Testosterone Gel | Androgel (Testosterone Gel)

Common names: testosterone gel
Brand Name: Testim, AndroGel

Manufacturer ANDROGEL
Solvay Pharmaceuticals

Indications
AndroGel is testosterone replacement or A deficiency of endogenous testosterone treatment of male-related conditions, said:

Primary hypogonadism (congenital or acquired)
Pituitary hypogonadism (congenital or acquired)
  
DOSAGE AND ADMINISTRATION
The recommended starting dose: 5 grams of adult men, applied topically once a day.
Apply to clean, dry, shoulders and upper arms and / or abdominal intact skin. Does not apply AndroGel genitals (2.1).
Adult male dosage adjustment: If the serum testosterone levels below the normal range, adjust the dose from 5 to 7.5 g and 7.5 to 10 grams.
  
Dosage forms and strengths
AndroGel (testosterone gel) 1% topical as:

2 × 75 克 pumps (each pump dispenses 60 metered 1.25 g doses)
Package 2.5 g or 5 g packet

Taboo
Men are known or suspected breast cancer or prostate cancer.
Pregnant or lactating women. Testosterone may cause fetal harm.

Note:
Benign prostatic hyperplasia (BPH) and androgen on the treatment of benign prostatic hyperplasia is in the signs and symptoms of increased risk of deterioration.
Secondary contact with children and women, testosterone and testosterone gel may occur in use. Children exposed resulting in secondary masculine report.
Children and women should avoid contact or unwashed clothes in the use of testosterone gel application site man.
In order to minimize the potential transfer to others, the patient should use AndroGel application-oriented products, and strictly adhere to the following:
After application wash your hands with soap and water.
Cover the application site with clothing after the gel dry.
Wash the site thoroughly with soap and water before any case, the site of skin on skin contact is anticipated with another person's.
On children and women masculine and the possibility of secondary exposure to testosterone gel signs should be brought to the attention of health care providers. Testosterone gel in time to stop, until masculine identification of the reason is.
As masculine women and the potential effects of lack of control evaluation, AndroGel is not for women.
Exogenous testosterone may result in the management of patients with azoospermia.
Edema may be in the patients, heart, kidney or liver disease complications.
Gynecomastia, breast enlargement, can be developed.
Sleep apnea can occur in those risk factors.
Monitoring of serum testosterone, prostate specific antigen, hemoglobin, hematocrit, liver function tests, regular and blood lipid levels.
Alcohol is flammable until the gel dry.
  
Adverse reactions
The most common (incidence ≥ 5%) adverse events were acne, application site reactions, laboratory abnormalities, prostate disease.

Testosterone resulted in double-exposure cases of children masculine report. Signs and symptoms reported have included the penis or clitoris, premature development of pubic hair to expand, increasing erections and sexual desire, aggression, and advanced bone age. It is reported that results in most cases, these symptoms and signs were reported to have exposure to testosterone and Removal Gel backwards. In a few cases, however, expand the genitals not fully restored to normal size age and bone age greater than the actual age is still modest.

Drug Interactions
Androgens can reduce blood sugar, insulin in diabetic patients, so request.
Using ACTH or steroids to increase testosterone may lead to fluid retention. Please use caution, especially in heart, kidney or liver disease.
Changes in anticoagulant activity can be seen with the male hormone. More frequent INR, prothrombin time monitoring recommendations.

Use in population
Pregnancy: AndroGel may cause teratogenic effects. AndroGel should not be used in pregnant women.
Breast-feeding women should not use AndroGel.
Safety and effectiveness of men <18 years old AndroGel has not been determined.
Have not been controlled in the use of AndroGel clinical studies involving elderly patients in sufficient quantity to determine whether these> 65 years younger subjects, from different patients. In addition, elderly patients do not have enough long-term safety data, to assess cardiovascular disease and prostate cancer (8.5) the potential risks.
No formal research is involved with renal or hepatic insufficiency patients.

