TESTOSTERONE CYPIONATE injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Hospira, Inc.

INN (nume internaţional):

TESTOSTERONE CYPIONATE

Compoziție:

TESTOSTERONE CYPIONATE 100 mg in 1 mL

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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. - Known hypersensitivity to the drug - Males with carcinoma of the breast - Males with known or suspected carcinoma of the prostate gland - Women who are pregnant (see PRECAUTIONS, Pregnancy) - Patients with serious cardiac, hepatic or renal disease (see WARNINGS) Testosterone Cypionate Injection contains testosterone, a Schedule III controlled substan

Rezumat produs:

Testosterone Cypionate Injection is available as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION
HOSPIRA, INC.
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TESTOSTERONE CYPIONATE INJECTION, USP CIII
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)-, (17ß)-. 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 two strengths, 100
mg/mL and 200 mg/mL testosterone
cypionate.
Each mL of the 100 MG/ML solution contains:
Testosterone cypionate
100 mg
Benzyl benzoate
0.1 mL
Cottonseed oil
736 mg
Benzyl alcohol (as preservative)
9.45 mg
Each mL of the 200 MG/ML 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,
27
40
3
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 growt