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:

Padagis US LLC

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 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), 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. Behaviors Associated with Addiction Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: • Taking greater dosages than prescribed • Continued drug use despite medical and social problems due to drug use • Spending significant time to obtain the drug when supplies of the drug are interrupted • Giving a higher priority to drug use than other obligations • Having difficulty in discontinuing the drug despite desires and attempts to do so • Experiencing withdrawal symptoms upon abrupt discontinuation of use 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.

Product summary:

Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows: 1 mL vials NDC 0574-0820-01 10 mL vials NDC 0574-0820-10 Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used. This product’s label may have been updated. For current full prescribing information, please visit www.padagis.com. Manufactured By Grand River Aseptic Manufacturing Grand Rapids, MI 49504 Distributed By Padagis Minneapolis, MN 55427 www.padagis.com 2R800 RC J9 Rev 12-21

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION
PADAGIS US LLC
----------
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 accelerate