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  药店国别: 加拿大药房
产地国家: 加拿大
所属类别: 神经系统药物->治疗精神分裂症
处方药:处方药
包装规格: 40毫克/片 30片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
SUNOVION
生产厂家英文名:
SUNOVION
该药品相关信息网址1:
http://www.latuda.com/
该药品相关信息网址2:
http://www.drugs.com/latuda.html
原产地英文商品名:
LATUDA 40mg/tab 30tabs/box Storage Temp: Ambient
原产地英文药品名:
LURASIDONE HCL
原产地英文化合物名称:
(3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole -1,3-dione
中文参考商品译名:
LATUDA 40毫克/片 30片/盒 储存温度:室温
中文参考药品译名:
盐酸鲁拉西酮
原产地国家批准上市年份:
2010/10/28
英文适应病症1:
Schizophrenia
英文适应病症2:
Antipsychotic
临床试验期:
完成
中文适应病症参考翻译1:
精神分裂症
中文适应病症参考翻译2:
抗精神病
药品信息:

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 详细处方信息以本药内容附件PDF文件(201121318094631.pdf)的“原文Priscribing Information”为准
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部分中文Latuda处方资料(仅供参考)

    美国食品和药品监督管理局2010年10月28日批准Latuda (lurasidone HCl)片为治疗精神分裂症成年。
    精神分裂症在给定年累及美国约约百分之一人口,年龄18岁和以上。最突出症状包括幻觉,妄念,思维和行为紊乱,和多疑。听到其他人听不到的声音是最常见类型的幻觉。这些经验可能使人们对这个疾病恐惧和孤独。
    FDA的药物评价和研究中心中精神病产品室主任Thomas Laughren, M.D.医学博士说“精神分裂症可能是一种需要终身治疗的毁灭性疾病,”“有些患者对某些类型药物治疗没有反应,所以可得到多种治疗选择很重要。”
    Latuda属于非典型抗精神病药物类。所有非典型抗精神病药物含一个黑框警告警示开处方者伴随说明书外使用这些药物治疗行为问题与痴呆相关的精神病的老年人增加死亡风险。这类中没有药物被批准治疗痴呆相关的精神病患者。
    精神分裂症成年的四项6周对照研究证实Latuda的有效性和安全性。在试验中,用Latuda治疗患者比服用一种无活性药丸(安慰剂)患者有较少精神分裂症的症状。
    在临床试验中报道的最常见不良反应是困倦,心情烦躁和移动的冲动(静坐不能),恶心,运动异常例如震,缓慢运动,或肌肉僵硬(帕金森病),和焦虑。

适应证和用途
LATUDA是一种非典型抗精神病药物适用于精神分裂症患者的治疗。在四项6周成年精神分裂患者对照研究中确定疗效。

剂量和给药方法
LATUDA的推荐开始剂量是40 mg每天1次。初始剂量不需要递增调整。最大推荐剂量为80 mg每天1次。LATUDA应与食物服用。

剂型和规格
片剂:40 mg和80 mg。

禁忌证
(1)任何已知对ATUDA或制剂中任何组分超敏性。
(2)同时给予一种强CYP3A4抑制剂如,酮康唑[ketoconazole]和诱导剂如,利福平[rifampin]

警告和注意事项
(1)脑血管不良反应:在有与痴呆相关的精神病的老年人用非典型抗精神药物治疗曾见到脑血管不良事件的发生率增加(如,中风,短暂性缺血发作)
(2)神经阻滞剂恶性综合征:立即终止处理和密切监视.
(3)迟发性运动障碍:如临床上适当停药.
(4)代谢变化:非典型抗精神病药物曾伴随代谢变化可能增加心血管/脑血管风险。这些代谢变化包括高血糖血症,血脂异常,和增重.
高血糖血症和糖尿病:监视患者高血糖血症的症状包括多饮,多尿,多食,和软弱。在糖尿病或处在糖尿病风险患者中定期监视葡萄糖。
血脂异常:在非典型抗精神病药物治疗患者中曾观察到不良改变。
增重:曾观察到体重增量,建议临床监视体重。
高催乳素血症:可能发生催乳素升高。
用抗精神病药物曾报道白细胞减少,中性粒细胞减少,和粒细胞缺乏症。预先存在低白细胞计数(WBC)或白细胞减少/中性粒细胞减少史患者治疗的头几个月期间应经常监测完全血细胞计数(CBC)和在缺乏其它致病因素时出现WBC下降第一个征象时应终止LATUDA。
直立性低血压和昏厥:可能发生眩晕,心动过速或心动过缓,和昏厥,尤其是在治疗早期。in 有已知心血管或脑血管病患者慎用,和在未用过抗精神病药物患者中。
癫痫发作:癫痫发作史或降低癫痫发作阈值情况患者慎用。
潜在认知和运动功能障碍:当操作机械时慎用。
自杀:精神分裂症中自杀意向的可能性是固有的。严密监督高风险患者。
为附加警告和注意事项见完整处方资料。

