Product Overview
[Drug Name]
Trade Name: Xikangbeibei
Generic Name: Omeprazole Enteric-Coated Capsules
[Indications]
Indicated for gastric ulcers, duodenal ulcers, stress ulcers, reflux esophagitis, and Zollinger-Ellison syndrome (gastrinoma).
[Descriptions]
This product consists of white or off-white enteric-coated pellets or granules.
[Dosage and Administration]
Oral administration; do not chew.
1. Peptic ulcer: 20 mg (1 capsule at a time), 1-2 times daily. Take in the morning or once in the morning and evening. The treatment course for gastric ulcers is usually 4-8 weeks, and for duodenal ulcers, 2-4 weeks.
2. Reflux esophagitis: 20-60 mg (1-3 capsules at a time), 1-2 times daily. Take in the morning or once in the morning and evening. The treatment course is usually 4-8 weeks.
3. Zollinger-Ellison syndrome: 60 mg (3 tablets at a time) once daily. The total daily dose can be adjusted to 20-120 mg (1-6 tablets) depending on the condition. If the total daily dose exceeds 80 mg (4 tablets), it should be taken in two divided doses.
[Contraindications]
This product is contraindicated in patients with allergies, severe renal insufficiency, and infants.
[Adverse Reactions]
This product is well tolerated. Adverse reactions may include:
1. Digestive system: Dry mouth, mild nausea, vomiting, abdominal distension, constipation, diarrhea, and abdominal pain may occur; elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin may occur, but these are generally mild and transient and generally do not affect treatment. Other international data have reported that gastric mucosal cell hyperplasia or atrophic gastritis may be observed in gastric corpus biopsy specimens of patients treated with long-term omeprazole.
2. Neuropsychiatric system: Paresthesias, dizziness, headache, drowsiness, insomnia, and peripheral neuritis may occur.
3. Metabolic/Endocrine System: Long-term use of omeprazole may lead to vitamin B12 deficiency.
4. Other: May cause rash, gynecomastia, hemolytic anemia, etc.
[Precautions]
1. Use with caution in patients with renal insufficiency or confirmed hepatic insufficiency.
2. Effects of the drug on diagnosis:
① Omeprazole can inhibit gastric acid secretion, increasing gastric pH, which in turn triggers the secretion of gastrin by G cells in the gastric mucosa, thereby increasing blood gastrin levels.
② Omeprazole can cause false-negative results in the C-urea breath test (UBT). The mechanism may be that omeprazole has a direct or indirect inhibitory effect on Helicobacter pylori (Hp). In clinical practice, C-urea breath testing should be performed after at least 4 weeks of omeprazole treatment.
3. Items that should be checked or monitored before, during, and after medication use:
① Efficacy monitoring. When treating peptic ulcers, an endoscopic examination should be performed to determine if the ulcer has healed. When treating H. pylori-related peptic ulcers, a UBT test can be performed 4-6 weeks after treatment completion to determine if H. pylori has been eradicated. When treating Zollinger-Ellison syndrome, basal gastric acid secretion should be measured to ensure it is less than 10 mEq/h (i.e., the treatment target).
② Toxicity testing: Liver function should be monitored regularly. Long-term users should undergo regular gastric mucosal examinations for tumor-like hyperplasia. Serum vitamin B12 levels should be measured if the medication has been used for more than 3 years.
4. When treating gastric ulcers, cancer should be ruled out before using this medication. Treatment with this medication may alleviate symptoms and delay diagnosis.
5. To prevent excessive acid suppression, long-term, high-dose use of this medication is not recommended for the treatment of general peptic ulcers (except in Zollinger-Ellison syndrome).
[Ingredients]
The main ingredient of this product is omeprazole.
[Manufacturer]
Hebei Sams Pharmaceutical Co., Ltd.
[Approval Number]
National Medicine Standard No. H20093291
