制造商： 远藤制药 药理分类： 雄激素。 活性成分（补）： 睾酮10mg/0.5g驱动;计量泵;外用凝胶。 指示（补）： 原发性性腺功能低下。脑下垂体性腺功能低下。 药理作用： Fortesta是一种雄激素，睾丸激素作为替代在与A缺乏症或内源激素治疗男性相关条件的情况下表示，外用凝胶配方。当应用得当，它提供了24小时连续睾酮交付。提供了一组每天服用睾丸激素生理量，产生血药浓度在健康男性的近似见过的水平。 原发性性腺功能低下，或睾丸功能衰竭，如隐睾，双侧睾丸扭转，睾丸切除，化疗，或重金属中毒，以及特发性促性腺激素或促黄体激素释放激素缺乏症，垂体，下丘脑损伤状况有关的睾丸激素可以治疗的替代品。 临床试验： 一个多中心，开放标签，非比较90天的试用版进行了涉及149个18至75岁男性性腺机能减退。起始剂量的40mg/day后来被用来调整和70mg/day之间10mg/day血清睾酮水平的基础上获得的后14天，35和60个应用2小时。主要终点是在正常范围的百分比平均血药浓度与患者（≥300ng/dL为≤1140ng/dL）第90天。在与研究药物治疗的患者中，77.5％的人在正常范围内第90天，平均血药浓度。 次要终点是预先确定的限额以上三例血药浓度最高的百分比。第90天，5.4％的患者血清中的最高浓度大于1500ng/dL，1.6％的患者之间1800ng/dL和2499ng/dL最大血药浓度。 平均血清水平的变化保持以上的为24小时给药间隔正常的下限。 法律分类： CIII 成人： 建议患者严格遵守建议的说明。 ≥18yrs：适用于清洁，干燥，前面只有大腿内侧完整的皮肤。最初40毫克（4泵actuations）曾经在每天上午。根据调整血清睾酮水平（见文献）;分：10mg/day，最大：70mg/day。申请后要洗手，不洗申请后2小时现场;覆盖服装网站。前第一首相泵使用。不能互换与其他睾酮产品。 儿童： “18yrs：不推荐。 禁忌（补）： 已知或怀疑有前列腺癌或乳腺癌。妊娠（Cat.X）。哺乳的母亲。 警告/注意事项： 二次曝光睾酮，及时中止如果在儿童和妇女男性化的迹象出现，直到查明原因。儿童和妇女必须避免与未洗或赤身应用网站联系。前列腺癌治疗开始前评估。良性前列腺增生监控恶化。已存在的心脏，肾脏或肝脏疾病。定期监测血清睾酮，PSA和血红蛋白，红细胞压积，肝功能，血脂，玻璃纸/印度卢比。如果风险监测血钙高血钙。产品是易燃。 互动（补）： 抗糖尿病药物可能需要调整。促肾上腺皮质激素，皮质类固醇：增加水肿。 不良反应（补）： 应用部位反应，雄激素效应，水肿，无精症，男性女乳症，睡眠呼吸暂停，异常的梦想。 如何提供： 泵（120 actuations）-1，2，3 最后更新： 2011年4月13日 局部外用凝胶Fortesta获准用于治疗性腺机能减退症 2010年12月29 日，远藤制药公司宣布，美国食品药品管理局(FDA)已经批准Fortesta 凝胶用于治疗男性睾酮水平降低(亦称“性腺机能减退症”)。性腺机能减退症的相关症状包括：勃起功能障碍、性欲减退、疲劳和乏力、抑郁、第二性征退化和骨质疏松。 Fortesta是一种无色无味的透明凝胶，使用方法是用一个手指轻轻地将其涂抹在大腿的前内侧。凝胶被装在一个计量泵内，每次完全按压计量泵即流出正确剂量的凝胶。 一项以患有性腺机能减退症的男性为受试者、历时90天、多中心、开放性、非比较性的重要Ⅲ期临床试验的结果显示，在使用Fortesta凝胶的患者中，有78%在第90天时平均血清总睾酮浓度恢复到正常范围。该试验报告的最常见不良反应是用药部位的反应。 FORTESTA Manufacturer: Endo Pharmaceuticals Pharmacological Class: Androgen. Active Ingredient(s): Testosterone 10mg/0.5g actuation; metered-dose pump; topical gel. Indication(s): Primary hypogonadism. Hypogonadotropic hypogonadism. Pharmacology: Fortesta is a topical gel formulation of the androgen, testosterone, indicated as replacement therapy in males for conditions associated with a deficiency or absence of the endogenous hormone. When applied correctly, it provides a continuous delivery of testosterone for 24 hours. Daily dosing supplies a physiologic amount of testosterone, producing serum concentrations that approximate those levels seen in healthy men. Primary hypogonadism, or testicular failure, associated with conditions such as cryptorchidism, bilateral torsion, orchiectomy, chemotherapy, or heavy metal toxicity, as well as idiopathic gonadotropin or luteinizing hormone-releasing hormone deficiency and pituitary-hypothalamic injury can be treated with testosterone replacement. Clinical Trials: A multicenter, open-label, noncomparative 90-day trial was conducted involving 149 hypogonadal males between 18 and 75 years of age. A starting dose of 40mg/day was used which was subsequently adjusted to between 10mg/day and 70mg/day based on serum testosterone levels obtained 2 hours after application on Days 14, 35, and 60. The primary endpoint was the percentage of patients with average serum concentrations within the normal range (≥300ng/dL to ≤1140ng/dL) on Day 90. In patients treated with the study drug, 77.5% had average serum concentrations within the normal range on Day 90. The secondary endpoint was the percentage of patients with maximum serum concentrations above three predetermined limits. On Day 90, 5.4% of patients had maximum serum concentrations greater than 1500ng/dL, and 1.6% of patients had maximum serum concentrations between 1800ng/dL and 2499ng/dL. Mean serum levels were observed to remain above the lower limit of normal for the 24-hour dosing interval. Legal Classification: CIII Adults: Advise patients to strictly adhere to recommended instructions. ≥18yrs: Apply to clean, dry, intact skin on front and inner thighs only. Initially 40mg (4 pump actuations) once daily in the AM. Adjust based on serum testosterone levels (see literature); min: 10mg/day, max: 70mg/day. Wash hands after application; do not wash site for 2 hours after application; cover site with clothing. Prime pump before 1st use. Not interchangeable with other testosterone products. Children: <18yrs: not recommended. Contraindication(s): Known or suspected prostate or breast cancer. Pregnancy (Cat.X). Nursing mothers. Warnings/Precautions: Secondary exposure to testosterone; promptly discontinue if signs of virilization in children and women occurs until cause is identified. Children and women must avoid contact with unwashed or unclothed application sites. Evaluate for prostate cancer before starting therapy. Monitor for worsening BPH. Pre-existing cardiac, renal, or hepatic disease. Periodically monitor serum testosterone, PSA, hemoglobin, hematocrit, liver function, lipid profile, PT/INR. Monitor serum calcium if risk of hypercalcemia. Product is flammable. Interaction(s): Antidiabetic drugs may need adjustment. ACTH, corticosteroids: increased fluid retention. Adverse Reaction(s): Application site reactions, androgenic effects, fluid retention, azoospermia, gynecomastia, sleep apnea, abnormal dreams. How Supplied: Pump (120 actuations)—1, 2, 3