Product Overview
[Drug Name]
Generic Name: Omeprazole Enteric-Coated Capsules
Trade Name: Tianlankang Omeprazole Enteric-Coated Capsules 20mg x 30 capsules
Pinyin Full Code: AoMeiLaZuoChangRongJiaoNang 20mg x 30Li
[Main Ingredients]
The main ingredient of this product is omeprazole.
[Properties]
This product contains white or off-white enteric-coated pellets or granules, or an off-white powder in an enteric-coated capsule.
[Indications/Main Functions]
Indicated for gastric ulcers, duodenal ulcers, stress ulcers, reflux esophagitis, and Zollinger-Ellison syndrome (gastrinoma).
[Specifications]
20mg x 30 capsules
[Dosage and Administration]
Oral administration, do not chew. 1. Peptic ulcer: 20mg (1 capsule) once or twice daily. Take orally 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: Take 20-60 mg (1-3 tablets) once or twice daily. Take orally in the morning or once in the morning and evening. The treatment course is usually 4-8 weeks. 3. Zollinger-Ellison syndrome: Take 60 mg (3 tablets) 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 occur, but these are generally mild and transient and 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. Omeprazole's acid-suppressing effect can affect iron absorption. 5. Omeprazole can alter gastric pH, thereby damaging sustained-release and controlled-release formulations and accelerating drug dissolution. 6. Omeprazole and Other Drug Interaction Studies have shown that daily oral administration of 20-40 mg of omeprazole does not affect other related CYP isoenzymes and has no metabolic interactions with the following enzyme 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 the drug on diagnosis: ① Omeprazole may inhibit gastric acid secretion, increasing gastric pH and, in turn, triggering the secretion of gastrin by G cells in the gastric mucosa, thereby increasing blood gastrin levels. ② Omeprazole may increase the 13C-urea breath test. False-negative UBT results may be due to omeprazole's direct or indirect inhibitory effect on Helicobacter pylori (HP). Clinically, the 13C-urea breath test should be performed at least four weeks after omeprazole treatment. 3. Items that should be monitored before, during, and after medication use: ① Efficacy monitoring: When treating peptic ulcers, an endoscopic examination should be performed to determine ulcer healing. When treating HP-related peptic ulcers, a UBT test may be performed 4-6 weeks after treatment completion to determine HP 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 monitored regularly. Long-term users should undergo regular gastric mucosal examinations 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 drug can alleviate symptoms and thus delay diagnosis. 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).
[Pediatric Use]
There is no experience with this drug in children. It is contraindicated in infants and young children.
[Elderly Use]
Dose adjustment is generally not required for elderly patients, but caution should be exercised.
[Overdose]
Manifestations of overdose include: blurred vision, confusion, sweating, drowsiness, dry mouth, facial flushing, headache, nausea, tachycardia or irregular heartbeat. Overdose management: Primarily symptomatic and supportive care. Omeprazole is not easily dialyzable; accidental overdose should be treated immediately.
[Pharmacology and Toxicology]
Proton pump inhibitor. This product is a fat-soluble weak alkaline drug that is easily concentrated in an acidic environment. Therefore, after oral administration, it can be specifically distributed in the secretory tubules of the gastric mucosal parietal cells and converted into the active form of sulfenamide in a sub-high acid environment. It then irreversibly binds to the sulfhydryl group of the H+, K+-ATPase (also known as the proton pump) in the secretory membrane of the parietal cells through a disulfide bond, thereby inhibiting the activity of the enzyme and blocking the final step of gastric acid secretion. Therefore, this product has a strong and lasting inhibitory effect on gastric acid secretion caused by various reasons.
