英文药名：Clobazam（Frisium、Urbanol）

中文药名：氯巴占片

药品介绍

氯巴占副作用;别名:氧异安定、氯巴扎姆、异安定酮、Frisium、Urbanol;氯巴占适应症:适用于焦虑症和难治性癫痫的治疗。对癫痫复杂性发作继发全身性发作和伦-加综合征效果更佳。;氯巴占药理学作用:本品为长效苯二氮卓类药物，药理作用与地西泮相似，其镇静副作用很小，更适合用于成人癫痫的辅助治疗。本品对不同病因引起的癫痫患者的部分性发作和全身性发作均有效，但通常作为辅助用药。对可预测癫痫发作的患者(例如妇女月经性癫痫)可采用间歇治疗。间歇方法有助于预防耐受性的产生。

分类名称
 
一级分类：神经系统药物 二级分类：抗癫痫药物 三级分类：其他 
 
药品英文名
 
Clobazam
 
药品别名
 
氧异安定、氯巴扎姆、异安定酮、Frisium、Urbanol
 
药物剂型
 
片剂：10mg，20mg。
 
药理作用
 
本品为长效苯二氮卓类药物，药理作用与地西泮相似，其镇静副作用很小，更适合用于成人癫痫的辅助治疗。本品对不同病因引起的癫痫患者的部分性发作和全身性发作均有效，但通常作为辅助用药。对可预测癫痫发作的患者(例如妇女月经性癫痫)可采用间歇治疗。间歇方法有助于预防耐受性的产生。
 
药动学
 
口服易于吸收，1～4h可达血药峰值，85%与血浆蛋白结合。在肝内通过，脱甲基和羟基化作用进行代谢。原药和活性代谢物N-去甲基氯巴占的平均t1/2分别为18h和42h。本品高度亲脂，迅速透过血-脑脊液屏障。原药和代谢物主要随尿排出。
 
适应证
 
适用于焦虑症和难治性癫痫的治疗。对癫痫复杂性发作继发全身性发作和伦-加综合征效果更佳。
 
禁忌证
 
1.对本品过敏者、孕妇、哺乳者禁用。
2.严重肝病、急性闭角型青光眼和卟啉症患者禁用。
 
注意事项
 
如连续应用，其抗惊厥作用逐渐减弱，可采用“放假疗法”，如女性患者，在月经期发作时，可在月经来潮前2～3天开始用药，10天后再用。
 
不良反应
 
1.参见地西泮。
2.偶有焦躁、抑郁和肌无力。
3.偶有月经性癫痫患者服药后经期推迟的报道。
4.突然停药可出现戒断症状，亦可加剧癫痫发作，故停药应逐渐减量过渡。
5.个例报道，本品可致中毒性表皮坏死松解症。
用法用量
1.治疗焦虑症：常用每天20～30mg，分次服，或单次晚间服。
2.用于癫痫的辅助治疗：剂量与用法同治疗焦虑症。
3.3岁或大于3岁儿童：推荐剂量为不超过成人剂量的1/2。4.老年或体弱患者的推荐剂量为每天10～20mg。
 
药物相应作用
 
1.参见地西泮。
2.与卡马西平、苯巴比妥、苯妥英钠、丙戊酸合用，本品的血浓度降低，而后者浓度升高。
 
专家点评
 
该药为广谱抗癫痫药物。但因其抗癫痫机制同氯硝西泮，除出现困倦等副作用外可产生药物依赖性。 

Oct 24, 201 (BUSINESS WIRE) -- Lundbeck Inc. ("Lundbeck"), a wholly owned subsidiary of H. Lundbeck A/S in Denmark (lun:Copenhagen Stock Exchange), announced today that the U.S. Food and Drug Administration (FDA) has approved ONFI(TM) (clobazam) as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older.(1) ONFI (pronounced "ON-fee") will be available in U.S. pharmacies in early January and is a federally controlled schedule four substance (C-IV).

LGS is a rare and severe form of epilepsy that is typically diagnosed in childhood and often persists into adulthood.(3,4) LGS is associated with multiple types of seizures with periods of frequent seizures, and daily seizures are common.(5) Some of these seizures, including atonic, tonic and myoclonic seizures, may cause falls, or "drop seizures" (also referred to as "drop attacks"), which may result in injury.(3)

"As an epileptologist treating patients with a variety of challenging seizure disorders, I'm aware of the need for new add-on therapies to address the severe and frequent seizures associated with LGS," said Joan A. Conry, MD, professor of neurology at Children's National Medical Center in Washington, D.C., and a principal investigator of the CONTAIN Trial. "Clobazam, now approved as ONFI, was shown to be effective as adjunctive therapy for reducing seizures associated with LGS,(1) and its upcoming availability provides hope for additional seizure management to patients and their physicians, caregivers and families."

The FDA approval of ONFI was based on two multicenter controlled studies similar in terms of disease characteristics and prior treatment of patients, including a pivotal Phase III study in 238 patients with a current or prior diagnosis of LGS.(1) Named the CONTAIN Trial, the study's primary endpoint was the percent reduction in the weekly frequency of drop seizures (atonic, tonic, or myoclonic), from the 4-week baseline period to the 12-week maintenance period. A Phase II dose-ranging study was also conducted (n=68) that was consistent with results of the CONTAIN Trial.(1)

The most common adverse reactions in the CONTAIN Trial included sleepiness or tiredness, fever, drooling, acting aggressive, irritability, lack of coordination and constipation. The adverse reactions leading to discontinuation in greater-than or equal to 1 percent in the CONTAIN Trial in decreasing order of frequency included tiredness, sleepiness, lack of coordination, acting aggressive, fatigue and difficulty sleeping.(1)

"The FDA approval of ONFI is a major milestone for Lundbeck as we continue our efforts to develop therapies for people with disorders of the central nervous system, including severe seizure disorders," said Christopher Silber, M.D., vice president of U.S. clinical research and medical affairs at Lundbeck. "ONFI will be the second therapy for challenging types of epilepsy that Lundbeck has launched in the last two and a half years."

