If using the multi-dose AndroGel Pump, patients should be instructed to prime the pump before using it for the first time by fully depressing the pump mechanism (actuation) 3 times and discard this portion of the product to assure precise dose delivery. After the priming procedure, patients should completely depress the pump one time (actuation) for every g of product required to achieve the daily prescribed dosage. The product may be delivered directly into the palm of the hand and then applied to the desired application sites, either one pump actuation at a time or upon completion of all pump actuations required for the daily dose. Alternatively, the product can be applied directly to the application sites. Application directly to the sites may prevent loss of product that may occur during transfer from the palm of the hand onto the application sites. Please refer to the chart below for specific dosing guidelines when the AndroGel Pump is used.
Androgel is a gel containing testosterone. It is administered through the skin for treatment of low testosterone levels. It belongs to a class of drugs called androgens. Other testosterone replacement products include Androderm , Axiron , Testim, and Fortesta. Testosterone is the major male sex hormone responsible for the normal growth and development of the male sex organs and secondary sex characteristics. These effects include development of the prostate, penis, and scrotum; distribution of facial, pubic, chest and axillary hair; development of a deep voice and alterations in muscle mass and fat distribution. Low production of testosterone leads to erectile dysfunction , reduced sexual desire, fatigue and loss of energy, depression , regression of secondary sexual characteristics, and weakening of bones ( osteoporosis ). Androgel and other testosterone replacement products supplement or replace natural production of testosterone and reverse symptoms of low testosterone levels. The FDA approved Androgel in February 2000.
The potential for testosterone transfer from healthy males dosed with FORTESTA to healthy females was evaluated in a placebo-controlled, three-way crossover study . The washout period was approximately 29 days. Six males were treated with either FORTESTA (30 mg testosterone) or placebo to one thigh only. At 2 hours after the application of FORTESTA to males, the females rubbed their forearms for 15 minutes on the thigh of the males. Serum concentrations of testosterone were monitored in females for 24 hours after the transfer procedure. When direct skin-to-skin transfer occurred with FORTESTA mean Cavg increased by 134% and mean Cmax increased by 191%, compared to direct skinto- skin transfer with placebo. When transfer occurred with FORTESTA while covering a thigh with boxer shorts, mean Cavg decreased by 3% and mean Cmax increased by 2%, compared to direct skin-toskin transfer with placebo [see DOSAGE AND ADMINISTRATION ].