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 详细处方信息以本药内容附件PDF文件（2018112821314426.pdf）的“原文Priscribing Information”为准
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部分中文氯卡色林处方资料（仅供参考）

FDA十三年来首次批准Arena公司减肥药Belviq上市

药理类别：

5 - 羟色胺2C受体激动剂。

活性成分（S）：

lorcaserin的盐酸10mg的标签。

公司: 卫材制药公司

指示（S）：

作为一个辅助低热量饮食和增加体力活动成年人慢性体重管理的初始BMI≥30kg/m2或≥27kg/m2的存在至少一个与体重相关的合并症（如高血压[HTN ]，血脂异常，2型糖尿病2型糖尿病）。

使用限制：其他减肥产品（例如，芬特明，OTC药品，草药PREPS）合用的安全性和有效性尚未确立。心血管疾病的发病率和死亡率的影响尚未建立。

药理作用：

lorcaserin的被认为是减少食品消费，促进饱足感，由位于下丘脑食欲亲阿黑皮素原神经元选择性5-HT2C受体激活。的确切作用机制是未知的。

临床试验：

Belviq慢性体重管理相结合，减少热量的摄入，增加体力活动的安全性和有效性进行了评估，三个随机，双盲，安慰剂对照的trials.The主要疗效参数是在1年内减肥，这是评估％的患者达到≥5％的重量损失，≥10％的重量损失，平均体重变化。

研究1是一个2年的研究，招收谁是肥胖（BMI 30-45kg/m2）或超重（BMI 27-29.9kg/m2）的有3,182例患者≥1与体重相关的合并症（如高血压或血脂异常）。在2年，继续服用安慰剂的患者和安慰剂Belviq患者重新随机2:1继续Belviq或切换到安慰剂。研究2是一项1年的研究中，4,008名谁是肥胖或超重，≥1与体重相关的合并症（如高血压或血脂异常）的患者。研究是为期1年的研究，招收604名患者与BMI≥27kg/m2，控制不佳的2型糖尿病的（糖化血红蛋白7-10％）与二甲双胍和/或磺脲类药物治疗。

在没有糖尿病的患者中，有统计学显着Belviq与安慰剂相比，在52周的减肥。 1年实现在Belviq治疗的患者是安慰剂调整减肥3.3千克（95％CI，-3.6，-2.9，P <0.001）。 ，47％的患者在Belviq治疗组失去≥5％的体重，22.4％，失去了≥10％的体重。在糖尿病患者中，有统计学显着更大的减肥Belviq比安慰剂。在的Belviq治疗组中，37.5％的患者失去体重≥5％，和16.3％≥10％体重丢失。

成人：

10毫克，每天两次。减肥12周后评估。停止如果没有达到≥5％的重量损失。

儿童：

<18岁：不推荐。

禁忌（S）：

怀孕（X类）。

警告/注意事项：

监测的5 - 羟色胺综合征或抗精神病药物恶性综合征样症状/体征;停止治疗如果发生。瑞士法郎。心脏瓣膜病的风险评估和考虑停止如果出现症状/体征。心动过缓或> 1度心脏传导阻滞。监测抑郁症，自杀的念头，和/或不寻常的行为改变，停止发展。增加低血糖的风险，与糖尿病患者降糖治疗开始前和治疗期间测量血糖。阴茎异常勃起的易感性。阴茎解剖变形。 CBCS治疗期间定期监控。如果怀疑高程测量催乳素水平。中度肾功能损害。严重肾功能不全或终末期肾病（ESRD）：不建议。严重肝功能损害。哺乳母亲：不推荐。

互动（补）

注意伴随曲普坦类药物，单胺氧化酶抑制剂，利奈唑胺，SNRIs的SSRIs类药物，三环类抗抑郁药，安非他酮，锂，曲马多，色氨酸，圣约翰草，抗精神病药物，或PDE-5抑制剂。增强效应右美沙芬和其他CYP2D6基板。心脏心瓣膜病伴药物，是有效的5-HT 2B受体激动剂（例如，卡麦角林）的风险增加。伴随胰岛素：没有研究过。

