Testosterone Topical

Reviewed on 5/16/2022

QUESTION

Testosterone is a chemical found only in men. See Answer

What Are Dosages of Testosterone Topical?

Adult dosage

Patch, transdermal: Schedule III

  • 2mg/24 hours
  • 4mg/24 hours

Gel, transdermal: Schedule III

  • 1% (12.5mg/actuation) (Androgel)
  • 1.62% (20.25mg/actuation) (Androgel)
  • 10mg/actuation (1 pump actuation dispenses 0.5 g of gel) (Fortesta)
  • 12.5mg/actuation (Vogelxo)
  • 20.25mg/1.25g
  • 25mg/2.5g
  • 40.5mg/2.5g
  • 50mg/5g (Testim)
  • 50mg/unit dose pack (Vogelxo)

Ointment, Topical: Schedule III

  • 2%

Solution, Topical: Schedule III

  • 30mg/actuation (90mL) (Axiron)

Cream, transdermal: Schedule III

  • 2%

Testosterone Deficiency

Adult dosage

Androderm

  • 4 mg/day initially, applied patch to back, abdomen, arm, or thigh (not to the scrotum) at bedtime; do not use 2 mg/day patches to achieve 4 mg dose
  • Nonvirilized: 2 mg/day initially
  • Usual dosing range: 2-6 mg/day

AndroGel

  • 1%: 50 mg/day initially, applied Topically to shoulders, upper arms, or abdomen (not to genitals) each morning; titrated as needed according to predose serum testosterone levels (25 mg/2.5 g, 50 mg/5 g); not to exceed 100 mg/day
  • 1.62%: 40.5 mg (2 pump actuations) daily initially, applied Topically to shoulders or upper arms (not to abdomen or genitals) each morning; titrated between 20.25 mg (1 pump actuation) and 81 mg (4 pump actuations) according to predose serum testosterone levels; not to exceed 81 mg/day
  • Measure serum testosterone levels 14 and 28 days after initiation, then periodically thereafter

Testim

  • 50 mg/day, applied Topically to shoulders and upper arms (not to genitals) each morning; may be increased to 100 mg as needed (50 mg/5 g)

Axiron

  • 60 mg/day, applied Topically to the axilla (1 pump actuation applied to each axilla) each morning; titrated according to serum testosterone levels obtained from a single blood draw 2-8 hours after application and more than 14 days after treatment initiation or dosage adjustment

Fortesta

  • 40 mg (4 pump actuations) daily initially, applied Topically to thighs each morning; titrated according to serum testosterone levels obtained from a single blood draw 2 hours after application and approximately 14 and 35 days after treatment initiation or dosage adjustment
  • Measure serum testosterone concentrations periodically

Vogelxo

  • 50 mg (1 unit dose pack or 4 pump actuations) Topically once daily at about the same time each day

Dosage Considerations – Should be Given as Follows: 

  • See “Dosages”

What Are Side Effects Associated with Using Testosterone Topical?

Common side effects of Testosterone Topical include:

  • redness, itching, burning, hardened skin, or other irritation at the injection site,
  • headache,
  • dizziness,
  • itching,
  • redness in the face,
  • muscle pain,
  • increased prostate-specific antigen,
  • increased blood pressure,
  • mood changes,
  • strange dreams,
  • frequent or prolonged erections,
  • nausea,
  • vomiting, 
  • hair loss, and
  • swelling in lower legs.

Serious side effects of Testosterone Topical include:

  • increased urination,
  • loss of bladder control,
  • painful or difficult urination,
  • breast pain or swelling,
  • swelling,
  • rapid weight gain,
  • shortness of breath during sleep,
  • chest pain or pressure,
  • pain spreading to the jaw or shoulder,
  • nausea,
  • upper stomach pain,
  • itching,
  • tired feeling,
  • loss of appetite,
  • dark urine,
  • clay-colored stools,
  • yellowing of the skin or eyes,
  • chest pain,
  • sudden cough,
  • wheezing,
  • rapid breathing,
  • coughing up blood, and
  • swelling, warmth, or redness in an arm or leg.

Rare side effects of Testosterone Topical include:

  • none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

What Other Drugs Interact with Testosterone Topical?

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

What Are Warnings and Precautions for Testosterone Topical?

