繁体中文
设为首页
加入收藏
当前位置:药品说明书与价格首页 >> 综合药讯 >> 他喷他多速释片Nucynta(tapentadol)

他喷他多速释片Nucynta(tapentadol)

2009-11-17 11:03:21  作者:新特药房  来源:中国新特药网  浏览次数:603  文字大小:【】【】【
简介: COMPANY: PriCara PHARMACOLOGIC CLASS: Opioid ACTIVE INGREDIENT: Tapentadol 50mg, 75mg, 100mg tabs. INDICATION: Moderate to severe acute pain in patients ≥18 years of age. PHAR ...

 制造商:
PriCara

药理分类:
阿片

活性成分(补):
50毫克了tapentadol,75毫克,100毫克;标签
指示(补):
中度至重度患者的年龄≥18yrs急性疼痛。

药理作用:
是一个集中了tapentadol效合成镇痛药。虽然其作用机制尚不清楚,镇痛效果被认为是由于μ-阿片受体激动剂活性和去甲肾上腺素再摄取抑制作用。

临床试验:
两项随机,双盲,安慰剂和积极的控制进行了研究,以评估在治疗的疗效和安全性中度至重度了tapentadol从第一跖骨bunionectomy和结束阶段的退行性关节疾病急性疼痛。

在bunionectomy研究中,患者18至80岁中度至重度疼痛的单侧,第一跖骨bunionectomy手术的患者给予了tapentadol 50毫克,75毫克,100毫克,或安慰剂,每4至6小时,72小时。患者的比例在48谁发现30%或更高,或50%或更高小时疼痛强度均显着减少了tapentadol在每个治疗剂量与安慰剂的病人高。

在最后阶段的退行性关节病的研究中,患者18至80岁的中度退化阶段,从结束的髋关节或膝关节疼痛是严重的疾病给予了tapentadol 50毫克,75毫克或安慰剂,每4至6小时10天。患者的比例在5谁发现30%或以上,或50%或更高天疼痛强度均显着降低了tapentadol在每个治疗剂量与安慰剂的病人高。

法律分类:
印度工业联合会

成人:
≥18yrs:50 - 100毫克每4-6小时内疼痛强度而定。首先给药日:5月第二次给予第一剂后一小时,如果没有足够的疼痛缓解第一剂达到,后来的剂量应每4-6小时。最大700mg/day的第一天,在随后的几天600mg/day。中度肝功能不全:最初50毫克,每8小时,最大3 doses/24小时。

儿童:
“18yrs:不推荐。

禁忌(补):
显着的呼吸抑制,急性或严重哮喘或高碳酸血症(在设置或在不受监督的复苏设备的情况下)。麻痹性肠梗阻。过程中或在14天的单胺氧化抑制剂。


警告/注意事项:
严重肾或肝功能不全:不推荐。哮喘。慢性阻塞性肺病。肺心病。重度肥胖。睡眠呼吸暂停综合征。粘液性水肿。侧后凸。中枢神经系统抑郁症。昏迷。头部受伤。颅内压增高。夺取混乱。胆道疾病。急性胰腺炎。吸毒者。避免突然停止。老人。虚弱。妊娠(Cat.C)。劳动和分娩,哺乳期妇女:不推荐。

互动(补):
见禁忌。添加剂与其他中枢神经系统中枢神经系统抑制剂(如全身麻醉剂,酚噻嗪,镇静药,安眠药,酒精)抑郁症,考虑降低剂量。羟色胺综合征伴SSRI类药物,SNRIs的,三环,单胺氧化抑制剂,曲坦,其他药物可能损害血清素代谢的影响。

不良反应(补):
胃肠不适,头晕,嗜睡,呼吸,中枢神经系统抑郁症。

如何提供:
制表- 100

最后更新:
2009/7/2

NUCYNTA

Manufacturer:

PriCara

Pharmacological Class:

Opioid

Active Ingredient(s):

Tapentadol 50mg, 75mg, 100mg; tabs.

Indication(s):

Moderate to severe acute pain in patients ≥18yrs of age.

Pharmacology:

Tapentadol is a centrally-acting synthetic analgesic. Although its mechanism of action is unknown, analgesic efficacy is thought to be due to mu-opioid agonist activity and the inhibition of norepinephrine reuptake.

Clinical Trials:

Two randomized, double-blind, placebo- and active-controlled studies were conducted to evaluate the efficacy and safety of tapentadol in the treatment of moderate to severe acute pain from first metatarsal bunionectomy and end-stage degenerative joint disease.

In the bunionectomy study, patients 18 to 80 years of age with moderate to severe pain following unilateral, first metatarsal bunionectomy surgery were given tapentadol 50mg, 75mg, 100mg, or placebo every 4 to 6 hours for 72 hours. The proportion of patients who showed reduction in pain intensity at 48 hours of 30% or greater, or 50% or greater were significantly higher in patients treated with tapentadol at each dose versus placebo.