不良反应（S）

头痛，头晕，乏力，恶心，口干，便秘，低血糖，背部疼痛，咳嗽，认知障碍，心动过缓，精神紊乱，血液的变化，催乳素升高。

FDA批准Belviq用于体重控制

2012年7月12日，FDA批准Belviq(lorcaserin HCl)用于肥胖成年人的慢性体重控制。Belviq作为针对在肥胖成年患者当中低卡热量饮食和较多的增加运动的一种补充品，这些患者的最初的身体质量指数（BMI）为30kg/㎡或更高（肥胖），或者至少伴随一种与体重相关的疾病（如，高血压、血脂异常、2型糖尿病）时BMI值为27kg/㎡或更高（超重）。指示包括以下使用限制：服用Belviq 的同时还服用别的药物时会不会达到减肥目的的安全性和疗效还有待进一步验证，并且使用Belviq 对心血管疾病的发病率和死亡率会不会产生影响也还不确定。

Belviq的使用对于那些和肥胖做斗争的还有伴有并发症的体重超重的需要通过慢性体重管理来代替饮食和锻炼的患者来说是件很重要的一种举措。

Belviq的双盲试验，随机对照试验和安慰剂对照试验这三项试验证实了Belviq在饮食和锻炼中服用在帮助患者病人减轻体重方面所产生的效应，比起只有饮食和锻炼更加有效，经过一年他们的体重减轻了5%或更多，并且管理减肥治疗长达两年。

临床试验中，那些使用了Belviq的非糖尿病患者最常见的不良反应是头痛，头晕，乏力，口干和便秘。而那些糖尿病患者当中，最常见的不良反应是：低糖血症，头痛，背痛，咳嗽和乏力。

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产地国家：美国

原产地英文商品名:

Belviq Tablets 10mg/tablets 30tablets/Bottle

原产地英文药品名:

lorcaserin hydrochloride

中文参考商品译名:

Belviq片 10毫克/片 30片/瓶

中文参考药品译名:

氯卡色林

生产厂家中文参考译名: 卫材公司

生产厂家英文名: Eisai Inc.

The FDA approved the listing of Arena's diet pills Belviq for the first time in 13 years

Pharmacological category:

5 - serotonin 2C receptor agonist.

Active ingredient (S):

Lorcaserin's 10mg label for hydrochloric acid.

Company: Eisai Pharmaceuticals Inc.

Indication (S):

As an auxiliary low-calorie diet and increased physical activity, the initial BMI ≥ 30kg/m2 or ≥27kg/m2 of chronic weight management in adults has at least one weight-related comorbidity (eg hypertension [HTN], dyslipidemia, type 2 Diabetes type 2 diabetes).

Usage restrictions: The safety and effectiveness of other weight loss products (eg, phentermine, OTC drugs, herbal PREPS) have not been established. The impact of cardiovascular disease morbidity and mortality has not been established.

Pharmacological action:

Lorcaserin is thought to reduce food consumption and promote satiety, activated by a selective 5-HT2C receptor located in the hypothalamic appetite pro-opioid progenitor neurons. The exact mechanism of action is unknown.

Clinical trial:

Belviq combined with chronic weight management, reduced calorie intake, increased safety and effectiveness of physical activity were evaluated, and three randomized, double-blind, placebo-controlled trials.The main efficacy parameter was weight loss within 1 year, which It is estimated that % of patients achieve a weight loss of ≥ 5%, a weight loss of ≥ 10%, and an average body weight change.

Study 1 is a 2-year study enrolling 3,182 patients with obesity (BMI 30-45 kg/m2) or overweight (BMI 27-29.9 kg/m2) with ≥1 weight-related comorbidities (eg Hypertension or dyslipidemia). At 2 years, patients who continued to take placebo and placebo Belviq patients re-randomized 2:1 to continue Belviq or switch to placebo. Study 2 was a 1-year study of 4,008 patients who were obese or overweight, ≥1 with weight-related comorbidities (such as hypertension or dyslipidemia). The study was a one-year study enrolling 604 patients with BMI ≥27 kg/m2, poorly controlled type 2 diabetes (glycated hemoglobin 7-10%) with metformin and/or sulfonylureas.

