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:

Dispensing Solutions, 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. - Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. - Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. - Known hypersensitivity to the drug Known hypersensitivity to the drug - Males with carcinoma of the breast Males with carcinoma of the breast - Males with known or suspected carc

Prehľad produktov:

Testosterone Cypionate Injection USP, 200 mg/mL is available in: 10 mL multiple dose vials, individually boxed. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Literature revised: July 2010 Product No.: 0256-10 Manufactured by: Hikma Farmaceutica (Portugal) S.A. 2705-906 Terrugem SNT, Portugal Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA PIN230-WAT/1

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION
DISPENSING SOLUTIONS, INC.
----------
TESTOSTERONE CYPIONATE INJECTION USP
FOR INTRAMUSCULAR USE ONLY C-III
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:
Each mL contains: Testosterone Cypionate 200 mg, Benzyl Benzoate 20%,
with Benzyl Alcohol 0.9%
as preservative in Cottonseed Oil q.s.
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
prostate, seminal vesicles, penis, and scrotum; development of male
hair distribution, such as beard,
pubic, chest and axillary hair; laryngeal enlargement, vocal chord
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 centers. In
children, exogenous androgens
accelerate linear growth rates, but may cause disproportionate
advancement in bone maturation. Use
over lo