部分中文睾酮（testosterone）局部用溶液制剂处方资料（仅供参考） 近日；美国FDA批准睾酮（testosterone）局部用溶液制剂，其商品名为Axiron。这是FDA批准的第一个（像除臭剂那样的）腋下用睾酮替代疗法（TRT）制剂，适合那些患有与睾丸激素不足或缺乏相关疾病男性。 睾酮替代疗法的其它制剂有口服片剂，口含片，皮下埋植片，透皮贴剂，注射剂，和局部凝胶。 Axiron常见的不良反应有：皮肤反应、红细胞数目增多，头疼、腹泻、呕吐、前列腺特异抗原活性升高等。该药物没有对18岁以下男性进行测试。 荷尔蒙可能通过紧密接触而影响他人，偶然有青少年应接触睾酮而性早熟的事件报告。患者在使用Axiom后应立即包裹用药区域和洗手，尽量避免该类事件发生。 通用名称为AXIRON 睾酮30mg/1.5mL泵驱动; soln的;含有酒精;乳胶免费。 法律分类： CIII 药理类为AXIRON 雄激素。 对AXIRON制造商 礼来公司，礼和公司 主治为AXIRON 睾酮替代疗法。 成人剂量为AXIRON 建议患者严格遵守建议的说明。应用清洁，擦干腋下皮肤完整，并不适用于阴囊，阴茎，腹部，肩部或上臂。 ≥0-18岁：最初申请60毫克（30毫克每腋下），每天一次，在上午测量血清睾酮水平，以确保响应。 2至8小时后，申请后至少14天开始治疗或调整剂量和血清睾酮浓度的基础上，可能会调整剂量。可能会增加剂量为30mg递增，如果血清睾酮<300ng/dL高达120毫克;减少剂量到30毫克，如果水平> 1050ng/dL，停止如果血清睾酮仍然1050ng/dL。申请后洗手。允许soln的干之前，它触及的服装。不与其他外用睾酮产品互换。 儿童剂量为AXIRON <18yrs：不推荐。 禁忌的AXIRON 男性乳腺癌或前列腺癌。妇女使用。怀孕（Cat.X）。哺乳的母亲。 为AXIRON警告/注意事项 其他人（尤其是儿童）必须避免接触与应用程序的网站。二次接触睾酮;及时停止，如果发生在儿童和妇女男性化体征，直到原因查明。恶化的前列腺增生症的风险增加。前列腺癌的评估开始前，治疗（尤其是老年人）。心脏，肾脏或肝脏疾病（停止，如果水肿发生）。睡眠呼吸暂停。监测血红蛋白，红细胞压积，肝功能，变压吸附，甲状腺功能，胆固醇，HDL-C和血清睾酮。高钙血症的风险;显示器。男性与BMI> 35kg/m2：没有研究过。避免申请后至少2小时洗澡或游泳。 为AXIRON的相互作用 监视器INR和PT抗凝血剂。可能会影响胰岛素的需求。水肿的风险增加促肾上腺皮质激素，皮质类固醇。 为AXIRON不良反应 局部反应，红细胞压积增高，头痛，腹泻，呕吐，增加血清PSA;儿童乳房发育，男性化。 AXIRON如何提供？ 泵-90ML（60计量剂量）（W.撒施） 相关疾病： 性腺机能减退 The FDA has approved Axiron (testosterone topical solution, from Eli Lilly and Acrux) for replacement therapy in men ≥18yrs for conditions associated with a deficiency or absence of endogenous testosterone. Axiron is a topical, alcohol-based testosterone solution applied to the underarm once daily using a metered dose applicator allowing for no touch application. This approval was based on a Phase III multicenter, open label, 120 day clinical trial which demonstrated that 84 percent of men who completed the study achieved average serum testosterone concentration within the normal range of 300—1050 ng/dL. Generic Name for AXIRON Testosterone 30mg/1.5mL pump actuation; soln; contains alcohol; latex-free. Legal Classification: CIII Pharmacological Class for AXIRON Androgen. Manufacturer of AXIRON Lilly, Eli and Company Indications for AXIRON Testosterone replacement therapy. Adult dose for AXIRON Advise patients to strictly adhere to recommended instructions. Apply to clean, dry intact skin of the axilla; do not apply to the scrotum, penis, abdomen, shoulders or upper arms. ≥18yrs: Initially apply 60mg (30mg per axilla) once daily in the AM; measure serum testosterone levels to ensure response. May adjust dose based on serum testosterone concentration 2 to 8 hours after applying and at least 14 days after starting therapy or following dose adjustment. May increase dose in 30mg increments if serum testosterone <300ng/dL up to 120mg; reduce dose to 30mg if levels >1050ng/dL, discontinue if serum testosterone remains >1050ng/dL. Wash hands after application. Allow soln to dry before it touches clothing. Not interchangeable with other topical testosterone products. Children's dosing for AXIRON <18yrs: not recommended. Contraindications for AXIRON Male breast or prostate cancer. Use in women. Pregnancy (Cat.X). Nursing mothers. Warnings/Precautions for AXIRON Other persons (esp. children) must avoid contact with application site. Secondary exposure to testosterone; promptly discontinue if signs of virilization in children and women occurs, until cause is identified. Increased risk for worsening BPH. Evaluate for prostate cancer before starting therapy (esp. elderly). Cardiac, renal, or hepatic disease (discontinue if edema occurs). Sleep apnea. Monitor hemoglobin, hematocrit, liver function, PSA, thyroid function, cholesterol, HDL-C, and serum testosterone. Risk of hypercalcemia; monitor. Men with BMI >35kg/m2: not studied. Avoid showering or swimming for at least 2 hours after application. Interactions for AXIRON Monitor INR and PT with anticoagulants. May affect insulin requirements. Increased risk of edema with ACTH, corticosteroids. Adverse Reactions for AXIRON Local reactions, increased hematocrit, headache, diarrhea, vomiting, increased serum PSA; gynecomastia, virilization in children. How is AXIRON supplied? Pump—90mL (60 metered doses) (w. applicator)