NUEDEXTA已获得美国FDA批准用于als患者治疗假性延髓病影响(PBA)

苹果丫丫

NUEDEXTA

The drug Nuedexta, developed by AvanirPharmaceuticals, has received approval from the U.S. Food and DrugAdministration to treat pseudobulbar affect (PBA) associated with amyotrophiclateral sclerosis (ALS).

药物Nuedexta由AVANIR医药开发，已获得美国食品和药物管理局批准用以治疗伴有肌萎缩侧索硬化症（ALS）的假性延髓病影响(PBA)。

Nuedexta is a combination of two drugs:dextromethorphan hydrobromide (20 milligrams) and quinidine sulfate (10milligrams). Dextromethorphan acts in the central nervous system to reduce thefrequency of unwanted episodes of laughing or crying, although the precisemechanism by which it works is unknown. Quinidine increases blood levels ofdextromethorphan by interfering with its breakdown in the body.

Nuedexta是两种药物的组合：氢溴酸右美沙芬（20毫克）和硫酸奎尼丁（10毫克）。右美沙芬作用于中枢神经系统，以减少不必要的哭笑发作的频率，虽然确切的机制和治疗原理尚未知晓。奎尼丁通过干扰其在人体内的沉积物，增加右美沙芬在血液中的药物浓度。

About NUEDEXTA

NUEDEXTAis the first and only FDA-approved treatment for PseudoBulbar Affect - PBA

If you suffer fromepisodes of PBA — sudden, involuntary outbursts of crying or laughing — thereis good news. Now there's a prescription medicine for PBA that may be able tohelp you regain control of your outbursts. It's called NUEDEXTA. With NUEDEXTA,unwanted episodes of crying or laughing may be reduced or eliminated for somepeople.

NUEDEXTA has been clinicallyproven to help reduce involuntary crying and laughing episodes:

·                               Many patients experienced fewer PBA episodes after the first week oftaking NUEDEXTA

·                               On average, patients taking NUEDEXTA experienced 80% fewer PBAepisodes

As with any medicine,the effects of NUEDEXTA may vary from person to person. You are encouraged totalk with your doctor about the risks and benefits of taking NUEDEXTA, and toread the Important Safety Information below.

关于NUEDEXTA

NUEDEXTA是第一个也是唯一获得美国FDA批准的治疗假性延髓病影响（PBA）的一种药物。如果你饱受PBA的折磨，就是突然的、不自主不受控制的哭笑，那么有好消息了。现在有一种治疗PBA的处方药，能帮助你重获对病情发作的掌控力。这种药物称为NUEDEXTA。有了NUEDEXTA，一些患者不必要的突然哭笑发作的情况可能会减少或者消除。

NUEDEXTA已被临床证明，可以帮助减少不由自主的哭笑发作的状况：

·                               许多患者服用NUEDEXTA的第一个星期后，PBA就较少发作。

·                               平均而言，患者服用NUEDEXTA后， PBA发作减少80％ 。如同其他任何药物一样，NUEDEXTA的效用因人而异。您应主动与您的医生沟通服用NUEDEXTA的相关风险和好处，并阅读下面的重要安全信息。

Safety & Side Effects

NUEDEXTAcan interact with other medications causing serious side effects or changes inhow your medications or NUEDEXTA may affect you.

Tell your doctor about all medicationsand supplements you are taking before taking NUEDEXTA. While taking NUEDEXTA,do not start any new medications without first talking with your doctor. Askyour doctor what medications you cannot use with NUEDEXTA. Tell your doctor ifyou or a family member currently have or have ever had any heart disease orproblems.

Themost common side effects of NUEDEXTA include diarrhea, dizziness, cough,vomiting, weakness, swelling of feet and ankles, urinary tract infection,feeling like you have the flu, abnormal liver tests, and gas. These sideeffects were seen in 13% or less of patients taking NUEDEXTA. Those are not allthe possible risks of NUEDEXTA. Tell your doctor about any side effect thatbothers you or does not go away.

