Testosterone Cypionate Injection, USP, for Intramuscular Injection, contains
testosterone
cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone
testosterone.
Testosterone Cypionate (
GP Test Cyp 250) 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.
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.
During exogenous administration of androgens, endogenous
testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH).
Testosterone esters are less polar than free testosterone.
Testosterone esters in oil injected intramuscularly are absorbed slowly from the lipid phase; thus,
testosterone cypionate (
GP Test Cyp 250) can be given at intervals of two to four weeks.
USAGE
Testosterone Cypionate Injection (
GP Test Cyp 250), 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)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalmic injury from tumors, trauma, or radiation.
SIDE EFFECTS
The following adverse reactions in the male have occurred with some androgens:
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Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages.
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Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne.
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Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
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Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis.
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Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
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Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
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Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions.
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Miscellaneous: Inflammation and pain at the site of intramuscular injection.