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1.1 Duodenal Ulcer (adults)
Omeprazole delayed-release capsules USP 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.
Omeprazole delayed-release capsules USP 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.
Omeprazole delayed-release capsules USP in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1)and Dosage and Administration (2)].
Among patients who fail therapy, omeprazole delayed-release capsules USP with clarithromycin are 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 Microbiology section (12.4)], and the clarithromycin package insert, Microbiology section.
1.2 Gastric Ulcer (adults)
Omeprazole delayed-release capsules USP are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults. [SeeClinical Studies (14.2)]
1.3 Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients)
Symptomatic GERD
Omeprazole delayed-release capsules USP are indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults for up to 4 weeks.
Erosive Esophagitis
Omeprazole delayed-release capsules USP are indicated for the short-term treatment (4 to 8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults. [See Clinical Studies (14.4)]
The efficacy of omeprazole delayed-release capsules USP used for longer than 8 weeks in these patients 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 erosive esophagitis or GERD symptoms (eg, heartburn), additional 4 to 8 week courses of omeprazole may be considered.
1.4 Maintenance of Healing of Erosive Esophagitis (adults and pediatric patients)
Omeprazole delayed-release capsules USP are indicated to maintain healing of erosive esophagitis in pediatric patients and adults.
Controlled studies do not extend beyond 12 months. [See Clinical Studies (14.4)].
1.5 Pathological Hypersecretory Conditions (adults)
Omeprazole delayed-release capsules USP are indicated for the long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
The active ingredient in omeprazole delayed-release capsules USP is a substituted benzimidazole, 5-methoxy-¬2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:
Omeprazole USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions.
Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole USP in the form of enteric-coated granules with the following inactive ingredients: anhydrous lactose, cetyl alcohol, di-sodium hydrogen phosphate dihydrate, hypromellose, hypromellose phthalate, mannitol, simethicone emulsion 30%, sodium lauryl sulfate and sugar sphere.
The capsule shell for omeprazole delayed-release capsules USP, 10 mg contains FD&C Red No. 40, FD&C Yellow No. 6, D&C Yellow No.10, gelatin, FD&C Blue No.1, FD&C Red No. 3, sodium lauryl sulfate and titanium dioxide.
The capsule shell for omeprazole delayed-release capsules USP, 20 mg contains FD&C Blue No.1, FD&C Red No.3, gelatin, sodium lauryl sulfate and titanium dioxide.
The capsule shell for omeprazole delayed-release capsules USP, 40 mg contains FD&C Red No. 40, FD&C Yellow No. 6, D&C Yellow No.10, gelatin, FD&C Blue No.1, FD&C Red No. 3, sodium lauryl sulfate and titanium dioxide.
The imprinting ink has the following components: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide.
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