TESTOSTERONE CYPIONATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

INN (International Name):

TESTOSTERONE CYPIONATE

Composition:

TESTOSTERONE CYPIONATE 200 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 ) Testosterone Cypionate Injection contains testoster

Product summary:

Product: 50090-0330 NDC: 50090-0330-0 10 mL in a VIAL

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION
A-S MEDICATION SOLUTIONS
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TESTOSTERONE CYPIONATE INJECTION, USP
RX Only CIII
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 growth centers.