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LUVOX CR(马来酸氟伏沙明控释胶囊)

2010-11-26 15:49:53  作者:新特药房  来源:中国新特药网天津分站  浏览次数:329  文字大小:【】【】【
简介: FLUVOXAMINE MALEATE(中文:马来酸氟伏沙明控释胶囊)【药理作用】 本药是作用于脑神经细胞的5-羟色胺再摄取抑制剂,对非肾上腺素能过程影响很小。同时受体结合实验表明,本药对α-肾上腺素能、β-肾上 ...

FLUVOXAMINE MALEATE(中文:马来酸氟伏沙明控释胶囊)
【药理作用】
本药是作用于脑神经细胞的5-羟色胺再摄取抑制剂,对非肾上腺素能过程影响很小。同时受体结合实验表明,本药对α-肾上腺素能、β-肾上腺素能、组胺、毒蕈碱、多巴胺或血清因子受体几乎不具亲和性。
【药代动力学】
口服后完全吸收。服药后3-8小时即达最高血浆浓度。单剂量服用的血浆半衰期为13-15小时,多次服用后的血浆半衰期为17-22小时。如果维持剂量不变,10-14天后可达稳定的血浆水平。本药主要在肝脏中代谢,氧化成9种代谢产物,经肾脏排泄。两种主要的代谢产物几乎无药理学活性。体外实验表明,80%的氟伏沙明可与人体血浆蛋白结合。
【适应症】
抑郁症及相关症状的治疗。强迫症症状治疗。
【用法用量】
抑郁症 建议起始剂量为每日50 mg或100 mg,晚上一次服用。逐渐增量直至有效。常用有效剂量为每天100 mg,且可根据个人反应调节。个别病例可增至每日300 mg。若每日剂量超过150 mg,可分次服用。世界卫生组织要求,患者症状缓解后,继续服用抗抑郁剂至少6个月。本药用于预防抑郁症复发的推荐剂量为每日100 mg。
强迫症 推荐的起始剂量为每日50 mg,服用3-4天,通常有效剂量在每日100-300 mg之间。应逐渐增量直至达到有效剂量。成人每日最大剂量为300 mg,8岁以上儿童和青少年的每日最大剂量为200 mg。单剂量口服可增至每日150 mg,睡前服。若每日剂量超过150 mg,可分2-3次服。如已获得良好的治疗效果,可继续应用此根据个人反应调整的剂量。如果服药10周内症状没有改善应继续使用本品。尽管尚无系统资料提示应用氟伏沙明持续治疗的最长时间,由于强迫症是一慢性疾病,治疗时间可大于10周。根据病人情况仔细调整剂量,使病人接受尽可能低的有效剂量。并应定期评估是否继续治疗。也可考虑同时采用行为疗法。
【不良反应】
恶心,有时伴呕吐,服药2周后通常会消失。
在对照的临床观察中出现的发生率大于1%或大于安慰剂组的其它不良反应报告有 ;
中枢神经系统 :嗜睡、眩晕、头痛、失眠、紧张、激动、焦虑、震颤 ;
消化系统 :便秘、厌食、消化不良、腹泻、腹部不适、口干 ;
皮肤 :多汗 ;
其它 :无力、心悸、心动过速。轻微心率减慢(2-6次/分)。
与其它五羟色胺再摄取抑制剂类似,极个别报道有低钠血症,停用本药,此情况逆转。一些患者可能由于抗利尿激素分泌异常综合征引起,大部分病例为老年患者。
出血性疾病 :见“注意事项”。
体重增加或减少偶有报道。
如突然停用本药,下列症状偶有发生 :头痛、恶心、头晕和焦虑。
上述症状有些可能因患者本身的抑郁症所致,而不一定与药物相关。
【禁忌症】
禁用于对马来酸氟伏沙明或其他辅料过敏的患者。
【注意事项】
抑郁症病人自身常有自杀倾向,常在症状明显改善前持续出现。
对肝或肾功能异常的病人,起始剂量应较低并密切监控。偶见无已知肝功异常的患者服药后出现肝酶升高,且多伴临床症状。若出现此情况,应立即停药。
动物实验未发现本品可引发惊厥 ,但有癫痫史的患者应慎用,如惊厥发生应立即停用本品。
有报告应用五羟色胺再摄取抑制剂有皮肤粘膜异常出血,如瘀斑和紫癜。同时应用影响血小板功能的药物(TCAs,阿司匹林,非甾体类抗炎药等),以及有不正常出血史患者慎用。健康志愿者,每天服用本品150 mg,对驾驶或机械操作没有影响。但有报告表明,用药后可能会出现困倦,驾驶与操作机器者应注意。
【孕妇及哺乳期妇女用药】
动物繁殖实验未发现高剂量的本药对繁殖能力的损害及致畸作用。但通常孕期应慎服任何药物。本药可少量排入乳汁,故服药期间应停止哺乳。
【儿童用药】
因临床数据不足,本品不推荐给儿童使用。
【老年患者用药】
老年人常规用量与年轻患者相比无显著临床差异。然而,对老年患者调整剂量时,应缓慢增量。
【药物相互作用】
本品禁与单胺氧化酶抑制剂合用,如果病人由服用单胺氧化酶抑制剂改服本品,治疗初期应注意 :如为不可逆转的单胺氧化酶抑制剂,至少应停药2周 ;如为可逆转的单胺氧化酶抑制剂(如吗氯贝胺),可于停药后1天改服本品。
若停用本品治疗,在改用单胺氧化酶抑制剂之前至少应停药1周。
本品可使经肝脏代谢的药物分解速度减慢。当与华法令、苯妥英、茶碱和卡马西平等合用时,即会产生明显的临床效应。如合用,请调节这些药物的剂量。
本药可增加经氧化代谢的苯丙二氮的血浆浓度。有报告表明,本药可增加三环类抗抑郁药原有的稳态血浆浓度。建议本品不与三环类抗抑郁药同时应用。
本品可提高心得安的血浆水平,同服时建议减少心得安的剂量。
本品与华法令合用两周,华法令的血浆浓度明显增加且凝血时间延长。患者在口服抗凝剂和氟伏沙明时,应监测凝血时间,并相应调整氟伏沙明的剂量。
治疗严重的,已抗药的抑郁患者,本品可与锂剂合用。但锂和色氨酸可能加重氟伏沙明的5—羟色胺能作用。
未观察到本品与地高辛和阿替洛尔的协同反应。
与其它精神科用药一样,在本药用药期间应避免摄入酒精。
【药物过量】
症状 最常见的是胃肠症状 (恶心、呕吐、腹泻)、精神不振、眩晕。其它如心脏症状(心动过速、心动过缓、低血压)、肝功异常、惊厥及昏迷等也有报道。迄今为止,报告过量服用本药已超过300例。最高剂量为10,000 mg,该患者经对症治疗完全康复。偶有患者因有意服用过量本药,并合用其它药物而致较严重的合并症。
治疗 尚无本品的特异性拮抗剂。如服用过量,应尽快排空胃内容物并对症治疗。建议反复使用活性碳。利尿和透析未见良好效果。
【用药须知】
宜用水吞服,不应咀嚼。
【贮藏/有效期】
本品应保存在干燥、避光处。

