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

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. 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 o

Product summary:

Testosterone Cypionate Injection, USP, 200 mg/mL is a clear, pale yellow oleaginous viscous, sterile solution intended for intramuscular administration available as: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A, e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed By Perrigo® Minneapolis, MN 55427 Revised: December 2018 PIN523-PER/1 8Z100 RC J6 or 462-794-00 8Z1E4RCJ1

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, 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
epiphyseal growth