Testosterone – FDA prescribing information, side effects …

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Testosterone CypionateInjection, USP for intramuscular injection, contains Testosterone Cypionate, USPwhich is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone Testosterone.

Testosterone Cypionate, USPis a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils.

The chemical name for Testosterone Cypionate, USPis androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17)-. Its molecular formula is C27H40O3, and the molecular weight 412.61.

The structural formula is represented below:

Testosterone CypionateInjection, USPis available in one strength,200 mg/mL Testosterone Cypionate, USP.

Each mL of the 200 mg/mL solution contains

Testosterone Cypionate, USP 200 mg Benzyl Benzoate, USP 0.2 mL Cottonseed Oil, USP 560 mg Benzyl Alcohol, USP(as preservative) 9.45 mg

Endogenous androgens are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair distribution, such as beard, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution. Drugs in this class also cause retention of nitrogen, sodium, potassium, and phosphorous, and decreased urinary excretion of calcium. Androgens have been reported to increase protein anabolism and decrease protein catabolism. Nitrogen balance is improved only when there is sufficient intake of calories and protein.

Androgens are responsible for the growth spurt of adolescence and for eventual termination of linear growth, brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates, but may cause disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. Androgens have been reported to stimulate production of red blood cells by enhancing production of erythropoietic stimulation factor.

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