Product Overview
[Drug Name]
Trade Name: Ostan
English Name: Omeprazole Enteric Capsules
Chinese Pinyin: Aomeilazuo Jiaonang
[Ingredients]
Main ingredient and its chemical name: Omeprazole, chemical name: 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfoxide}-1H-benzimidazole. Molecular formula: C₁ₐH₁ₐN₃O₃S, molecular weight: 345.41.
[Properties]
This product is a capsule containing small granules in an off-white enteric coating.
[Indications]
Indicated for gastric ulcers, duodenal ulcers, stress ulcers, reflux esophagitis, and Zollinger-Ellison syndrome (gastrinoma).
[Dosage and Administration]
Oral administration, do not chew.
1. Peptic ulcer: 20 mg (one tablet at a time), 1-2 times daily. Take orally in the morning or once in the morning and evening. The treatment course for gastric ulcers is usually 4 to 8 weeks, and for duodenal ulcers is usually 2 to 4 weeks.
2. Reflux esophagitis: Take 20 to 60 mg (1 to 3 tablets) once or twice daily. Take orally in the morning or once in the morning and evening. The treatment course is usually 4 to 8 weeks.
3. Zollinger-Ellison syndrome: Take 60 mg (3 tablets) once daily. The total daily dose can be adjusted to 20 to 120 mg (1 to 6 tablets) depending on the condition. If the total daily dose exceeds 80 mg (4 tablets), it should be taken in two divided doses.
[Adverse Reactions]
This product is well tolerated. Common adverse reactions include diarrhea, headache, nausea, abdominal pain, flatulence, and constipation. Rarely, elevated serum aminotransferases (ALT, AST), rash, dizziness, drowsiness, and insomnia may occur. These adverse reactions are generally mild, disappear spontaneously, and are not related to dose. Long-term treatment has not been associated with serious adverse reactions, but gastric mucosal cell hyperplasia and atrophic gastritis may occur in some cases.
[Contraindications]
This product is contraindicated in patients with allergies, severe renal insufficiency, and infants and young children.
[Precautions]
1. When treating gastric ulcers, the possibility of ulcerative gastric cancer should be ruled out first, as this product may alleviate symptoms and delay treatment.
2. Use with caution in patients with hepatic and renal insufficiency. 3. This product comes in enteric-coated capsules; be careful not to chew them when taking to prevent premature release of the drug in the stomach, which could affect efficacy.
[Use in Special Populations]
Precautions for Children:
This product is contraindicated for infants and young children.
Precautions for Pregnancy and Lactation:
Although this product has not been shown to cause teratogenicity in animal studies, it should generally not be used in pregnant women, and should also be used with caution in lactating women.
Precautions for Elderly People:
This product is not yet available.
[Drug Interactions]
This product may delay the elimination of drugs metabolized by the liver, such as diazepam, phenytoin, warfarin, and nifedipine. When used with these medications, the dosage of the latter should be reduced.
[Pharmacological Actions]
Proton pump inhibitor. This product is a lipid-soluble, weakly alkaline drug that tends to concentrate in acidic environments. Therefore, after oral administration, it is specifically distributed in the secretory tubules of the gastric parietal cells. In this highly acidic environment, it is converted to its active form, the sulfenamide. It then irreversibly binds to the sulfhydryl group of the H+,K+-ATPase (also known as the proton pump) in the parietal cell secretory membrane via a disulfide bond, forming a sulfenamide-proton pump complex. This complex inhibits the enzyme's activity and blocks the final step in gastric acid secretion. Therefore, this product has a strong and long-lasting inhibitory effect on gastric acid secretion caused by various causes.
[Storage]
Store tightly closed in a cool, dry place.
[Strength]
20mg
[Packaging]
Plastic bottle, 14 tablets/bottle
[Expiry Date]
24 months
[Approval Number]
National Medicine Standard H10980308
[Manufacturer]
Shantou Special Economic Zone Qibin Pharmaceutical Factory