Generic Name: Testosterone Gel
Strength: 1%
Manufacturer: Solvay Pharmaceuticals
Trade Name: Androgel
Type: Androgen
Class: CIII

『原产地英文商品名』Androgel 50mg/pack 30packs/box
『原产地英文药品名』Testosterone Gel
『中文参考商品译名』
注：以下产品不同的价格和不同规格，凭处方购买，购买时请以电话咨询为准！
·昂斯妥 50毫克/包 30包/盒
·昂斯妥0.05/5g凝胶 50毫克/管 30管/盒
·昂斯妥 25毫克/包 30包/盒
·昂斯妥 50毫克/包 30包/盒
『中文参考药品译名』
睾酮凝胶
『生产厂家中文参考译名』Solvay Pharm S.A.S. (France)
『生产厂家英文名』Solvay Pharm S.A.S. (France)

美国FDA批准睾酮替代凝胶Androgel
美国FDA已批准Unimed公司的睾酮替代凝胶Androgel 1％用于治疗男性性腺机能不足。预计夏季上市，届时，它将成为在美国上市的唯一睾酮凝胶。该产品是从BesinsIscovesco公司获许可，此前在法国上市。Unimed公司说，Androgel凝胶比睾酮的相关制剂，如可能引起刺激的肌注剂或贴剂更易被病人接受。该产品是一个局部凝胶，一天一次用于双肩、上臂腹部，供给快速吸收系统。该产品的临床资料将在6月召开的内分泌学会会议上发表。另悉Unimed公司研究开发中的产品包括Andractim（二氢睾酮凝胶），处于Ⅲ期临床，用于老年性机能不足；Compassia（屈大麻酚）在进行治疗阿尔茨海默氏症性痴呆的Ⅱ期临床试验；Relibra，一个用于绝经妇女的睾酮凝胶，目前处于Ⅰ期临床试验。
AndroGel治疗糖尿病和低睾酮男性患者
Solvay制药公司宣布开始进行一个概念证实试验，评价睾酮凝胶（testosterone,AndroGel）1% CIII做为一种辅助口服低血糖疗法在控制2型糖尿病和性腺机能减退（也被称为低睾酮或低T）患者血糖水平中的疗效和安全性。DEMAND（DiabEtes在雄激素男性）试验是第一个评价口服睾酮凝胶帮助控制糖尿病和低T男性患者血糖水平效果的临床试验。
据估计，目前已经有1300多万45岁以上的低T男性患者。研究表明，糖尿病男性患者容易患低T疾病。事实上，最近的研究发现糖尿病男性患者患低T危险是正常人的两倍。
这个双盲、平行、随机、安慰剂对照试验将在美国大约55个地点募集180名病人。公司还计划对此试验进行扩展，试验数据和分析结果将被用于进行另一个III期临床试验。
AndroGel是一种每日一次、透明无味的局部用睾丸激素凝胶，美国食品与药品管理局（FDA）在2000年批准该药用于男性睾丸激素缺乏或不足引起的各种症状的替代疗法。AndroGel是第一个获得FDA批准的睾丸激素凝胶，该药也是美国销售排名第一的睾丸激素替代治疗药物。
AndroGel是第一个也是目前唯一的一个睾丸激素凝胶药物，该药为一种非气雾剂的可以定量的泵，每次压迫泵一次可以释放1.25克睾丸激素凝胶。AndroGel还有2.5克和5克两种包装。这为患者提供了两种不同的用药选择，这也使医生在决定每天5到7.5克或7.5到10克剂量的药物时选择性更大。
低睾丸激素综合症包括性欲低下、肌肉无力、骨密度降低、情绪低沉和疲劳等。患有糖尿病、肥胖或高血压等慢性疾病的男性较正常男性更容易患睾丸激素低下综合症。AndroGel不能用于患有乳腺癌或者前列腺癌的男性患者。该药不宜用于女性，而且该药对于女性的各种影响均未研究，因此该药禁止用于女性。老年患者使用该药会增加前列腺增生或前列腺癌的患病几率。有关该药更多的安全性信息请参考该药的处方信息