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  药店国别: 日本药房
产地国家: 日本
所属类别: 神经系统药物->多动症
处方药:处方药
包装规格: 100毫升/支
计价单位:
  点击放大  
生产厂家中文参考译名:
礼来
生产厂家英文名:
Eli Lilly
该药品相关信息网址1:
http://www.strattera.com/pages/side-effects-child-adhd-medicine.aspx?WT.srch=1&srcid=strsem_ggl_br_core-br_43700004494109729_e
原产地英文商品名:
Strattera Oral Solution 0.4% 100ml/bottle
原产地英文药品名:
Atomoxetine HCL
中文参考商品译名:
Strattera口服液0.4% 100毫升/支
中文参考药品译名:
盐酸阿托莫西汀
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Attention Deficit
英文适应病症2:
Hyperactivity disorder
临床试验期:
完成
中文适应病症参考翻译1:
注意力缺陷
中文适应病症参考翻译2:
多动障碍
药品信息:

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 详细处方信息以本药内容附件PDF文件(20144923453511.pdf)的“原文Priscribing Information”为准
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部分中文Strattera处方资料(仅供参考)

    2003年1月14日,Lilly 公司宣告,获FDA许可用于治疗注意缺陷与多动障碍(ADHD)的第一个非中枢兴奋剂atomoxetine HCl(Strattera)现在美国上市。

    包括大型连锁药房在内的全国46000多家药房已备有Strattera ,可以马上开始凭处方供药。Strattera 不是受管制物质,因此便于医生试用和打电话再处方,从而减少了处方麻烦。

    Strattera 于2002年11月26日获FDA许可用于儿童、青少年和成人ADHD的治疗。此后,Lilly公司一直在为Strattera 进入全国药房而积极工作,并提供医生小包样品试用。

    Strattera为选择性去甲肾上腺素再摄取抑制剂,其作用机制与先前获FDA许可的ADHD治疗药不同,较老的药物均为中枢兴奋剂。Strattera是第一个经临床证实对成人ADHD有效的药物,并且能全天缓解大多数儿童和青少年的ADHD症状而不导致失眠。

    Strattera(atomoxetine HCL)是一种选择性去甲肾上腺素重吸收抑制剂,由礼来公司今年1月正式推出,每日口服1~2次,用于儿童、青少年及成人患者注意力缺陷障碍(多动症)的治疗,是近十几年来FDA在此领域批准的第一种非中枢兴奋性药物。

    美国FDA已批准了第一种无年龄限制的注意力缺陷障碍(ADHD)治疗药物—礼来公司的盐酸阿托莫西汀(atomoxetine HCl,Strattera),它也是第一种被批准用于成人患者的药品。阿托莫西汀于2003年1月上市。2002年8月,礼来公司收到了阿托莫西汀的可批准信,并预计在2003年春天获得最后的批准,公司在这段时间进行了商标内容的讨论,准备补充已有试验或者进行新试验的数据和分析。但是在收到批准信后3个月礼来公司就通过了FDA的最后批准,比预计时间早。 批准如此迅速使得礼来公司接近最初的于2002年底在美国上市阿托莫西汀的计划。礼来公司计划在2004年前上市8种产品,而阿托莫西汀是第一个。公司目前面临生产问题,它的上市也将成为公司的推动力。除美国外,公司还向澳大利亚、新西兰和加拿大提交了该药的申请,并计划在12个月内向欧盟提出申请。 阿托莫西汀在美国上市后必将影响ADHA药品市场,目前ADHD市场主要由兴奋剂类药品所垄断,如诺华公司/Celgene公司的哌甲酯(methylphenidate,Ritalin)。阿托莫西汀作为一种选择性去甲肾上腺素重吸收抑制剂,为患者提供了第一种可代替精神兴奋剂,可以不定期使用的备选药物。神经兴奋剂在儿童患者中的使用已引起人们的争论。礼来公司希望那些不愿使用受控药品的患者,以及无法忍受这类药品的患者能选择他们的产品。 同时,阿托莫西汀还是第一种即适于儿童也适于成年ADHD患者的药物,而成人ADHD市场已越来越为大家所关注。但是,礼来公司可能无法长时间地垄断成年人市场,因为Shire制药公司已计划在今年底向美国提交他们的成人用ADHD治疗药混合苯丙胺盐(mixed amphetamine salts,Adderall XR)。 阿托莫西汀将以胶囊形式上市,每日一次或两次。除Adderall XR外,该药的主要竞争产品是每日一次的哌甲酯产品,如利他林XR、Celltech公司的Metadate CD 和Alza公司(属于强生公司)的Concerta。一项非盲试验结果表明阿托莫西汀和Ritalin可以同样有效地减少患者精神不集中、好动或易冲动等ADHD症状,但没有数据显示阿托莫西汀的疗效优于Ritalin。但是,礼来公司相信,阿托莫西汀作为非受控药品可使它在拥挤的市场中具备良好的竞争力。WestLB Panmure的分析家预计阿托莫西汀将最终占有约20%市场。礼来公司承认他们还无法解释阿托莫西汀如何缓解ADHD症状,但是他们强调说,6组安慰剂对照试验的临床数据确证阿托莫西汀对大部分的儿童和成人都可以全天缓解症状,而不会引起失眠。儿童和青少年ADHD患者在治疗后最常见的副作用是食欲下降、恶心、呕吐、疲倦和反胃;而成人患者的常见副作用是嗜睡、口干、食欲下降、反胃、恶心、呕吐、头晕、尿频及性功能下降等。

