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7月20日，FDA已接受卫材公司关于口服混悬剂（40毫克/毫升）Banzel的新药申请，该药用于治疗癫痫症。
卫材表示，这种制剂可用于4岁以上儿童及成人患者，为那些吞咽片剂药物有困难的病人提供了一种更为便利的用药选择。
该公司此次主要申请该药可作为4岁以上儿童和成人雷诺斯-格斯特综合症（LGS）患者的辅助治疗药物。LGS是一种儿童难治性癫痫综合征，以某些类型癫痫发作、常伴精神发育迟缓及典型EEG改变为特征，占儿童癫痫4.2%～10.8%。
这份申请于今年4月30日向FDA递交，支持数据来源于一项证实口服混悬剂和目前市场已经有售的片剂具有等效性的临床实验。
Banzel片剂剂量分为200毫克和400毫克两种，于2008年11月获得FDA批准，目前也用作这类LGS癫痫症人群的辅助治疗药。
卫材北美子公司(Eisai Corporation)于2008年11月19日对外宣布称美国FDA已经批准该公司的卢非酰胺（rufinamide ，Banzel）用于癫痫Lennox-Gastaut综合征（IGS）的辅助治疗，适用年龄为4岁以上的儿童患者和成人患者。
LGS 是一种最严重的小儿癫痫症，其特点为病情反复频繁的发作。所有的儿童癫痫病例中LGS占4%，美国14岁以下的儿童中大约有30万患者。LGS 对于患者和他们的看护人员来说都是一种灾难，儿童患者一般开始发病的年龄为1～5岁间，大约3%～7%的儿童患者死于LGS的平均年龄不到10岁。这种疾病很难治疗，通常患者为了控制癫痫的发作要服用多种抗癫痫药物。
癫痫的多种类型以及频繁的发作，导致了儿童患者的发育迟缓，以及行为失调。LGS型癫痫包括了多种癫痫症状，比如肌肉僵硬、伤失张力（即全身失张性发作）这些都是其最常见的症状，而全身失张性发作是该疾病导致患者受伤最要的原因。
本品是一种三唑类的衍生物，其化合结构与目前已经上市的抗癫痫药物不同，其作用机制是通过调节大脑电压门钠离子通道而发挥作用。
一项关于卢非酰胺用于辅助治疗LGS 癫痫患者的双盲安慰剂对照的研究结果显示，患者服用本品后全身失张性发作频率的中位数下降了42.5%。全身失张性发作是指癫痫发作时，患者失去意识，突然跌落在地。而安慰剂对照组患者全身失张性发作频率的中位数增加了1.4%。
辛辛那提儿童医院医学中心综合性癫痫治疗方案的主任及卢非酰胺临床试验的主要研究员Tracy Glauser说：“LGS 患者需要更多的治疗选择”，“这项研究中，卢非酰胺的疗效及在普遍采用多种其他抗癫痫药物无效的LGS 儿童患者中表现出的良好的耐受性，我们觉得令人振奋。”
Generic Name: Rufinamide ((ru-FIN-a-mide))
Used to Treat: Control seizures associated with Lennox-Gastaut syndrome
Seizure Type: Myoclonic, Absence Seizures, Drop Attacks, Lennox-Gastaut Syndrome
Forms of the medicine:
Tablets
Dosing:
200mg and 400 mg
General Info:
What is Banzel?
Banzel (BAN-zel) is the brand name for the seizure medicine rufinamide (ru-FIN-a-mide). Banzel is usually used as an add-on treatment to control seizures associated with Lennox-Gastaut syndrome, which is a severe form of epilepsy. Banzel is taken orally and is available in 200mg and 400 mg film-coated tablets.
How do I take Banzel?
Take this medication exactly as it is prescribed for you. Usually your doctor will tell you to take Banzel two times a day. Your doctor will start you on low dose of Banzel and gradually increase your dose. To precisely adjust dose, tablet can be taken whole, as half tablets or crushed. Do not take the medication in larger amounts or longer than recommended by your doctor. Banzel is absorbed better when taken with food so it is usually taken with a meal. However, try to take in the same manner and at the same time every day. Do not change your dosage or taking schedule without your doctor's advice. Call your doctor if you are not sure about your dose or schedule of the medication. Banzel is not for the people who have Familial Short QT syndrome, which is a rare familial disease of abnormal heart rhythm. If you or your family member have a heart rhythm problem, discuss with your doctor before taking Banzel so that your doctor could check your heart rhythm with an electrocardiogram (EKG).
What if I miss a dose?
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. Do not take an extra dose, unless prescribed by your doctor. What if I experience side effects? Various side effects may occur while taking this medicine. Call your doctor if you have any questions concerning your possible side effects. However, do not stop taking your medication without advice from your doctor. They will discuss and recommend possible options. At times it is necessary to continue taking your medication despite these side effects. There are other side effects that may be serious and indicate that your body is not tolerating the drug properly. Call a doctor right away if these side effects become severe or cause considerable problems in your daily functions. If you experience a change in seizures, severe rash, allergic reaction, or thoughts about dying contact your doctor immediately as these may indicate potentially serious or life threatening problems.
Side Effects
- drowsiness
- vomiting
- headache
- fatigue
- loss of appetite
- dizziness
- irritability
- attention difficulty
- itchiness
- stomach pain
Contact your physician immediately if you experience any of the following side effects:
- worsening or longer lasting seizures
- thoughts about suicide or dying
- attempt to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- other unusual changes in behavior or mood
- severe fever or chilling
Storage
Keep this medicine in its original container, tightly closed, and out of reach of children. Store your prescription at room temperature, away from excess heat and moisture (i.e. not the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
Recommendation for women
Women taking birth control pills should discuss contraception with a physician before taking Banzel. Safety in pregnancy has not been established. Women who are taking this medication and who wish to become pregnant should discuss treatment options with their physicians before the pregnancy begins. Banzel is likely to be excreted in breast milk. Breast feeding mothers should talk to a physician before taking this medication.
Side Effects | 
