Product Overview
[Drug Name]
Generic Name: Omeprazole Enteric-Coated Capsules
Trade Name: HaoDaFu Omeprazole Enteric-Coated Capsules 20mg x 24 Capsules
Pinyin Full Code: HaoDaFu AoMeiLaZuoChangRongJiaoNang 20mg x 24Li
[Main Ingredients]
The main ingredient of this product is omeprazole magnesium. Its chemical name is: bis-5-methylchloro-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl}-1H-benzimidazole magnesium.
[Indications/Main Functions]
Indicated for gastric ulcers, duodenal ulcers, stress ulcers, reflux esophagitis, and Zollinger-Ellison syndrome (gastrinoma).
[Specifications]
20mg x 24 capsules
[Dosage and Administration]
Oral administration, do not chew. 1. Peptic gastric ulcer: 20mg (1 capsule at a time), 1-2 times daily. Take orally once daily in the morning or in the 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 (1-3 tablets at a time) once or twice daily. Take orally once daily in the morning or in the 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.
[Adverse Reactions]
This product is well tolerated. Adverse reactions may include: 1. Digestive system: May cause dry mouth, mild nausea, vomiting, abdominal distension, constipation, diarrhea, and abdominal pain; Elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels may be mild and transient, and most do not affect treatment. In addition, international data have reported that gastric mucosal cell hyperplasia or atrophic gastritis can be observed in gastric corpus biopsy specimens from patients treated with long-term omeprazole therapy. 2. Neuropsychiatric System: Symptoms include paresthesias, dizziness, headaches, drowsiness, insomnia, and peripheral neuritis. 3. Metabolic/Endocrine System: Long-term use of omeprazole can lead to vitamin B12 deficiency. 4. Other Symptoms: Rash, gynecomastia, and hemolytic anemia may occur.
[Contraindications]
This product is contraindicated in patients with allergies, severe renal insufficiency, and infants.
[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 blood concentrations may increase. However, there is no interaction with metronidazole or amoxicillin. 3. Omeprazole has enzyme inhibitory effects. When used in combination with drugs metabolized by the hepatic cytochrome P450 system (CYP2C19), such as dicoumarol, warfarin, diazepam, and phenytoin, it can prolong the latter's half-life and slow their metabolism. 4. The acid-suppressing effect of omeprazole enteric-coated capsules can affect iron absorption. 5. Omeprazole can alter gastric pH, thereby damaging sustained-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 treatment with omeprazole enteric-coated capsules: ① Efficacy monitoring. When treating peptic ulcers, an 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 tests should be performed regularly; long-term users should have their gastric mucosa checked for tumor-like hyperplasia. Serum vitamin B12 levels should also be monitored for users taking the drug for more than three years. 4. When treating gastric ulcers, this drug should be used only after the possibility of cancer has been ruled out. This can alleviate symptoms and delay treatment. 5. To prevent excessive acid suppression, long-term, high-dose use of omeprazole enteric-coated capsules is not recommended for the treatment of general peptic ulcers (except in the case of Zollinger-Ellison syndrome).
[Pharmacology and Toxicology]
This drug is a proton pump inhibitor of the H+, K+-ATPase. After absorption from the small intestine, it circulates through the bloodstream and concentrates in the stomach wall, thereby suppressing gastric acid.
