Testosterone (12 brand names, 7 dosage forms, 5 routes)
Available dosage forms: GEL, SOLUTION, METERED, GEL, METERED, PELLET, FILM, EXTENDED RELEASE, INJECTABLE, TABLET, EXTENDED RELEASE.
Routes of administration: TRANSDERMAL, IMPLANTATION, NASAL, INJECTION, BUCCAL.
Brand Names
- ANDRODERM
- ANDROGEL
- AXIRON
- FORTESTA
- NATESTO
- STRIANT
- TESTIM
- TESTODERM
- TESTODERM TTS
- TESTOPEL
- TESTOSTERONE
- VOGELXO
Boxed Warning
Virilization has been reported in children who were secondarily exposed to topical testosterone products [ see Warnings and Precautions ( 5.2 )]. Children should avoid contact with unwashed or unclothed application sites in men using Testosterone Topical Solution [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.2 )]. Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.2 ) and Pati ent Counselling Information ( 17 )].
Indications and Usage
Testosterone Topical Solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired); testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum concentrations and gonadotropins (FSH, LH) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropic or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma or radiation. These men have low testosterone serum-concentrations but have gonadotropins in the normal or low range. Limitations of use: Safety and efficacy of Testosterone Topical Solution in men with “age-related hypogonadism’ (also referred to as “late-onset hypogonadism”) have not been established. Safety and efficacy of Testosterone Topical Solution in males < 18 years old have not been established [see Use in Specific Populations ( 8.4 )].
Dosage and Administration
Prior to initiating Testosterone Topical Solution, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.
Contraindications
Testosterone Topical Solution is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precaution ( 5.1 )]. Testosterone Topical Solution is contraindicated in women who are, or who may become pregnant, or who are breastfeeding. Testosterone Topical Solution may cause fetal harm when administered to a pregnant woman. Testosterone Topical Solution may cause serious adverse reactions in nursing infants. If a pregnant woman is exposed to Testosterone Topical Solution, she should be apprised of the potential hazard to the fetus. [See Use in Specific Populations ( 8.1 , 8.3 )].
Mechanism of Action
Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
Overdosage
No cases of overdose with Testosterone Topical Solution have been reported in clinical trials. There is one report of acute overdosage by injection of testosterone enanthate: testosterone concentrations of up to 11,400 ng/dL were implicated in a cerebrovascular accident. Treatment of overdosage would consist of discontinuation of Testosterone Topical Solution together with appropriate symptomatic and supportive care.