阿托莫西汀( atomoxetine )
商品名 Strattera
化学名 (-)-N- 甲基 -3- ( 2- 甲基苯氧基) -3- 苯丙基胺,是治疗注意力缺陷与多动障碍 (ADHD) 的药物。
    阿托莫西汀最早由礼来公司( Lilly )于 1975 年 1 月 9 日在美国申请化学品专利( US5658590 ), 1981 年 11 月 13 日在欧洲申请化学品专利( EP52492 )并在 1995 年 1 月 11 日申请治疗 ADHD 的专利( US4314081 ), 2007 年 11 月日专利到期。但是阿托莫西汀在我国没有相关专利,也没有申请行政保护。 ADHD 是一种常见的行为疾病,多发生于儿童和青少年,在成人中也有相当大的比例,。这种疾病的临床症状表现为活动过度,集中注意困难、情绪不稳、冲动任性以及学习困难等,不但对个人的成长有较大的影响,而且容易造成社会的危害,已经得到了国内外的共同关注。针对我国7项调查的分析结果表明,在学龄儿童中其患病率为4 . 31%-5 . 83%,估计全国共有患儿1461万-1979万,有将近 2/3 的儿童并没有得到有效的治疗而使其中 70% 患儿的症状会持续到青春期, 30% 会持续终身。治疗 ADHD 的方法主要是药物治疗。现在比较常见的药物有三种,分别是沙耳制药 (Shire) 的 AdderMl 、 Alza 公司的 Concerta 和礼来公司研制的阿托莫西汀。前两种药物属于中枢兴奋性药物,其主要成分是右旋苯丙胺和哌甲酯。中枢兴奋性药物虽然对 ADHD 有较好的疗效,但是也伴随着失眠、食欲减退等副作用,而且使用者对药物有很强的依赖性,六周岁以下的儿童是不能使用的。阿托莫西汀作为非中枢兴奋性的药物,很好的解决了前两种药物的不足。它的工作原理是通过阻断或减少去甲肾上腺素的再摄取,使大脑前额叶神经元中保留较多的去甲肾上腺素,而去甲肾上腺素正是管理注意力、活动和冲动性的化学物质。由于只是提高本身的去甲肾上腺素水平,而不是增加外来药物,所以阿托莫西汀对中枢神经系统没有明显的副作用,并具有很强的耐药性。

Strattera
Generic Name: atomoxetine (AT oh mox e teen)
Brand Names: Strattera

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What is Strattera?
Strattera affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Strattera is used to treat attention deficit hyperactivity disorder (ADHD).

Strattera may also be used for other purposes not listed in this medication guide.

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Important information about Strattera
Do not use Strattera if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you use Strattera before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to atomoxetine, or if you have glaucoma.

Some ADHD medicines have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Tell your doctor if you have any heart problems.

You may have suicidal thoughts or behavior while taking Strattera. Watch for symptoms of depression, unusual behavior, or thoughts of hurting yourself. Your doctor may need to check you at regular visits while you are taking this medication.

In addition to you watching for changes in your mood or behavior, your family or caregivers should be alert to changes in your mood or symptoms.

