TESTOSTERONE CYPIONATE injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

TESTOSTERONE CYPIONATE (UNII: M0XW1UBI14) (TESTOSTERONE - UNII:3XMK78S47O)

Disponible depuis:

Alvogen Inc.

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate injection in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. 1.  Known hypersensitivity to the drug 2.  Males with carcinoma of the breast 3.  Males with known or suspected carcinoma of the prostate gland 4.  Women who are pregnant (see PRECAUTIONS, Pregnancy) 5.  Patients with serious cardiac, hepatic or renal disease (see WARNINGS) Testosterone cypionate injection contains testosterone, a Schedule III contr

Descriptif du produit:

Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION
ALVOGEN INC.
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TESTOSTERONE CYPIONATE INJECTION, USP CIII
RX ONLY
DESCRIPTION
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 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 is
androst-4-en-3-one,17-(3-cyclopentyl-
1-oxopropoxy)-, (17β)-. Its molecular formula is C
H
O , and the molecular weight
412.61.
The structural formula is represented below:
Testosterone Cypionate Injection, USP is available as 200 mg/mL
testosterone cypionate.
Each mL of the solution contains Testosterone Cypionate, 200 mg;
Benzyl Benzoate, 0.2
mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg.
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 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.
27
40
3
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 line