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Omeprazole enteric capsule

Product description
Approved date: March 16, 2007
 
Date of revision: October 1, 2010
 
         October 01, 2012
 
         November 30, 2015
 
Omeprazole enteric capsule instructions
 
  Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
Common name: Omeprazole enteric capsule
 
Product Name: Peske
 
English name: Omeprazole Enteric Capsules
 
Pinyin: Aomeilazuo Changrongjiaonang
 
[Ingredients] The main ingredient of this product is: omeprazole. Its chemical name is: 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl]-1H-benzimidazole.
 
 
 
Molecular formula: C17H19N3O3S
 
Molecular weight: 345.42
 
【Properties】 This product is a capsule, the content of which is white or white-like enteric pellets or granules.
 
[Indications] For gastric ulcer, duodenal ulcer, stress ulcer, reflux esophagitis and Zhuo-Eye syndrome (gastrin).
 
【Specification】20mg
 
[Usage and Dosage] Oral, not chewable.
 
(1) Peptic ulcer: 20mg once (1 capsule 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: once 20 ~ 60 mg (1 to 3 capsules 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: 60mg once (3 capsules at a time), once a day, after the total daily dose can be adjusted according to the condition of 20 ~ 120mg (1 ~ 6), if the total dose of a day needs to exceed 80mg (4 capsules) should be divided into two doses.
 
[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. These adverse reactions are usually mild and can disappear automatically, regardless of the 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 capsule. Be careful not to chew when taking it, so as to prevent the drug from being released prematurely in the stomach 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 also be used with caution in lactating women.
 
[Children's medication] There is no experience in children's medication, infants and children are prohibited.
 
[Geriatric medication] is not clear.
 
[Drug interaction] 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 amount of the latter should be reduced.
 
[Drug overdose] is not clear.
 
[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. And then through the disulfide bond and the irreversible binding of the thiol group of the H+, K+-ATPase (also known as proton pump) in the secretory membrane of the parietal cell to form a complex of the sulfinamide and the proton pump, thereby inhibiting the activity of the enzyme, The last step of blocking gastric acid secretion, so this product has a strong and lasting inhibitory effect on gastric acid secretion caused by various reasons.
 
[Pharmacokinetics] After oral administration of this product, it is absorbed through the small intestine and takes effect within 1 hour. The blood concentration reaches a peak at 0.5 to 3.5 hours. The effect lasts for more than 24 hours and can be distributed to the liver, kidney, stomach and duodenum. , thyroid and other tissues, and easy to pass through the placenta. Usually, the single-dose bioavailability is about 35%, the multi-dose bioavailability is 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. About 80% of the metabolites are excreted in the urine, and the rest are excreted from the feces after bile secretion.
 
[Storage] shading, sealing, and storing in a dry place (10 ~ 30 ° C).
 
[Package] Oral solid medicinal high-density polyethylene bottle, medicinal solid paper bag silica gel desiccant, 7 capsules per bottle; 14 capsules per bottle; 21 capsules per bottle; 28 capsules per bottle.
 
[Validity Period] 24 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval No.] National Drug Standard H44023977
 
【manufacturer】
 
  Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
  Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
  Postal code: 529331
 
  Phone number: (0750) 2789348
 
400-8899-328 (National Service Phone)
 
  Fax number: (0750) 2789348
 
  Website: http://www.pdpharm.com
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