What it's for (Indications)
- Testosterone is indicated for the treatment of male hypogonadism (primary and secondary), which should be confirmed by morning serum testosterone concentrations below the normal range on at least two separate days.
- It is also used for potency disorders, protein deficiency during recovery (after surgery or in wasting diseases), liver cirrhosis, aplastic anemia, delayed healing of bones, and osteoporosis due to androgen deficiency.
- In women, it is indicated for the treatment of progressive mammary or endometrial carcinoma and climacteric complaints with existing mammary or endometrial carcinoma.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | Prior to initiating testosterone therapy for hypogonadism, confirm the diagnosis by ensuring that morning serum testosterone concentrations have been measured on at least two separate days and are below the normal range. Dosage and administration may vary depending on the formulation (e.g., gel vs. other forms) and concentration. For testosterone gel, 1.62%, the starting dose is typically 40.5 mg of testosterone. Patients must strictly adhere to the recommended instructions for use and the amount prescribed, as long-term and large doses are associated with increased risks, including hindering bone lengthening and potential liver cancer. Consult specific product information for detailed dosage instructions for other formulations. |
Safety & Warnings
Common Side Effects
- Common side effects in men include gynecomastia (enlargement of breast tissue), excessive penile erection, decreased testicular function, testicular atrophy (shrinking), impotence, and an increase in prostate-specific antigen (PSA).
- In females, side effects include amenorrhea and other menstrual irregularities, as well as the development of male pattern characteristics (virilization).
- Prolonged use may also lead to liver cancer.
- Virilization has also been reported in children who were secondarily exposed to testosterone gel.
Serious Warnings
- Black Box Warning: WARNING: SECONDARY EXPOSURE TO TESTOSTERONE. Virilization has been reported in children who were secondarily exposed to testosterone gel. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
- Caution is advised for individuals with cardiac, liver, and kidney insufficiencies, epilepsy, migraine, and hypertension.
- Long-term and large doses are reported to hinder bone lengthening and may lead to liver cancer and the development of male pattern characteristics in women.
- Patients should strictly adhere to prescribed dosages and administration instructions.
- Alcohol consumption should be avoided while taking this medication.
- There is a risk of secondary exposure to testosterone, particularly with topical formulations; children should avoid contact with unwashed or unclothed application sites to prevent virilization.
- If a pregnant woman is exposed to testosterone (either directly or via secondary transfer from a treated man), she should be apprised of the potential hazard of virilization to the fetus.
How it Works (Mechanism of Action)
Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of male sex organs and the maintenance of secondary sex characteristics. These effects include the growth and maturation of the prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution (facial, pubic, chest, and axillary); laryngeal enlargement; vocal cord thickening; and alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics. Male hypogonadism results from insufficient secretion of testosterone, arising from either primary gonadal defects (e.g., Klinefelter's syndrome, Leydig cell aplasia) or secondary failure of the hypothalamus or pituitary to produce sufficient gonadotropins (FSH, LH).
Commercial Brands (Alternatives)
No other brands found for this formula.