Androgel 16.2 mg/g (Testosterone Gel)

MALES Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. a. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchiectomy. b. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropic LHRH deficiency, or pituitary - hypothalamic injury from tumors, trauma or radiation. If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sex characteristics. …

• Prior to initiating, TESTOPEL ® (testosterone pellets) 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
• The suggested dosage for androgens varies depending on the age, and diagnosis of the individual patient
• Dosage is adjusted according to the patient’s response and the appearance of adverse reactions
• The dosage guideline for the testosterone pellets for replacement therapy in androgen-deficient males is 150mg to 450mg subcutaneously every 3 to 6 months
• Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower doses initially, gradually increasing the dose as puberty progresses, with or without a decrease in maintenance levels
• Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty
• The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose
• Dosages in delayed puberty generally are in the lower range of that listed above and, for a limited duration, for example 4 to 6 months
• The number of pellets to be implanted depends upon the minimal daily requirements of testosterone propionate determined by a gradual reduction of the amount administered parenterally
• The usual dosage is as follows: implant two 75mg pellets for each 25mg testosterone propionate required weekly. …

• Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate
• If administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus
• The virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. …

In patients with breast cancer, androgen therapy may cause hypercalcemia by stimulating osteolysis. In this case, the drug should be discontinued. Prolonged use of high doses of androgens has been associated with the development of peliosis hepatis and hepatic neoplasms including hepatocellular carcinoma (see PRECAUTIONS - Carcinogenesis, Mutagenesis, Impairment of Fertility). Peliosis hepatis can be a life-threatening or fatal complication. Men treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma. …

The following adverse reactions have been identified during post-approval use of testosterone replacement therapy, including TESTOPEL ® . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Implantation Site Infection and Pellet Extrusion: (see WARNINGS) Endocrine and Urogenital, Male. Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages (see CLINICAL PHARMACOLOGY ). Skin and Appendages. Hirsutism, male pattern of baldness, and acne. Cardiovascular Disorders. …

There have been no reports of acute overdosage with the androgens.

Controlled Substance TESTOPEL ® contains testosterone, a Schedule III controlled substance in the Controlled Substances Act. Abuse Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.