不良反应
常观察到不良反应(发生率≥5%和至少安慰剂率2倍)包括嗜睡, 静坐不能, 恶心, 帕金森症和焦虑。

药物相互作用
(1)建议LATUDA不要与强CYP3A4抑制剂联用。如,酮康唑。
(2)建议对中等CYP3A4抑制剂(如地尔硫卓[diltiazem])调整剂量。
(3)建议LATUDA不要与强CYP3A4诱导剂,如,利福平联用。

在特殊人群中的使用
(1)老年人使用:无需调整剂量。
(2)妊娠:只有潜在效益合理大于潜在风险时才在妊娠期间使用LATUDA。
(3)哺乳母亲:不建议母乳喂养。
(4)儿童使用:安全性和有效性尚未确定。
(5)肾损伤:建议调整剂量。
(6)肝损伤:建议调整剂量。

一般描述
    LATUDA是一种影响精神剂属于benzoisothiazol衍生物的化学品类。
    其化学名为(3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole -1,3-dione盐酸盐。其分子式为C28H36N4O2S?HCl和其分子量为529.14。
    盐酸鲁拉西酮(lurasidone HCI)每日一次片剂用于精神分裂症患者一线治疗,其商品名为Latuda。鲁拉西酮是日本Dainippon Sumitomo制药公司开发一种非典型抗精神病药物。
    鲁拉西酮的疗效在4项为期6周的安慰剂对照试验得到证实。在这些研究中,鲁拉西酮在主要疗效指标方面相对安慰剂显示明显大的改善,其中包括在研究终结时阳性和阴性症状量表(PANSS)总分和简明精神病评定量表(从PANSS量表衍生)。共有5项试验证实了鲁拉西酮的耐受性和安全性。
    鲁拉西酮短期临床研究中报告的与之相关的常见不良反应有嗜睡、静坐不能、恶心、帕金森氏症样症状和情绪激动。
 
Latuda
Generic Name: lurasidone
Date of Approval: October 28, 2010
Company: Sunovion Pharmaceuticals Inc.
Treatment for: Schizophrenia

FDA Approves Latuda
The U.S. Food and Drug Administration has approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.

Latuda Patient Information
Read this Patient Information before you start taking Latuda and each time you get a refill. There may be new information. This Information Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is Latuda?
Latuda is an antipsychotic medication. It is an "atypical antipsychotic". It works by changing the effects of chemicals in the brain.

Latuda is used to treat schizophrenia in adults.

Latuda may also be used for purposes other than those listed in this medication guide.

Important information about Latuda
Elderly people with dementia-related psychosis (a severe mental health problem) taking atypical antipsychotic drugs, including Latuda, are at an increased risk for death compared with those taking placebo (sugar tablet). Latuda is not approved for the treatment of people with dementia-related psychosis (see BOXED WARNING). An increased risk for stroke and ministroke has been reported in elderly people with dementia-related psychosis.

Neuroleptic malignant syndrome (NMS): NMS is a rare and potentially fatal side effect reported with Latuda and similar medicines. Call your healthcare provider right away if you have high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; sweating; or muscle pain and weakness. Treatment should be stopped if you have NMS.

Tardive dyskinesia (TD): TD is a serious and sometimes permanent side effect reported with Latuda and similar medicines. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk for developing TD and the chance that it will become permanent is thought to increase the longer a person takes the medicine and the more medicine a person takes over time. TD can develop after a person has been taking the medicine for a short time at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if the person stops taking the medicine.

