Product Overview
[Drug Name]
Generic Name: Oxytoprazole Sodium Enteric-Coated Capsules
Trade Name: Oxytoprazole Sodium Enteric-Coated Capsules (Microbeads), 40mg x 7 capsules
Pinyin Full Code: WeiZhu ZuoTuoLaZuoNaChangRongJiaoNang, 40mg x 7Li/He
[Main Ingredient] Oxytoprazole sodium. Chemical Name: 5-Difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]-sulfinyl-1H-benzimidazole sodium salt monohydrate
[Properties]
This product is a hard capsule containing white or off-white pellets.
[Indications/Main Functions]
Indicated for active peptic ulcers (gastric and duodenal ulcers), reflux esophagitis, and Zollinger-Ellison syndrome.
[Specifications]
40mg x 7 capsules (microbeads)
[Dosage and Administration]
Oral administration: 40mg (1 capsule) daily before breakfast. The treatment course for duodenal ulcers is typically 2-4 weeks, while the treatment course for gastric ulcers and reflux esophagitis is typically 4-8 weeks.
[Adverse Reactions]
Clinical use may occasionally result in headache, dizziness, insomnia, drowsiness, nausea, abdominal pain, diarrhea and constipation, abdominal distension, rash, and muscle pain.
[Contraindications]
1. Contraindicated for use by lactating women and women within the first trimester of pregnancy.
2. Contraindicated for use by those allergic to this product.
[Drug Interactions]
Oxytoprazole has minimal drug interactions with other medications. Compared with omeprazole, it has less effect on the cytochrome P450 system and does not affect the duration of diazepam action. It has no significant interactions with oral contraceptives, digoxin, warfarin, phenytoin, or theophylline.
[Precautions]
1. High doses may cause arrhythmia, elevated transaminases, changes in renal function, and decreased granulocyte counts.
2. This product is enteric-coated; do not chew when taking.
3. When gastric ulcers are suspected, the possibility of cancer should be ruled out first, as treatment with this product may alleviate symptoms and thus delay diagnosis.
[Pediatric Use]
The efficacy and safety data for this product in children have not been established. It is contraindicated in infants and young children.
[Elderly Use]
No dose adjustment is required.
[Overdose]
Unknown.
[Pharmacology and Toxicology]
This product is a proton pump inhibitor of gastric parietal cells. It is relatively stable under neutral and weakly acidic conditions and rapidly activated under strongly acidic conditions. Its pH-dependent activation properties make it highly selective for H+ and K+-ATPases. This product specifically inhibits H+ and K+-ATPases located in the secretory microtubules of the parietal cell apical membrane and in the tubular vesicles within the cytoplasm, causing irreversible inhibition of the enzymes, thereby effectively suppressing gastric acid secretion. Because H+ and K+-ATPases are the final step in the acid secretion process of parietal cells, this product has a strong acid-suppressing effect. It not only non-competitively inhibits gastric acid secretion induced by gastrin, histamine, and choline, but also inhibits a portion of basal gastric acid secretion that is unaffected by choline or H2 receptor blockers. This product has the advantage of minimal drug-drug interactions when used in combination with other drugs. This product is metabolized by System I of the cytochrome P450 enzyme system within hepatocytes, and can also be metabolized by System II. When used in combination with other drugs metabolized by the P450 enzyme system, this product's metabolic pathway proceeds through System I, making competition with drug-metabolizing enzymes less likely to occur, thereby reducing drug-drug interactions in the body. It is non-mutagenic, carcinogenic, and non-teratogenic.
