What is the recommended dosage and treatment protocol for Androgel (testosterone) in patients with hypogonadism?

From the Guidelines

AndroGel (testosterone gel) for hypogonadism is typically started at 50 mg (one 5-g packet or four pump actuations) applied once daily to clean, dry skin of the shoulders, upper arms, or abdomen, as recommended by the most recent and highest quality study 1. The dose may be adjusted based on serum testosterone levels, with a maximum recommended dose of 100 mg daily. Patients should apply the gel in the morning, allow it to dry completely before dressing, and wash hands thoroughly after application.

Key Considerations

• Treatment response should be monitored with testosterone levels measured 2-8 hours after morning application, typically at 2-4 weeks after starting therapy and periodically thereafter.
• Target testosterone levels should be in the mid-normal range (400-700 ng/dL) 1.
• Patients should avoid washing the application site for at least 2 hours and avoid skin-to-skin contact with others at the application site to prevent testosterone transfer.
• Long-term therapy is typically required as hypogonadism is often a chronic condition.

Monitoring and Safety

• Regular monitoring should include complete blood counts, prostate-specific antigen, and lipid profiles to assess for potential adverse effects such as polycythemia, prostate issues, or cardiovascular effects 1.
• The gel formulation provides steady testosterone levels throughout the day, mimicking the body's natural pattern better than some other formulations.

Application and Dosage

• The typical dose range for AndroGel 1% is 50-100 mg/d, applied to the skin of the back, abdomen, upper thighs, and upper arms 1.
• The typical dose range for AndroGel 1.62% is 20.25-81 mg/d, applied to the skin of the back, abdomen, upper thighs, and upper arms 1.

From the FDA Drug Label

The recommended 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 to the shoulders and upper arms. The dose can be adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation or a single 20.25 mg packet) and a maximum of 81 mg of testosterone (4 pump actuations or two 40.5 mg packets). To ensure proper dosing, the dose should be titrated based on the pre-dose morning serum testosterone concentration from a single blood draw at approximately 14 days and 28 days after starting treatment or following dose adjustment.

The recommended dosage and treatment protocol for Androgel (testosterone) in patients with hypogonadism is to start with a dose of 40.5 mg of testosterone applied topically once daily in the morning to the shoulders and upper arms. The dose can be adjusted based on the patient's serum testosterone concentration, with a minimum dose of 20.25 mg and a maximum dose of 81 mg. The dose should be titrated at approximately 14 days and 28 days after starting treatment or following dose adjustment. Key points to consider include:

• Application site: The gel should be applied to clean, dry, intact skin of the upper arms and shoulders.
• Dose adjustment: The dose should be adjusted based on the patient's serum testosterone concentration.
• Monitoring: The patient's serum testosterone concentration should be assessed periodically to ensure proper dosing. 2

From the Research

Recommended Dosage and Treatment Protocol for Androgel

The recommended dosage and treatment protocol for Androgel (testosterone) in patients with hypogonadism vary depending on the individual patient's needs and response to treatment.

• The starting dose of AndroGel 1% is 50 mg of testosterone per day, applied to the abdomen, shoulders, or upper arms 3.
• The dose can be adjusted based on the patient's response to treatment and serum testosterone levels.
• In clinical trials, AndroGel 1% has been shown to be effective in improving symptoms of hypogonadism, including erectile dysfunction, libido, and fatigue 4, 3.

Application Sites and Absorption

• AndroGel 1% can be applied to the abdomen, shoulders, or upper arms 3.
• The absorption of testosterone from AndroGel 1% can vary depending on the application site, with the arms/shoulders being the most effective site 5.
• The flexibility in the application site of AndroGel is possible if testosterone levels are monitored to ensure adequate therapeutic levels 5.

Comparison with Other Treatments

• AndroGel 1% has been compared to other treatments for hypogonadism, including enclomiphene citrate and transdermal testosterone 6.
• Enclomiphene citrate has been shown to increase serum testosterone levels and improve symptoms of hypogonadism, but its effects on luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are different from those of AndroGel 1% 6.
• Transdermal testosterone has been shown to increase serum testosterone levels, but its effects on LH and FSH are also different from those of AndroGel 1% 6.

Safety and Efficacy

• AndroGel 1% has been shown to be safe and effective in clinical trials, with minimal risk of inducing priapism 4.
• The incidence of priapism and related symptoms reported as urogenital or reproductive system adverse events is extremely low, indicating a minimal risk of inducing priapism 4.
• Local genital skin irritation has not been observed with the use of AndroGel 1% 7.