In patients without diabetes, there was a statistically significant loss of Belviq compared to placebo at 52 weeks. One year of treatment in patients treated with Belviq was a placebo adjusted for weight loss of 3.3 kg (95% CI, -3.6, -2.9, P < 0.001). 47% of patients lost ≥5% of body weight, 22.4% in the Belviq treatment group, and lost ≥10% of body weight. Among diabetic patients, there was a statistically significant reduction in Belviq compared to placebo. In the Belviq treatment group, 37.5% of patients lost weight ≥ 5%, and 16.3% ≥ 10% lost weight.

Adult:

10 mg twice daily. After 12 weeks of weight loss assessment. Stop if the weight loss of ≥ 5% is not reached.

Children:

<18 years old: Not recommended.

Contraindications (S):

Pregnant (Class X).

Warning/Note:

Monitor serotonin syndrome or antipsychotic malignant syndrome-like symptoms/signs; stop treatment if it occurs. Swiss franc. Risk assessment of valvular heart disease and consideration of discontinuation if symptoms/signs appear. Bradycardia or >1 degree heart block. Monitor depression, suicidal thoughts, and/or unusual behavioral changes that stop development. Increase the risk of hypoglycemia and measure blood glucose before and during the onset of hypoglycemic therapy in diabetic patients. Susceptibility to abnormal erection of the penis. The penis is dissected and deformed. Regular monitoring during CBCS treatment. If you suspect elevation measurements of prolactin levels. Moderate renal impairment. Severe renal insufficiency or end-stage renal disease (ESRD): Not recommended. Severe liver damage. Breastfeeding mother: Not recommended.

Interaction (complement)

Note the accompanying triptans, monoamine oxidase inhibitors, linezolid, SSRIs of SNRIs, tricyclic antidepressants, bupropion, lithium, tramadol, tryptophan, St. John's wort, antipsychotic Drug, or PDE-5 inhibitor. Enhance the effect of dextromethorphan and other CYP2D6 substrates. Cardiac valvular disease with drugs is an increased risk of a potent 5-HT 2B receptor agonist (eg, cabergoline). Accompanying insulin: no research.

Adverse reactions (S)

Headache, dizziness, fatigue, nausea, dry mouth, constipation, hypoglycemia, back pain, cough, cognitive impairment, bradycardia, mental disorder, blood changes, elevated prolactin.

FDA approves Belviq for weight control

On July 12, 2012, the FDA approved Belviq (lorcaserin HCl) for chronic weight control in obese adults. Belviq is a supplement for low calorie diets and increased exercise in obese adult patients who have an initial body mass index (BMI) of 30 kg/m2 or higher (obesity), or at least one A BMI value of 27 kg/m 2 or higher (overweight) in a weight-related disease (eg, hypertension, dyslipidemia, type 2 diabetes). The instructions include the following restrictions on use: The safety and efficacy of taking Belviq while taking other medications for weight loss purposes remains to be further verified, and whether Belviq will have an impact on cardiovascular morbidity and mortality Still not sure.

The use of Belviq is an important step for those who are struggling with obesity and who are overweight with complications and need to replace diet and exercise with chronic weight management.

Belviq's double-blind trial, randomized controlled trial and placebo-controlled trial. These three trials demonstrate the effect of Belviq on diet and exercise in helping patients with weight loss, which is more effective than diet and exercise alone. After a year they lost 5% or more of their weight and managed weight loss treatment for up to two years.

In clinical trials, the most common adverse reactions in non-diabetic patients who use Belviq are headache, dizziness, fatigue, dry mouth and constipation. Among the diabetic patients, the most common adverse reactions are: hypoglycemia, headache, back pain, cough and fatigue.

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Country of origin: United States

origin English English product name:

Belviq Tablets 10mg/tablets 30tablets/Bottle

Original English drug name:

lorcaserin hydrochloride

Chinese reference product translation name:

Belviq tablets 10 mg/tablet 30 tablets/bottle

Chinese reference drug translation:

Chlorosin

Manufacturer Chinese Reference Translation Name: Eisai Company

Manufacturer English name: Eisai Inc.

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 详细处方信息以本药内容附件PDF文件（2018112821314426.pdf）的“原文Priscribing Information”为准
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