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  药店国别: 美国药房
产地国家: 美国
所属类别: 神经系统药物->抗经神病药物
处方药:处方药
包装规格: 50毫克/片 60片/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
阿斯利康
生产厂家英文名:
ASTRAZENECA
该药品相关信息网址1:
http://www.drugs.com/seroquel.html
该药品相关信息网址2:
http://www.rxlist.com/seroquel-drug.htm
该药品相关信息网址3:
http://www.seroquelxr.com/
原产地英文商品名:
SEROQUEL XR 50mg/tab 60tabs/bottle
原产地英文药品名:
QUETIAPINE FUMARATE
中文参考商品译名:
思瑞康XR 缓释片 50毫克/片 60片/瓶
中文参考药品译名:
富马酸喹硫平
原产地国家批准上市年份:
2007/05/17
英文适应病症1:
Bipolar disorder
英文适应病症2:
Manic episode
临床试验期:
完成
中文适应病症参考翻译1:
双向情感障碍
中文适应病症参考翻译2:
躁狂发作
药品信息:

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 详细处方信息以本药内容附件PDF文件(2010101019410936.pdf)的“原文Priscribing Information”为准
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部分中文SEROQUEL XR处方资料(仅供参考)

    阿斯利康公司(AstraZeneca)于2008年11月13日对外宣布,其每日一次的富马酸喹硫平缓释片(quetiapine fumarate,思瑞康XR ,SEROQUEL XR)和富马酸喹硫平(quetiapine fumarate,思瑞康,SEROQUEL)已通过欧盟的互承认审评程序,批准用于治疗双相情感障碍。其中,思瑞康XR与思瑞康已经被批准用于抑郁发作的双相情感障碍的治疗。此外,思瑞康XR已被批准用于中度至重度躁狂发作的双相情感障碍的治疗。

  在此之前, 2008年10月思瑞康 XR缓释片相似的适应证已获美国FDA批准。由于这些新适应证针对成年患者,所以思瑞康XR与思瑞康是目前唯一获准的用于治疗情感相关性双相情感障碍的非典型抗精神病药物,也是目前欧盟唯一许可用于治疗双相情感障碍的药物。

  由于思瑞康XR与思瑞康具有安定和抗抑郁的双重作用机理,这也解释了为什么本品对与情感相关的双向情感障碍有效。

  阿斯利康公司将推动思瑞康XR与思瑞康在欧盟17个成员国的互承认程序。双相情感障碍是一种常见的严重的精神疾病,它会导致严重的荒唐的情绪波动。其中,双相I型情感障碍的临床表现很典型,其特征为躁狂和抑郁的反复发作。双相II型情感障碍是指以抑郁发作为主,伴有一次或多次轻躁狂发作。

  据估计:双相情感障碍在全球的发病率高达3%~5%,其中高达一半以上的双相情感障碍的患者在一生中至少有1次企图自杀的倾向,而大约有10%~15%的双相情感障碍患者在一生中实施了自杀。由于在此之前欧盟国家还没有被许可用于治疗双相情感障碍的药物,所以思瑞康XR与思瑞康的获准对于临床医生和患者而言都向前迈出了重要的一步。

  一项关于本品的随机双盲的临床研究结果表明,服用思瑞康XR与思瑞康后的第一周患者的躁狂和抑郁的症状就大大的减少(其中服药4天后,躁狂的症状就大大减少)。而且症状的改善一致维持到研究的持续期。

  思瑞康XR双相抑郁症的获准是基于一项为期8周的安慰剂对照研究。研究采用MADRS对1~8周的情况进行评分,发现本品与安慰剂相比,患者的症状得到了明显改善。

  关于思瑞康针对双相抑郁症的有效性研究共纳入2500例患者,4项结果表明本品明显改善了患者的症状。

  思瑞康XR关于双项躁狂症的获准是基于一项为期3周的临床研究,结果采用YMRS评分。结果显示,在服药后4天本品与安慰剂组对比患者的症状就得到明显改善。

  在所有关于思瑞康XR与思瑞康的研究报道中,其良好的安全性和耐受性是普遍公认的事实。思瑞康XR最常见的不良反应为口干、嗜睡和镇静。思瑞康最常见的不良反应为口干、嗜睡、头昏、及便秘。

Seroquel
Generic Name: quetiapine (kwe TYE a peen)
Brand Names: Seroquel, Seroquel XR

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What is Seroquel?
Seroquel (quetiapine) is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Seroquel is used to treat schizophrenia in adults and children who are at least 13 years old. It is used to treat bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Seroquel is also used together with antidepressant medications to treat major depressive disorder in adults.

