通用名称为FORTESTA
睾酮10mg/0.5g驱动;计量泵;外用凝胶。
法律分类：
CIII
药理班级FORTESTA
雄激素。
制造商FORTESTA
远藤制药
适应症FORTESTA
主性腺功能低下。 Hypogonadotropic性腺功能低下。
成人剂量为FORTESTA
建议患者严格遵守建议的说明。 ≥18yrs：应用前面和大腿内侧只有清洁，干燥，完好的皮肤。最初40毫克（4泵actuations）曾经在每日上午。根据调整血清睾酮水平（见文献）;分钟：10mg/day，最大：70mg/day。洗净后，应用洗手;不洗2小时后，申请网站;盖现场搭配服装。前第一首相泵使用。不与其他睾酮产品互换。
儿童剂量为FORTESTA
<18yrs：不推荐。
禁忌的FORTESTA
已知或怀疑有前列腺癌或乳腺癌。妊娠（Cat.X）。护理母亲。
警告/注意事项为FORTESTA
二次接触睾丸激素，及时停止，如果在儿童和妇女男性化体征出现，直到查明原因。儿童和妇女必须避免与未洗或unclothed应用网站联系。前列腺癌的治疗开始前评估。监测恶化BPH。已存在的心脏，肾脏或肝脏疾病。定期监测血清睾酮，PSA，血红蛋白，红细胞压积，肝功能，血脂，PT / INR。监测血清钙如果高钙血症的危险。产品是易燃。
相互作用的FORTESTA
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：增加液体潴留。
为FORTESTA不良反应
应用部位反应，雄激素的影响，水肿，无精症，男性乳房发育，睡眠呼吸暂停，异常的梦想。
如何FORTESTA提供？
泵（120 actuations）-1，2，3
局部外用凝胶Fortesta获准用于治疗性腺机能减退症
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
Generic Name for FORTESTA
Testosterone 10mg/0.5g actuation; metered-dose pump; topical gel.
Legal Classification:
CIII
Pharmacological Class for FORTESTA
Androgen.
Manufacturer of FORTESTA
Endo Pharmaceuticals
Indications for FORTESTA
Primary hypogonadism. Hypogonadotropic hypogonadism.
Adult dose for FORTESTA
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's dosing for FORTESTA
<18yrs: not recommended.
Contraindications for FORTESTA
Known or suspected prostate or breast cancer. Pregnancy (Cat.X). Nursing mothers.
Warnings/Precautions for FORTESTA
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.
Interactions for FORTESTA
Antidiabetic drugs may need adjustment. ACTH, corticosteroids: increased fluid retention.
Adverse Reactions for FORTESTA
Application site reactions, androgenic effects, fluid retention, azoospermia, gynecomastia, sleep apnea, abnormal dreams.
How is FORTESTA supplied?
Pump (120 actuations)—1, 2, 3