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ENGLISH NAME: Omeprazole Enteric-coated Tablets
SPECIFICATIONS: (1) 10 mg; (2) 20 mg
LICENSE NUMBER: (1) 10 mg  H20083831; (2) 20 mg  H20083815
PRODUCT PACKAGING: Aluminium Composite Panel, 7 tablets/blister pack,  1 blister pack/box, 2 blister packs/box, 3 blister packs/box, 4 blister packs/box
FORMULATION: Tablets
STORAGE CONDITION: Shading, Closed, Preservation of the Shade
SHELF LIFE: 24 Months
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Description: The active ingredient in Omeprazole Enteric-coated Tablets 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. Omeprazole 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. 

Pharmacological effects: role in the gastric parietal cells for the H +, K +-ATPase inhibitor, selective right inhibit gastric acid secretion, rapid onset, taking a meeting on the 1st that can inhibit gastric acid secretion of sustainable about 24 hours.

Pharmacokinetics: According to reports, after oral administration of the goods, the intestinal absorption, mainly distributed in the gastrointestinal tract, the plasma half-life of 30 to 60 minutes, usually single-dose bioavailability of approximately 35% multiple-dose bioavailability increased to about 60%, mainly in the liver metabolism, taking about 80% of the metabolites in the form of urine excretion of fecal excretion from the rest.

Indications: Omeprazole is a proton pump inhibitor indicated for duodenal ulcer in adults gastric ulcer in adults gastroesophageal reflux disease (GERD) in pediatric patients and adults. Maintenance of healing of erosive esophagitis in pediatric patients and adults. Treatment of pathological hypersecretory conditions in adults

Precautions: Omeprazole is a proton pump inhibitor indicated for duodenal ulcer in adults, gastric ulcer in adults gastroesophageal reflux disease (GERD) in pediatric patients and adults, maintenance of healing of erosive esophagitis in pediatric patients and adults, pathological hypersecretory conditions in adults.

Adverse reaction: well tolerated, had a headache, diarrhea, constipation, abdominal pain, nausea or vomiting, and abdominal distension, occasionally serum amino acid transferase (ALT, AST) increased, rash, dizziness, lethargy, insomnia, reaction and the reaction of its own causal relationship has not been determined. 
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