Omeprazole Sodium Enteric-coated Tablets

Proton pump inhibitor. This product is a fat-soluble weakly alkaline drug that is easily concentrated in an acidic environment. Therefore, after oral administration, it can be specifically distributed in the secretory tubules of the gastric mucosal parietal cells and converted into the active form of sulfenamide in this high-acid environment. It then irreversibly combines with the sulfhydryl group of the H,K-ATPase (also known as the proton pump) in the secretory membrane of the parietal cells through a disulfide bond to form a complex of sulfenamide and the proton pump, thereby inhibiting the activity of the enzyme and blocking the final step of gastric acid secretion. Therefore, this product has a strong and lasting inhibitory effect on gastric acid secretion caused by various reasons.

The main ingredients of this product: Omeprazole sodium. Chemical name: 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl}-1H-benzimidazole sodium. Chemical structure: Molecular formula: C17H18N3NaO3S Molecular weight: 367.40

This product is an enteric-coated tablet, which appears white or off-white after removing the enteric coating.

It is suitable for gastric ulcer, duodenal ulcer, stress ulcer, reflux esophagitis and Zollinger-Ellison syndrome (gastrinoma).

Oral administration, do not chew. 1. Peptic ulcer: 20 mg (1 tablet at a time), 1 to 2 times a day. Swallow in the morning or once in the morning and evening. The treatment course for gastric ulcer is usually 4 to 8 weeks, and the treatment course for duodenal ulcer is usually 2 to 4 weeks. 2. Reflux esophagitis: 20 to 60 mg (1 to 3 tablets at a time), 1 to 2 times a day. Swallow in the morning or once in the morning and evening. The treatment course is usually 4 to 8 weeks. 3. Zollinger-Ellison syndrome: 60 mg (3 tablets at a time), once a day. The total daily dose can be adjusted to 20 to 120 mg (1 to 6 tablets) according to the condition. If the total daily dose needs to exceed 80 mg (4 tablets), it should be taken in two doses.

This product is well tolerated. Common adverse reactions include diarrhea, headache, nausea, abdominal pain, flatulence and constipation. Occasionally, serum aminotransferase (ALT, AST) increases, rash, dizziness, drowsiness, insomnia, etc. These adverse reactions are usually mild, disappear automatically, and are not related to the dose. No serious adverse reactions have been observed in long-term treatment, but gastric mucosal cell hyperplasia and atrophic gastritis may occur in some cases.

It is contraindicated for patients who are allergic to this product, those with severe renal insufficiency and infants.

Precautions for children: There is no experience with the use of the drug in children. It is not recommended for use in children and is contraindicated for infants and young children. Precautions for pregnancy and lactation: Epidemiological studies have shown that omeprazole has no adverse effects on pregnant women or healthy fetuses/newborns. Pregnant women can use omeprazole. Omeprazole can be secreted into breast milk, and its effects on infants are unknown. Use with caution in lactating women. Precautions for the elderly: No dosage adjustment is required for elderly patients.

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

Sealed, store in a cool, dry place.

10mg (based on omeprazole)

24 months

Suzhou Chung- HWA Chemical & Pharmaceutical Industrial Co., Ltd.

• Founded in:

  1993-04-27

• Address:

  No. 66, Yong'an Road, Suzhou High-tech Zone

• Tax NO.:

  913205056081966464

• Registered Funds:

  $25.5 million

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