Omeprazole 20 mg Capsules — Generic For Prilosec — Rising Pharma

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

Omeprazole is a proton pump inhibitor (PPI) indicated for the:

Treatment of active duodenal ulcer in adults (1.1)

Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2)

Treatment of active benign gastric ulcer in adults (1.3)

Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4)

Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6)

Pathologic hypersecretory conditions in adults (1.7)

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 delayed- release capsules

20 mg

Each drug twice daily for 10 days (2.1)*

Amoxicillin

1000 mg

Clarithromycin

500 mg

Dual Therapy:

Omeprazole delayed- release capsules

40 mg once daily for 14 days**

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)***

Maintenance of Healing of EE due to Acid-Mediated GERD

20 mg once daily (2.1)****

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)

Dosage Forms And Strengths

Omeprazole delayed-release capsules USP: 10 mg, 20 mg, and 40 mg. (3)

Contraindications

Patients with known hypersensitivity to substituted benzimidazoles or any component of the formulation. (4)

Patients receiving rilpivirine-containing products. (4, 7)

Refer to the Contraindications section of the prescribing information for clarithromycin and amoxicillin, when administered in combination with omeprazole delayed- release capsules. (4)

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

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: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. (5.5)

Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue omeprazole and refer to specialist for evaluation. (5.6)

Interaction with Clopidogrel: Avoid concomitant use of omeprazole.(5.7, 7)

Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. (5.8)

Hypomagnesemia and Mineral Metabolism: Reported rarely with prolonged treatment with PPIs. (5.9)

Interaction with St. John’s Wort or Rifampin: Avoid concomitant use of omeprazole. (5.10, 7)

Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Increased Chromogranin A (CgA) levels may interfere with diagnostic investigations for neuroendocrine tumors; temporarily stop omeprazole at least 14 days before assessing CgA levels. (5.11, 7)

Interaction with Methotrexate: Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of omeprazole. (5.12, 7)

Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. (5.13)

Adverse Reactions

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

Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. (6)

Pediatric patients (2 to 16 years of age):

Safety profile similar to that in adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies. (8.4)

To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 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: 10/2024