TESTOSTERONE CYPIONATE injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Physicians Total Care, Inc.

Designación común internacional (DCI):

TESTOSTERONE CYPIONATE

Composición:

TESTOSTERONE CYPIONATE 100 mg in 1 mL

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Testosterone cypionate injection, USP 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. - Hypogonadotropic hypogonadism (congenital or acquired) idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. - Known hypersensitivity to the drug - Males with carcinoma of the breast - Males with known or suspected carcinoma of the prostate gland - Women who are or who may become pregnant - Patients with serious cardiac, hepatic or renal disease Testosterone is a controlled substance under the Anabolic Steroid Control Act, and testosterone cypionate injection, USP has been assigned to Schedule III.

Resumen del producto:

Testosterone cypionate injection, USP is available as follows: 100 mg/mL: NDC 54868-3669-0 – 10 mL multidose vial Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light. 03-2009M U1006824 Manufactured in Canada by Sandoz Canada Inc. for Sandoz Inc., Princeton, NJ 08540 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma      74146

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

TESTOSTERONE CYPIONATE - TESTOSTERONE CYPIONATE INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
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TESTOSTERONE CYPIONATE INJECTION, USP
100 MG/ML AND 200 MG/ML
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 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
27
40
3
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 protei