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AndroGel gel 1% pump(testosterone 睾酮凝胶)

  药店国别:

  产地国家:美国

  处 方 药:

  所属类别:2瓶/包装

  包装规格:2瓶/包装

  计价单位:

  生产厂家中文参考译名:艾伯维

  生产厂家英文名:AbbVie Inc

  原产地英文商品名:AndroGel gel 1% pump 2pump twinpack

  原产地英文药品名:testosterone

  中文参考商品译名:AndroGel凝胶1% 泵 2瓶/包装

  中文参考药品译名:睾酮

  简介:

  近日,美国食品和药物管理局(FDA)批准凝胶制剂ANDROGEL(testosterone,睾酮凝胶)用于治疗睾酮水平低的男性患者。该制剂以一半的首剂量即可恢复性腺机能减退男性的睾酮水平。

  批准日期:2019年5月 公司:艾伯维

  AndroGel(睾酮[testosterone])凝胶1%,用于局部使用CIII

  最初的美国批准:1953年

  警告:对TESTOSTERONE的二次接触有关完整的盒装警告,请参阅完整的处方信息。

  •据报道,其次是儿童的病毒化暴露于睾酮凝胶。

  •儿童应避免接触使用睾酮凝胶的男性未洗过或未穿衣的应用。

  •医疗保健提供者应建议患者严格遵守建议的使用说明。

  作用机制:

  内源性雄激素,包括睾酮和二氢睾酮(DHT),负责男性性器官的正常生长和发育以及维持二次性特征。 这些影响包括前列腺,精囊,阴茎和阴囊的生长和成熟; 男性头发分布的发展,如面部,耻骨,胸部和腋毛; 喉扩大,声带增厚,身体肌肉组织改变和脂肪分布。睾酮和DHT是secondarysex特征正常发育所必需的。

  男性性腺功能减退症是由睾酮分泌不足引起的临床综合症,有两个主要病因。原发性性腺功能减退症是由性腺缺陷引起的,例如Klinefelter综合征或Leydig细胞发育不全,而继发性性腺功能减退症是下丘脑(或垂体)不能产生足够的促性腺激素(FSH,LH)。

  适应症和用法:

  AndroGel 1%适用于男性替代治疗,适用于缺乏或缺乏内源性睾酮的疾病:

  •原发性性腺功能减退症(先天性或后天性)。

  •低促性腺功能减退症(先天性或后天性)。

  使用限制:

  •尚未确定AndroGel 1%患有“年龄相关性性腺功能减退症”的男性的安全性和有效性。

  •AndroGel的安全性和有效性在18岁以下的男性中尚未建立1%。

  •局部睾丸激素产品可能具有不同的剂量,强度应用说明,可能导致不同的全身暴露。

  剂量和给药

  •AndroGel 1%的剂量和用量与AndroGel1.62%不同。对于AndroGel的剂量和给药1.62%参考其完整的处方信息。

  •在启动AndroGel 1%之前,确认对性腺功能低下的诊断,确保在早晨至少两天测量血清睾酮,并且这些浓度低于正常范围。

  •AndroGel 1%的起始剂量是50毫克睾酮(两个25毫克包或一个50毫克包),每天早上应用一次。

  •涂抹于肩部,上臂和/腹部的干净,干燥,完整的皮肤上。不要将AndroGel 1%涂抹在身体的任何其他部位,包括生殖器,胸部,腋窝(腋窝),膝盖或背部。

  •剂量调整:AndroGel 1%可根据总血清睾酮浓度使用50 mg,75 mg或100 mg睾酮进行剂量调整。应根据血清睾酮浓度滴定剂量。此外,应定期评估血清睾酮浓度。

  •患者应在使用1%的AndroGel后立即用肥皂和水洗手,并在凝胶干燥后用衣服盖住敷贴部位。在预期应用场所与其他人的皮肤接触的情况之前,用肥皂和水彻底清洗施用部位。

  剂量形式和强度:

  AndroGel(睾酮凝胶)1%局部使用可用如下:

  •含有25毫克睾酮的小包。

  •含有50毫克睾酮的小包。

  禁忌症:

  •患有乳腺癌或已知或疑似前列腺癌的男性。

  •怀孕的妇女。睾丸激素可能会导致胎儿受到伤害。

  警告和注意事项:

  •监测良性前列腺增生(BPH)患者的BPH症状和体征恶化。

  •避免女性或儿童无意中接触AndroGel 1%。次要暴露于睾丸激素可产生男性化的迹象。应停止使用1%的雄激素,直至确定​​男性化的原因。

  •使用睾酮产品的患者已报告静脉血栓栓塞(VTE),包括深静脉血栓形成(DVT)和肺栓塞(PE)。评估具有与DVT或PE一致的体征或症状的患者。

  •一些上市后研究显示,与使用睾酮替代疗法相关的心肌梗塞和中风风险增加。

  •雄激素的外源性给药可能导致无精子症。

  •伴有或不伴有充血性心力衰竭(CHF)的水肿可能是患有心脏,肾脏或肝脏疾病的患者的并发症。

  •有风险因素的人可能会出现睡眠呼吸暂停。

  •定期监测血清睾酮,前列腺特异性抗原(PSA),血红蛋白,血细胞比容,肝功能检查和脂质浓度。

  •AndroGel 1%易燃,直至干燥。

  不良反应:

  最常见的不良反应(发生率≥5%)是痤疮,应用部位反应,异常实验室检查和前列腺疾病。

  药物相互作用:

  •雄激素可降低血糖,因此可降低糖尿病患者的胰岛素需求。

  •雄激素可见抗凝血活性的变化。建议更频繁地监测INR和凝血酶原时间。

  •使用睾酮和促肾上腺皮质激素(ACTH)或皮质类固醇可能会导致液体潴留增加。谨慎使用,尤其是患有心脏病,肾病或肝病的患者。

  用于特定人群:老年患者的长期安全性数据不足,使用AnroGel 1%来评估心血管疾病和前列腺癌的潜在风险。

  AndroGel(testosterone gel) 1% for topical use CIII

  Initial U.S. Approval: 1953

  USE AND IMPORTANT SAFETY INFORMATION

  USE: AndroGel® (testosterone gel) 1% and 1.62%

  AndroGel® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone due to certain medical conditions.

  It is not known if AndroGel is safe or effective to treat men who have low testosterone due to aging.

  It is not known if AndroGel is safe or effective in children younger than 18 years old.

  Testosterone products that are applied to the skin may have different doses, strengths, or application instructions that may lead to different levels of testosterone in your body.

  IMPORTANT SAFETY INFORMATION

  AndroGel can transfer from your body to others. This can happen if other people come into contact with the area where AndroGel was applied.

  Signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through skin-to-skin contact with men using topical testosterone products like AndroGel.

  Women and children should avoid contact with the unwashed or unclothed area where AndroGel has been applied. If a woman or child makes contact with the AndroGel application area, the contact area on the woman or child should be washed well with soap and water right away.

  To lower the risk of transfer of AndroGel 1.62%, you should apply it only to your shoulders and upper arms, areas that will be covered by a short-sleeve T-shirt. Do not apply AndroGel 1.62% to any other parts of your body, such as your stomach area (abdomen), penis, scrotum, chest, armpits (axillae), or knees. Wash your hands right away with soap and water after applying. After the gel has dried, cover the application area with clothing until you have washed the application area well or have showered. If you expect another person to have skin-to-skin contact with your shoulders or upper arms, first wash the application area well with soap and water.

  To lower the risk of transfer of AndroGel 1%, you should apply it only to areas that will be covered by a short-sleeve T-shirt. These areas include shoulders, upper arms, and stomach area. Do not apply AndroGel 1% to any other parts of your body, such as your penis, scrotum, chest, armpits (axillae), knees, or back. Wash your hands right away with soap and water after applying AndroGel. After the gel has dried, cover the application area with clothing. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.

  Stop using AndroGel and call your healthcare provider right away if you see any signs and symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have occurred through accidental exposure to AndroGel.

  Do not use AndroGel if you have breast cancer or have or might have prostate cancer.

  AndroGel is not meant for use in women and must not be used in women who are pregnant. AndroGel may harm the unborn baby. Women who are pregnant should avoid contact with the area of skin where AndroGel has been applied.

  Before you use AndroGel, tell your healthcare provider if you have breast cancer; prostate cancer; urinary problems due to enlarged prostate; heart, kidney, or liver problems; problems breathing while you sleep (sleep apnea); or have any other medical conditions.

  AndroGel can cause serious side effects, including:

  If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AndroGel (including changes in urination)

  Possible increased risk of prostate cancer

  Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.

  Possible increased risk of heart attack or stroke

  AndroGel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep it in a safe place to protect it and never give it to anyone else. Selling or giving away this medicine may harm others and is against the law.

  In large doses, AndroGel may lower your sperm count

  Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease

  Enlarged or painful breasts

  Having problems breathing while you sleep (sleep apnea)

  Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take insulin, medicines that decrease blood clotting, or corticosteroids.

  AndroGel is flammable until dry. Let AndroGel dry before smoking or going near an open flame.

  The most common side effects of AndroGel 1.62% are increased prostate specific antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red blood cell count, and skin irritation where the gel is applied. The most common side effects of AndroGel 1% are acne, skin irritation where the gel is applied, increased cholesterol levels, increased prostate specific antigen, increased red blood cell count, and increased liver function tests.

用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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