Application Nr Approved Date Route Status External Links
ANDA075410 2009-01-23 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Omeprazole Delayed-Release Capsules 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 1 Year Of Age And Older (1.4) Treatment Of Erosive Esophagitis (ee) Due To Acid-Mediated Gerd In Patients 1 Year Of Age And Older (1.5) Maintenance Of Healing Of Ee Due To Acid-Mediated Gerd In Patients 1 Year Of Age And Older (1.6) Pathologic Hypersecretory Conditions In Adults (1.7) The Safety And Effectiveness Of Omeprazole Delayed-Release Capsules In Pediatric Patients < 1 Year Of Age Have Not Been Established (8.4). 1.1 Treatment Of Active Duodenal Ulcer Omeprazole Delayed-Release Capsules 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. 1.2 Helicobacter Pylori Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence Eradication Of H. Pylori Has Been Shown To Reduce The Risk Of Duodenal Ulcer Recurrence. Triple Therapy Omeprazole Delayed-Release Capsules 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. Dual Therapy Omeprazole Delayed-Release Capsules In Combination With Clarithromycin Is Indicated For Treatment Of Patients With H. Pylori Infection And Duodenal Ulcer Disease To Eradicate H . Pylori In Adults. Among Patients Who Fail Therapy, Omeprazole Delayed-Release Capsules 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 C L I Nical Pharmacology (12.4) And The Clarithromycin Prescribing Information, Microbiology Section]. 1.3 Treatment Of Active Benign Gastric Ulcer Omeprazole Delayed-Release Capsules Is Indicated For Short-Term Treatment (4 To 8 Weeks) Of Active Benign Gastric Ulcer In Adults. 1.4 Treatment Of Symptomatic Gastroesophageal Reflux Disease (gerd) Omeprazole Delayed-Release Capsules Is Indicated For The Treatment Of Heartburn And Other Symptoms Associated With Gerd For Up To 4 Weeks In Patients 1 Year Of Age And Older. 1.5 Treatment Of Erosive Esophagitis (ee) Due To Acid-Mediated Gerd Pediatric Patients 1 Year Of Age To Adults Omeprazole Delayed-Release Capsules Is Indicated For The Short-Term Treatment (4 To 8 Weeks) Of Ee Due To Acid-Mediated Gerd That Has Been Diagnosed By Endoscopy In Patients 1 Year Of Age And Older. The Efficacy Of Omeprazole Delayed-Release Capsules Used For Longer Than 8 Weeks In Patients With Ee 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 Ee Or Gerd Symptoms (e.g., Heartburn), Additional 4 To 8 Week Courses Of Omeprazole Delayed-Release Capsules May Be Considered. The Safety And Effectiveness Of Omeprazole Delayed-Release Capsules In Pediatric Patients < 1 Year Of Age Have Not Been Established (8.4). 1.6 Maintenance Of Healing Of Ee Due To Acid-Mediated Gerd Omeprazole Delayed-Release Capsules Is Indicated For The Maintenance Healing Of Ee Due To Acid-Mediated Gerd In Patients 1 Year Of Age And Older. Controlled Studies Do Not Extend Beyond 12 Months. 1.7 Pathological Hypersecretory Conditions Omeprazole Delayed-Release Capsules Is Indicated For The Long-Term Treatment Of Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas And Systemic Mastocytosis) In Adults.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Glyceryl Dibehenate GLYCERYL DIBEHENATE Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
5. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Omeprazole OMEPRAZOLE ZINC4693575

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