Product Overview
[Generic Name]
Omeprazole Enteric-Coated Capsules
[Drug Name]
Revised Omeprazole Enteric-Coated Capsules
[Main Ingredients]
The main ingredient of this product is omeprazole.
[Indications]
Indicated for gastric ulcers, duodenal ulcers, stress ulcers, reflux esophagitis, and Zollinger-Ellison syndrome (gastrinoma).
[Dosage and Administration]
Oral administration, do not chew.
1. Peptic gastric ulcer: 20 mg (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: 20-60 mg (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:
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.
[Appearance]
This product consists of white or off-white enteric-coated pellets or granules, or enteric-coated capsules containing an off-white powder.
[Adverse Reactions]
This product is well tolerated. Uncommon 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 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: May experience paresthesia, dizziness, headache, drowsiness, insomnia, and peripheral neuritis. 3. Metabolic/Endocrine System: Long-term use of omeprazole may lead to vitamin B12 deficiency. 4. Other: May cause rash, gynecomastia, and hemolytic anemia.
[Contraindications]
This product is contraindicated in patients with allergies, severe renal insufficiency, and infants.
[Precautions]
1. When treating gastric ulcers, the possibility of ulcerative gastric cancer should be ruled out first, as this product may alleviate its symptoms and thus delay treatment.
2. Use with caution in patients with hepatic and renal insufficiency.
3. This product is an enteric-coated capsule. Be careful not to chew it when taking it to prevent premature release of drug particles in the stomach, which could affect efficacy.
4. This product is sensitive to light and heat and is recommended to be stored below 20°C.
[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 taken with clarithromycin or erythromycin, their blood concentrations increase. However, there is no interaction with metronidazole or amoxicillin. 3. Omeprazole has enzyme inhibitory properties. When used 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 have shown that daily oral administration of omeprazole (20-40 mg) 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).
[Storage Conditions]
Store in a dry, airtight container protected from light.
[Specifications]
14 capsules/box
[Approval Number]
National Medicine Standard H20033484
[Manufacturer]
Correct Pharmaceutical Group Changchun High-Tech Pharmaceutical Co., Ltd.
