TESTOSTERONE CYPIONATE injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

A-S Medication Solutions

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Testosterone Cypionate Injection, USP 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. Testosterone Cypionate Injection contains testosterone, a Schedule III controlled substance in the Controlled Substances Act. Abuse 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), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. Abuse-Related Adverse Reactions Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dependence Behaviors Associated with Addiction Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

leaflet_short:

Product: 50090-4920 NDC: 50090-4920-0 10 mL in a VIAL, GLASS / 1 in a CARTON

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
----------
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)-, (17ß)-. 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:
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;
27
40
3
Testosterone Cypionate, USP 200 mg
Benzyl Benzoate, USP 0.2 mL
Cottonseed Oil, USP 560 mg
Benzyl Alcohol, USP (as preservative) 9.45 mg
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
epiphyse