LUVOX CR Now Available
 

Jazz Pharmaceuticals, Inc., has announced that Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules is now available at pharmacies nationwide. LUVOX CR was recently approved by the FDA for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD) in adult patients. For more information about LUVOX CR, please visit www.luvoxcr.com.

Online Consumer Resource
The Network of Care is a Web portal that provides consumers, families, and social service providers local resources, a health library, and a secure consumer-centered personal health record. The Network of Care is made up of more than 375 individual Web sites in more than 20 states and is being considered in other countries. It recently was named a finalist for the Stockholm Challenge; an international award that the Network says is the Nobel Prize for technology solutions addressing public needs. For more information, visit www.networkofcare.org.

Netsmart Acquires Therapist Helper
Netsmart Technologies, Inc., has acquired the Therapist Helper product suite and operations from Nightingale VantageMed Corp. Therapist Helper is a practice management and clinical system for individual and small group private-practice psychiatrists, psychologists, counselors, therapists, and social workers. By acquiring Therapist Helper, Netsmart says it is creating a greater opportunity to share clinical information among all points of care, as Netsmart offers software for other behavioral healthcare and human services settings. For more information, visit www.ntst.com.

Anxiety Disorders Treatment
Remuda Programs for Eating Disorders, an inpatient treatment center for women and girls suffering from eating disorders, has launched a treatment program for anxiety disorders. The inpatient program treats adolescents and children suffering from obsessive compulsive disorder and OCD spectrum disorders such as body dysmorphic disorder or trichotillomania, panic disorder, specific phobias, social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, and anxiety disorder not otherwise specified. All therapies occur within a cognitive-behavioral framework, are based on Biblical Christianity, and include exposure with response prevention therapy, didactic presentations, spiritual growth groups, art therapy, and more. Each patient is treated by a multidisciplinary team. For more information, visit www.remudaranch.com.

Book on Leadership Training
William A. Anthony and Kevin Ann Huckshorn have written Principled Leadership in Mental Health Systems and Programs, which explores how mental health organizations become successful and responsive systems of care that are recovery-oriented, consumer-centered, and noncoercive. Anthony and Huckshorn interviewed leaders at all levels in the mental health field who have shown the ability to transform their organizations—federal administrators, commissioners, agency directors, and program managers. They found that it’s the quality and effectiveness of leadership that fuels a successful organization. Based on these interviews, they advance eight principles and accompanying tasks critical for effective leadership. For more information, visit www.bu.edu/cpr/products/books/titles/leadership.html.

