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  药店国别: 意大利药房
产地国家: 意大利
所属类别: 作用于呼吸系统药物->支气管扩张
处方药:处方药
包装规格: 300毫克/胶囊 20胶囊/盒
计价单位:
   
生产厂家英文名:
Rottapharm SpA
原产地英文商品名:
Erdotin 300mg 20 capsules
原产地英文药品名:
Erdosteine
中文参考商品译名:
好舒丹 300毫克/胶囊 20胶囊/盒
中文参考药品译名:
厄多司坦
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
bronchitis
英文适应病症2:
respiratory-tract congestion
临床试验期:
完成
中文适应病症参考翻译1:
支气管炎
中文适应病症参考翻译2:
呼吸道充血
药品信息:
药理作用:本品属粘液溶解剂,为一前体药物,其分子结构中含有被封闭的巯基(-SH),通过肝脏生物转化成含有游离巯基的活性代谢产物而发挥粘痰溶解作用。其作用机理可能主要是通过含游离巯基的代谢产物使支气管分泌物的粘蛋白的二硫键断裂,改变其组成成分和流变学性质(降低痰液粘度),从而有利于痰液排除。另外,本品还具有增强粘膜纤毛运动功能等作用。 毒理研究: 重复给药毒性:Beagle犬和SD大鼠连续经口给予本品3个月的无毒性反应剂量分别为48mg/kg/日和300mg/kg/日(按体表面积折算,分别相当于人临床拟用剂量的2.7倍和4.9倍),与给药相关的毒性反应为尿酮体阳性,停药后可恢复。 遗传毒性:本品Ames试验、CHL细胞染色体畸变试验和ICR小鼠骨髓微核试验结果均为阴性。 致畸敏感期生殖毒性:SD孕大鼠在怀孕第6~15天连续灌服本品,剂量达1000mg/kg/日(按体表面折算,相当于人临床拟用剂量的162倍)时,母鼠体重增长抑制,胎仔头骨、舌骨、胸椎椎体中心及耻骨骨化迟缓,尾椎、剑突、掌骨骨化点数减少。无毒性反应剂量为500mg/kg/日(按体表面积折算,相当于人临床拟用剂量的81倍)。 药动学: 本品经口服后迅速被胃肠道吸收,并很快代谢转化为3个含有游离巯基的代谢物,代谢物经尿、粪便和胆汁清除。健康成人单次或多次口服本品后发现,血浆中会出现少量、短时的原形药物,代谢物有64.5%与血浆蛋白结合,其无机硫酸盐化合物主要经肾排泄,食物对其吸收代谢和排泄的影响很小。多次给药未发现药物蓄积作用。患急性或慢性支气管炎的,儿童或成年人及健康老年志愿者口服相当于成人剂量的厄多司坦后,药物代谢同健康成年人一样。中度肝肾功能障碍不会显著改变厄多司坦的药物动力学特性。 适应症: 粘痰溶解药。用于急性和慢性支气管炎痰液粘稠所致的呼吸道阻塞。 用法用量: 口服,一次300mg,一日2次。 不良反应: 较常见的不良反应为消化不良、恶心、呕吐、胃痛等胃肠道反应。 相互作用: 注意事项: 1、服药期间,应避免同服强力镇咳药,亦不能同服使支气管分泌物减少的药物。 2、有胃溃疡或十二指肠溃疡的患者,慎用本品。 3、对本品过敏者禁用。不足15岁的儿童、严重肝肾功能不全者禁用。 Pharmacological effects : This is a mucolytic agent , is a prodrug , which is closed in the molecular structure containing mercapto (-SH), and play a role in dissolving phlegm by hepatic biotransformation to the active metabolite containing a free thiol group . The mechanism may be mainly through the free sulfhydryl -containing metabolites bronchial mucin secretion break disulfide bonds , and the composition changes its rheological properties ( viscosity reducing sputum ) , thus facilitating sputum excluded. In addition, the product also has enhanced mucociliary movement function and so on . Toxicology : Repeat dose toxicity : Beagle dogs and SD rats were orally administered continuously for 3 months this product NOAEL was 48mg/kg / day and 300mg/kg / day ( converted by the body surface area , representing one of the clinical with a dose of 2.7 -fold and 4.9 -fold ) , toxic reactions associated with the administration of positive urine ketone bodies resume after the withdrawal . Genetic Toxicity: Ames test , CHL cell chromosome aberration test in bone marrow micronucleus test results and ICR mice were negative. Teratogenic sensitive period reproductive toxicity : SD pregnant rats during pregnancy 6 to 15 days in a row this product gavage at doses up to 1000mg/kg / day ( converted by the body surface , equivalent to 162 times the human dose intended to be used in clinical ), the maternal weight gain, depression, fetal skull , the hyoid bone , thoracic vertebral ossification centers and pubic slow , caudal , xiphoid process , metacarpal ossification points decrease . NOAEL was 500mg/kg / day ( converted by the body surface area , equivalent to 81 times the proposed human clinical dose of ) . Pharmacokinetics : After oral administration of the product is rapidly absorbed from the gastrointestinal , metabolic conversion and soon to contain free sulfhydryl three metabolites , metabolite in the urine , feces and bile cleared. Healthy adults after single or repeated oral administration of discovery , there will be a small amount of plasma , short of unchanged drug , metabolites 64.5% bound to plasma proteins, inorganic sulfate compounds primarily by renal excretion, their absorption and metabolism of food and excretion of small. Multiple doses found no drug accumulation effect. Suffering from acute or chronic bronchitis , a child or adult and elderly healthy volunteers, the equivalent of the adult dose oral Erdosteine ​​, healthy adults with the same drug metabolism . Moderate kidney dysfunction does not significantly alter the pharmacokinetic properties of erdosteine ​​. Indications: Mucolytics . For acute and chronic bronchitis caused by airway obstruction viscous sputum . Dosage: Orally, 300mg, 2 times a day . Adverse reactions: The more common adverse reactions indigestion , nausea , vomiting, stomach pain and other gastrointestinal reactions . Interactions: Note: 1 , during the medication should be avoided strong antitussive same service , nor a drug to reduce bronchial secretions to make the same service . 2, there are patients with gastric or duodenal ulcer careful using . 3 , allergic to the chemicals were banned. Children under 15 years of age, severe liver and kidney dysfunction disabled.
更新日期: 2014-04-03
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