TESTOSTERONE ENANTHATE injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

TESTOSTERONE ENANTHATE (UNII: 7Z6522T8N9) (TESTOSTERONE - UNII:3XMK78S47O)

Disponible depuis:

Hikma Pharmaceuticals USA Inc.

DCI (Dénomination commune internationale):

TESTOSTERONE ENANTHATE

Composition:

TESTOSTERONE ENANTHATE 200 mg in 1 mL

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Testosterone Enanthate Injection, USP is indicated for replacement therapy in conditions associated with a 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. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. Safety and efficacy of Testost

Descriptif du produit:

Testosterone Enanthate Injection, USP 200 mg/mL is available as: 5 mL Multiple Dose vial, Cartons of 1 vial      NDC 0143-9750-01

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

TESTOSTERONE ENANTHATE- TESTOSTERONE ENANTHATE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
TESTOSTERONE ENANTHATE INJECTION, USP
RX ONLY
CIII
DESCRIPTION
Testosterone Enanthate Injection, USP provides Testosterone Enanthate,
USP, a
derivative of the primary endogenous androgen testosterone, for
intramuscular
administration. In their active form, androgens have a 17-beta-hydroxy
group.
Esterification of the 17-beta-hydroxy group increases the duration of
action of
testosterone; hydrolysis to free testosterone occurs _in vivo_. Each
mL of sterile,
colorless to pale yellow, solution provides 200 mg Testosterone
Enanthate, USP in
sesame oil with 5 mg chlorobutanol (chloral derivative) as a
preservative.
Testosterone Enanthate, USP is designated chemically as
androst-4-en-3-one, 17-[(1-
oxoheptyl)-oxy]-, (17β)-. Structural formula:
CLINICAL PHARMACOLOGY
Endogenous androgens are responsible for the 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; alterations in body
musculature; and fat
distribution.
Androgens 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
the eventual
termination of linear growth which is brought about by fusion of the
epiphyseal growth
centers. In children, exogenous androgens accelerate linear growth
rates but may
cause a disproportionate advancement in bone maturation. Use over long
periods may
result in fusion of the epiphyseal growth centers and termination of
the growth process.
And