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  药店国别: 美国药房
产地国家: 美国
所属类别: 妇科药物->月经量过多
处方药:处方药
包装规格: 650毫克/片 30片/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
辉凌制药
生产厂家英文名:
FERRING PHARMS AS
该药品相关信息网址1:
http://www.lysteda.com/
该药品相关信息网址2:
http://www.drugs.com/lysteda.html
该药品相关信息网址3:
http://www.rxlist.com/lysteda-drug.htm
原产地英文商品名:
LYSTEDA 650MG/TAB 30TABS/BOTTLE
原产地英文药品名:
TRANEXAMIC ACID
中文参考商品译名:
LYSTEDA 650毫克/片 30片/瓶
中文参考药品译名:
氨甲环酸
原产地国家批准上市年份:
2009/11/13
英文适应病症1:
Excessive menstrual
临床试验期:
完成
中文适应病症参考翻译1:
月经量过多
药品信息:

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 详细处方信息以本药内容附件PDF文件(201032321380728.pdf)的“原文Priscribing Information”为准
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部分中文氨甲环酸处方资料(仅供参考)

氨甲环酸片(Lysteda)被FDA批准治疗妇女月经量过多
    Lysteda(氨甲环酸片)作为首个非激素类药物美国食品药品管理局(FDA)于2009年11月13日批准上市用于治疗月经期出血量过多。

    FDA通报:美国每年有大约300,0000名育龄妇女出现月经期出血量过多现象。患有子宫平滑肌瘤的妇女可能还会出现月经期过长症状,但大多数情况下,经血过多与子宫平滑肌瘤并没有潜在的联系。

      氨甲环酸(Tranexamic acid)于1986年首次在美国以注射剂形式获批,商品名为Cyklokapron,主要用于血友病(一种由于缺少凝血因子而导致凝血障碍的遗传性疾病)患者拔牙过程中及拔牙后的止血和预防出血。

      Lysteda的临床试验显示,Lysteda最常见的不良反应主要包括头痛、鼻窦症状、背痛、腹痛、肌肉和关节疼痛、肌肉痛性痉挛、贫血和疲劳等症状。接受安慰剂组妇女与接受ysteda治疗的妇女在经期出血量方面的差异具有统计学意义。

      FDA药品审评与研究中心生殖与泌尿外科部主任、医学博士Scott Monroe认为,Lysteda与激素类避孕药同时使用可能会使出现血栓、中风、心脏病发作的风险增大。使用激素类避孕药的女性只有在具有强烈的用药需求或使用后的收益大于潜在风险时才能够同时服用Lysteda。

LYSTEDA was consistently effective in clinical trials across every month it was studied, including the very first month. In two clinical studies LYSTEDA reduced Heavy Monthly Bleeding by 38% and 39% compared with 12% and 5% with placebo (sugar pills).

LYSTEDA® is a prescription medicine used to treat your heavy monthly period (menstruation) when your bleeding gets in the way of social, leisure and physical activities. LYSTEDA does not contain any hormones and is taken only during your period. It does not treat premenstrual symptoms, does not affect your fertility, and cannot be used as birth control. It does not protect against sexually transmitted diseases.

LYSTEDA has not been studied in adolescents younger than 18 years of age.

Important Safety Information
You should not take LYSTEDA if you currently have or have ever had a blood clot, have been told you are at risk for having a blood clot, or are allergic to LYSTEDA or tranexamic acid.

LYSTEDA can cause serious side effects, including:
•The risk of serious blood clots may be increased when LYSTEDA is taken with hormonal contraceptives, especially if you are taking higher than your normal dose of birth control, are overweight, or if you smoke cigarettes. Risk of serious blood clots may also be increased if you take LYSTEDA with medicines used to help your blood clot or some medicines used to treat leukemia.
•Stop taking LYSTEDA and promptly report any eye problems to your healthcare provider.
•If you have shortness of breath and your throat feels tight, stop taking LYSTEDA and get medical help right away.

Before taking LYSTEDA, tell your healthcare provider about all of your medical conditions, including whether: you have ever had a blood clot or been told that you are at risk of having a blood clot, you are using a form of birth control that contains hormones, you are pregnant or think you may be pregnant, you are breastfeeding or plan to breast-feed, the time between the start of your periods is less than 21 days or more than 35 days, or you have any other medical conditions.

Tell your healthcare provider about all the medicines you take, especially if you take: birth control pills or other hormonal birth control, medicines used to help your blood clot, medicines used to break up blood clots, or any medicines to treat leukemia.

The most common side effects of LYSTEDA include: headaches, sinus and nasal problems, back pain, pain in your abdomen, pain in your muscles or joints, anemia, and fatigue.

If you notice a change in your usual bleeding pattern that worries you, or your heavy bleeding continues, contact your healthcare provider right away. This may be a sign of a more serious condition.

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 详细处方信息以本药内容附件PDF文件(201032321380728.pdf)的“原文Priscribing Information”为准
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更新日期: 2013-06-27
附件:






2011113017154733.PDF    

 
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