Product Overview
[Drug Name]
Generic Name: Hemtoprazole Sodium Enteric-Coated Capsules
Trade Name: Yanglisu Hemtoprazole Sodium Enteric-Coated Capsules 20mg x 14 capsules
Pinyin Code: ZuoLiSuZuoTuoLaZuoNaChangRongJiaoNang20mg x 14Li
[Main Ingredients]
The main ingredient of this product is hemtoprazole sodium.
[Properties]
This product is a capsule containing white or off-white enteric-coated micropellets.
[Indications/Main Functions]
Indicated for active peptic ulcers (gastric and duodenal ulcers), reflux esophagitis, and Zollinger-Ellison syndrome.
[Specifications]
20mg x 14 capsules
[Dosage and Administration]
Oral administration: one 40mg capsule daily before meals. The treatment course for duodenal ulcers is usually 2-4 weeks, while the treatment course for gastric ulcers and reflux esophagitis is usually 4-8 weeks. For patients with severe liver impairment, the daily dose should not exceed 20mg. No dose adjustment is required for patients with impaired renal function.
[Adverse Reactions]
Dizziness, insomnia, drowsiness, nausea, diarrhea and constipation, rash, and muscle pain are occasionally reported during clinical use.
[Contraindications]
This product is contraindicated in patients with known hypersensitivity to any of its components or any of its benzoimidazole substituents.
[Drug Interactions]
1. Effects on antiretroviral drugs. 2. Anticoagulants. 3. Drugs whose bioavailability may be affected by gastric acid. 4. May produce false-positive results in urine tests for THC.
[Precautions]
1. This product is an enteric-coated formulation; do not chew it before taking. 2. Concomitant gastric cancer. 3. Atrophic gastritis. Atrophic gastritis may occasionally be observed in gastric corpus biopsies of patients treated with long-term hemitoprazole sodium therapy, especially in patients who are positive for Helicobacter pylori. 4. Vitamin B12 insufficiency. 5. Fractures. 6. Carcinogenicity. 7. Effects on urine tests for THC. 8. Hypomagnesemia. 9. Decreased gastric acid secretion caused by any route can reduce the number of bacteria normally living in the gastrointestinal tract. 10. Impact on the ability to drive or operate machinery.
[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]
Not yet known.
[Pharmacology and Toxicology]
This product is a proton pump inhibitor in gastric parietal cells. Under neutral and weakly acidic conditions, its H-dependent activation makes it more selective for H+ and K+-ATPase. This product specifically inhibits H+ and K+-ATPase located in the secretory microtubules of the parietal cell apical membrane and in the tubular vesicles within the cytoplasm, causing irreversible inhibition of the enzyme, thereby effectively inhibiting gastric acid secretion. Because H+ and K+-ATPase 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 some basal gastric acid secretion that is unaffected by choline or H2 receptor blockers. When used in combination with other drugs, this product has the advantage of minimal drug-drug interactions. 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 can proceed through System I, making competitive action with the drug-metabolizing enzyme system less likely to occur, thereby reducing drug-drug interactions in the body. It has no mutagenic, carcinogenic, or teratogenic effects.
