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SAMSCA 托伐普坦

通用名称托伐普坦 Tolvaptan
品牌名称SAMSCA
产地|公司日本(Japan) | Otsuka Pharmaceutical(Otsuka Pharmaceutical)
技术状态
成分|含量7.5mg
包装|存储20片/盒 室温
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通用中文 托伐普坦 通用外文 Tolvaptan
品牌中文 品牌外文 SAMSCA
其他名称
公司 Otsuka Pharmaceutical(Otsuka Pharmaceutical) 产地 日本(Japan)
含量 7.5mg 包装 20片/盒
剂型给药 片剂口服 储存 室温
适用范围 治疗由充血性心衰、肝硬化以及抗利尿激素分泌不足综合征导致的低钠血症。
通用中文 托伐普坦
通用外文 Tolvaptan
品牌中文
品牌外文 SAMSCA
其他名称
公司 Otsuka Pharmaceutical(Otsuka Pharmaceutical)
产地 日本(Japan)
含量 7.5mg
包装 20片/盒
剂型给药 片剂口服
储存 室温
适用范围 治疗由充血性心衰、肝硬化以及抗利尿激素分泌不足综合征导致的低钠血症。

使用说明书

(免责声明:本说明书仅供参考,不作为治疗的依据,不可取代任何医生、药剂师等专业性的指导。本站不提供治疗建议,药物是否适合您,请专业医生(或药剂师)决定。)
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中文说明

(免责声明:本说明书仅供参考,不作为治疗的依据,不可取代任何医生、药剂师等专业性的指导。本站不提供治疗建议,药物是否适合您,请专业医生(或药剂师)决定。)

【药品名称】

  通用名称:托伐普坦片

  商品名称:托伐普坦片(苏麦卡)

  英文名称:Tolvaptan Tablets

 

【主要成份】 主要成分为托伐普坦。化学名称:N-[4-[(5R)-7-氯-5-羟基-2,3,4,5-四氢-1-苯并氮杂卓-1-甲酰基]-3-甲基苯基]-2-甲基苯甲酰胺。

【成 份】

   分子量:C26H25ClN2O3

【性 状】 本品为蓝色片剂。

【适应症/功能主治】 本品用于治疗临床上明显的高容量性和正常容量性低钠血症(血钠浓度<125mEq/L,或低钠血症不明显但有症状并且限液治疗效果不佳),包括伴有心力衰竭、肝硬化以及抗利尿激素分泌异常综合征(SIADH)的患者。(详见说明书)

【规格型号】 7.5mg*20s

【用法用量】 本品通常的起始剂量是15mg、每日1次,餐前餐后服药均可。服药至少24小时以后,可将服用剂量增加到30mg,每日1次。根据血清钠浓度,最大可增加至60mg,每日1次。在初次服药和增加剂量期间,要经常检测血清电解质和血容量的变化情况,应避免在治疗最初的24小时内限制液体摄入。直到服用本品的患者,口渴时应即使饮水。(详见说明书)

【不良反应】 口渴、口干、乏力、便秘、尿频或多尿以及高血糖。

【禁 忌】 1、急需快速升高血清钠浓度。 2、对口渴不敏感或对口可不恩呢号正常反应的患者。 3、低容量性低钠血症。 4、与强效CYP3A抑制剂合并应用。 5、无尿症患者。 6、对本品任何成份过敏者。 7、高血钠症患者。(详见说明书)

【注意事项】 1.过快纠正血清钠浓度会导致严重的神经系统后遗症。 2.肝硬化患者的胃肠道出血。 3.脱水及血容量减少。(详见说明书)
请仔细阅读说明书并遵医嘱使用。

