TC-250

DESCRIPTION

TC-250 for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone Testosterone.
Testosterone Cypionate, USP is 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, USP is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61.
TC-250 (Testosterone Cypionate) Injection, USP is available in one strength, 250 mg/mL Testosterone Cypionate.

Clinical Pharmacology
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 phosphorus, 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.

Indications and Usage
TC-250 (Testosterone Cypionate) Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous Testosterone.
Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
Safety and efficacy of Testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Contraindications
– Known hypersensitivity to the drug
– Males with carcinoma of the breast
– Males with known or suspected carcinoma of the prostate gland
– Women who are or who may become pregnant
– Patients with serious cardiac, hepatic or renal disease

Information for patients
Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.

Dosage and Administration
Prior to initiating Testosterone cypionate, 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.
TC-250 (Testosterone cypionate) injection is for intramuscular use only.
It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle.
The suggested dosage for Testosterone cypionate injection varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient’s response and the appearance of adverse reactions.

How is Testosterone Supplied
TC-250 (Testosterone Cypionate), 250 mg per mL is available in vials of 1 mL, in cartons of 10. Store at 20° to 25°C (68° to 77°F). PROTECT FROM LIGHT. Store in carton until contents are used.