PRILOSEC (omeprazole) for more than 5 years.

Pediatric Patients

For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 1 to 16 years of age is as follows:

On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule.

Alternative Administration Options

PRILOSEC (omeprazole) is available as a delayed-release capsule or as a delayed-release oral suspension.

For patients who have difficulty swallowing capsules, the contents of a PRILOSEC (omeprazole) Delayed-Release Capsule can be added to applesauce.

One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

PRILOSEC (omeprazole) For Delayed-Release Oral Suspension should be administered as follows:

• Empty the contents of a 2.5 mg packet into a container containing 5 mL of water.
• Empty the contents of a 10 mg packet into a container containing 15 mL of water.
• Stir
• Leave 2 to 3 minutes to thicken.
• Stir and drink within 30 minutes.
• If any material remains after drinking, add more water, stir and drink immediately.

For patients with a nasogastric or gastric tube in place:

• Add 5 mL of water to a catheter tipped syringe and then add the contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet). It is important to only use a catheter tipped syringe when administering PRILOSEC (omeprazole) through a nasogastric tube or gastric tube.
• Immediately shake the syringe and leave 2 to 3 minutes to thicken.
• Shake the syringe and inject through the nasogastric or gastric tube, French size 6 or larger, into the stomach within 30 minutes.
• Refill the syringe with an equal amount of water.
• Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

Use with clopidogrel

Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Dosage Forms And Strengths

PRILOSEC (omeprazole) Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC (omeprazole) 10 on the body.

PRILOSEC (omeprazole) Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC (omeprazole) 20 on body.

PRILOSEC (omeprazole) Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC (omeprazole) 40 on the body.

PRILOSEC (omeprazole) For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules.

Storage And Handling

PRILOSEC (omeprazole) Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC (omeprazole) 10 on the body. They are supplied as follows:

NDC 0186-0606-31 unit of use bottles of 30

PRILOSEC (omeprazole) Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC (omeprazole) 20 on body. They are supplied as follows:

NDC 0186-0742-31 unit of use bottles of 30
NDC 0186-0742-82 bottles of 1000.

PRILOSEC (omeprazole) Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC (omeprazole) 40 on the body. They are supplied as follows:

NDC 0186-0743-31 unit of use bottles of 30
NDC 0186-0743-68 bottles of 100

PRILOSEC (omeprazole) For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC (omeprazole) unit dose packets are supplied as follows:

NDC 0186-0625-01 unit dose packages of 30: 2.5 mg packets
NDC 0186-0610-01 unit dose packages of 30: 10 mg packets

Storage

Store PRILOSEC (omeprazole) Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F).

Store PRILOSEC (omeprazole) For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature].

Manufactured for: AstraZeneca LP, Wilmington, DE 19850. Rev January 2011

Last reviewed on RxList: 3/15/2011
This monograph has been modified to include the generic and brand name in many instances.