Androgel 1.62% Dosing for Adult Male Hypogonadism
Start with 40.5 mg of testosterone (2 pump actuations or one 40.5 mg packet) applied once daily in the morning to the shoulders and upper arms. 1
Initial Dosing Protocol
- Apply 40.5 mg testosterone gel 1.62% topically once daily in the morning to clean, dry, intact skin of the upper arms and shoulders only—never to the abdomen, genitals, chest, armpits, or knees 1
- Limit application area to what would be covered by a short-sleeve t-shirt 1
- Use the palm of your hand to spread the gel across the maximum surface area: apply half the dose (1 pump actuation or half a 40.5 mg packet) to each shoulder and upper arm 1
Dose Titration Algorithm
Measure pre-dose morning serum testosterone at 14 days and 28 days after starting treatment, then adjust based on these specific thresholds: 1
- If testosterone >750 ng/dL: Decrease by 20.25 mg (reduce by 1 pump actuation) 1
- If testosterone 350-750 ng/dL: Continue current dose—no change needed 1
- If testosterone <350 ng/dL: Increase by 20.25 mg (add 1 pump actuation) 1
Dosing Range and Limits
- Minimum dose: 20.25 mg (1 pump actuation or one 20.25 mg packet) 1
- Maximum dose: 81 mg (4 pump actuations or two 40.5 mg packets) 1
- Target mid-normal testosterone levels of 500-600 ng/dL during ongoing monitoring 2
Application Instructions
- Allow the application site to dry completely, then cover with clothing before any contact with others 1
- Wash hands thoroughly with soap and water immediately after application 1
- Avoid swimming, showering, or washing the application site for at least 2 hours after application 1
- Avoid fire, flames, or smoking until the gel has dried, as alcohol-based products are flammable 1
Critical Safety Precautions
- Children must avoid contact with unwashed or unclothed application sites due to risk of virilization from secondary exposure 1
- Confirm diagnosis with two separate morning (8-10 AM) testosterone measurements below 300 ng/dL before initiating therapy 2, 1
- Document baseline hematocrit (contraindicated if >54%), PSA in men over 40, and perform digital rectal examination before starting 2
Ongoing Monitoring Schedule
- Check testosterone levels at 14 days, 28 days, then every 6-12 months once stable 2, 1
- Monitor hematocrit periodically and withhold treatment if >54% 2
- Monitor PSA annually in men over 40 years 2
Important Clinical Context
The 1.62% gel formulation achieved eugonadal testosterone levels (300-1,000 ng/dL) in 81.6-82.5% of hypogonadal men after dose titration, compared to only 28.6-37.0% with placebo 3. This formulation is NOT interchangeable with 1% testosterone gel—the application sites and dosing differ significantly 1. The European guidelines favor transdermal preparations like this gel over intramuscular injections due to more stable day-to-day testosterone levels and lower risk of erythrocytosis 2.