Product Overview
[Drug Name]
Trade Name: Jianlangchen
English Name: Pantoprazole Sodium Enteric-coated Capsules
Chinese Pinyin: Pantuolazuona Changrongjiaonang
[Ingredients]
The main ingredient of this product is pantoprazole sodium. Its chemical name is 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl-1H-benzoimidazole sodium salt monohydrate. Molecular formula: C₁₆H₁₄F₂N₃NaO₄S₈H₂O. Molecular weight: 423.38
[Properties]
This product is a white or off-white loose block or powder. The special solvent is a colorless, clear liquid.
[Indications]
Main indication: 1. Peptic ulcer bleeding. 2. Acute gastric mucosal damage caused by nonsteroidal anti-inflammatory drugs and the occurrence of severe ulcer bleeding under stress; 3. Preventing gastric acid reflux and aspiration pneumonia after general anesthesia or major surgery, as well as in debilitated and comatose patients.
[Dosage and Administration]
This product must be taken under a physician's guidance according to the following dosage. Take one tablet orally daily before breakfast. The treatment course for duodenal ulcers is usually 2-4 weeks, and for gastric ulcers and reflux esophagitis is usually 4 weeks. Continue taking the product as needed. This product has minimal individual variability, and the dosage does not require adjustment in elderly patients.
[Adverse Reactions]
Occasional symptoms include dizziness, insomnia, drowsiness, nausea, diarrhea, constipation, rash, and muscle pain. High doses may cause cardiac arrhythmias, elevated aminotransferases, changes in renal function, and granulocytopenia.
[Contraindications]
This product is contraindicated in patients with allergies and during pregnancy and lactation.
[Precautions]
1. This product has a strong and long-lasting inhibitory effect on gastric acid secretion. Therefore, it should not be taken concurrently with other antacids or acid suppressants. To prevent excessive acid suppression, high-dose, long-term use is not recommended for conditions such as peptic ulcers (except for Zollinger-Ellison syndrome).
2. No dose adjustment is required for patients with impaired renal function; however, a dose reduction may be appropriate for patients with impaired liver function.
3. This product should only be used to treat gastric ulcers after gastric cancer has been ruled out to avoid delays in diagnosis and treatment.
4. In animal studies, long-term, high-dose use of this product has been associated with hypergastrinemia and subsequent enlargement of gastric ECL cells and benign tumors. These changes can also occur with the use of other acid suppressants and after subtotal gastrectomy.
[Use in Special Populations]
Precautions for Pediatrics: Not yet available.
Precautions for Pregnancy and Lactation: Contraindicated in pregnant and lactating women.
Precautions for Elderly: Not yet available.
[Drug Interactions]
Not yet available.
[Pharmacological Action]
This drug 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 drug specifically inhibits H+ and K+-ATPases located in the secretory microtubules and tubulo-vacuoles of the apical membrane of parietal cells, causing irreversible inhibition of these enzymes and thereby effectively suppressing gastric acid secretion. Because H+ and K+-ATPases are the final step in the acid secretion process of parietal cells, this drug has a strong acid-suppressing effect. It not only non-competitively inhibits gastric acid secretion induced by gastrin, histamine, and choline, but also inhibits basal gastric acid secretion that is not affected by cholinergics or H2 receptor blockers. This drug has the advantage of minimal drug-drug interactions when used in combination with other drugs. This drug is metabolized by system I of the cytochrome P450 enzyme system in hepatocytes, but can also be metabolized by system II. When used with other drugs metabolized by the P450 enzyme system, this product is metabolized through the P450 enzyme system, making it less likely to compete with drug-metabolizing enzymes and reducing drug-drug interactions in the body. It is non-mutagenic, carcinogenic, or teratogenic.
[Storage]
Store tightly closed.
[Specifications]
40 mg
[Packaging]
40 mg x 7 tablets
[Expiry Life]
24 months
[Approval Number]
National Medicine Standard H19990260
[Manufacturer]
Company Name: Hunan Jianlang Pharmaceutical Co., Ltd.
