Description: The instructions for omeprazole enteric-coated tablets were issued by the State Pharmaceutical Products Supervision and Administration on February 5, 2002 in the Notice on Publishing the Catalogue of Instructions for the Second Batch of Chemicals. The instructions published by the State Administration of Pharmaceutical Products are reference samples for revising the specifications. In case of doubt, the enterprise may propose amendments. Indications should be consistent with the original approval; Adverse reactions, drug interactions and other contents, the instructions provided by the enterprise can not be less than those listed in the sample draft. For empty or incomplete items in the sample manual, enterprises should be required to fill in according to the actual situation, such as product name and specifications.
Drug name
Generic name: omeprazole enteric-coated tablets
Former name:
Commodity name:
English name: Omeprazole enteric-coated tablets
Chinese Pinyin: Homer Zuoqi n ɡ Ron ɡ Pi ɡ n
Main components and chemical name: omeprazole, chemical name 5 methoxy 2{[(4 methoxy 3,5 dimethyl 2 pyridyl) methyl] sulfoxide} 1H benzimidazole.
Structural formula:
Molecular formula: C 17H 19N3O3S.
Molecular weight: 345.4 1
Character; Role; letter
This product is an enteric-coated tablet, which is white after removing the enteric coating.
Pharmacology and toxicology
Proton pump inhibitor. This product is a fat-soluble weakly alkaline drug, which is easy to concentrate in acidic environment, so it can be specifically distributed in the secretory tubules of parietal cells of gastric mucosa after oral administration, and transformed into the active form of sulfenamide in this high-acid environment, and then irreversibly combined with sulfhydryl groups of H+ and K+ATPase (also known as proton pump) in parietal cells through disulfide bonds to form a complex of sulfenamide and proton pump, thus inhibiting the activity of this enzyme and blocking the last step of gastric acid secretion.
pharmacokinetics
After oral administration, this product is absorbed by small intestine, and it takes effect within 65438 0 hours, and the blood concentration reaches the peak in 0.5 ~ 3.5 hours, and the effect lasts for more than 24 hours. It can be distributed in liver, kidney, stomach, duodenum, thyroid and other tissues, and easily penetrates the placenta. Generally, the bioavailability of a single dose is about 35%, and it can be increased to about 60% after multiple doses. The plasma protein binding rate is 95% ~ 96%, and the plasma half-life is 0.5 ~ 1 hour, which is 3 hours for patients with chronic liver disease. This product is metabolized by liver microsomal cytochrome P450 oxidase system in vivo, 80% of the metabolites are excreted in urine, and the rest are secreted by bile and excreted in feces.
indicate
It is suitable for gastric ulcer, duodenal ulcer, stress ulcer, reflux esophagitis, and Zhuoai syndrome (gastrinoma).
dosage
Oral, not chewing.
(1) Peptic ulcer: 20mg once (1 tablet once), 1 ~ 2 times a day. Swallow it once every morning or in the morning and evening. The course of treatment for gastric ulcer is usually 4-8 weeks, and that for duodenal ulcer is usually 2-4 weeks.
(2) Reflux esophagitis: 20 ~ 60 mg once (1 ~ 3 tablets once), 1 ~ 2 times a day. Swallow it in the morning or once in the morning and evening, and the course of treatment is usually 4-8 weeks.
(3) Zhuoai syndrome: 60mg once (3 tablets each time), daily 1 time, and then the total daily dose can be adjusted to 20 ~ 120 mg (1 ~ 6 tablets) according to the condition. If the total daily dose needs to exceed 80mg(4 tablets), it should be taken twice.
counteraction
This product is well tolerated. Common adverse reactions include diarrhea, headache, nausea, abdominal pain, flatulence and constipation. Occasionally, serum transaminase (ALT, AST) rises, rash, dizziness, drowsiness, insomnia, etc. These adverse reactions are usually mild and can disappear automatically, regardless of dosage. No serious adverse reactions were found after long-term treatment, but gastric mucosal cell proliferation and atrophic gastritis may occur in some cases.
taboo
It is forbidden for those who are allergic to this product, severe renal insufficiency and infants.
Matters needing attention
(1) When treating gastric ulcer, the possibility of ulcer gastric cancer should be ruled out first, because this product can alleviate its symptoms and delay treatment.
(2) Use with caution in patients with hepatic and renal insufficiency.
(3) This product is an enteric-coated tablet. Please be careful not to chew it up when taking it, so as to avoid the premature release of drug particles in the stomach and affect the curative effect.
Medication 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 lactating women with caution.
Children's medication
Children are inexperienced in drug use, and infants are prohibited.
Medication for elderly patients
drug interaction
This product can delay the elimination of drugs metabolized by the liver, such as diazepam, phenytoin sodium, warfarin and nifedipine. When this product is combined with the above drugs, the dosage of the latter should be reduced.
excessive
standard
10 mg
store
Sealed and stored in a cool and dry place.
parcel
term of validity
Registration authentication number
Production enterprise
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