【儿童用药】 尚不明确。

【老年患者用药】 尚不明确。

【孕妇及哺乳期妇女用药】 尚不明确。

【药物相互作用】 如与其他药物同时使用可能会发生药物相互作用,详情请咨询医师或药师。

【药物过量】 尚不明确。

【药理毒理】 一种血管加压素V2受体拮抗药(非肽类AVP2受体拮抗剂),可以升高血浆中钠离子浓度,帮助多余的水分从尿液排出。增强肾脏处理水的能力。多囊肾细胞内环磷酸腺苷(cAMP)积聚,其通过刺激囊液分泌和内衬细胞增生促进囊肿生长。托伐普坦是2型加压素受体拮抗剂,可抑制cAMP生成和聚积。在多种PKD动物模型研究中,托伐普坦显示出良好疗效。

【药代动力学】 尚不明确。

【贮 藏】 密封。

 

 

外文说明

(免责声明:本说明书仅供参考,不作为治疗的依据,不可取代任何医生、药剂师等专业性的指导。本站不提供治疗建议,药物是否适合您,请专业医生(或药剂师)决定。)

Description

This medicine acts on the kidneys and resolves swelling of the body by increasing the urine output and removing unnecessary fluids.
It is usually used in combination with other diuretics when the other diuretics alone do not show sufficient effect.

Presentation

20tablets

Feature

Blue square tablet

Active Ingredients

Tolvaptan

Effect/Efficacy

This medicine acts on the kidneys and resolves swelling of the body by increasing the urine output and removing unnecessary fluids.
It is usually used in combination with other diuretics when the other diuretics alone do not show sufficient effect.

Usage/Dosage

○ General dosage :
  ●Volume overload in heart failure when adequate response is not obtained with other diuretics (e.g., loop diuretics): for adults, take 2 tablets (15 mg of active ingredient), once daily. In order to avoid nocturnal urination, it is desirable to take the medicine in the morning. Your doctor may decide to start the medicine at 1 tablet (7.5 mg of active ingredient) or to later reduce the dose to half according to your symptoms.
  ●Body fluid retention in hepatic cirrhosis when adequate response is not obtained with other diuretics (e.g., loop diuretics): for adults, take 1 tablet (7.5 mg of active ingredient), once daily. In order to avoid nocturnal urination, it is desirable to take the medicine in the morning. Your doctor may decide to start the medicine at half dose (3.75 mg of active ingredient) or to later reduce the dose to half according to your symptoms.

○ In each case, strictly follow the instructions.
○ If you miss a dose, take the missed dose as soon as you remember it. However, if it is close to the time for the next dose, skip the missed dose and continue your regular dosing schedule. You shoul

Cautions

- If you feel thirst, drink an appropriate amount of water to prevent dehydration but be careful not to drink an excessive amount.
- This medicine increases both urine volume and urination frequency and should therefore be used with caution.
- Women of childbearing potential should use contraception to avoid pregnancy while taking this medicine. Contact your doctor immediately if you discover that you are pregnant while on this medicine.
- This medicine may cause dizziness and caution is therefore required to avoid falling accidents. In particular, you should pay sufficient attention when working in high places or operating potentially hazardous machinery, including motor vehicles, while on this medicine.
- Avoid taking this medicine with grapefruit juice since it may enhance the effects of this medicine.
- Avoid taking this medicine with health foods containing Hypericum perforatum (St. John's wort) since it may reduce the therapeutic effect of this medicine.
- As frequent serum sodium concentration measurements are necessary whille on this medicine, follow the instructions of your doctor.

Contraindication

● The most commonly reported adverse reactions are following symptoms. If any of these symptoms occur, consult with your doctor or pharmacist.
  - thirst, dizziness, frequent urination, excessive urination, headache, and constipation

● 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.
  - decrease of urine output, swelling, thirst [renal failure]
  - localized pain, pressured pain, erythema [thromboembolism]
  - mental confusion and hyperventilation, dehydration symptoms such as thirst, decreased consciousness (in serious cases, coma) [hypernatremia]
  - general malaise, loss of appetite, yellowing in skin and white of eyes [liver dysfunction]
  - decreased blood pressure, hives, respiratory distress [shock, anaphylaxis]

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.