Product Overview
[Drug Name]
Trade Name: Pantoprazole Sodium Enteric-Coated Capsules
Chinese Pinyin: Pantuolazuona Changrong Jiaonang
[Ingredients]
Pantoprazole Sodium
[Properties]
This product is a white or off-white loose block or powder. The dedicated solvent is a colorless, clear liquid.
[Indications]
Primarily used for: ① Peptic ulcer bleeding. ② Acute gastric mucosal injury caused by nonsteroidal anti-inflammatory drugs and 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]
One tablet orally daily in the morning.
[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. It is contraindicated in pregnant and lactating women.
[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; 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 Pediatric Use: Efficacy and safety data for this product in children have not been established. This product is contraindicated in infants and young children.
Precautions for Pregnancy and Lactation: This product is contraindicated in pregnant and lactating women. Elderly Precautions: No dose adjustment required.
[Drug Interactions]
Not yet known.
[Pharmacological Actions]
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, thereby effectively suppressing gastric acid secretion. Because H+ and K+-ATPases are the final step in parietal cell acid secretion, 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 choline 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]
40mg x 14 tablets
[Packaging]
Box
[Expiration]
24 months
[Approval Number]
National Medicine Standard H20010032
[Manufacturer]
Company Name: Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd.
