Product Overview
[Drug Name]
Generic Name: Omeprazole Enteric-Coated Capsules
Trade Name: Zhongjie Omeprazole Enteric-Coated Capsules 20mg*21 Capsules
Pinyin Code: ZhongJie AoMeiLaZuoChangRongJiaoNang 20mg*21Li
[Main Ingredients]
The main ingredient of this product is omeprazole, whose chemical name is 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfinyl)-1H-benzimidazole. Its chemical formula is: Molecular formula: C₁₇H₁₇N₃O₃S Molecular weight: 345.42.
[Properties]
This product contains white or off-white enteric-coated pellets or granules.
[Indications/Main Functions]
It is suitable for gastric ulcers, duodenal ulcers, stress ulcers, reflux esophagitis, and Zollinger-Ellison syndrome (gastrinoma).
[Specifications]
20mg*21 tablets
[Dosage and Administration]
Oral administration, do not chew. 1. Peptic ulcer: 20mg (1 tablet 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: 20-60mg (1-3 tablets 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: 60mg (3 tablets at a time), once daily. The total daily dose can be adjusted to 20-120mg (1-6 tablets) depending on the condition. If the total daily dose exceeds 80mg (4 tablets), it should be taken in two divided doses.
[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. Elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels may occur, but these are 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 corpus biopsy specimens from patients receiving long-term omeprazole therapy. 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: Rash, gynecomastia, and hemolytic anemia may occur.
[Contraindications]
This product is contraindicated in patients with allergies, severe renal insufficiency, and infants and young children.
Drug Interactions
1. Omeprazole can create an alkaline environment in the stomach, reducing the absorption of drugs such as ketoconazole and itraconazole. 2. When omeprazole is used in combination with clarithromycin or erythromycin, their plasma concentrations may increase. However, there is no interaction with metronidazole or amoxicillin. 3. Omeprazole has enzyme inhibitory properties. When used in combination with drugs metabolized by the hepatic cytochrome P450 system (CYP2C19), such as dicoumarol, warfarin, diazepam, and phenytoin, it can prolong their half-lives and slow their metabolism. 4. Omeprazole's acid-suppressing effect can affect iron absorption. 5. Omeprazole can alter gastric pH, potentially damaging extended-release and controlled-release formulations and accelerating drug dissolution. 6. Drug Interaction Studies with Other Drugs: Omeprazole (20-40 mg daily) has shown that oral omeprazole does not affect other related CYP isoenzymes and has no metabolic interactions with the following substrates: CYP1A2 (caffeine, phenacetin, theophylline), CYP2C9 (S-warfarin, piroxicam, diclofenac, and naproxen), CYP2D6 (metoprolol, propranolol), CYP2E1 (ethanol), and CYP3A (lidocaine, quinidine, estradiol, and budesonide).
[Precautions]
1. Use with caution in patients with renal or severe hepatic impairment. 2. Effects of Drugs on Diagnosis: ① Omeprazole can inhibit gastric acid secretion, increasing gastric pH. This feedback loop triggers the secretion of gastrin by G cells in the gastric mucosa, leading to elevated blood gastrin levels. ② Omeprazole can cause false-negative results on the 13C-urea breath test (UBT). This mechanism may be due to omeprazole's direct or indirect inhibitory effect on Helicobacter pylori (H. pylori). Clinically, the 13C-urea breath test should be performed at least 4 weeks after omeprazole treatment. 3. Items that should be monitored before, during, and after medication use: ① Efficacy monitoring. When treating peptic ulcers, endoscopic examination should be performed to determine ulcer healing. When treating H. pylori-related peptic ulcers, a UBT test can be performed 4-6 weeks after treatment completion to determine H. pylori eradication. 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 monitoring. Liver function should be checked regularly; long-term users should have their gastric mucosa checked regularly for tumor-like hyperplasia. Serum vitamin B12 levels should also be monitored for users who have used 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 the case of Zollinger-Ellison syndrome).
