Testosterone
ANDROGEL
Pronunciation: tes-TOS-ter-oen
What it isAndrogen-receptor agonist and principal endogenous androgen; replacement for hypogonadism.
Why this oneTopical gels and depot injections trade level stability against convenience and transfer risk.
What limits itIt suppresses spermatogenesis, so discuss fertility first; monitor hematocrit, and prevent skin transfer from gels.
FDA-approved for
- hypogonadism (~1953)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Hypogonadism, primary or hypogonadotropic (congenital or acquired) | Adult males | 40.5 mg (2 pump actuations or one 40.5 mg packet) topically QAM | 20.25–81 mg QAM, titrated to pre-dose AM total T 350–750 ng/dL | 81 mg QD (4 pump actuations or two 40.5 mg packets) |
Titration Check pre-dose AM serum testosterone ~14 and 28 days after start or any dose change; adjust in 20.25 mg (1 pump) steps
Renal Undefined
Hepatic Undefined
Confirm hypogonadism with AM serum testosterone below normal on ≥2 separate days. Not established in age-related hypogonadism or males <18 yr. Dosing differs from AndroGel 1%.
Instructions
- Apply to clean, dry, intact skin of shoulders and upper arms only (area covered by a short-sleeve t-shirt); not abdomen, genitals, chest, axillae, or knees
- Wash hands with soap and water after applying; cover site with clothing once dry
- Wash site thoroughly before anticipated skin-to-skin contact
- Avoid swimming, showering, or washing the site for ≥2 hours after application
- Flammable until dry — avoid fire, flames, smoking
- Prime new pump by discarding the first 3 actuations
Available strengths
- gel 1.62 %
- gel 5.5 mg/0.122 g
- gel 10 mg/0.5 g
- gel 12.5 mg/1.25 g
- gel 25 mg/2.5 g
- gel 50 mg/5 g
- pellet 75 mg
- sol 30 mg/1.5 mL
- + 1 other marketed form not shown
Contraindications
- Men with breast carcinoma or known/suspected prostate carcinoma
- Pregnant women (virilization of female fetus)
Cautions
- Secondary exposure to testosterone (virilization in children/women)
- Polycythemia
- Venous thromboembolism
- Worsening BPH; potential prostate cancer risk
- Blood pressure increases (avoid in uncontrolled hypertension)
- Abuse of testosterone; monitor serum levels
- Not for use in women
- Adverse effects on spermatogenesis
- Hepatic adverse effects
- Edema (± CHF)
- Gynecomastia
- Sleep apnea
- Lipid changes
- Hypercalcemia
- Decreased thyroxine-binding globulin
- Flammability
Adverse reactions
- PSA increased (11.1%)
- Emotional lability
- Hypertension
- Hematocrit/hemoglobin increased
- Contact dermatitis
Pregnancy Contraindicated in pregnancy — teratogenic; may cause virilization of a female fetus.
Lactation Not indicated for use in women.
Cost
| Strength | #/mo | generic $/unit | brand $/unit | CostPlus | |
|---|---|---|---|---|---|
| 1.62 % | gel | per unit | — | not offered | |
| 5.5 mg/0.122 g | gel | per unit | — | $41.28/g | not offered |
| 10 mg/0.5 g | gel | per unit | $0.83/g | — | not offered |
| 12.5 mg/1.25 g | gel | per unit | $0.83/g | — | not offered |
| 25 mg/2.5 g | gel | per unit | — | not offered | |
| 50 mg/5 g | gel | per unit | $0.57/g | — | not offered |
Generic entry2041 est.
⚠ BOXED WARNINGS
- Blood pressure increases
- Secondary exposure in children
Classes and tags
Clinical profile
Legacy pregnancy categoryX
Defining liabilityErythrocytosis, infertility, hepatic/lipid effects and mood or misuse concerns.
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