High blood sugar: High blood sugar and diabetes have been reported with Latuda. In studies, most people taking Latuda had no problems with their blood sugar. If you have diabetes or risk factors for diabetes, such as being overweight or a family history of diabetes, your blood sugar should be tested at the beginning of and throughout treatment with Latuda. Complications of diabetes can be serious and even life threatening. Tell your healthcare provider if you have blood sugar problems or signs of diabetes, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry.

Weight gain: Some patients may gain weight while taking Latuda. Your healthcare provider should check your weight regularly. Talk to your healthcare provider about ways to help control your weight, such as eating a healthy, balanced diet and exercising.

Additional Important Warnings
Light-headedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting position has been reported with Latuda.
Low white blood cell counts and related conditions have been reported with Latuda and similar medicines. Tell your healthcare provider if you have or had low white blood cell counts.
Latuda and medicines like it may raise the levels of prolactin. Tell your healthcare provider if you experience a lack of menstrual periods, leaking or enlarged breasts, or impotence.
Tell your healthcare provider if you have a seizure disorder, have had seizures in the past, or have conditions that increase your risk for seizures.
Tell your healthcare provider if you experience prolonged, abnormal muscle spasm or contraction, which may be signs of a condition called dystonia.
Latuda can affect your judgment, thinking, and motor skills. You should not drive or operate hazardous machinery until you know how Latuda affects you.
Latuda may make you more sensitive to heat. You may have trouble cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm.
The symptoms of schizophrenia may include thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your healthcare provider or go to an emergency room right away.
Latuda and medicines like it have been associated with swallowing problems. If you have had or have swallowing problems, you should tell your healthcare provider.

Pregnancy: Tell your healthcare provider if you are pregnant or if you are planning to get pregnant while taking Latuda. Breast feeding is not recommended during treatment with Latuda.

Tell your healthcare provider about all prescription and over-the-counter medicines you are taking or plan to take, since there are some risks for drug interactions with Latuda. Do not drink alcohol while taking Latuda.

In people with schizophrenia, the most common side effects that occurred with Latuda were sleepiness, an inner sense of restlessness or need to move (akathisia), uncontrolled movements of the body and face (parkinsonism), upset stomach, and agitation.

This is not a complete summary of safety information. Please discuss the full Prescribing Information for prescription Latuda with your doctor.

How should I take Latuda?
Take Latuda 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.

Latuda should be taken with food.

Take Latuda regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store Latuda at room temperature away from moisture, light, and heat.

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.

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

Overdose symptoms may include drowsiness, fast heart rate, feeling light-headed, fainting, and restless muscle movements in your eyes, tongue, jaw, or neck.

What should I avoid while taking Latuda?
While you are taking Latuda, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Latuda.

Latuda 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. Avoid drinking alcohol. It can increase some of the side effects of Latuda.

Latuda 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 Latuda and call your doctor at once if you have a serious side effect such as:
fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
restless muscle movements in your eyes, tongue, jaw, or neck;
tremor (uncontrolled shaking);
fever, chills, body aches, flu symptoms;
trouble swallowing; or
feeling light-headed, fainting.
increased thirst or urination, weakness

Less serious Latuda side effects may include:
mild restlessness,agitiation, drowsiness, or tremor;
sleepiness, dreaming more than usual;
blurred vision;
abdominal pain;
dizziness or headache;
weight gain;
problems with urination;
nausea, diarrhea;
decreased appetite;
excessive salivation;
rash or itching

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.

Latuda Dosing Information
The recommended starting dose of Latuda is 40 mg once daily. The maximum recommended dose is 80 mg once daily. Latuda should be taken with food.

What other drugs will affect Latuda?
Before you take Latuda, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Latuda.

Also tell your doctor if you are taking any of the following medicines:
ketoconazole (Nizoral);
diltiazem (Cardizem, Dilacor);
rifampin (Rifadin, Rimactane, Rifater);

This list is not complete and other drugs may interact with Risperdal. 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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 详细处方信息以本药内容附件PDF文件(201121318094631.pdf)的“原文Priscribing Information”为准
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更新日期: 2015-11-30
附件:






201121318094631.pdf    

 
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