testosterone gel (Androgel)

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.

What brand names are available for testosterone gel-topical?

Androgel

Is testosterone gel available as a generic drug?

No

Do I need a prescription for testosterone gel?

Yes

The most common side effects of Androgel are:

• headache,
• high blood pressure,
• acne,
• abnormal lab tests (for example, glucose and cholesterol tests),
• application site reactions (for example, itching, blisters, and redness),
• enlarged prostate, and
• increased serum prostate specific antigen (PSA) levels.

: Testosterone may decrease blood glucose levels. Therefore, less insulin may be required in diabetic patients. Testosterone may increase the action of the blood thinner warfarin (Coumadin), increasing the risk of bleeding. Combining steroids with testosterone may increase fluid retention.

Androgel should not be used by nursing mothers because of the possibility of adverse effects in the nursing infant.

What preparations of testosterone gel-topical are available?

1% Solution; 1.62% solution; 20 mg/1.25gm: 25 mg/2.5 gm; 40.5 mg/2.5gm: 50 mg/5 g, 1%: 1.62%.

How should I keep testosterone gel-topical stored?

Androgel should be stored at room temperature 15 C to 30 C (59 F to 86 F)

DOSING: The recommended starting dose is 50 mg applied once daily to the skin of shoulders, upper arm, or abdomen. The dose may be increased based on blood testosterone levels. The hands should be washed thoroughly with soap and water after applying Androgel.