Omeprazole

OMEPRAZOLE- omeprazole capsule, delayed release
RedPharm Drug, Inc.

HIGHLIGHTS OF PRESCRIBING INFORMATION


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

RECENT MAJOR CHANGES


Warnings and Precautions, Fundic Gland Polyps ( 5.12) 02/2018

INDICATIONS AND USAGE


Omeprazole delayed-release capsules are 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 20 mg Each drug twice daily for 10 days (2.1)*
Amoxicillin 1000 mg Each drug twice daily for 10 days (2.1)*
Clarithromycin 500 mg Each drug twice daily for 10 days (2.1)*
Dual Therapy:
Omeprazole 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) ‡ 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) 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)

* if ulcer present, continue Omeprazole 20 mg once daily for an additional 18 days.
† if ulcer present, continue Omeprazole 20 mg once daily for an additional 14 days.
‡ an additional 4 weeks of treatment may be given if no response; if recurrence additional 4 to 8 week courses may be considered.

DOSAGE FORMS AND STRENGTHS


Omeprazole delayed-release capsules: 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. ( 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 Interstitial Nephritis: Observed in patients taking PPIs. ( 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)

Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue omeprazole and refer to specialist for evaluation. ( 5.5)

Interaction with Clopidogrel: Avoid concomitant use of omeprazole.( 5.6, 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. ( 5.7)

Hypomagnesemia: Reported rarely with prolonged treatment with PPIs. ( 5.8)

Interaction with St. John’s Wort or Rifampin: Avoid concomitant use of omeprazole. ( 5.9, 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. ( 5.10, 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. ( 5.11, 7).

Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the lowest dose and shortest duration of therapy. ( 5.12)

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 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: 2/2018

CLOSE

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE
1.1 Treatment of Active Duodenal Ulcer
1.2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
1.3 Treatment of Active Benign Gastric Ulcer
1.4 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
1.5 Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD
1.6 Maintenance of Healing of EE Due to Acid-Mediated GERD
1.7 Pathological Hypersecretory Conditions
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Adult Dosage Regimen by Indication
2.2 Recommended Pediatric Dosage Regimen by Indication
2.3 Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Presence of Gastric Malignancy
5.2 Acute Interstitial Nephritis
5.3 Clostridium difficile-Associated Diarrhea
5.4 Bone Fracture
5.5 Cutaneous and Systemic Lupus Erythematosus
5.6 Interaction with Clopidogrel
5.7 Cyanocobalamin (Vitamin B-12) Deficiency
5.8 Hypomagnesemia
5.9 Interaction with St. John’s Wort or Rifampin
5.10 Interactions with Diagnostic Investigations for Neuroendocrine Tumors
5.11 Interaction with Methotrexate
5.12 Fundic Gland Polyps
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience with Omeprazole
6.2 Clinical Trials Experience with Omeprazole in Combination Therapy for H. pyloriEradication
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Asian Population
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
12.5 Pharmacogenomics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Active Duodenal Ulcer
14.2 H. pylori Eradication in Patients with Duodenal Ulcer Disease
14.3 Active Benign Gastric Ulcer
14.4 Symptomatic GERD
14.5 EE due to Acid-Mediated GERD
14.6 Maintenance of Healing of EE due to Acid-Mediated GERD
14.7 Pathological Hypersecretory Conditions
14.8 Pediatric Studies for the Treatment of Symptomatic GERD, Treatment of EE due to Acid-Mediated GERD, and Maintenance of Healing of EE due to Acid-Mediated GERD
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION

* Sections or subsections omitted from the full prescribing information are not listed.

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