TESTOSTERONE CYPIONATE injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

A-S Medication Solutions

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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. - Known hypersensitivity to the drug - Males with carcinoma of the breast - Males with known or suspected carcinoma of the prostate gland - Women who are pregnant (see PRECAUTIONS, Pregnancy ) - Patients with serious cardiac, hepatic or renal disease (see WARNINGS ) Safety and effectiveness in pediatric patients bel

Rezumat produs:

Product: 50090-4921 NDC: 50090-4921-0 10 mL in a VIAL, GLASS / 1 in a CARTON

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
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TESTOSTERONE CYPIONATE INJECTION, USP
CIII RX Only
DESCRIPTION
Testosterone Cypionate Injection, USP 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 C
H O , and the molecular weight 412.61.
The structural formula is represented below:
Testosterone Cypionate Injection, USP is 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
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 growt