In the end-stage degenerative joint disease study, patients 18 to 80 years of age with moderate to severe pain from end stage degenerative joint disease of the hip or knee were given tapentadol 50mg, 75mg, or placebo every 4 to 6 hours for 10 days. The proportion of patients who showed reductions in pain intensity at 5 days of 30% or greater, or 50% or greater were significantly higher in patients treated with tapentadol at each dose versus placebo.

Legal Classification:

CII

Adults:

≥18yrs: 50–100mg every 4–6 hours depending upon pain intensity. First day of dosing: may give second dose one hour after first dose if adequate pain relief not attained with first dose; subsequent doses should be given every 4–6 hours. Max 700mg/day on the first day, 600mg/day on subsequent days. Moderate hepatic impairment: initially 50mg every 8 hours; max 3 doses/24 hours.

Children:

<18yrs: not recommended.

Contraindication(s):

Significant respiratory depression, acute or severe asthma or hypercapnia (in unmonitored settings or in the absence of resuscitative equipment). Paralytic ileus. During or within 14 days of MAOIs.

Warnings/Precautions:

Severe renal or hepatic impairment: not recommended. Asthma. COPD. Cor pulmonale. Severe obesity. Sleep apnea syndrome. Myxedema. Kyphoscoliosis. CNS depression. Coma. Head injury. Increased intracranial pressure. Seizure disorders. Biliary tract disease. Acute pancreatitis. Drug abusers. Avoid abrupt cessation. Elderly. Debilitated. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended.

Interaction(s):

See Contraindications. Additive CNS depression with other CNS depressants (eg, general anesthetics, phenothiazines, sedatives, hypnotics, alcohol); consider reducing dose. Serotonin syndrome possible with concomitant SSRIs, SNRIs, tricyclics, MAOIs, triptans, other drugs that impair metabolism of serotonin.

Adverse Reaction(s):

GI upset, dizziness, somnolence; respiratory, CNS depression.

How Supplied:

Tabs—100

美国FDA批准新药他喷他多NUCYNTA™(tapentadol)速释片上市
美国食品和药物管理局(FDA)批准强生药物研究与开发公司研制的他喷他多(NUCYNTA™tapentadol)速释片上市,用于解除成人中度至严重急性疼痛。

本品系一中枢作用的新口服镇痛药 ,通过激动μ型阿片受体和抑制去甲肾上腺素再摄取两种作用机制发挥疗效。批准的剂量规格:tapentadol 50 、75 和100 mg /片。

μ型阿片受体激动剂可结合于并可激活中枢神经系统的μ型阿片受体,改变疼痛的感觉、抑制疼痛在脊髓传递和控制脑疼痛接收区的活动。去甲肾上腺素再摄取抑制剂则是可通过抑制去甲肾上腺素被再吸收入神经细胞来增加脑内去甲肾上腺素浓度的中枢神经系统药物。这2种化合物均具有镇痛作用。

本品的药理作用与曲马多相似,但后者含左旋、右旋异构体的消旋体,激动μ型阿片类受体和抑制去甲肾上腺素再吸收作用分别获自曲马多不同构型的异构体及其代谢产物;而本品激动μ型阿片类受体和抑制去甲肾上腺素再吸收则是同一分子构型起作用不经过中间代谢途径。本品的镇痛作用强于曲马多。

本品获准上市是基于纳入2 100例患者的临床研究结果。此研究2008年初在27届美国疼痛协会科学年会上作了介绍,显示其较安慰剂可显著解除中度至严重急性疼痛。

本品最常见的不良反应是恶心、眩晕、呕吐、嗜眠和头痛。本品禁用于下列患者:呼吸明显抑制、急性或严重支气管哮喘或高碳血等禁用μ型阿片受体激动剂,麻痹性肠梗阻,目前正在使用或14日内使用过单胺氧化酶抑制剂的患者。

责任编辑:admin


相关文章
NUCYNTA CR(TAPENTADOL HYDROCHLORIDE tabs)
XARTEMIS XR(复方羟考酮/对乙酰氨基酚缓释片)
 

最新文章

更多

· 无水酒精注射液(DEHYDR...
· DEHYDRATED ALCOHOL(无...
· 除铁能注射剂DESFERAL(D...
· ALBUMINAR IV SOLUTION(...
· Dantrium Intravenous I...
· Bunavail(盐酸丁丙诺啡...
· Dyloject(diclofenac so...
· THAM SOLUTION(trometha...
· THAM Injection SET(Tr...
· 首个基因新药Glybera注射...

推荐文章

更多

· 无水酒精注射液(DEHYDR...
· DEHYDRATED ALCOHOL(无...
· 除铁能注射剂DESFERAL(D...
· ALBUMINAR IV SOLUTION(...
· Dantrium Intravenous I...
· Bunavail(盐酸丁丙诺啡...
· Dyloject(diclofenac so...
· THAM SOLUTION(trometha...
· THAM Injection SET(Tr...
· 首个基因新药Glybera注射...

热点文章

更多

· 除铁能注射剂DESFERAL(D...
· DEHYDRATED ALCOHOL(无...
· 无水酒精注射液(DEHYDR...