Anallergic reaction to NUEDEXTA could occur. Seek medical attention immediatelyif you develop symptoms of an allergic reaction such as swelling of the throatand tongue, difficulty breathing, abnormal heart rate or rhythm (arrhythmia),dizziness, fever, rash, or hives after taking NUEDEXTA. NUEDEXTA may causedizziness. Precautions to reduce the risk of falls should be taken.

Thisinformation does not take the place of talking with your doctor about yourhealth problem or treatment.

Pleasesee below for Important Safety Information or Full Prescribing Information.

安全与副作用

NUEDEXTA可能会与其他药物作用反应，造成严重的副作用或改变，关于药物NUEDEXTA可能怎样影响你。

告诉你的医生在服用NUEDEXTA之前你所服用的所有药物和补品。在服用NUEDEXTA期间，若没有事先与你的医生交流过，不要开始任何新药的服用。问问你的医生什么药不能与NUEDEXTA一同服用。告诉你的医生是否你或你的家人目前有或曾经有过任何心脏疾病或问题。

NUEDEXTA最常见的副作用包括腹泻、头晕、咳嗽、呕吐、四肢无力、脚和踝关节肿胀、尿路感染、有得流感的感觉、肝功能检查异常和胀气。这些副作用过去主要出现在13％或不到13%服用NUEDEXTA的患者身上。这些不是NUEDEXTA所有可能的风险。告诉你的医生任何困扰你或挥散不去的副作用。

NUEDEXTA可能会发生过敏反应。如果在服用NUEDEXTA后出现例如咽喉和舌头肿胀、呼吸困难、心脏速率或节律异常（心律失常）、头晕、发热、皮疹或荨麻疹等的过敏反应，应立即就医。NUEDEXTA可能会导致头晕。还应采取预防措施，以减少跌倒的风险。

Getting Started with NUEDEXTA

Onlyyour doctor can decide if NUEDEXTA is right for you. Take NUEDEXTA exactly asyour doctor prescribes it. For the first week (days 1 through 7), take 1capsule each morning. Beginning on day 8, increase your dose to 2 capsules perday—one capsule every 12 hours. NUEDEXTA may be taken with or withoutfood.

If you miss adose:

Ifyou forget to take 1 or more capsules, do not take a double dose. Take yournext dose of NUEDEXTA in the prescribed amount at the usual time. Do not takemore than 2 capsules in a 24-hour period. Make sure that 12 hours pass betweendoses.

Themost common side effects of NUEDEXTA are diarrhea, dizziness, cough, vomiting,weakness, swelling of feet and ankles, urinary tract infection, feeling likeyou have the flu, elevated liver enzymes, and gas. These side effects were seenin 13% or less of patients taking NUEDEXTA. Tell your doctor about any sideeffect that bother you or does not go away.

Please read Important Safety Information below or click here for Full Prescribing Information.

NUEDEXTA的入门

只有你的医生可断定NUEDEXTA是否适用于你。严格遵照医嘱服用NEDEXTA。第一周（第1～7天），每天早晨服用1粒胶囊。从第8天开始，增加剂量至每天2粒，每12小时服用1粒。NUEDEXTA空腹也可进食服用。

如果你错过了某一剂量：

如果您忘记服用1粒或多粒胶囊，不要服用双重剂量。下一次服用依然按照平时的时间，服用规定的数额。24小时内不要超过2粒。确保两次剂量之间已过去12小时。

NUEDEXTA最常见的副作用包括腹泻、头晕、咳嗽、呕吐、四肢无力、脚和踝关节肿胀、尿路感染、有得流感的感觉、肝酶升高和胀气。这些副作用过去主要出现在13％或不到13%服用NUEDEXTA的患者身上。告诉你的医生任何困扰你或挥散不去的副作用。

请阅读下面的重要安全信息或点击此处查看完整的处方信息

苹果丫丫

2011年上市，但是家园没有这个内容，补上

笔筒

国内有了吗

戒戒坏坏

国内什么时候有:victory:

602380327

{:1_1:}:hug::victory:

希望2

:hug::victory::hug:

作家侍

:victory:

爱人加油

谢谢楼主

『喝油条的豆浆

谢谢

冰掉玫瑰2014

具体药名字是什么？

litianguang

望梅