In a clinical trial:

• Steady state achieved by day 2 to 3¹
• T levels were maintained over the entire 180-day period¹
• During the study, significant increases in hemoglobin/hematocrit and PSA levels occurred. An increase in PSA levels occurred in 18% of individual patients in a 3 year extension study ^{1, 10}

Wang, C. J Clin Endocrinal Metab 2000. AndroGel was evaluated in a multicenter, randomized, parallel-group, 180-day trial in 227 hypogonandal men.

Patients with benign prostatic hyperplasia (BPH) treated with androgens are at an increased risk for worsening signs and symptoms of BPH.
Patients treated with androgens may be at an increased risk for prostate cancer.

• AndroGel is available in metered-dose pumps or packets. The metered-dose pump delivers 1.25 g of product when the pump mechanism is fully depressed once
• The recommended starting dose of AndroGel is 5 g delivering 5 mg of testosterone systemically, applied once daily (preferably in the morning) to clean, dry, intact skin on the shoulders and upper arms and/or abdomen
• Serum testosterone levels should be monitored regularly to ensure proper dosing. If the serum testosterone concentration is below the normal range, or if the desired clinical response is not achieved, the daily AndroGel dose may be increased from 5 g to 7.5 g and from 7.5 g to 10 g as instructed by the physician

Provide the following instructions to your patients:

Before using the pump for the first time, you'll need to press down firmly on the pump 3 times. Do not use any AndroGel that came out while priming. Wash it down the sink or throw it in the trash to avoid accidental exposure to others. You do not have to prime your pump every day, only the first day you use it.


Check the label on your bottle to see how many times to press the pump for the dose your doctor has prescribed.

In addition to the pump, AndroGel comes in packets (in 2.5 g and 5 g dosing options).
After use, throw away the packet in the trash out of the reach of children to avoid accidental exposure.

Make your application part of your daily routine.

1. Apply AndroGel at the same time every day, preferably every morning, to clean, dry, intact skin. Do not apply to genitals.
2. If using the pump, press down firmly on the pump one time. AndroGel also comes in 2.5 g and 5g packets. If using the packets, you can open them by tearing along the perforation. Squeeze the contents into the palm of your hand. Squeeze from the bottom of the packet up.
3. Apply the gel to one or more of the application sites (see illustration below). Do not apply to your penis or scrotum.
4. Repeat steps 2 and 3 until you have applied the dose your doctor has prescribed for you.
   
   AndroGel is not indicated for use in women.
   

After you apply AndroGel:

1. Wash your hands right away with soap and water.
2. Let the application sites dry.
3. Cover the application sites with a shirt.

If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water. If a woman or child comes in contact with the AndroGel application area, that area on the woman or child should be washed well with soap and water right away. Stop using AndroGel and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred though accidental exposure to AndroGel.