TESTOSTERONE CYPIONATE injection

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

ASP Cares

投与経路:

INTRAMUSCULAR

処方タイプ:

PRESCRIPTION DRUG

適応症:

Testosterone Cypionate Injection, USP 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 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. 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 or who may become pregnant 5. Patients with serious cardiac, hepatic or renal disease Controlled Substa

製品概要:

Testosterone Cypionate Injection, USP, 200 mg/mL is a clear, pale yellow oleaginous viscous, sterile solution intended for intramuscular or subcutaneous administration available as: 30 mL Multiple Dose Vials, Cartons of 1 vial NDC 72833-678-30 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect From Light. Manufactured by: ASP Cares 2414 Babcock Rd Ste 106 San Antonio, TX 78229

認証ステータス:

unapproved drug other

製品の特徴

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION
ASP CARES
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
DES CRIPTION
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)-, (17b)-. Its molecular formula is C27H40O3 and the
molecular weight 412.61.
The structural formula is represented below:
Each mL of the 200 mg/mL solution contains:
Testosterone Cypionate, USP 200 mg
Benzyl Benzoate, USP 0.25 mL
Benzyl Alcohol, USP 0.02 mL
Grape Seed Oil 0.50 mL
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
chi