TESTOSTERONE CYPIONATE injection

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Hikma Pharmaceuticals USA Inc.

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate 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 testoster

Descriptif du produit:

Testosterone Cypionate Injection, USP, 200 mg/mL is a clear, pale yellow oleaginous viscous, sterile solution intended for intramuscular administration available as: 10 mL Multiple Dose Vials, Cartons of 1 vial NDC 0143-9005-01 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mό, 8, 8A e 8B - Fervença, - 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ 07922 Novaplus is a registered trademark of Vizient, Inc. novaplus+   Revised: April 2021 PIN574-NOV/1

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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TESTOSTERONE CYPIONATE INJECTION, USP
RX Only CIII
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)-, (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 one strength,
200 mg/mL
Testosterone Cypionate, USP.
Each mL of the 200 mg/mL solution contains:
Testosterone Cypionate, USP 200 mg
Benzyl Benzoate, USP 0.2 mL
Cottonseed Oil, USP 560 mg
Benzyl Alcohol, USP (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;
27
40
3
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 g