Omeprazole

Omeprazole
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

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Overview

Omeprazole is a proton pump inhibitor that is FDA approved for the {{{indicationType}}} of duodenal ulcer, gastric ulcer, gastroesophageal reflux disease (GERD), maintenance of healing of erosive esophagitis and pathological hypersecretory conditions. Common adverse reactions include headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Duodenal Ulcer

• Short-Term Treatment of Active Duodenal Ulcer

• The recommended adult oral dose of omeprazole delayed-release capsule USP 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 (omeprazole/clarithromycin/amoxicillin)
  • The recommended adult oral regimen is omeprazole delayed-release capsule USP 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 omeprazole delayed-release capsule USP 20 mg once daily is recommended for ulcer healing and symptom relief.

• Dual Therapy (omeprazole/clarithromycin)
  • The recommended adult oral regimen is omeprazole delayed-release capsule USP 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 omeprazole delayed-release capsule USP 20 mg once daily is recommended for ulcer healing and symptom relief.

Gastric Ulcer

• Omeprazole delayed-release capsules USP are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.

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

Gastroesophageal Reflux Disease (GERD)

• Symptomatic GERD

• Omeprazole delayed-release capsules USP are indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults.
• 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.

• Erosive Esophagitis

• Omeprazole delayed-release capsules USP are indicated for the short-term treatment (4 to 8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults. [See Clinical Studies (14.4)]
• The efficacy of omeprazole delayed-release capsules USP 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 to 8 week courses of omeprazole may be considered.
• 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

• Omeprazole delayed-release capsules USP are indicated to maintain healing of erosive esophagitis in pediatric patients and adults.

• Controlled studies do not extend beyond 12 months.

• The recommended adult oral dose is 20 mg daily.

Pathological Hypersecretory Conditions

• Omeprazole delayed-release capsules USP are indicated for the long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

• The dosage of omeprazole delayed-release capsule USP 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 omeprazole delayed-release capsule USP for more than 5 years.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Omeprazole in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Omeprazole in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Omeprazole in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Omeprazole in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Omeprazole in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Omeprazole in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Omeprazole in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Omeprazole in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Omeprazole during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Omeprazole with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Omeprazole with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Omeprazole with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Omeprazole with respect to specific gender populations.

Race

There is no FDA guidance on the use of Omeprazole with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Omeprazole in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Omeprazole in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Omeprazole in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Omeprazole in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Omeprazole in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Omeprazole in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Omeprazole in the drug label.

Pharmacology

There is limited information regarding Omeprazole Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Omeprazole in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Omeprazole in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Omeprazole in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Omeprazole in the drug label.

How Supplied

Storage

There is limited information regarding Omeprazole Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Omeprazole in the drug label.

Precautions with Alcohol

• Alcohol-Omeprazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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