About ONFI(TM) (clobazam)

ONFI is an oral antiepileptic drug developed in the United States by Lundbeck Inc, and will be available in 5 mg, 10 mg, and 20 mg tablets. ONFI is a 1,5 benzodiazepine. The exact mechanism of action for ONFI is not fully understood, but is thought to involve potentiation of GABAergic neurotransmission resulting from binding at the benzodiazepine site of the GABAA receptor.(1)

Important Safety Information(1)

-- ONFI is a prescription medicine used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome in people 2 years of age or older.

-- ONFI can make you sleepy or dizzy and can slow your thinking and make you clumsy which may get better over time. Do not drive, operate heavy machinery, or other dangerous activities until you know how ONFI affects you. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking ONFI without first talking to your healthcare provider as your sleepiness or dizziness may get much worse.

-- ONFI can cause withdrawal symptoms. Do not stop suddenly taking ONFI without first talking to a healthcare provider. Stopping ONFI suddenly can cause seizures that will not stop (status epilepticus), hearing or seeing things that are not there (hallucinations), shaking, nervousness, and stomach and muscle cramps.

-- ONFI can be abused and cause dependence. Physical dependence is not the same as drug addiction. Talk to your healthcare provider about the differences. ONFI is a federally controlled substance (C-IV) because it can be abused or lead to dependence.

-- Like other antiepileptic drugs, ONFI may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings, and especially if they are new, worse, or worry you.

-- If you are pregnant or plan to become pregnant, ONFI may harm your unborn baby. You and your healthcare provider will have to decide if you should take ONFI while you are pregnant.

-- ONFI can pass into breast milk. You and your healthcare provider should decide if you should take ONFI or breast feed. You should not do both.

-- The most common side effects seen in ONFI patients include: sleepiness; drooling; constipation; cough; pain with urination; fever; acting aggressive, being angry or violent; difficulty sleeping; slurred speech; tiredness and problems with breathing.

For more information, please see the ONFI Medication Guide and Full Prescribing Information.

ONFI is a trademark of Lundbeck Inc.

pharmaceutical preparations made in significant part from clobazam for the prevention and treatment of disorders of the nervous system
health educational services for doctors and patients, namely, conducting programs to increase patient awareness and compliance relating to disorders of the nervous system, and distributing related health education materials in connection therewith

Onfi Approved for Lennox-Gastaut Syndrome
The FDA has approved Onfi (clobazam tablets; Lundbeck) as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) in patients ≥2 years of age. The approval of Onfi was based on data from two multicenter controlled studies similar in terms of disease characteristics and prior treatment of patients, including a pivotal Phase 3 study in 238 patients with a current or prior diagnosis of LGS. Named the CONTAIN Trial, the study's primary endpoint was the percent reduction in the weekly frequency of drop seizures (atonic, tonic, or myoclonic), from the 4-week baseline period to the 12-week maintenance period. A Phase 2 dose-ranging study was also conducted in 68 patients that was consistent with results of the CONTAIN Trial.

Onfi, a schedule C-IV substance, is a 1,5 benzodiazepine oral antiepileptic. It will be available early January 2012 in 5mg, 10mg, and 20mg dosage strengths.

FDA批准氯巴占（clobazam）治疗重型癫痫

10月24日，美国食品和药物管理局（FDA）批准Onfi（通用名：氯巴占 clobazam）用于成人和≥2岁儿童，作为Lennox-Gastaut综合征相关癫痫的辅助治疗。

美国FDA药物评价与研究中心神经病产品部主任罗素（Russell Katz）说：“Lennox-Gastaut综合征是癫痫的严重类型，可引起致残性惊厥发作。这种疾病治疗困难，这种药使该病有了更多的治疗选择。”

Lennox-Gastaut综合征通常在4岁前发病，很多情况可引起该症，包括脑畸形、严重脑损伤、中枢神经系统感染和遗传性变性或代谢性疾病。30%~35%的病人原因不明。病人经常有频繁的惊厥发作。

多数Lennox-Gastaut综合征儿童有某种程度的智力损害、发育迟缓和行为障碍。

氯巴占的有效性（加至正在用的抗癫痫药中时）在2项纳入≥2岁儿童的多中心对照研究中确立。研究检测了从4周的基线期至维持期每周减少的跌倒发作次数。两项研究中，与对照组相比，服用氯巴占病人的惊厥控制情况有所改善。

服用氯巴占的病人常报告的不良反应包括：嗜睡、镇静、发热、多涎、便秘、咳嗽、尿道感染、失眠、攻击性、乏力、上呼吸道感染、易激惹、呕吐、吞咽困难、共济失调、支气管炎和肺炎。

FDA告诫，与其他的抗癫痫药物相似，氯巴占可能增加少数用药病人的自杀念头和行为的危险。应监测服用抗癫痫药病人的抑郁、自杀念头或行为，以及情绪或行为的异常变化。FDA还告诫，氯巴占可能减慢思维和损害运动技能，所以，服用该药的病人不能驾驶、操纵重型机械，或从事其他危险的活动，直到他们了解了药物对其影响。氯巴占能引起药物滥用和依赖。该药被归类为Schedule IV类药，属管制药品条例下。氯巴占不应突然停药。服用该药的病人应与医师沟通，缓慢停药以避免戒断症状。