Product Overview
[Generic Name]
Omeprazole Enteric-Coated Capsules
[Drug Name]
Luoxin Enkang Omeprazole Enteric-Coated Capsules
[Main Ingredient]
Omeprazole.
[Indications]
For the short-term relief of heartburn and acid reflux symptoms caused by excessive stomach acid.
[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 is usually 2-4 weeks. 2. Reflux esophagitis: 20-60 mg (1-2 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 capsules at a time), once daily. The total daily dose can be adjusted to 20-120 mg (1-6 capsules) depending on the condition. If the total daily dose exceeds 80 mg (4 tablets), it should be taken in two divided doses.
[Properties]
This product consists of white or off-white enteric-coated pellets or granules.
[Adverse Reactions]
This product is well tolerated. Possible adverse reactions 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, generally mild and transient, and generally do not affect treatment. Furthermore, international data have reported that gastric mucosal cell hyperplasia or atrophic gastritis may be observed in gastric biopsy specimens of patients treated with long-term omeprazole therapy. 2. Neuropsychiatric System: Paresthesias, dizziness, headaches, drowsiness, insomnia, and peripheral neuritis may occur. 3. Metabolic/Endocrine System: Long-term use of omeprazole may lead to vitamin B12 deficiency. 4. Other: Rash, gynecomastia, and hemolytic anemia may occur.
[Precautions]
1. Use with caution in patients with renal or severe hepatic impairment. 2. Effects of the drug on diagnosis: ① Omeprazole may inhibit gastric acid secretion, increasing gastric pH. This feedback loop stimulates the secretion of gastrin by G cells in the gastric mucosa, thereby increasing blood gastrin levels. ② Omeprazole may cause false-negative results in the 13C-urea breath test (UBT). The mechanism may be a direct or indirect inhibitory effect of omeprazole on Helicobacter pylori (Hp). Clinically, the 13C-urea breath test should not be performed for at least 4 weeks after 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 to 6 weeks after treatment completion to determine if H. pylori has been eradicated. When treating Zollinger-Ellison syndrome, basal gastric acid secretion should be monitored to ensure it is less than 10 mEq/h (i.e., the treatment target). ② Toxicity Monitoring: Liver function tests should be performed regularly. Long-term users should regularly examine the gastric mucosa for tumor-like hyperplasia. Serum vitamin B12 levels should also be monitored for users taking the drug for more than 3 years. 4. When treating gastric ulcers, this drug should be used only after the possibility of cancer has been ruled out. This medication can alleviate symptoms and thus delay treatment. 5. To prevent excessive acid suppression, long-term, high-dose use of this drug is not recommended for the treatment of general peptic ulcers (except in Zollinger-Ellison syndrome).
[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.
[Specifications]
14 tablets/box
[Approval Number]
National Medicine Standard No. H20033444
[Manufacturer]
Shandong Luoxin Pharmaceutical Group Co., Ltd.
