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Omeprazole enteric capsule

Product description

Approval date: 16 March 2007

 

Modified date: 01 October 2010

 

October 1st, 2012

 

November 30, 2015

 

Instructions for omeprazole enteric capsules

 

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

 

[name of drug]

 

Generic name: omeprazole enteric capsules

 

Product name: bisco

 

English name: Omeprazole Enteric Capsules

 

Chinese phonetic alphabet: Aomeilazuo Changrongjiaonang

 

The main ingredient of this product is omeprazole. Its chemical name is: 5- methoxy -2- [(4- methoxy - 3,5 - dimethyl -2- pyridine) methyl] sulfonyl] -1H- benzimidazole.

 

Molecular formula: C17H19N3O3S

 

Molecular weight: 345.42

 

[properties] this product is capsule, the content is white or white enteric-soluble pellets or particles.

 

[indications] suitable for gastric ulcer, duodenal ulcer, stress ulcer, reflux esophagitis and zhuo-ai syndrome (gastrinoma).

 

[specification] 20mg

 

[usage and dosage] oral, not chewing.

 

(1) peptic ulcer: 20mg once (1 tablet once), 1-2 times a day. The course of treatment is usually 4-8 weeks for gastric ulcer and 2-4 weeks for duodenal ulcer.

 

(2) reflux esophagitis: 20 ~ 60 mg once (1 ~ 3 pills once), 1-2 times a day. Morning swallow or morning and evening each one, the course of treatment is usually 4 ~ 8 weeks.

 

(3) zhuo-ai syndrome: 60mg once (3 pills once), once a day, the daily total dose can be adjusted to 20 ~ 120mg (1 ~ 6 pills) according to the condition, if the daily total dose needs to exceed 80mg (4 pills), it should be divided into two doses.

 

[adverse reactions] this product is well tolerated. The common adverse reactions are diarrhea, headache, nausea, abdominal pain, gastrointestinal flatulence and constipation, and occasionally increased 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 has not seen serious adverse reactions, but in some cases can occur gastric mucosal cell hyperplasia and atrophic gastritis.

 

[contraindication] allergic to this product, severe renal insufficiency and infants should not be allowed.

 

[precautions]

 

(1) when treating gastric ulcer, the possibility of ulcerative gastric cancer should be firstly ruled out, because the treatment with this product can reduce its symptoms, thus delaying treatment.

 

(2) use with caution in patients with liver and kidney dysfunction.

 

(3) this product is enteric-coated capsule. Please be careful not to crush it when taking it, so as not to affect the curative effect due to the premature release of the medicine in the stomach.

 

[drugs for pregnant and lactating women] although animal experiments show that this product has no fetal toxicity or teratogenic effect, it is generally not used for pregnant women and should be used with caution for lactating women.

 

[medication for children] no medication experience for children is available, and it is forbidden for infants and children.

 

[geriatric medication] is not clear.

 

[drug interaction] this product can delay the elimination of liver metabolizing drugs in the body, such as diazepam, phenytoin sodium, warfarin, nitrobenzidine, etc. When used together with the above drugs, the dosage of the latter should be reduced.

 

[drug overdose] is unclear.

 

[pharmacology and toxicology] proton pump inhibitors. This product is a fat-soluble weak alkaline, easy concentration in acid environment, so after oral specific distribution in the secretion of gastric mucosa cell wall tubular, and under the environment of high acid into the active form of sulfonamide, then through disulfide bond with the parietal cells secrete membrane of H +, K + atpase (also known as proton pump) of thiol is a combination of irreversibility, generate the sulfonamide compounds with proton pump, thus inhibiting the enzyme activity, blocking the final stages of gastric acid secretion, so this product for a variety of reasons caused by inhibition of gastric acid secretion has a strong and long lasting.

 

[pharmacokinetics] after oral administration of this product, it is absorbed by the small intestine and takes effect within 1 hour. The blood concentration reaches the peak within 0.5 ~ 3.5 hours, and the effect lasts for more than 24 hours. It can be distributed to liver, kidney, stomach, duodenum, thyroid and other tissues, and it can easily pass through the placenta. Generally, the bioavailability of single dose is about 35%, while that of multi-dose increases to about 60%, with the plasma protein binding rate of 95% ~ 96%, plasma half-life of 0.5 ~ 1 hour, and 3 hours for patients with chronic liver disease. This product is metabolized by liver microparticle somatochrome P450 oxidase system in vivo, about 80% of metabolites are excreted by urine, and the rest are excreted from feces after secretion by bile.

 

[storage] shading, sealing, stored in a dry place (10 ~ 30℃).

 

[packaging] oral solid medicinal high-density polyethylene bottles and medical solid paper bags are packed with silica gel desiccant, 7 grains per bottle; 14 capsules per bottle; 21 capsules per bottle; 28 capsules per bottle.

 

[validity period] 24 months

 

[executive standard] the second edition of Chinese pharmacopoeia in 2015

 

[approval document no.] national drug approval number H44023977

 

[production enterprise]

 

Company name: guangdong peidi pharmaceutical co., LTD

 

Production address: 66 peidi avenue, yueshan town, kaiping city, guangdong province

 

Zip: 529331

 

Telephone number :(0750)2789348

 

400-8899-328 (national service telephone number)

 

Fax number :(0750)2789348

 

Website: http://www.pdpharm.com

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