英文药名: Seroquel XR(Quetiapine Fumarate Extended Release Tablets)

中文药名: 思瑞康（富马酸喹硫平缓释片）

此药品需要处方

生产厂家: AstraZeneca

药品名称

思瑞康（富马酸喹硫平片）
适应症

用于治疗精神分裂症。
服用方法

应每日两次给药，饭前饭后均可。
成人：
前4天治疗期的日总剂量为50毫克(第一日)，100毫克(第二日)，200毫克(第三日)和300毫克(第四日)。从第四日以后，将近剂量逐渐增加到有效剂量范围，一般为300－450毫克/日。可根据病人的临床反应和耐受性将剂量在150－750毫克/日之间调整。
肾脏和肝脏损害 ：
口服喹硫平后的清除率在肾脏和肝脏损伤的病人中下降约25%。喹硫平在肝脏中代谢广泛，因此就慎用于肝脏损害的患者。
有肾脏或肝脏损害的病人，“思瑞康：的开始剂量应为25毫克/日。随后每日增加剂量，幅度为25－50毫克，直到有效剂量。
如果您有任何疑问，请遵医嘱。
禁忌症
禁用于对该产品的任何成分过敏的病人。
注意事项
心血管疾病
“思瑞康”可能会导致直立性低血压，尤其是在最初的加药期;在老年患者中上述现象较年轻患者多见。在临床试验中，使用喹硫平不伴发持久性QTc间期的延长。但与其它抗精神病药一样，如果效喹硫平与其它已知会延长QTc间期的药物合用时就在当谨慎，尤其是用于老年人时。
“思瑞康”应慎用于已知有心血管疾病、脑血管疾病或其它有低血压倾向的病人。
抽搐
在临床对照试验中，服用“思瑞康”的病人的抽搐发生率与服用安慰剂的病人无区别。与其它抗精神病药物一样，当用于治疗有抽搐病史的患者时应予以注意。

神经阻滞剂恶性综合征

抗精神病药物治疗会伴发神经阻滞剂恶性综合征。临床表现包手高热、精神状态改变、肌肉强直、植物神经功能紊乱以及肌酸磷酸激酶活性增加。若出现此种情况，应停用“思瑞康”并给予适当的治疗。
迟发性运动障碍
与其它抗精神病药物一样，长期服用“思瑞康”治疗也有导致迟发性运动障碍的可能性。如果出现迟发性运动障碍的体征和症状，应考虑减少“思瑞康”剂量或停用。
 
孕妇及哺乳

用于人类妊娠时的疗效和安全性尚未肯定(对动物的生殖毒性资料见临床前案例性资料一节的生殖研究部分)。因此，只有在获益大于潜在危险的情况下“思瑞康”才能用于妊娠中的患者。
储藏:应贮存于30℃以下。

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。

【原产地英文商品名】SEROQUEL XR 24H 400mg/tab 30tabs/bottle
【原产地英文药品名】QUETIAPINE FUMARATE
【中文参考商品译名】
注：以下产品不同规格和不同价格，购买时请以电话咨询为准！
◆以下是阿斯利康在美国生产
·思瑞康XR 24小时缓释片 200毫克/片 60片/瓶
·思瑞康XR 24小时缓释片 300毫克/片 60片/瓶
·思瑞康XR 24小时缓释片 400毫克/片 60片/瓶
·思瑞康XR 24小时缓释片 50毫克/片 60片/瓶
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◆以下是阿斯利康在加拿大生产；
·思瑞康XR 24小时缓释片 50毫克/片 60片/瓶
·思瑞康XR 24小时缓释片 150毫克/片 60片/瓶
·思瑞康XR 24小时缓释片 200毫克/片 60片/瓶
·思瑞康XR 24小时缓释片 300毫克/片 60片/瓶
·思瑞康XR 24小时缓释片 400毫克/片 30片/瓶
【中文参考药品译名】富马酸喹硫平
【生产厂家中文参考译名】阿斯利康
【生产厂家英文名】ASTRAZENECA

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.