SAAS/NIATx Conference
The State Associations of Addiction Services (SAAS) is teaming up with the Network for the Improvement of Addiction Treatment (NIATx) to present their annual conferences in one event on June 23 through 25 in Orlando. The conference agenda has been designed to appeal to both managers and clinicians in addiction treatment, prevention, and recovery organizations, as well as to policy makers and payers. In keeping with a NIATx principle that encourages organizations to seek innovation from unlikely sources, plenary sessions will showcase quality improvement initiatives outside of healthcare.

Preconference workshops on June 22 will share fundamentals in performance measurement and process improvement. For more information about the joint conference, visit www.saasnet.org/national.cfm.

Brown Consulting and NextStep Team Up
Brown Consulting has formed a strategic alliance with NextStep Solutions, Inc., a developer of decision-support software for addiction and mental health services agencies. Brown Consulting states that it was attracted to NextStep’s Web-based patient management information system and medical records management system. For more information, e-mail Erin Brown at ebrown@danbrownconsulting.com.

Esteam Integrates Software with Microsoft Dynamics GP
Esteam, LLC, plans to deliver a Microsoft-based human services solution that combines Esteam’s TOTAL: Record integrated clinical and financial software with the Microsoft Dynamics GP business management solution. This combination will provide an enterprise solution with the electronic client record and complex reimbursement cycle management functionality of TOTAL: Record and the accounting, human resources, and business intelligence features of Microsoft Dynamics GP. Esteam also will become a reseller of Microsoft Dynamics GP. For more information, contact Carolyn Hartzell at chartzell@esteam.net.

What Is LUVOX CR?

LUVOX CR is a once-a-day medicine that is taken at bedtime. It has been proven safe and effective to treat

Social anxiety disorder (SAD) — people with SAD, also known as social phobia, have an ongoing intense fear of social situations

Obsessive compulsive disorder (OCD) — people with OCD have 2 key symptoms: obsessions and compulsions

Obsessions are unwanted, recurring, anxiety-causing thoughts

Compulsions are repetitive behaviors that people do to help relieve the anxiety caused by obsessions

What does serotonin do?

LUVOX CR is a medicine known as an SSRI. That stands for Selective Serotonin Reuptake Inhibitor. The exact mechanism by which SSRIs work is unknown. SSRIs are thought to help restore the chemical balance of serotonin in the body. This is believed to help people by allowing the brain to send and receive messages better. In turn, this may reduce the symptoms that you experience.

What does serotonin do?

Serotonin helps the nerve cells in your brain send messages. It also helps them communicate with each other. For some people, changes in serotonin levels can affect how their brain sends and receives messages. It can also affect how they feel.

For example, you may feel the need to avoid certain social situations. Or you may spend a long time going over the same issue in your head. LUVOX CR helps to increase the amount of serotonin in the area between your brain's nerve cells. This may help reduce your symptoms. It may also help the way you feel.

Once-A-Day LUVOX CR® (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD).

Important Safety Information

CONTRAINDICATIONS:The use of alosetron, tizanidine, thioridazine, or pimozide with LUVOX CR Capsules is contraindicated. The use of MAO inhibitors in combination with LUVOX CR Capsules, or within 14 days of discontinuing treatment with LUVOX CR Capsules, is contraindicated (see WARNINGS and PRECAUTIONS). LUVOX CR Capsules are also contraindicated in patients with a history of hypersensitivity to fluvoxamine maleate or any of its excipients.

ADVERSE EVENTS:In clinical trials, the most commonly observed adverse events with an incidence of ≥5% and at least twice that of placebo were nausea, somnolence, asthenia, diarrhea, anorexia, tremor, and sweating. Overall, these side effects were mild to moderate in severity and transient in nature. Other common adverse events (≥5% and at least twice that of placebo) included abnormal ejaculation and anorgasmia.

【-原产地英文商品名-】 LUVOX CR 150mg/capsule 30capsules/bottle
【-原产地英文药品名-】 FLUVOXAMINE MALEATE
【-中文参考商品译名-】 LUVOX CR 150毫克/胶囊 30胶囊/瓶
【-中文参考药品译名-】 马来酸氟伏沙明
【-临床试验期-】 完成
【-中文适应病症参考-】 抑郁症
【-中文适应病症参考-】 强迫症
【-生产厂家中文参考-】 爵士
【-生产厂家英文名-】 Jazz Pharmaceuticals, Inc
【-产地国家-】 美国

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相关文章
马来酸氟伏沙明控释胶囊(fluvoxamine maleate,Luvox CR)
美国FDA批准马来酸氟伏沙明控释胶囊上市
兰释(氟伏沙明片)Luvox(Fluvoxamine Tablets)
美国FDA批准马来酸氟伏沙明控释胶囊上市
兰释-抑郁症、强迫症的治疗
兰释(马来酸氟伏沙明片)治疗精神分裂症后抑郁
 

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