testosterone topical solution (Axiron)

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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 topical solution

BRAND NAME: Axiron

DRUG CLASS AND MECHANISM: Axiron is a solution of testosterone that is administered through the skin of the armpit for treatment of low testosterone levels. It belongs to a class of drugs called androgens. Other testosterone replacement products include Androderm, Androgel, 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). Testosterone replacement products supplement or replace natural production of testosterone and reverse symptoms of low testosterone levels. The FDA approved Axiron in November 2010.

GENERIC AVAILABLE: No

PRESCRIPTION: Yes

PREPARATIONS: Solution: 2% (30 mg/1.5 ml actuation)

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

PRESCRIBED FOR: Axiron 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 dose is 30 to 120 mg daily once every morning at approximately the same time. The starting dose is 30 mg (1 pump actuation) applied to each armpit (60 mg total). The total daily dose may be decreased to 30 mg or increased to 90 mg (3 pump actuations) or from 90 to 120 mg (4 pump actuations) based on blood testosterone levels. Hands should be washed thoroughly with soap and water after applying Axiron.

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

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

NURSING MOTHERS: Axiron 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 are application site reactions such as itching, blisters, and redness. Other side effects include headache, diarrhea, vomiting, acne, enlarged breasts, high blood pressure, mood swings, nervousness, changes in libido, increased serum prostate specific antigen (PSA) levels, and increased volume of red blood cells. Reduced sperm production, prolonged painful erection, enlarged prostate, depression, and worsening of heart failure also occur.

REFERENCE: FDA Prescribing Information.

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