AndroGel® (Testosterone Gel) 16.2 mg/g, 88 g pump

Common brand names: AndroGel, Testim, Fortesta, Axiron, Natesto, Vogelxo, Striant, TestoGel, Testoderm, Androderm

What is AndroGel® (Testosterone Gel) 16.2 mg/g?

AndroGel® is a topical gel that contains testosterone, a male hormone essential for the development and maintenance of male characteristics. Each gram of the gel contains 16.2 mg of testosterone. This gel is primarily used in hormone replacement therapy for men who have low testosterone levels, a condition known as hypogonadism. By applying AndroGel® to the skin, testosterone is absorbed into the bloodstream, helping to maintain steady hormone levels throughout the day.

How Does AndroGel® Work?

AndroGel® is a topical testosterone replacement therapy designed to treat men with low testosterone levels, a condition known as hypogonadism. Testosterone is a critical hormone for male health, playing a vital role in the development of male sexual characteristics, muscle mass, bone density, and overall energy levels.

Absorption and Bioavailability:
When AndroGel® is applied to the skin, testosterone is absorbed transdermally—meaning it passes through the skin into the bloodstream. The absorption rate of testosterone through the skin can vary between 1% to 8.5% of the applied dose, depending on factors like skin condition, application site, and environmental factors. Once absorbed, testosterone enters the systemic circulation, providing relatively stable blood testosterone levels over a 24-hour period.

Pharmacokinetics:
After application, testosterone levels in the blood begin to rise within the first hour, reaching a steady state by the second day of treatment. This steady delivery helps to mimic the natural circadian rhythm of testosterone production in the body, where levels typically peak in the morning. Unlike testosterone injections, which can cause sharp peaks and troughs in hormone levels, AndroGel® provides a more consistent and gradual increase, reducing the risk of side effects associated with fluctuating testosterone levels.

Metabolism and Excretion:
Once in the bloodstream, testosterone is metabolized primarily into two active metabolites: dihydrotestosterone (DHT) and estradiol. DHT is responsible for many of the androgenic effects of testosterone, such as the development of male secondary sexual characteristics. Estradiol, a form of estrogen, plays a role in bone density and other physiological processes. Testosterone and its metabolites are eventually excreted through the urine and, to a lesser extent, the feces.

What are the benefits of using AndroGel®?

The primary benefit of AndroGel® is its ability to restore normal testosterone levels in men with hypogonadism.

This can lead to improvements in various symptoms, such as increased energy, improved mood, enhanced sexual function, and better maintenance of muscle mass and bone density.

AndroGel® also supports the development of secondary sexual characteristics, such as body hair and deepening of the voice.

How is AndroGel® Applied?

Dosage and Administration:
AndroGel® is available in a pump that delivers a specific amount of gel per pump, making it easy to administer the correct dose.

The standard starting dose is 2.5 g of gel, which delivers 40.5 mg of testosterone.

This dose is applied once daily, typically in the morning, at the same time each day to maintain consistent testosterone levels.

Depending on the patient’s response and testosterone levels, the dosage may be adjusted by a healthcare provider but should not exceed 5 g of gel (81 mg of testosterone) per day.

Application Sites:
AndroGel® should be applied to clean, dry, and undamaged skin on areas where absorption is most efficient—typically the shoulders, upper arms, or abdomen.

The gel should be spread evenly in a thin layer and does not need to be rubbed in.

After applying the gel, it’s important to allow it to dry for about 3-5 minutes before dressing to prevent the gel from rubbing off on clothes.

Initial Setup:
Before the first full dose, the pump needs to be primed by pressing it three times.

The gel that comes out during this priming should be discarded, as it may not contain the correct dose.

After priming, each pump will deliver the correct amount of gel.

Hygiene Practices:
After applying AndroGel®, it is essential to wash your hands with soap and water to prevent the accidental transfer of testosterone to others.

Additionally, the area of application should be washed with soap and water before any skin-to-skin contact with another person to prevent unintended exposure to testosterone, which can cause side effects like increased body hair or changes in skin texture.

What Should You Avoid While Using AndroGel®?

Application to Genitals:
AndroGel® should never be applied to the genital area, including the penis and scrotum.

The skin in these areas is more sensitive, and the high alcohol content in the gel can cause significant irritation or burning.

Avoiding Contact with Others:
To prevent accidental transfer of testosterone to others, avoid skin-to-skin contact with the application area immediately after applying the gel.

If contact is expected, it’s crucial to cover the area with clothing, such as a shirt with long sleeves, after the gel has dried.

If another person does come into contact with the application site, they should wash the area thoroughly with soap and water as soon as possible.

Caution with Women and Children:
Women, especially pregnant or breastfeeding women, and children should avoid any contact with the skin where AndroGel® has been applied.

Testosterone can cause harmful effects such as virilization in women and premature puberty in children.

If contact does occur, the area should be washed immediately with soap and water.

Sun Exposure and Bathing:
It’s recommended to avoid bathing or swimming for at least 2 hours after applying AndroGel® to ensure optimal absorption.

If the gel is accidentally washed off within this time frame, its effectiveness may be reduced. Sun exposure immediately after application should also be minimized to avoid irritation at the application site.

Alcohol and Smoking:
Although not directly related to the gel's effectiveness, patients should be aware that excessive alcohol consumption and smoking can interfere with testosterone therapy's overall health benefits and may exacerbate certain side effects.

Interaction with Other Products:
Using sunscreens, lotions, or other topical products on the same area where AndroGel® is applied might alter the absorption of testosterone.

If sunscreen or lotion use is necessary, apply it after AndroGel® has fully dried.

What are the possible side effects of AndroGel®?

Common side effects of AndroGel® include skin reactions at the application site, such as redness, dryness, or irritation.

Some users may experience increased acne, hair loss, or changes in mood. Rarely, more serious side effects like increased blood pressure, weight gain, or sleep apnea can occur.

It’s important to report any unusual symptoms to your healthcare provider.

How should AndroGel® be stored?

AndroGel® should be stored at a temperature not exceeding 25°C (77°F) and kept out of reach of children to prevent accidental exposure.

What precautions should you take while using AndroGel®?

Before starting AndroGel®, a thorough medical examination is necessary to rule out conditions like prostate cancer.

Regular monitoring of testosterone levels, blood pressure, and prostate health is essential during treatment.

Patients with heart, liver, or kidney problems should use AndroGel® with caution, as testosterone therapy can exacerbate these conditions.