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HOME >> API >> API List 3 >> Testosterone >> Precautions

PRECAUTIONS
Testosterone CAS number 58-22-0

Potential for Testosterone Transfer to Others

Transfer of testosterone to others (including women and children) can occur when vigorous skin-to-skin contact is made with the application site [see Clinical Studies]. The following precautions are recommended to minimize potential transfer of testosterone from Testosterone -treated skin to another person:

* Patients should wash their hands immediately with soap and water after application of Testosterone .
* Patients should cover the application site(s) with clothing after the gel has dried (e.g., a shirt).
* In the event that unwashed or unclothed skin to which Testosterone  has been applied does come in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible. In vitro studies show that residual testosterone is removed from the skin surface by washing with soap and water.
* Women and children should avoid skin contact with Testosterone  application sites in males. Changes in body hair distribution, significant increase in acne, or other signs of virilization should be brought to the attention of a physician. Testosterone  may cause fetal harm in a pregnant woman due to virilization of a female fetus

Use in Women

Due to lack of controlled evaluations in women and potential virilizing effects, Testosterone  is not indicated for use in women [see Use in Specific Populations].
Potential for Adverse Effects on Spermatogenesis

At large doses of exogenous androgens, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.
Hepatic Adverse Effects

Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long- term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. Testosterone  is not known to produce these adverse effects.

There are rare reports of hepatocellular carcinoma in patients receiving long-term oral therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.
Flammable until Dry

* Alcohol Based Products including Testosterone  are flammable; therefore avoid fire, flame or smoking until the gel has dried.

Pediatric Use

Safety and efficacy of Testosterone  in males < 18 years old has not been established.
Geriatric Use

There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing Testosterone  to determine whether efficacy in those over 65 years of age differs from younger subjects. Additionally, there is insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer.

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