Testosterone Cypionate (
Testodex Cypionate 250)
Injection, USP, for Intramuscular Injection, contains
testosterone
cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone
testosterone.
Testosterone Cypionate (
Testodex Cypionate 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 can be given at intervals of two to four weeks.
USAGE
Testosterone Cypionate (
Testodex Cypionate 250)
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)-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:
-
Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages.
-
Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne.
-
Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
-
Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis.
-
Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
-
Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
-
Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions.
-
Miscellaneous: Inflammation and pain at the site of intramuscular injection.