TESTOSTERONE CYPIONATE injection, solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

American Regent, Inc.

Spôsob podávania:

INTRAMUSCULAR

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate injection 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 cont

Prehľad produktov:

Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows: 1 mL Vials        NDC 0517-1830-01    Individually Packaged 10 mL Vials      NDC 0517-1831-01    IndividuallyPackaged Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION
AMERICAN REGENT, INC.
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TESTOSTERONE CYPIONATE INJECTION, USP CIII
RX ONLY
DESCRIPTION
Testosterone Cypionate Injection, USP, 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, USP is available as 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 phosphorous, 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. In
children, exogenous androgens
accelerate lin