Omeprazole Enteric-coated Tablets

Indication

Suitable for gastric ulcer, duodenal ulcer, stress ulcer, reflux esophagitis and Zhuo-Eye syndrome (gastrin)

Clinical pharmacology

Proton pump inhibitors. This product is a fat-soluble weakly basic drug, which is easily concentrated in an acidic environment. Therefore, it can be specifically distributed in the secretory tubules of gastric mucosal cells after oral administration, and converted into an active form of sulfenamide in this high acid environment. . Then, through the disulfide bond, the thiol group of H+, K+-ATPase (also known as proton pump) in the secretory membrane of parietal cells is irreversibly combined to form a complex of sulfinamide and proton pump, thereby inhibiting the activity of the enzyme and blocking The final step of gastric acid secretion, so this product has a strong and lasting inhibitory effect on gastric acid secretion caused by various causes.

Dosage

Oral, not chewable. (1) Peptic ulcer: 2 tablets at a time, 1 or 2 times a day. Swallow every morning or morning and evening, the course of gastric ulcer is usually 4 to 8 weeks, and the course of duodenal ulcer is usually 2 to 4 weeks... (see instructions)

Formulation

Enteric coated tablets

specification

10mg.

Instruction manual

Approval date:

Date of revision: December 01, 2015 December 29, 2015

Omeprazole enteric coated tablets

Please read the instructions carefully and use them under the guidance of a physician.

【Drug Name】

Common name: Omeprazole enteric-coated tablets

English name: Omeprazole Enteric-coated Tablets

Chinese Pinyin: Aomeilazuo Changrongpian

【Ingredients】 The main ingredient of this product is omeprazole.

Chemical name: 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfinyl]-1H-benzimidazole

Chemical Structure:

Molecular formula: C17H19N3O3S

Molecular weight: 345.42

【Properties】 This product is an enteric coated tablet, which is white or off-white after removal of the coating.

【Indications】 For gastric ulcer, duodenal ulcer, stress ulcer, reflux esophagitis and Zhuo-Eye syndrome (gastrin).

【Specification】 10mg.

【Usage and Dosage】Oral, not chewable.

(1) Peptic ulcer: 2 tablets at a time, 1 or 2 times a day. Swallow every morning or morning and evening, the course of gastric ulcer is usually 4 to 8 weeks, and the course of duodenal ulcer is usually 2 to 4 weeks.

(2) reflux esophagitis: 2 to 6 tablets at a time, 1 or 2 times a day. Swallow in the morning or morning and evening, usually for 4 to 8 weeks.

(3) Zhuo-Ai syndrome: 6 tablets at a time, once a day, the total daily dose can be adjusted to 2 to 12 tablets according to the condition. If the total dose needs more than 8 tablets per day, it should be divided into two times. Take it.

【Adverse reactions】

This product is well tolerated, common adverse reactions are diarrhea, headache, nausea, abdominal pain, flatulence and constipation, occasionally elevated serum aminotransferase (ALT, AST), rash, dizziness, lethargy, insomnia, etc. Usually mild, it disappears automatically, regardless of dose. Long-term treatment did not show serious adverse reactions, but in some cases gastric mucosal cell proliferation and atrophic gastritis may occur.

【Contraindications】 Disabled for those who are allergic to this product, severe renal insufficiency, and infants.

【Precautions】

(1) When treating gastric ulcer, the possibility of ulcerative gastric cancer should be ruled out first, because treatment with this product can alleviate its symptoms and delay treatment.

(2) Patients with liver and kidney dysfunction should be used with caution.

(3) This product is an enteric-coated tablet. Please take care not to chew it when taking it to prevent the drug particles from being released in the stomach too early and affecting the curative effect.

【Pregnant women and lactating women】

Although animal experiments have shown that this product has no fetal toxicity or teratogenic effects, it is generally not used for pregnant women and should be used with caution in lactating women.

【Children's medication】 There is no experience in children's medication, infants and children are prohibited.

【Geriatric Use】 This experiment was not performed and there is no reliable reference.

【medicine interactions】

This product can delay the elimination of drugs metabolized by the liver, such as diazepam, phenytoin, warfarin, nifedipine, etc. When this product is used together with the above drugs, the dose of the latter should be reduced.

【Drug overdose】 This experiment was not performed and there is no reliable reference.

【Pharmacology and Toxicology】

Proton pump inhibitors. This product is a fat-soluble weakly basic drug, which is easily concentrated in an acidic environment. Therefore, it can be specifically distributed in the secretory tubules of gastric mucosal cells after oral administration, and converted into an active form of sulfenamide in this high acid environment. . Then, through the disulfide bond, the thiol group of H+, K+-ATPase (also known as proton pump) in the secretory membrane of parietal cells is irreversibly combined to form a complex of sulfinamide and proton pump, thereby inhibiting the activity of the enzyme and blocking The final step of gastric acid secretion, so this product has a strong and lasting inhibitory effect on gastric acid secretion caused by various causes.

【Pharmacokinetics】

After oral administration of this product, it is absorbed through the small intestine and takes effect within 1 hour. The blood drug concentration reaches a peak at 0.5 to 3.5 hours, and the effect lasts for more than 24 hours. Can be distributed to the liver, kidney, stomach, duodenum, thyroid and other tissues, and easy to penetrate the placenta. Usually, the single-dose bioavailability is about 35%, the multi-dose can be increased to about 60%, the plasma protein binding rate is 95% to 96%, the plasma half-life is 0.5 to 1 hour, and the chronic liver disease is 3 hours. This product is metabolized in the body by the liver microsomal cytochrome P450 oxidase system, 80% of metabolites are excreted in the urine, and the rest is excreted from the feces after bile secretion.

【Storage】shading, sealed, and stored in a cool place (not more than 20 ° C).

【Packing】Double aluminum packaging. 14 pieces / box, 28 pieces / box, 36 pieces / box.

【Validity period】24 months.

【Executive Standards】 "Chinese Pharmacopoeia" 2015 Edition 2

【Approval No.】National Drug Standard H20044871

【manufacturer】

Company Name: Shandong New Times Pharmaceutical Co., Ltd.

Production address: No. 1 North Outer Ring Road, Feixian County, Shandong Province

Postal code: 273400

Phone number: 0539-8336336 (Sales) 5030608 (Quality Management Department)

Fax number: 0539-5030900

Website: www.LUNAN.com.cn

24-hour customer service hotline: 400-0539-310