Product Overview
[Drug Name]
Generic Name: Erdosteine Capsules
Trade Name: Haixin Erdosteine Capsules 150mg*12 Capsules
Pinyin Code: HaiXin EDuoSiTanJiaoNang 150mg*12Li
[Main Ingredient]
The main ingredient of this product is erdosteine.
[Properties]
This product is a hard capsule containing a white or off-white powder.
[Indications/Main Functions]
It is indicated for acute and chronic bronchitis and airway obstruction caused by thick sputum.
[Precautions]
Use with caution in patients with severe liver or kidney dysfunction. Patients with peptic ulcers should take this product under the guidance of a physician.
[Drug Interactions]
This product is contraindicated in patients with allergies.
[Pediatric Use]
This product is contraindicated in children under 15 years of age.
[Elderly Use]
The safety of this product during pregnancy has not been established. Therefore, pregnant and breastfeeding women should avoid this product.
[Specifications]
150mg*12 tablets
[Dosage and Administration]
Oral, 0.3g (2 tablets) twice daily.
[Adverse Reactions]
Nausea, stomach discomfort, bloating, and gastrointestinal disturbances.
[Contraindications]
Contraindicated in patients with allergies to this product.
[Overdose]
Unknown.
[Pharmacology and Toxicology]
Pharmacological Action: This product is a mucolytic agent and a prodrug. Its molecular structure contains a blocked sulfhydryl group (-SH). It is biotransformed in the liver into an active metabolite containing a free sulfhydryl group, which exerts its mucolytic effect. Its mechanism of action is likely to be that the free sulfhydryl metabolite cleaves the disulfide bonds of mucins in bronchial secretions, altering their composition and rheological properties (reducing sputum viscosity), thereby facilitating sputum excretion. Additionally, this product may enhance mucociliary function. Toxicology Studies: Repeated-dose toxicity: Continuous oral administration of this product for three months in Beagle dogs and SD rats at doses of 48 mg/kg/day and 300 mg/kg/day, respectively (equivalent to 2.7 times and 4.9 times the proposed human clinical dose, based on body surface area conversion), resulted in positive urine ketone bodies, a toxic reaction that was reversible after drug discontinuation. Genotoxicity: The Ames test, CHL cell chromosome aberration test, and ICR mouse bone marrow micronucleus test were all negative. Reproductive toxicity during the teratogenically sensitive period: Continuous gavage administration of 1000 mg/kg/day (equivalent to 162 times the proposed human clinical dose based on body surface area) to pregnant SD rats from gestational days 6 to 15 resulted in suppressed maternal weight gain, delayed fetal ossification of the skull, hyoid bone, thoracic vertebral center, and pubic bone, and decreased ossification points in the caudal vertebrae, xiphoid process, and metacarpal bones. The no-toxicity dose was 500 mg/kg/day (equivalent to 81 times the proposed human clinical dose based on body surface area).
[Pharmacokinetics]
Research reports indicate that single and multiple oral doses of erdosteine in healthy adults resulted in low plasma concentrations of the unchanged drug, and at least three metabolites containing free sulfhydryl groups were detected. The drug has a plasma protein binding rate of 64.5% and is primarily excreted via the kidneys as an inorganic sulfate salt. Food rarely affects its absorption. Metabolism and excretion are well documented, and no accumulation was observed after multiple doses. The metabolism of this product after oral administration in healthy elderly volunteers and children and adults with acute and chronic bronchitis is the same as that in healthy adult volunteers. In patients with moderate liver and kidney impairment, the pharmacokinetics of this product are not significantly changed.
