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 >> 男性科 >> 新药推存 >> Staxyn(伐地那非口腔崩解片)

Staxyn(伐地那非口腔崩解片)

2011-11-21 10:42:37  作者:新特药房  来源:中国新特药网天津分站  浏览次数:355  文字大小:【】【】【
简介: 2010年6月18日,默克公司宣布,美国食品药品管理局(FDA)已批准口腔崩解片Staxyn(伐地那非)用于治疗勃起功能障碍(ED)。Staxyn在美国将由葛兰素史克和默克专门销售,该药预计于2010年年底前作为处方药上市 ...

2010年6月18日,默克公司宣布,美国食品药品管理局(FDA)已批准口腔崩解片Staxyn(伐地那非)用于治疗勃起功能障碍(ED)。Staxyn在美国将由葛兰素史克和默克专门销售,该药预计于2010年年底前作为处方药上市。

Staxyn等ED治疗药不宜用于因潜在的心血管疾病[如不稳定性心绞痛、低血压、高血压控制不良、近期卒中病史、致死性心律失常、心肌梗死(发生于最近6个月内)以及重度心衰]而不建议发生性行为的男性。Staxyn不宜与中效和强效CYP3A4抑制剂(如促红细胞生成素、葡萄柚汁、克拉霉素、酮康唑、伊曲康唑、茚地那韦、沙奎那韦、阿扎那韦、利托那韦)联合用药,因为联合用药会导致血浆伐地那非浓度显著升高。

在临床试验中,最常报告的与Staxyn用药有关的不良事件有头痛、潮红、鼻充血、消化不良、头晕及背痛。

Staxyn不能与10 mg伐地那非薄膜衣片(艾力达)互换,因为Staxyn释放入血液中的有效成分浓度较高。Staxyn的最大给药频率为每天1片。

制造商:
拜耳和葛兰素史克公司

类药物:
磷酸二酯酶5型抑制剂(cGMP特定的)。

活性成分(S):
伐地那非(以HCl)10毫克;口腔崩解选项卡;薄荷味;含有苯丙氨酸。
指示(S):
勃起功能障碍。

药理:
Staxyn是一个环鸟苷酸(cGMP)的特定的5型磷酸二酯酶(PDE5)抑制剂。抑制PDE5的增加cGMP的量,这反过来又触发平滑肌松弛,使阴茎血流增加,从而导致勃起。由于性刺激是需要启动局部释放一氧化氮,PDE5的抑制性刺激的情况下没有任何效果。

临床试验:
Staxyn的疗效和安全性进行评估,在两个相同的跨国公司,随机,双盲,安慰剂对照试验(研究1 [n = 355]和研究2 [N = 331])。 Staxyn管理需要的基础上对男性勃起功能障碍,其中许多人有多个其他的医疗条件。在这两项研究中,随机分层,使大约50%的患者≥65年的老。勃起功能(EF)国际勃起功能问卷(IIEF)和性接触概况(SEP),处理问题的能力,从而达到阴道渗透(SEP2)指数的验证域得分手段,主要疗效评估保持足够长的勃起性交成功(SEP3)的能力。

在研究1,平均基线EF域分数Staxyn组和安慰剂组为13。端点,为Staxyn EF域得分是21相比,安慰剂组14; SEP2 Staxyn的74%与45%,服用安慰剂的患者;和SEP3 Staxyn的65% - 26%,服用安慰剂的患者为。

在研究2中,平均基线EF域分数分别为Staxyn 12和安慰剂组为13。端点,为Staxyn EF域得分是21相比,安慰剂组14; SEP2 Staxyn的69% - 43%,服用安慰剂的患者为;和SEP3 Staxyn的60% - 27%,服用安慰剂的患者为。

在这两项研究中,Staxyn证明临床意义和统计学意义(P <0.0001)改进对安慰剂在所有三个主要的疗效变量。

法律分类:
接收

成人:
互换与伐地那非(艾力达)10毫克膜衣选项卡。以无液体。将一粒舌,性活动前约1小时,最大1标签/天。伴随α-受体阻滞剂:使用低剂量的伐地那非薄膜包衣标签作为初始治疗。

儿童:
不推荐。

禁忌(S):
伴随硝酸盐,或一氧化氮供体。

警告/注意事项:
确认诊断。先天性QT间期延长:避免使用。心血管疾病(如不稳定型心绞痛;收缩压<90或BP>一百一十分之一百七十零;最近中风,危及生命的心律失常或心肌梗死(6个月内);严重心脏衰竭,左室流出道梗阻),中度或重度肝功能不全,视网膜色素变性,肾透析,及相关的视网膜疾病:不推荐。解剖阴茎变形。易感性异常勃起。出血性疾病。活动性消化性溃疡。果糖不耐受。怀孕(部件乙)。

相互作用(S):
见禁忌。避免类IA(如奎尼丁,普鲁卡因胺)或III类(如胺碘酮,索他洛尔)抗心律失常药物,其他导致QT间期延长。低血压与硝酸盐,α-受体阻滞剂,其它降压药。伴随中度或强效CYP3A4抑制剂(:例如,红霉素,葡萄柚汁,克拉霉素,酮康唑,伊曲康唑,茚地那韦,沙奎那韦,阿扎那韦,利托那韦),或其他治疗勃起功能障碍治疗:不推荐。与α-受体阻滞剂的注意事项。

不良反应(S):
头痛,潮红,鼻塞,消化不良,头晕,背痛,突然视力或听力损失(如果出现停止),心血管的影响(例如,低血压,心动过速),QT间期延长;罕见:阴茎异常勃起。

如何提供:
吸塑卡(标签)-1 × 4 1​​0 × 4

最后更新:
2011年11月15日


STAXYN

Manufacturer:

Bayer and GlaxoSmithKline

Pharmacological Class:

Phosphodiesterase type 5 inhibitor (cGMP-specific).

