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For more information regarding post dose washing see section 4.4 (subsection Potential for testosterone transfer). In patients on a daily TESTOGEL 16.2 mg/g dose the average (±SD) daily testosterone concentration on day 266 (Cav) was 459 (±218) ng/dl, mean Cmax was 689 (±414) ng/dl and mean Cmin was 305 (±121) ng/dl. The corresponding concentrations on Day 364 (extended open-label period) were Cav 454 (±193) ng/dl, mean Cmax 698 (±382) ng/dl and mean Cmin 302 (±126) ng/dl. The physician should inform the patient carefully about the risk of testosterone transfer and about safety instructions (see below). TESTOGEL 16.2 mg/g should not be prescribed in patients with a major risk of non-compliance with safety instructions (e.g. severe alcoholism, drug abuse, severe psychiatric disorders). Reporting suspected adverse reactions after authorisation of the medicinal product is important.

• To improve partner safety, the patient should be advised, for example, to wash the area with soap for instance during a shower before sexual intercourse or, if not possible, wear clothing such as a shirt or a T-shirt covering the application site during the contact period.
• TESTOGEL 16.2 mg/g should not be used by women due to possibly virilising effects.
• Steady state blood testosterone levels are reached usually by the second day of treatment with TESTOGEL 16.2 mg/g.

When treatment is stopped, testosterone levels start decreasing approximately 24 hours after the last administration. Testosterone levels return to baseline approximately 72 to 96 hours after the final administration. The attention of athletes should be drawn to the fact that this proprietary medicinal product contains an active substance (testosterone) that may produce a positive result in doping control tests. The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment. Administration of 5 g of TESTOGEL 16.2 mg/g produces an average testosterone level increase of approximately 2.3 ng/ml (8.0 nmol/l) in plasma. Androgens have also an effect on protein anabolism, on development of skeletal muscle and body fat distribution and also reduce urinary nitrogen, sodium, potassium, chloride, phosphate and water excretion.

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Because of the alcohol contained in the product, frequent applications to the skin may cause irritation and dry skin. The application should be administered by the patient himself, onto clean, dry, healthy skin over right and http://inu.edu.jo/?p=23481 left upper arms and shoulders. Sex hormones are known to facilitate the development of certain tumours induced by known carcinogenic agents. The importance of these findings and the actual risk in human beings is unknown.

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In patients suffering from severe cardiac, hepatic or renal insufficiency, or ischaemic disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. To improve partner safety, the patient should be advised, for example, to wash the area with soap for instance during a shower before sexual intercourse or, if not possible, wear clothing such as a shirt or a T-shirt covering the application site during the contact period. Improved insulin sensitivity may be observed in patients treated with androgens and may require lowering antidiabetics’ dosage. There is limited experience on the safety and efficacy of the use of TESTOGEL 16.2 mg/g in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference levels.

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The potential risk of transfer is substantially reduced (but not eliminated) by wearing clothes (such as a sleeved shirt) covering the application area. The majority of residual testosterone is removed from the skin surface by washing with soap and water prior to contact. Testosterone should be used with caution in patients with thrombophilia or risk factors for venous thromboembolism (VTE), as there have been post-marketing reports of thrombotic events (e.g. deep-vein thrombosis, pulmonary embolism, ocular thrombosis) in these patients during testosterone therapy.