Contraindications

  • Males with breast or prostate cancer
  • Hypersensitivity
  • Breastfeeding women
  • Pregnancy

Effects of drug abuse

  • Physical and psychological effects

Short-Term Effects

  • See “What Are Side Effects Associated with Using Testosterone Topical?”

Long-Term Effects

  • See “What Are Side Effects Associated with Using Testosterone Topical?”

Cautions

  • Use with caution in patients with chronic lung disease, obesity, advanced age, or preexisting cardiac, renal, or hepatic disease
  • Employ caution with prolonged use of high doses, which may be associated with hepatic effects
  • May increase the risk of prostate cancer
  • Risk of gynecomastia when used for male hypogonadism
  • May change serum lipid profile; use with caution in patients who have a history of myocardial infarction (MI) or coronary artery disease (CAD)
  • Large doses may suppress spermatogenesis
  • May increase hematocrit, which requires dose adjustment or discontinuation; monitor serum testosterone, prostate-specific antigen (PSA), liver function, lipid concentrations, hematocrit, and hemoglobin periodically
  • May cause hypercalcemia in patients with prolonged immobilization or cancer
  • Anabolic activity of androgens may enhance hypoglycemia
  • Children: Risks of inappropriate genital enlargement, premature pubic hair, advanced bone age, increased libido, and aggressive behavior
  • Fortesta: Exogenous administration of androgens may lead to azoospermia; sleep apnea may occur in those with risk factors; preparation is flammable until dry
  • Discontinue if urethral obstruction develops in patients with benign prostatic hyperplasia (BPH); monitor patients with BPH for worsening signs and symptoms of BPH
  • Edema with or without congestive heart failure, maybe a complication in patients with pre-existing cardiac, renal, or hepatic disease; use with caution
  • May worsen sleep apnea in some male patients
  • Evaluate patients for cardiovascular risk factors before initiating therapy and monitor closely during therapy
  • Use caution in patients with diseases that may be exacerbated by fluid retention, including cardiac, hepatic, or renal dysfunction; not recommended for men with poorly controlled heart failure
  • Monitor women for virilization when treating for metastatic breast cancer
  • Geriatric patients may be at greater risk for prostatic hyperplasia, prostate cancer, fluid retention, and an increase in transaminase levels
  • Increased hematocrit (polycythemia), reflective of increased red blood cell mass, may require discontinuation; increases the risk for thromboembolism
  • Venous thromboembolism, including DVT and PE, is reported in patients using testosterone products; these observations have included patients with and without polycythemia; evaluate signs or symptoms consistent with DVT or PE; if the venous thromboembolic event is suspected, discontinue treatment with testosterone and initiate appropriate workup and management
  • Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids; anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions; if testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range; consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events
  • Skin burns were reported at the application site in patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI); because the transdermal testosterone patch contains aluminum, it is recommended to remove the system before undergoing MRI
  • Cardiovascular risks
    • Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with the use of testosterone replacement therapy
    • January 31, 2014: FDA is investigating the risk of stroke, MI, and death in men taking prescription testosterone drugs; the investigation was prompted by findings from 2 studies suggesting an increased risk of MI in men who take testosterone
    • In one study, an analysis of 55,593 men with a history of MI showed that men above 65 years had a 2-fold increase in MI risk within 90 days of filing an initial prescription for testosterone drug; among younger men (below 65 years) with a history of heart disease, MI risk was increased 2- to 3-fold
    • This study confirmed the results of an earlier, much smaller study, which found that older men, many with underlying heart disease, had a 30% increased chance of death, MI, and stroke after receiving testosterone therapy

Pregnancy and Lactation

  • Contraindicated in pregnant women; the drug is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action; exposure of the female fetus to androgens may result in varying degrees of virilization
  • Infertility
    • During treatment with large doses of exogenous androgens, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis; reduced fertility is observed in some men taking testosterone replacement therapy; testicular atrophy, subfertility, and infertility have been reported in men who abuse anabolic androgenic steroids; with either type of use, the impact on fertility may be irreversible
  • Lactation
    • The drug is not indicated for use in women

SLIDESHOW

Low Testosterone (Low T) Treatments See Slideshow
References
https://reference.medscape.com/drug/androgel-testosterone-Topical-342796#0

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