TESTOSTERONE CYPIONATE injection, solution

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

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 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 pregnant (see PRECAUTIONS, Pregnancy) 5. Patients with serious cardiac, hepatic or renal disease (see WARNINGS) Testosterone Cypionate Injection contains testosterone, a Schedule III controlled substance in the Controlled Substances Act. Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS),

Product summary:

Product: 50090-4147 NDC: 50090-4147-0 10 mL in a VIAL, GLASS / 1 in a CARTON

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
----------
TESTOSTERONE CYPIONATE INJECTION, USP CIII
RX ONLY
DESCRIPTION
Testosterone cypionate injection, 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 is available in one strength, 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 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
27
40
3
termination of linear growth, brought about by fusion of the
epiphyseal growth centers.
In children, exogenous androgens