Product Overview
[Drug Name]
Generic Name: Omeprazole Enteric-Coated Capsules
Trade Name: Huasu Pharmaceutical Omeprazole Enteric-Coated Capsules 20mg*14 Capsules
Pinyin Full Code: HuaSuZhiYaoAoMeiLaZuoChangRongJiaoNang 20mg*14Li
[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: C17H19N3O3S Molecular Weight: 345.42
[Properties]
This product contains white or off-white enteric-coated pellets or granules.
[Indications/Main Functions]
It is indicated for gastric ulcers, duodenal ulcers, stress ulcers, reflux esophagitis, and Zollinger-Ellison syndrome (gastrinoma).
[Specifications]
20mg*14 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 Monitoring of therapeutic efficacy. 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 to 6 weeks after treatment to determine whether H. pylori has been eradicated. When treating Zollinger-Ellison syndrome, basal gastric acid secretion should be measured to ensure it is less than 10 mEqh (i.e., the treatment target). ② Toxicity monitoring: Regular liver function tests are recommended. Long-term users should regularly check their gastric mucosa 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 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; infants and young children should not use it.
[Elderly Use]
Generally, this drug does not require dose adjustment in the elderly, but caution should be used.
[Overdose]
1. Manifestations of overdose include: blurred vision, confusion, sweating, drowsiness, dry mouth, facial flushing, headache, nausea, tachycardia or arrhythmia. 2. Management of overdose: Primarily symptomatic and supportive care. Omeprazole is not easily dialyzed; accidental overdose should be treated immediately.
[Pharmacology and Toxicology]
Proton pump inhibitor. This drug is a lipid-soluble, weakly alkaline drug that readily concentrates in acidic environments. Therefore, after oral administration, it is specifically distributed in the secretory tubules of the gastric mucosal parietal cells. In this highly acidic environment, it is converted into its active form, the sulfenamide. It then irreversibly binds to the sulfhydryl group of the H+,K+-ATPase (also known as the proton pump) in the parietal cell secretory membrane via a disulfide bond, forming a sulfenamide-proton pump complex. This complex inhibits the enzyme's activity and blocks the final step in gastric acid secretion. Therefore, this drug has a strong and long-lasting inhibitory effect on gastric acid secretion caused by various reasons.
