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【药品名称】

  通用名称：枸橼酸莫沙必利片

 

  英文名称：Mosapride Citrate Tablets

 

【主要成份】 枸橼酸莫沙必利。

【成 份】

  化学名：4-氨基-5-氯-2-乙氧基-N-{[4-(4-氟苄基)-2-吗啉基]甲基}苯甲酰胺枸橼酸盐

   分子量：C21H25ClFN3O3·C6H8O7·2H2O

【性 状】 本品为白色或类白色片。

【适应症/功能主治】 本品为消化道促动力剂，主要用于功能性消化不良伴有胃灼热、嗳气、恶心、呕吐、早饱、上腹胀等消化道症状；也可用于胃食管反流性疾病、糖尿病性胃轻瘫及部分胃切除患者的胃功能障碍。

【规格型号】 5mg*24s(快力)

【用法用量】 口服，一次1片，一日3次，饭前服用。

【不良反应】 主要表现为腹泻、腹痛、口干、皮疹及倦怠、头晕等。偶见嗜酸性粒细胞增多、甘油三酯升高及谷草转氨酶(GOT)、谷丙转氨酶(GPT)、碱性磷酸酶(AKP)、γ-谷氨酰转肽酶(GGT)升高。

【禁 忌】 对本品过敏者禁用。

【注意事项】 服用一段时间(通常为2周)，消化道症状没有改变时，应停止服用。
请仔细阅读说明书并遵医嘱使用。

【儿童用药】 儿童使用本品的安全性尚未确定(没有使用经验)。

【老年患者用药】 老年人用药需注意观察，发现不良反应应立即进行适当的处理，如减量用药。

【孕妇及哺乳期妇女用药】 因其安全性未确定，应避免使用本品。

【药物相互作用】 与抗胆碱药物(如硫酸阿托品、溴化丁基东莨菪碱等)合用可能减弱本品的作用。

【药物过量】 未进行该项实验且无可参考文献。

【药理毒理】 本品为选择性5-羟色胺4(5-HT4)受体激动剂，通过兴奋胃肠道胆碱能中间神经元及肌间神经丛的5-HT4受体，促进乙酰胆碱的释放，从而增强胃肠道运动，改善功能性消化不良病人的胃肠道症状，不影响胃酸的分泌。本品与大脑突触膜上的多巴胺D2、5-HT1、5-HT2受体无亲和力，因而没有这些受体阻滞所引起的锥体外系的副作用。毒理试验中，小鼠口服莫沙必利的LD502004mg/kg，腹腔注射的LD50587.77mg/kg。

【药代动力学】 药品主要从胃肠道吸收，分布以胃肠、肝肾局部药物浓度最高，血浆次之，脑内几乎没有分布。健康成人空腹一次口服本品5mg，吸收迅速，血药峰浓度为30.7ng/ml，达峰时间为0.8小时，半衰期为2小时，血浆蛋白结合率为99.0%。药品在肝脏中由细胞色素P-450中的CYP3A4酶代谢，其主要代谢产物为脱-4-氟苄基莫沙必利，本品主要经尿液和粪便排泄。

【贮 藏】 置阴凉干燥处保存。

 

 

 

 

Description

This medicine stimulates serotonin receptor in the digestive tract and increases acetylcholine release in order to improve functions of enterokinesis and gastric emptying.

Presentation

100Tablets

Feature

White tablet

Active Ingredients

Mosapride citrate hydrate

Effect/Efficacy

This medicine stimulates serotonin receptor in the digestive tract and increases acetylcholine release in order to improve functions of enterokinesis and gastric emptying.

It is usually used to treat heartburn, nausea and vomiting caused by chronic gastritis and adjunctive treatment to the pretreatment with orally gastrointestinal lavage solution for barium enema X-ray examination.

Usage/Dosage

●　For the treatment of heartburn, nausea/vomiting associated with chronic gastritis.
　　In general, for adults, take 1 tablet (5mg of mosapride citrate), 3 times a day, before or after meal.
　　Strictly follow the instructions.
●　For the treatment of adjunctive treatment to the pretreatment with orally gastrointestinal lavage solution for barium enema X-ray examination.
　　In general, for adults, take 4 tablets (20mg of mosapride citrate) with the orally gastrointestinal lavage solution (approx. 180mL) at the time of administration of the lavage solution, and take 4 tablets with a small amount of water after administration of the lavage solution.
●　For heartburn, nausea/vomiting associated with chronic gastritis, take the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.You should never take two doses at one time.

If you accidentally took more than your prescribed dose,consult with your doctor or pharmacist.
Do not stop taking this medicine unless your doctor instructs you to do so.

Cautions

Contraindication

The most reported adverse reaction include diarrhea/loose stool, dry mouth, abdominal pain, lassitude, rash, hives, nausea, feeling of fullness, headache, etc. If any of these symptoms occur, consult with your doctor or pharmacist.

The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
　　- generalized fatigability, loss of appetite, yellowness in the skin and the conjunctiva [fulminant hepatitis, liver dysfunction, jaundice]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.