[English name] Omeprazole Enteric-coated Capsules 

[element] The main ingredients of this product are: omeprazole.

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

Chemical structure formula: Molecular formula: C17H19N3O3S Molecular weight: 345.42 [Characteristics] This product is a capsule, and the contents are white or white-like enteric-soluble pills or particles.

[Indications] Suitable for gastric ulcer, duodenal ulcer, stress ulcer, reflux esophagitis, and Zhuoyi AIDS syndrome (gastrinoma).

[Specification] 20mg [usage and dosage] Oral administration, not chewing.

(1) Peptic ulcer: 20mg once (one l particle), 1~2 times a day.

Every morning after swallowing or once in the morning and evening, gastric ulcer course is usually 4 to 8 weeks, duodenal ulcer course is usually 2 to 4 weeks.

(2) Reflux esophagitis: one time 20~60 mg at once (one l~3 grains), 1~2 times a day.

Once in the morning or once in the morning and evening, the course of treatment is usually 4 to 8 weeks.

(3) Zhuo-AIDS syndrome: 60mg (3 grains at a time), once a day. Later, the total daily dose can be adjusted to 20-120 mg (1~6 grains) according to the condition. If the total daily dose exceeds 80mg (4 grains), it should be divided into two doses.

[Adverse reactions] This product is well tolerated, and the common adverse reactions are diarrhea, headache, nausea, abdominal pain, gastrointestinal flatulence and constipation, and occasionally increased serum aminotransferase (ALT, AST), rash, dizziness, drowsiness, insomnia, etc. These adverse reactions are usually mild and can disappear automatically, regardless of the dose.

Long-term treatment shows no serious adverse effects, but gastric mucosal cell hyperplasia and atrophic gastritis can occur in some cases.

[Contraindications] to this product allergy, severe renal insufficiency and infants are prohibited.

[Notes] (1) In the treatment of gastric ulcer, the possibility of ulcer-type gastric cancer should be excluded first, because the treatment with this product can reduce its symptoms, thus delaying the treatment.

(2) Use with caution in patients with liver and kidney insufficiency.

(3) This product is an enteric capsule, take attention not to chew when taking it, so as to avoid the premature release of drugs in the stomach and affect the curative effect.

(4) Combination of this product will reduce the efficacy of clopidogrel and increase thrombotic adverse events.

(5) Long-term use of this product should pay attention to the possible fracture risk, especially in elderly patients, the blood magnesium level should be monitored regularly to prevent the occurrence of hypomagnesemia.

(6) Patients who are using clopidogrel drugs should pay attention to drug interaction and communicate with doctors on drug safety issues before treatment to ensure drug safety.

[Use for pregnant and lactating women] Although animal experiments have shown 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.

[Children] there is no drug experience for children, infants are prohibited.

[Geriatric medication] This experiment was not conducted and there is no reliable reference.

[Drug interaction] This product can delay the elimination of liver metabolic drugs in the body, such as stability, phenytoin sodium, Chinese decree, nitrobidine, etc. When this product is used together with the above drugs, the amount of the latter should be reduced.

[Overdose] This experiment was not performed and no reliable references.

[Pharmacological toxicology] proton pump inhibitor.

This product is fat-soluble weak alkali drugs, easy to concentration in acidic environment, so after oral administration can be specifically distributed in the gastric mucosa wall cells secretion tubules, and in this high acid environment into the active form of sulfonamide, and then through the disulfide bond and wall cells secretion membrane of H +, K + -ATP enzyme (also known as proton pump) irreversible combination, form sulfonamide and proton pump complex, thus inhibit the activity of the enzyme, to block the last step of gastric acid secretion, so this product has a strong and lasting inhibition of gastric acid secretion caused by various reasons.

[Pharmacokinetics] After oral administration of this product, it is absorbed by the small intestine and effective within l hours. The blood concentration reaches 0.5~3.5 hours. The effect lasts for more than 24 hours, and can be distributed to liver, kidney, stomach, duodenum, thyroid and other tissues, and easily pass through the placenta.

Usually single dose bioavailability is about 35%, multiple dose bioavailability increases to about 60%, plasma protein binding rate of 95% to 96%, plasma half-life of 0.5 to l hours, and 3 hours in patients with chronic liver disease.

This product is metabolized by the liver microsomal cytochrome P450 oxidase system in the body. About 80% of the metabolites are excreted by urine, and the rest is excreted from feces by bile.

[Storage] shading, sealed, stored in a dry place.

[Packaging] Aluminum foil packaging, 12 / plate 1 board / box; 12 / plate 2 board / box; 10 / plate 2 board / box; 14 / board 1 board / box; 14 / plate 2 board / box.

[Expiry date] of 36 months 

[Approval No.] Chinese drug approval word H20184020 

[Drug Marketing License Holder] Shanghai Yan'an Pharmaceutical Co., LTD