Omeprazole 40 mg Capsules — Generic For Prilosec — Glenmark

These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES.

OMEPRAZOLE delayed-release capsules, for oral use

Initial U.S. Approval: 1989

Indications And Usage

Dosage And Administration

Indication

Recommended Adult (2.1) and Pediatric Dosage (2.2)

Treatment of Active Duodenal Ulcer

20 mg once daily for 4 weeks; some patients may require an additional 4 weeks (2.1)

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy:

Omeprazole

20 mg

Each drug twice daily for 10 days (2.1)1

Amoxicillin

1000 mg

Clarithromycin

500 mg

Dual Therapy:

Omeprazole

40 mg once daily for 14 days2

Clarithromycin

500 mg three times daily for 14 days (2.1)

Active Benign Gastric Ulcer

40 mg once daily for 4 to 8 weeks (2.1)

Symptomatic GERD

20 mg once daily for up to 4 weeks (2.1) See full prescribing information for weight based dosing in pediatric patients 2 years of age and older (2.2)

EE due to Acid-Mediated GERD

20 mg once daily for 4 to 8 weeks (2.1)3 See full prescribing information for weight based dosing in pediatric patients 2 years of age and older (2.2)

Maintenance of Healing of EE due to Acid-Mediated GERD

20 mg once daily (2.1)3

See full prescribing information for weight based dosing in pediatric patients 2 years of age and older (2.2)

Pathological Hypersecretory Conditions

Starting dose is 60 mg once daily (varies with individual patient, see full prescribing information) as long as clinically indicated (2.1)

1. if ulcer present, continue Omeprazole 20 mg once daily for an additional 18 days.

2. if ulcer present, continue Omeprazole 20 mg once daily for an additional 14 days.

3. an additional 4 weeks of treatment may be given if no response; if recurrence additional 4 to 8 week courses may be considered.

4. studied for 12 months. Reduce the dosage to 10 mg once daily for patients with hepatic impairment (Child-Pugh Class A, B, or C) and Asian patients (8.6, 8.7)

Dosage Forms And Strengths

Contraindications

Warnings And Precautions

• Gastric Malignancy: In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1)
• Acute Tubulointerstitial Nephritis: discontinue treatment and evaluate patients. (5.2)
• Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk. (5.3)
• Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.4)
• Severe Cutaneous

• Gastric Malignancy: In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1)
• Acute Tubulointerstitial Nephritis: discontinue treatment and evaluate patients. (5.2)
• Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk. (5.3)
• Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.4)
• Severe Cutaneous

Adverse Reactions

Adults: Most common adverse reactions in adults (incidence ≥2%) are

Pediatric patients (2 to 16 years of age):

To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

See full prescribing information for a list of clinically important drug interactions. (7)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 8/2025