Testosterone is the main male hormone that maintains muscle mass and strength, fat distribution, bone mass, sperm production, sex drive, and potency.
Testosterone: A "male hormone" -- a sex hormone produced by the testes that encourages the development of male sexual characteristics, stimulates the activity of the male secondary sex characteristics, and prevents changes in them following castration. Chemically, testosterone is 17-beta-hydroxy-4-androstene-3-one. Testosterone is the most potent of the naturally occurring androgens. The androgens cause the development of male sex characteristics, such as a deep voice and a beard; they also strengthen muscle tone and bone mass.
High levels of testosterone appear to promote good health in men. For example, testosterone has been associated with lowering the risks of high blood pressure and heart attack. High testosterone levels also correlate with risky behavior, however, including increased aggressiveness and smoking , which may cancel out these health benefits.
Testosterone therapy may be given to treat medical conditions, including female (but not male) breast cancer, hypogonadism (low gonadal function) in the male, cryptorchism (nondescent of the testis into the scrotum), and menorrhagia (irregular periods).
Testosterone is the primary androgenic hormone and is responsible for normal growth and development of male sex organs and maintenance of secondary sex characteristics. Pre-pubertal hypogonadism is generally characterized by infantile genitalia and lack of virilization, while the development of hypogonadism after puberty frequently results in complaints such as diminished libido, erectile dysfunction, infertility, gynecomastia, impaired masculinization, changes in body composition, reductions in body and facial hair, and osteoporosis. Hypogonadal men also report levels of anger, confusion, depression, and fatigue that are significantly higher than those reported in eugonadal men.
Evaluation of potential candidates for testosterone replacement therapy should include a complete medical history and hormonal screening. Total serum testosterone should be measured in the morning. When the serum testosterone level is low and LH is elevated, testosterone replacement therapy is warranted. Patients with low serum LH and testosterone levels need an imaging study of their pituitary and may need endocrinologic consultation.
Category A 21.7 (Male sex hormones)
In the eunuch and eunuchoid male, androgens act to stimulate and maintain the secondary sexual characteristics associated with the adult male. Androgens influence closure of the epiphyseal lines in males and some females, administration of androgens reduces urinary excretion of nitrogen, sodium, potassium, chloride, phosphorus and water.
Based on a review by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the indications for certain androgens as follows:
Effective - In the male:
- Eunuchism, eunuchoidism, deficiency after castration.
- Male climacteric symptoms when these are secondary to androgen deficiency.
Probably Effective - In the female or male:
- Postmenopausal or senile osteoporosis. Androgens are without value as a primary therapy, but may be of value as adjunctive therapy. Equal or greater consideration should be given to diet, calcium balance, physiotherapy, and good general health-promoting measures. Final classification of the less-than-effective indications requires further investigation.
- Carcinoma of the male breast.
- Carcinoma known or suspected of the prostate.
- Cardiac, hepatic or renal decompensation.
- Liver function impairment.
- Prepubertal males.
DEPO-TESTOSTERONE is for intramuscular use only. Dosage will vary depending upon the individual, the condition being treated, its severity, and prior androgen therapy. Because of the protracted action of DEPO-TESTOSTERONE injections more frequently than every two weeks are seldom required.
Eunuchism; Eunuchoidism - For complete replacement in eunuchs and eunuchoid patients, the usual dose of DEPO-TESTOSTERONE is 200 to 400 mg injected at intervals of three to four weeks. It is usually preferable to begin treatment with full therapeutic doses, which are later adjusted to individual requirements.
Priapism is a sign of excessive dosage and is an indication for temporary withdrawal of androgen therapy.
Impotence due to Testicular Deficiency; Male Climacteric
DEPO-TESTOSTERONE may be given every three to four weeks in doses ranging from 200 to 400 mg.
To stimulate spermatogenesis when trial androgen therapy is indicated in subfertile males with oligospermia, recommended dosage of DEPO-TESTOSTERONE is: (1) 100 to 200 mg every three to six weeks for development and maintenance of testicular function; (2) 200 mg each week for six to ten weeks for suppression which may then be followed by rebound spermatogenesis following discontinuance of the injection.
Anabolic Effect; Osteoporosis
- The dosage of DEPO-TESTOSTERONE for anabolic effect should be adjusted according to age, sex, and the condition of the individual patient. In the majority of cases, the dose will range from 200 to 400 mg injected every three to four weeks. In addition, an adequate diet should be provided and prolonged immobilization avoided whenever possible.
Hypercalcaemia may occur in immobilized patients, and in patients with breast cancer. In patients with cancer this may indicate progression of bony metastasis. If this occurs the drug should be discontinued. Testosterone propionate must not be used interchangeably with testosterone cypionate, enanthate or phenylacetate due to the difference in duration of action.
Do not give intravenously.
Watch female patients closely for signs of virilization. Some effects such as voice changes may not be reversible when the drug is stopped.
Due to the prolonged action of this drug, it should be administered with caution to patients with organic heart disease of debilitation.
Patients with cardiac, renal or hepatic derangement may retain sodium and water thus forming oedema.
Priapism or excessive sexual stimulation may develop. Oligospermia and reduced ejaculatory volume may occur after prolonged administration or excessive dosage. Hypersensitivity and gynecomastia may occur. When any of these effects appear the androgen should be stopped and if restarted, a lower dosage should be utilized.
The PBI may increase during androgen therapy without clinical significance.
- Acne Priapism
- Decreased ejaculatory volume
- Hypercalcaemia (especially in immobile patients Gynecomastia and those with metastatic breast carcinoma)
- Local irritation
- Hypersensitivity, including skin manifestations and anaphylactiod reactions
- Virilization in females
Treatment should be symptomatic and supportive.
A pale yellow oily solution.
DEPO-TESTOSTERONE 100 mg is available in 1 mL and 10 mL vials.
Store at room temperature (15°C - 30°C)
Keep out of reach of children
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