Testosterone topical application route

Testosterone topical Uses, Side Effects & Warnings

After direct skin-to-skin contact with the site of application, mean testosterone Cavg and Cmax in female subjects increased by 280% and 267%, respectively, compared to mean baseline testosterone concentrations. In a second study evaluating transfer of testosterone, 12 male subjects applied a single dose of testosterone gel 1.62% 81 mg to their shoulders and upper arms. Two (2) hours after application, female subjects rubbed their hands, wrists, arms, and shoulders to the application site of the male subjects for 15 minutes while the site of application was covered by a t-shirt. When a t-shirt was used to cover the site of application, mean testosterone Cavg and Cmax in female subjects increased by 6% and 11%, respectively, compared to mean baseline testosterone concentrations. Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel.

Simply put, the fact that women’s levels of this hormone drop with age does not necessarily mean that supplementing with testosterone will be beneficial for them. Furthermore, testosterone gel should not be used for the treatment of male infertility or impotence. Remember that when you use testosterone gel, there are additional risks for others who may come in contact with you.

The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur.

About 6% of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of testosterone occurs primarily in the liver. Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

Testosterone gel is a topical medication containing testosterone and is prescribed for the treatment of low testosterone levels. Testosterone gel 1.62% delivers physiologic amounts of testosterone, producing circulating testosterone concentrations that approximate normal levels (300 to 1000 ng/dL) seen in healthy men. Testosterone gel 1.62% provides continuous transdermal delivery of testosterone for 24 hours following once daily application to clean, dry, intact skin of the shoulders and upper arms. The rotation of abdomen and upper arms/shoulders was a method used in the pivotal clinical trial [see CLINICAL STUDIES (14.1)]. Two (2) hours after application to the males on each day, the female subjects rubbed their abdomens oral peptides for testosterone 15 minutes to the abdomen of the males.

The application site and dose of testosterone gel 1.62% are not interchangeable with other topical testosterone products. Depending on the topical testosterone product you are using, it should be applied to your shoulders, armpits, or parts of your upper arms that will be covered by a short-sleeved T-shirt. Do not apply topical testosterone to other areas not recommended in the product instructions, such as your stomach, penis, or scrotum. If you measure your blood pressure and the top number (systolic) is 180 or higher or the bottom number (diastolic) is 120 or higher, get medical attention right away.

Secondary exposure to testosterone in children and women can occur with the use of testosterone gel in men [see WARNINGS AND PRECAUTIONS (5.2)]. Cases of secondary exposure to testosterone have been reported in children. Testosterone gel 1.62% was evaluated in a two-phase, 364-day, controlled clinical study. The first phase was a multi-center, randomized, double-blind, parallel-group, placebo-controlled period of 182 days, in which 234 hypogonadal men were treated with testosterone gel 1.62% and 40 received placebo. Patients could continue in an open-label, non-comparative, maintenance period for an additional 182 days [see CLINICAL STUDIES (14.1)].

For more information, ask your healthcare provider or pharmacist. Testosterone gel 1.62% is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your testosterone gel 1.62% in a safe place to protect it.

Increases in blood pressure may not be noticeable, but look out for and tell your health care provider right away if you have any of the following symptoms of severely high blood pressure. Androgel (testosterone gel) is a topical gel containing testosterone. It is administered through the skin for treatment of low testosterone levels. Androgel and other testosterone replacement products supplement or replace the natural production of testosterone and reverse symptoms of low testosterone levels. These are not all the possible side effects of testosterone gel 1.62%.