Product Overview
[Drug Name]
Generic Name: Pantoprazole Sodium Enteric-Coated Tablets
Trade Name: TongBang Pantoprazole Sodium Enteric-Coated Tablets 40mg x 14 Tablets
Pinyin Code: TongBang ZuoTuoLaZuoNaChangRongPian 40mg x 14 Tablets
[Main Ingredient]
Pantoprazole sodium. Its chemical name is: 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]-sulfinyl}-1H-benzimidazole sodium monohydrate.
[Properties]
Reddish-brown enteric-coated film-coated tablets, appearing white after removal of the film coating.
[Indications/Main Functions]
For duodenal ulcers, gastric ulcers, reflux esophagitis, and Zollinger-Ellison syndrome.
[Specifications]
40mg x 14 tablets
[Dosage and Administration]
Oral administration: 40mg once daily in the morning for 2-4 weeks.
[Adverse Reactions]
Occasional symptoms include dizziness, insomnia, drowsiness, nausea, diarrhea, constipation, rash, and muscle pain. High doses may cause irregular heartbeats, elevated transaminases, changes in renal function, and decreased granulocytes.
[Contraindications]
This product is contraindicated in patients with allergies, breastfeeding women, and women in the first trimester of pregnancy.
[Drug Interactions]
Oxytoprazole has minimal interactions with other drugs. 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 sodium, aminophylline, aminopyrine, nifedipine, or antacids.
[Precautions]
1. High doses may cause irregular heartbeats, elevated transaminases, changes in renal function, and decreased granulocytes.
2. This product is enteric-coated and should not be chewed.
3. When gastric ulcers are suspected, the possibility of cancer should be ruled out first. Because treatment with this drug may alleviate symptoms, this may delay diagnosis.
4. Efficacy and safety data for this drug in children have not been established.
5. Use with caution in patients with hepatic and renal impairment.
[Pediatric Use]
Currently, there is no experience with this drug in children; use with caution.
[Elderly Use]
AUC and Cmax were slightly increased in elderly volunteers compared with healthy young subjects, but this was not clinically significant. Therefore, no dose adjustment is required for elderly patients.
[Overdose]
High doses may cause arrhythmias, elevated transaminases, changes in renal function, and granulocytopenia.
[Pharmacology and Toxicology]
This drug is a gastric parietal cell proton pump inhibitor. It is relatively stable under neutral and weakly acidic conditions and rapidly activated under strongly acidic conditions. Its pH-dependent activation properties make it more selective for H+ and K+-ATPases. This product specifically inhibits H+ and K+-ATPases on the secretory microtubules and tubulo-vacuoles of the apical membrane of parietal cells, causing irreversible inhibition of the enzymes, thereby effectively suppressing gastric acid secretion. Because H+ and K+-ATPases are the final step in parietal cell acid secretion, this product has a powerful 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 minimizing drug-drug interactions when used in combination with other drugs. This product is metabolized by system I of the cytochrome P450 enzyme system in 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 metabolism proceeds through system II, making competition with drug-metabolizing enzymes less likely, thereby reducing drug-drug interactions in the body. It is non-mutagenic, carcinogenic, and teratogenic.
