药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201411318484329.pdf)的“原文Prescribing Information”为准 --------------------------------------------------------------- 部分中文mirabegron处方资料(仅供参考)
美国FDA于2011年6月10日批准Potiga(ezogabine)片剂作为添加治疗药物(add-on medication)治疗成人癫痫发作。Potiga主要用于治疗癫痫的部分发作,这是癫痫患者最常见的一种发作方式。癫痫是一种脑部疾病,发病原因是大脑神经细胞活动不正常或活动过度。癫痫部分发作时一般只影响大脑的部分区域,但会扩散到其他脑区。癫痫发作会引发系列症状,包括痉挛、行为异常、意识丧失伴随抽搐等。FDA相关主管官员指出,大约有1/3的癫痫患者不能通过现用药物很好地控制发作,因此为他们提供更多的治疗选择非常重要。Potiga是第一种用于治疗癫痫的神经元钾通道开放剂(neuronal potassium channel opener)。Potiga可通过稳定开放神经元钾通道,降低神经细胞应激性而起到抗痉挛作用,但作用机制还不十分明确。在临床试验中,Potiga最常见的副作用包括:眩晕、疲倦、意识模糊、震颤、协调性障碍、复视、注意力不集中、乏力等。Potiga会引起尿潴留,一般在治疗的头6个月内出现。尿潴留是癫痫治疗药物的一种独特的副作用,应予密切留意。
Potiga (ezogabine) is an anti-epileptic drug, also called an anticonvulsant.
Potiga is used to treat partial-onset seizures in adults.
Potiga may also be used for purposes not listed in this medication guide.
Important information about Potiga
Potiga can cause abnormal changes in your retina (the membrane layer inside your eye that helps produce vision). These changes may cause vision changes that could be permanent. Your vision will need to be checked before you start taking Potiga, and every 6 months while you are taking it.
Potiga can cause urination problems. Call your doctor at once if you have little or no urination, painful or difficult urination, or trouble emptying your bladder.
Before taking Potiga
You should not use Potiga if you are allergic to ezogabine.
To make sure you can safely use Potiga, tell your doctor if you have any of these other conditions:
kidney disease;
liver disease;
an enlarged prostate;
urination problems;
heart disease or a heart rhythm disorder;
a history of depression, mental illness, or suicidal thoughts or actions;
a personal or family history of Long QT syndrome; or
an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).
Long-term use of Potiga has caused a blue-colored appearance of the skin or eyes in some people. This effect was seen mainly in the lips, face, legs, fingernails, and toenails.
You should have your eyes checked before you start taking Potiga.
Potiga may be habit forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
FDA pregnancy category C. It is not known whether Potiga will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
See also: Potiga pregnancy and breastfeeding warnings (in more detail)
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Potiga on the baby.
It is not known whether ezogabine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using Potiga.
Along with its needed effects, ezogabine (the active ingredient contained in Potiga) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking ezogabine:
More common
Decrease in the frequency of urination
decrease in the urine volume
difficulty with passing urine (dribbling)
painful urination
shakiness in the legs, arms, hands, or feet |