Product Overview
[Drug Name]
Trade Name: Fangsheng
English Name: Omeprazole Enteric-coated Tablets
Chinese Pinyin: Aomeilazuo Jiaonang
[Ingredients]
The main ingredient of this product is omeprazole.
[Properties]
This product is an enteric-coated tablet, which appears white or off-white after removing the coating.
[Indications]
It is suitable 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 (1 tablet at a time), 1-2 times daily. Swallow once in the morning or once in the morning and evening. The treatment course for gastric ulcers is usually 4-8 weeks, and the treatment course for duodenal ulcers is usually 2-4 weeks.
2. Reflux esophagitis: 20-60 mg (1-3 tablets at a time), 1-2 times daily. Take in the morning or once in the morning and evening. The course of treatment is usually 4 to 8 weeks.
3. Zollinger-Ellison syndrome: 60 mg (3 tablets at a time) 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, gastrointestinal bloating, and constipation. Occasionally, elevated serum aminotransferases (ALT, AST), rash, dizziness, drowsiness, and insomnia may occur. These adverse reactions are generally mild, resolve spontaneously, and are not related to dosage.
[Contraindications]
1. This product is contraindicated in patients with allergies, severe renal insufficiency, and infants and young children.
2. It should also be used with caution in breastfeeding women.
[Precautions]
1. When treating gastric ulcers, the possibility of ulcerative gastric cancer should be ruled out first, as this drug may alleviate symptoms and thus delay treatment.
2. Use with caution in patients with hepatic and renal insufficiency.
3. This product is an enteric-coated tablet. Be careful not to chew it when taking it to prevent premature release of drug particles in the stomach and affect efficacy.
[Special Population Use]
Precautions for Children: Contraindicated in infants and young children.
Precautions for Pregnancy and Lactation: Use with caution in lactating women.
Precautions for the Elderly: Dosage adjustment is generally not required for elderly patients, but caution is advised.
[Drug Interactions]
1. Avoid concomitant use with oral imidazole antifungals such as ketoconazole, itraconazole, miconazole, and fluconazole.
2. Concomitant use of omeprazole and clarithromycin may increase the incidence of central nervous system (primarily headache) and gastrointestinal adverse reactions.
3. Avoid concomitant use with diazepam (Valium), phenytoin, warfarin, nifedipine, digoxin, cisapride, quinidine, cyclosporine, caffeine, and theophylline.
4. Concomitant use with other medications may cause drug interactions. Please consult your physician or pharmacist for details.
[Pharmacological Action]
Proton pump inhibitor. This drug is a lipid-soluble, weakly alkaline drug that is easily concentrated in acidic environments. Therefore, after oral administration, it is specifically distributed in the secretory tubules of the gastric mucosal 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 of gastric acid secretion. Therefore, this drug has a strong and long-lasting inhibitory effect on gastric acid secretion caused by various reasons.
[Storage]
Store in a dry, airtight container away from light.
[Specification]
20mg
[Packaging]
20mg x 14 tablets
[Expiration Period]
18 months
[Approval Number]
National Medical Products Approval No. H20103295
[Manufacturer]
Company Name: Hunan Fangsheng Pharmaceutical Co., Ltd.
