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Omeprazole

 

CATEGORIES, DRUG CLASSES, BRAND NAMES

CATEGORIES: Acid/peptic disorder; Adenoma, endocrine; Esophagitis, erosive; Mastocytosis, systemic; Reflux, gastroesophagea; Ulcer, duodenal; Ulcer, gastric; Ulcer, peptic; Zollinger-Ellison syndrome; Pregnancy Category C

Drug Classes: Acid/Peptic Disorders; Gastrointestinal, Miscellaneous

BRAND NAMES: Acidex; Antra; Audazol; Desec; Dizprazol; Dudencer; Epirazole; Gastroloc; Gibancer; Inhibitron; Inhipump; Logastric; Lomac; Losec; Miracid; Mopral; Ocid; Omed; Omedar; OMEP; Omepril; Omepral; Omeprazon; Omezol; Omezzol; Omid; Omizac; Omisec; OMP; OMZ; Oprax; Opraz; Ozoken; Parizac; Peptilcer; Prazidec; Prilosec; Ramezol; Result; Roweprazol; Ulcozol; Ulsen; Ulzone; Zefxon; Zoltum
(Foreign Brand names outside U.S. in italics)

DESCRIPTION

The active ingredient in Prilosec Delayed-Release Capsules 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.

Omeprazole is a white to off-white crystalline powder which 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.

Prilosec is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: cellulose, disodium hydrogen phosphate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose, mannitol, sodium lauryl sulfate and other ingredients. The capsule shells have the following inactive ingredients: gelatin-NF, FD&C blue #1, FD&C red #40, D&C red #28, titanium dioxide, synthetic black iron oxide, isopropanol, butyl alcohol, FD&C blue #2, D&C red #7 calcium lake, and, in addition, the 10 mg capsule shell also contains D&C yellow #10.



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