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TESTIM
通用名称TESTIM
睾酮1％;凝胶。
法律分类：
CIII
药理班TESTIM
雄激素。
制造商TESTIM
Auxilium制药公司
适应症TESTIM
睾酮替代疗法。
成人剂量TESTIM
建议患者严格遵守建议的说明。适用于清洁，干燥的肩膀完整的皮肤和/或上臂，并不适用于阴部或腹部。 ≥18岁：最初适用5克（1管）每天一次在上午;测定血清睾酮水平，以确保反应;可能会增加2周后到10G。不洗至少2个小时后，申请的网站。
儿童剂量为TESTIM
<18年：不推荐。
禁忌的TESTIM
男性乳腺癌或前列腺癌。不适合于女性使用。孕妇及哺乳期妇女应避免与皮肤接触对男性应用网站。妊娠（Cat.X）。哺乳的母亲。
警告/注意事项的TESTIM
（尤其是儿童）的人必须避免与其他申请地点接触。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。前列腺增生症恶化的风险增加。前列腺癌治疗开始前评估（尤其是老年人）。心脏，肾脏或肝脏疾病（如停止水肿发生）。睡眠呼吸暂停。监测血红蛋白，红细胞压积，肝功能，前列腺特异抗原，胆固醇，HDL - C和血清睾酮。避免淋浴或在申请后至少2小时游泳。老人（可能会增加前列腺增生和前列腺癌的风险）。
互作TESTIM
口服抗凝血剂，会增强，oxyphenbutazone。可能会改变胰岛素的影响。增加促肾上腺皮质激素与类固醇或水肿的危险。
不良反应为TESTIM
局部反应，头痛，增加血红蛋白/红细胞压积或BP，抑郁，潮热，失眠，情绪不稳，乳房发育，味觉障碍，在儿童男性化。
如何TESTIM提供？
凝胶（5克）-30
FORTESTA™ (testosterone) Gel
This product information is intended for U.S. residents only.
FORTESTA™ (testosterone) Gel for topical use CIII is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism or hypogonadotrophic hypogonadism. Important limitations of use: Safety and efficacy of FORTESTA Gel in males <18 years old have not been established.
- Important Safety Information
-
- WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
- Virilization has been reported in children who were secondarily exposed to testosterone gel.
- Children should avoid contact with unwashed or unclothed application sites in men using FORTESTA Gel.
- Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
- FORTESTA™ Gel is contraindicated in men with carcinoma of the breast or known or suspected prostate cancer and in women who are, or may become pregnant, or who are breastfeeding. Testosterone may cause fetal harm and serious adverse reactions to nursing infants.
- Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH.
- Avoid unintentional exposure of women or children to FORTESTA Gel. Secondary exposure to testosterone can produce signs of virilization. FORTESTA Gel should be discontinued until the cause of virilization is identified.
- To minimize the potential for transfer to others, strict adherence to the following is advised:
- Children and women should avoid contact with unwashed or unclothed application site(s) in men using FORTESTA Gel.
- To minimize the potential for transfer to others, patients using FORTESTA Gel should apply the product as directed and strictly adhere to the following:
- Wash hands with soap and water after application;
- Cover the application site with clothing after the gel has dried;
- Wash the application site thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated.
- Increases of hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone.
- Due to lack of controlled evaluations in women and potential virilizing effects, FORTESTA Gel is not indicated for use in women.
- Exogenous administration of androgens may lead to azoospermia, gynecomastia, or sleep apnea in those with risk factors.
- Edema with or without congestive heart failure may be a complication in patients with pre-existing cardiac, renal, or hepatic disease.
- There is insufficient long-term data in geriatric patients using FORTESTA Gel to assess potential risks of cardiovascular disease and prostate cancer.
- Do not apply FORTESTA Gel to the scrotum.
- Monitor serum testosterone, prostate specific antigen, hemoglobin, hematocrit, liver function tests, and lipid concentrations periodically.
- FORTESTA Gel is flammable until dry.
- The most common adverse reaction (incidence ≥3%) reported with the recommended dose of FORTESTA Gel was skin reactions at the application site (16.1%).
- Please see the Full Prescribing Information, including Boxed Warning for FORTESTA Gel.
FORTESTA™ is a trademark of Endo Pharmaceuticals.
完整处方 http://www.endo.com/pdf/products/fortesta_pi.pdf
TESTIM
Generic Name for TESTIM
Testosterone 1%; gel.
Legal Classification:
CIII
Pharmacological Class for TESTIM
Androgen.
Manufacturer of TESTIM
Auxilium Pharmaceuticals, Inc.
Indications for TESTIM
Testosterone replacement therapy.
Adult dose for TESTIM
Advise patients to strictly adhere to recommended instructions. Apply to clean, dry intact skin of the shoulders and/or upper arms; do not apply to genitals or abdomen. ≥18 years: initially apply 5g (1 tube) once daily in the AM; measure serum testosterone level to ensure response; may increase to 10g after 2 weeks. Do not wash site for at least 2 hours after application.
Children's dosing for TESTIM
<18 years: not recommended.
Contraindications for TESTIM
Male breast or prostate cancer. Not for use in women. Pregnant and nursing women must avoid skin contact with application sites on men. Pregnancy (Cat.X). Nursing mothers.
Warnings/Precautions for TESTIM
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, cholesterol, HDL-C, and serum testosterone. Avoid showering or swimming for at least 2 hours after application. Elderly (may increase risk of prostatic hyperplasia and prostatic carcinoma).
Interactions for TESTIM
May potentiate oral anticoagulants, oxyphenbutazone. May alter insulin effects. Increased risk of edema with corticosteroids or ACTH.
Adverse Reactions for TESTIM
Local reactions, headache, increased hemoglobin/hematocrit or BP, depression, hot flushes, insomnia, mood swings, gynecomastia, dysgeusia; virilization in children.
How is TESTIM supplied?
Gel (5g)—30
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