Omeprazole 40 mg
1 INDICATIONS AND USAGE Omeprazole delayed-release capsules are 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 month 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 ) 1.1 Treatment of active duodenal ulcer Omeprazole delayed-release capsules are 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, are 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 are 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 Clinical Pharmacology ( 12.4 ) and the clarithromycin prescribing information, Microbiology section ] . 1.3 Treatment of Active Benign Gastric Ulcer Omeprazole delayed-release capsules are 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 are 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 are 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 may be considered. Pediatric Patients 1 Month to Less than 1 Year of Age Omeprazole delayed-release capsules are indicated for the short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age. 1.6 Maintenance of Healing of EE Due to Acid-Mediated GERD Omeprazole delayed-release capsules are 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 are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
Zydus Pharmaceuticals (USA) Inc.
CAPSULE PURPLE ZA 11 40 mg
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Omeprazole 40 mg
Zydus Pharmaceuticals (USA) Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
OMEPRAZOLE Delayed-Release capsules, USP 10 mg are white to off-white free flowing pellets filled in size '3' hard gelatin capsules with amethyst purple- colored cap printed with "ZA-09"in black ink & white body printed with "10 mg" in black ink, complies with USP dissolution test 2 and are supplied as follows: NDC 68382-411-06 in bottles of 30 capsules with child-resistant closures NDC 68382-411-16 in bottles of 90 capsules with child-resistant closures NDC 68382-411-01 in bottles of 100 capsules with child-resistant closures NDC 68382-411-05 in bottles of 500 capsules NDC 68382-411-10 in bottles of 1,000 capsules
OMEPRAZOLE Delayed-Release capsules, USP 20 mg are white to off-white free flowing pellets filled in size '2' hard gelatin capsules with tan-colored cap printed with "ZA-10"in black ink & white body printed with "20 mg" in black ink, complies with USP dissolution test 2 and are supplied as follows: NDC 68382-412-06 in bottles of 30 capsules with child-resistant closures NDC 68382-412-16 in bottles of 90 capsules with child-resistant closures NDC 68382-412-01 in bottles of 100 capsules with child-resistant closures NDC 68382-412-05 in bottles of 500 capsules NDC 68382-412-10 in bottles of 1,000 capsules
OMEPRAZOLE Delayed-Release capsules USP, 40 mg are off-white to pale brown free flowing pellets filled in size '1' hard gelatin capsules with amethyst purple colored cap printed with "ZA-11" in black ink & white body printed with "40 mg" in black ink, complies with USP dissolution test 2 and are supplied as follows: NDC 68382-500-06 in bottles of 30 capsules with child-resistant closures NDC 68382-500-16 in bottles of 90 capsules with child-resistant closures NDC 68382-500-01 in bottles of 100 capsules with child-resistant closures NDC 68382-500-05 in bottles of 500 capsules NDC 68382-500-10 in bottles of 1,000 capsules Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Keep in a tightly closed container. Dispense in a tight, light-resistant container.
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