Extended-release quetiapine (Seroquel XR) is for use only in adults and should not be given to anyone younger than 18 years old.

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

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Important information about Seroquel
Seroquel is not for use in psychotic conditions related to dementia. Seroquel may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Stop using Seroquel and call your doctor at once if you have the following symptoms: very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, uncontrolled muscle movements, feeling light-headed, blurred vision, eye pain, increased thirst and urination, excessive hunger, fruity breath odor, weakness, nausea and vomiting.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

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Before taking Seroquel
Seroquel is not for use in psychotic conditions related to dementia. Seroquel may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Seroquel:
liver or kidney disease;
heart disease, high blood pressure, heart rhythm problems;
a history of heart attack or stroke;
a history of low white blood cell (WBC) counts;
a thyroid disorder;
seizures or epilepsy;
cataracts;
high cholesterol or triglycerides;
a personal or family history of diabetes; or
trouble swallowing.

You may have thoughts about suicide when you first start taking an antidepressant such as Seroquel, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. It is not known whether Seroquel will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Seroquel. It is not known whether quetiapine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking this medication. Do not give Seroquel to a child without a doctor's advice. Extended-release quetiapine (Seroquel XR) is for use only in adults and should not be given to anyone younger than 18 years old.

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How should I take Seroquel?
Take Seroquel exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your Seroquel dose to make sure you get the best results.

Take this medicine with a full glass of water. You may take Seroquel with or without food. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

To be sure Seroquel is not causing harmful effects, your blood cells, blood pressure, and vision may need to be tested often. Visit your doctor regularly.

Seroquel may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness. If you are diabetic, check your blood sugar levels on a regular basis while you are taking Seroquel.

Store Seroquel 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme drowsiness, fast heart rate, feeling light-headed, or fainting.

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What should I avoid while taking Seroquel?
Seroquel may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather. You may be more prone to heat stroke.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase certain side effects of Seroquel.

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

Call your doctor at once if you have any new or worsening symptoms while taking Seroquel, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Stop using Seroquel and call your doctor at once if you have a serious side effect such as:
very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors;
feeling like you might pass out;
jerky muscle movements you cannot control, trouble swallowing, problems with speech;
blurred vision, eye pain, or seeing halos around lights;
increased thirst and urination, excessive hunger, fruity breath odor, weakness, nausea and vomiting;
fever, chills, body aches, flu symptoms; or
white patches or sores inside your mouth or on your lips.

Less serious Seroquel side effects may include:
dizziness, drowsiness, tired feeling;
dry mouth, sore throat;
nausea, vomiting;
stomach pain, upset stomach, constipation;
increased appetite;
breast swelling or discharge;
missed menstrual periods; or
weight gain.

This is not a complete list of Seroquel 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 Seroquel?
Before using Seroquel, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Seroquel.

Tell your doctor about all other medicines you use, especially:
cimetidine (Tagamet);
lorazepam (Ativan);
steroids (prednisone and others);
an antibiotic such as erythromycin (E-Mycin, E.E.S, Ery-Tab), rifabutin (Mycobutin) or rifampin (Rifadin, Rimactane, Rifater);
an antifungal medication such as fluconazole (Diflucan), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or itraconazole (Sporanox);
HIV medicines such as fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), saquinavir (Invirase), and others;
medicine for depression or mental illness, such as fluoxetine (Prozac), haloperidol (Haldol), imipramine (Tofranil), risperidone (Risperdal), or thioridazine (Mellaril);
a medication to treat high blood pressure or a heart condition;
medications to treat Parkinson's disease; or
seizure medication such as carbamazepine (Tegretol), divalproex (Depakote), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), or valproate (Depakene).

This list is not complete and other drugs may interact with Seroquel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Seroquel 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(2010101019410936.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-1-24
附件:




2010101019410936.pdf    



 
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