Active Ingredient(s):

Vardenafil (as HCl) 10mg; orally disintegrating tabs; peppermint flavor; contains phenylalanine.

Indication(s):

Erectile dysfunction.

Pharmacology:

Staxyn is a cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases the amount of cGMP, which in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.

Clinical Trials:

The efficacy and safety of Staxyn were evaluated in two identical multinational, randomized, double-blind, placebo-controlled trials (Study 1 [N=355] and Study 2 [N=331]). Staxyn was administered on an as-needed basis in men with erectile dysfunction, many of whom had multiple other medical conditions. In both studies, randomization was stratified so that approximately 50% of patients were ≥65 years old. Primary efficacy assessment was by means of the Erectile Function (EF) Domain score of the validated International Index of Erectile Function (IIEF) Questionnaire and two questions from the Sexual Encounter Profile (SEP) dealing with the ability to achieve vaginal penetration (SEP2) and the ability to maintain an erection long enough for successful intercourse (SEP3).

In Study 1, the mean baseline EF domain scores were 13 for both Staxyn and placebo groups. At endpoint, the EF domain score for Staxyn was 21 compared to 14 in the placebo group; SEP2 was 74% for Staxyn vs. 45% for placebo; and SEP3 was 65% for Staxyn vs. 26% for placebo.

In Study 2, the mean baseline EF domain scores were 12 for Staxyn and 13 for placebo. At endpoint, the EF domain score for Staxyn was 21 compared to 14 in the placebo group; SEP2 was 69% for Staxyn vs. 43% for placebo; and SEP3 was 60% for Staxyn vs. 27% for placebo.

In both studies, Staxyn demonstrated clinically meaningful and statistically significant (p<.0001) improvements over placebo in all three primary efficacy variables.

Legal Classification:

Rx

Adults:

Not interchangeable with vardenafil (Levitra) 10mg film-coated tabs. Take without liquid. Place one tablet on tongue, about 1 hour before sexual activity; max 1 tab/day. Concomitant α-blockers: use lower doses of vardenafil film-coated tabs as initial therapy.

Children:

Not recommended.

Contraindication(s):

Concomitant nitrates, or nitric oxide donors.

Warnings/Precautions:

Confirm diagnosis. Congenital QT prolongation: avoid use. Cardiovascular disease (eg, unstable angina; systolic BP<90 or BP>170/110; recent stroke, life-threatening arrhythmia, or MI (within 6 months); severe cardiac failure; LV outflow obstruction), moderate or severe hepatic impairment, renal dialysis, retinitis pigmentosa, and related retinal disorders: not recommended. Anatomical penile deformation. Predisposition to priapism. Bleeding disorders. Active peptic ulcer. Fructose intolerance. Pregnancy (Cat. B).

Interaction(s):

See Contraindications. Avoid Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmics, others that cause QT prolongation. Hypotension with nitrates, α-blockers, other antihypertensives. Concomitant moderate or potent CYP3A4 inhibitors (eg, erythromycin, grapefruit juice, clarithromycin, ketoconazole, itraconazole, indinavir, saquinavir, atazanavir, ritonavir), or other erectile dysfunction treatments: not recommended. Caution with α-blockers.

Adverse Reaction(s):

Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain, sudden vision or hearing loss (discontinue if occurs), cardiovascular effects (eg, hypotension, tachycardia), QT prolongation; rare: priapism.

How Supplied:

Tabs (blister cards)—1 x 4, 10 x 4

Last Updated:

11/15/2011

责任编辑:admin


相关文章
Staxyn(盐酸伐地那非)口腔崩解片-用于治疗男性勃起功能障碍
Staxyn(盐酸伐地那非vardenafil HCI)FDA批准在美上市
 

最新文章

更多

· 睾酮素凝胶|AndroGel(te...
· Xiaflex(注射用胶原酶溶...
· DESMOPRESSIN Spray(醋...
· 马尿酸乌洛托品片|Hipre...
· Uracyst solution vials...
· Vitaros cream(alprosta...
· Natesto(testosterone) ...
· SILDENAFIL OD TABLETS(...
· Glycine 1.5% solution(...
· 西地那非口腔崩解片(SI...

推荐文章

更多

· 睾酮素凝胶|AndroGel(te...
· Xiaflex(注射用胶原酶溶...
· DESMOPRESSIN Spray(醋...
· 马尿酸乌洛托品片|Hipre...
· Uracyst solution vials...
· Vitaros cream(alprosta...
· Natesto(testosterone) ...
· SILDENAFIL OD TABLETS(...
· Glycine 1.5% solution(...
· 西地那非口腔崩解片(SI...

热点文章

更多

· 睾酮素凝胶|AndroGel(te...
· Xiaflex(注射用胶原酶溶...
· DESMOPRESSIN Spray(醋...