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Axiron

What is testosterone?

Testosterone is a steroid hormone which is made in the testes in males and in the ovaries in women (a minimal amount is also made in the adrenal glands). Testosterone has two major functions in the human body.

  1. Testosterone is needed to form and maintain the male sex organs and promote secondary male sex characteristics (in both men and women) such as voice deepening and hair growth patterns. This function is related to its androgenic properties.
  2. Testosterone is the facilitation of muscle growth as well as bone development and maintenance. This is a result of its anabolic properties.

Testosterone production is regulated by hormones released from the brain. The hypothalamus and pituitary gland located in the brain produce hormonal signals that ultimately result in the production of testosterone. The hypothalamus is located just above the brain stem, and among its many functions, it produces...

Axiron

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AXIRON
(testosterone)

WARNING

SECONDARY EXPOSURE TO TESTOSTERONE

  • Virilization has been reported in children who were secondarily exposed to topical testosterone products [see WARNINGS AND PRECAUTIONS].
  • Children should avoid contact with unwashed or unclothed application sites in men using AXIRON [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
  • Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].

DRUG DESCRIPTION

AXIRON (testosterone) topical solution is a clear, colorless, single phase solution containing 30 mg of testosterone in 1.5 mL of AXIRON solution for topical administration through the axilla. The active pharmacologic ingredient in AXIRON is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is:

AXIRON (testosterone) Structural Formula Illustration

The inactive ingredients are ethanol, isopropyl alcohol, octisalate, and povidone.

Last reviewed on RxList: 1/9/2012
This monograph has been modified to include the generic and brand name in many instances.

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