What is the recommended starting dose of Androgel (testosterone) for treating hypogonadism in adult males?

From the Guidelines

The recommended starting dose of AndroGel for treating hypogonadism in adult males is 50-100 mg/d, applied once daily to clean, dry, intact skin of the back, abdomen, upper thighs, and upper arms. This dosing regimen is based on the most recent and highest quality study available, which provides guidance on the practical use of pharmacotherapy for hypogonadism 1. The dose can be adjusted based on serum testosterone levels measured 2-4 weeks after starting therapy.

Key Considerations

• The gel should be applied in the morning, allowed to dry completely before dressing, and hands should be washed thoroughly after application.
• Patients should avoid swimming, showering, or allowing the application site to come in contact with others for at least 2 hours after application to prevent transfer of testosterone to others.
• This dosing regimen aims to restore testosterone levels to the normal physiological range (300-1000 ng/dL) to alleviate symptoms of hypogonadism such as fatigue, decreased libido, and reduced muscle mass, while minimizing potential side effects including polycythemia, acne, and prostate issues.
• It is essential to monitor patients regularly and adjust the dose as needed to ensure optimal treatment outcomes and minimize potential adverse effects.

Additional Guidance

• The American College of Physicians suggests that clinicians discuss the potential benefits, harms, costs, and patient's preferences when considering testosterone treatment for age-related low testosterone 1.
• Clinicians should reevaluate symptoms within 12 months and periodically thereafter, and discontinue testosterone treatment if there is no improvement in symptoms.
• The choice of testosterone formulation, including transdermal gels like AndroGel, should be based on individual patient needs and preferences, as well as considerations of cost and potential side effects.

From the FDA Drug Label

DOSAGE AND ADMINISTRATION ... Starting dose of testosterone gel 1.62% is 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet), applied topically once daily in the morning. The recommended starting dose of Androgel (testosterone) for treating hypogonadism in adult males is 40.5 mg of testosterone, applied topically once daily in the morning.

• The dose can be adjusted between a minimum of 20.25 mg and a maximum of 81 mg of testosterone, based on the pre-dose morning serum testosterone concentration. 2

From the Research

Androgel Dosing for Hypogonadism in Adult Males

• The recommended starting dose of Androgel (testosterone) for treating hypogonadism in adult males is not explicitly stated in the provided studies, but the studies suggest various dosing regimens.
• A study published in 2011 3 used doses of 1.25 g, 2.5 g, 3.75 g, and 5.0 g of 1.62% testosterone gel, with dose adjustments made on days 14,28, and 42.
• Another study published in 2012 4 continued the use of 1.62% testosterone gel, with dose adjustments allowed at specific visits to maintain serum testosterone within a normal range.
• A study published in 2004 5 used doses of 5,7.5, or 10 g of AndroGel (T gel) 1% per day for up to 42 months.
• A study published in 2008 6 mentioned a starting dose of 50 mg testosterone per day for AndroGel (testosterone 1% gel).
• It is essential to note that the dosing regimen may vary depending on the individual patient's response and serum testosterone levels, and should be determined by a healthcare professional.

Key Considerations

• The studies emphasize the importance of titrating the dose to achieve normal serum testosterone levels 3, 4.
• The safety and efficacy of Androgel have been demonstrated in various studies 3, 4, 5.
• Patients should be monitored for potential adverse effects, such as prostate cancer and erythrocytosis 5.