testosterone gel (Androgel)

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Pharmacy Author:

Omudhome Ogbru, PharmD

Omudhome Ogbru, PharmD

Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

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Medical and Pharmacy Editor:

Jay W. Marks, MD

Jay W. Marks, MD

Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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GENERIC NAME: testosterone gel

BRAND NAME: Androgel

DRUG CLASS AND MECHANISM: 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.

GENERIC AVAILABLE: No

PRESCRIPTION: Yes

PREPARATIONS: 1% Solution: 25 mg/2.5 g, 50 mg/5 g, 1.25 g/Actuation

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

PRESCRIBED FOR: Androgel is a testosterone replacement product used for men 18 years old or older with a deficiency or absence of testosterone due to primary hypogonadism or hypogonadotropic hypogonadism.

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.

DRUG INTERACTIONS: 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.

PREGNANCY: Androgel should not be used during pregnancy because testosterone is harmful to the fetus.

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

SIDE EFFECTS: 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.

REFERENCE: FDA Prescribing Information.

Report Problems to the Food and Drug Administration You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088. Need help identifying pills and medications? Use the pill identifier tool on RxList.