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: 类药物: 活性成分(S): 药理: 临床试验: 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: 成人: 儿童: 禁忌(S): 警告/注意事项: 相互作用(S): 不良反应(S): 如何提供: 最后更新: 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 |
Staxyn(伐地那非口腔崩解片)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 ... 责任编辑:admin
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