雌二醇透皮贴MINIVELLE
药理类别: 雌激素。
活性成分(S): 雌二醇0.0375mg/day,0.05mg/day,0.075mg/day,0.1mg/day;透皮贴剂。
指示(S): 由于更年期的中度至重度血管舒缩症状。
药理作用: 通过核受体在雌激素反应组织结合雌激素的作用。
循环雌激素调节的脑垂体分泌的促性腺激素,促黄体生成激素(LH)和卵泡刺激素(FSH)通过负反馈机制。雌激素的作用,以减少这些激素的浓度升高见于绝经后妇女。
临床试验: 目前还没有疗效和安全性试验进行Minivelle。
法律分类: 接收
成人: 适用于清洁,干燥的地方,小腹或臀部,(不是胸部或腰部);旋转应用程序的网站。使用最低有效剂量,最短的工期。最初0.0375mg/day补丁每周两次(每3-4天)。定期重新评估。尝试锥度或停止在3-6个月的时间间隔。
儿童: 没有研究过。
禁忌(S): 未确诊的异常生殖器出血。已知或疑似乳腺癌病史。已知或怀疑有雌激素依赖性瘤。主动DVT,PE或历史。主动动脉血栓栓塞性疾病的历史。肝功能损害。已知的蛋白质C,蛋白质S,抗凝血酶缺乏或其它已知的血栓形成倾向的疾病。怀孕(Cat.X)。
警告/注意事项: 心血管疾病的风险增加。子宫内膜癌或乳腺癌。妇女> 65yrs岁的老年痴呆症可能的风险。胆囊疾病。骨病伴有高钙血症。视觉异常。考虑增加一个完整的子宫,以避免子宫内膜增生患者孕激素。历史血症。肝功能损害。监测甲状腺功能。条件加重体液潴留。甲状旁腺功能减退。子宫内膜异位症。遗传性血管性水肿。哮喘,糖尿病,癫痫,偏头痛,卟啉病,系统性红斑狼疮,肝血管瘤的注意事项。做初步完整的物理和重复每年(包括子宫颈抹片检查,乳房X光检查,BP)。停止如果出现黄疸,心脏事件,严重高血钙或胰腺炎。停止增加血栓栓塞的风险,或长时间无法行走时伴有手术前至少需要4-6周。哺乳期的母亲。
互动(补) 可能是拮抗由CYP3A4诱导剂(如苯巴比妥,卡马西平,利福平,圣约翰草)。可能会增强通过CYP3A4抑制剂(如红霉素,克拉霉素,酮康唑,伊曲康唑,利托那韦,西柚汁)。
不良反应(S) 请参阅完整的标签。头痛,乳房胀痛,腰痛,肢体疼痛,鼻咽炎,消化不良,恶心,鼻窦炎,经间期出血。
如何提供: 补丁-8,24
最后更新: 2013年4月15日
规格:0375.05.075 and.10mg
Minivelle® (estradiol transdermal system) Smallest Estrogen Therapy Patch 2013, Noven launched Minivelle® (estradiol transdermal system), the planet’s smallest estrogen therapy patch, in the U.S. This state-of-the-art patch, developed and manufactured by Noven, is approved by the FDA for the treatment of moderate to severe hot flashes and night sweats due to menopause. Noven markets and sells Minivelle through the Women’s Health unit of its subsidiary, Noven Therapeutics, LLC. Minivelle is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and is available in 4 dosage strengths (0375, .05, .075 and .10 mg/day). INDICATION MINIVELLE® (estradiol transdermal system) is a prescription medicine patch that contains estradiol (an estrogen hormone). MINIVELLE is used to treat moderate to severe hot flashes due to menopause. IMPORTANT SAFETY INFORMATION
What is the most important information I should know about MINIVELLE (an estrogen hormone)? •Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using MINIVELLE. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause •Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function) •Using estrogen-alone may increase your chances of getting strokes or blood clots •Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older •Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia •Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots •Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older •You and your healthcare provider should talk regularly about whether you still need treatment with MINIVELLE | MINIVELLE should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to MINIVELLE or any of its ingredients, or think you may be pregnant. The most common side effects that may occur with MINIVELLE are headache, breast tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation of the sinuses and irregular vaginal bleeding or spotting. MINIVELLE should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks. http://www.medicationdaily.com/minivelle/spl/6c5c47ab-28ee-11e1-bfc2-0800200c9a66 |