Do not use an open or broken capsule. If the medicine from inside the capsule gets into your eyes, rinse thoroughly with water and call your doctor.

Strattera can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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Before taking Strattera
Do not use Strattera if you are allergic to atomoxetine or if you have glaucoma.

Do not take atomoxetine if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you use Strattera before the MAO inhibitor has cleared from your body. Some ADHD medicines have caused sudden death in children and adolescents with serious heart problems or congenital heart defects.

If you have certain conditions, you may need a dose adjustment or special tests to safely take Strattera. Before taking this medication, tell your doctor if you have:
a congenital heart defect;
heart disease, a heart rhythm disorder, or recent heart attack;
coronary artery disease;
a history of stroke, blood clots, or heart attack;
high or low blood pressure;
liver disease;
problems with urination;
a personal or family history of mental illness, psychotic disorder, bipolar illness, depression, or suicide attempt; or
if anyone in your family has died suddenly from a heart problem.

You may have suicidal thoughts or behavior while taking Strattera. Watch for symptoms of depression, unusual behavior, or thoughts of hurting yourself. Your doctor may need to check you at regular visits while you are taking this medication.

In addition to you watching for changes in your mood or behavior, your family or caregivers should be alert to changes in your mood or symptoms.

FDA pregnancy category C. It is not known whether Strattera is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether atomoxetine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings in more detail

Strattera is not meant for long-term use. Because ADHD may be a long-term condition, especially in children and young adults, your doctor may recommend another ADHD medication after you stop taking Strattera.

Long-term use of Strattera can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Do not give Strattera to a child younger than 6 years old without the advice of a doctor.

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How should I take Strattera?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Strattera is usually taken once daily, but it may be taken in the morning and late afternoon. Follow your doctor's instructions.

It is important to use Strattera regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not use a capsule that has been opened or accidentally broken. The medicine from inside the capsule can be dangerous if it gets in your eyes. If you must handle a broken capsule, ask your doctor or pharmacist how to safely handle and dispose of the tablet. Store Strattera at room temperature away from moisture and heat.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose. Take the medication only one time per day.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include drowsiness, agitation, hyperactivity, unusual behavior, stomach problems, blurred vision, dry mouth, and fast heartbeat.

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What should I avoid while taking Strattera?
Avoid using or handling an open or broken capsule. If the medicine from inside the capsule gets in your eyes, rinse them thoroughly with water and call your doctor. Strattera can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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Strattera side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking Strattera and call your doctor at once if you have a serious side effect such as:
chest pain, shortness of breath, fast or uneven heartbeats;
feeling light-headed or fainting;
unusual thoughts or behavior, aggression, hallucinations (seeing things that are not there);
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or
urinating less than usual or not at all.

Less serious side effects may include:
feeling irritable;
feeling dizzy or drowsy;
constipation;
cough, dry mouth;
skin rash or itching;
sleep problems (insomnia);
increased menstrual cramps; or
impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect Strattera?
Before taking Strattera, tell your doctor if you are using any of the following drugs:
albuterol (Proventil, Ventolin);
amiodarone (Cordarone, Pacerone);
bupropion (Wellbutrin, Zyban);
celecoxib (Celebrex);
cimetidine (Tagamet);
doxorubicin (Adriamycin);
methadone (Dolophine, Methadose);
metoclopramide (Reglan);
quinidine (Cardioquin, Quinaglute, Quinidex);
ritonavir (Norvir);
ranitidine (Zantac);
terbinafine (Lamisil);
antidepressants such as citalopram (Celexa), clomipramine (Anafranil); escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft); or
antihistamines or sleep medicine such as diphenhydramine (Benadryl, Unisom, and others) or chlorpheniramine (Chlor-Trimeton and others).

This list is not complete and there may be other drugs that can interact with Strattera. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Where can I get more information?
Your pharmacist can provide more information about Strattera.

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What does my medication look like?
Atomoxetine is available with a prescription under the brand name Strattera. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Strattera 10 mg - opaque, white capsules
Strattera 18 mg - opaque, gold and white capsules
Strattera 25 mg - opaque, blue and white capsules
Strattera 40 mg - opaque, blue capsules
Strattera 60 mg - opaque, blue and gold capsules

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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 详细处方信息以本药内容附件PDF文件(20144923453511.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2019-1-15
附件:
20144923453511.pdf    

 
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