TESTOSTERONE ENANTHATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

TESTOSTERONE ENANTHATE

Composition:

TESTOSTERONE ENANTHATE 200 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Males Testosterone enanthate injection 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 testo

Product summary:

Testosterone enanthate injection, USP is available in 5 mL (200 mg/mL) multiple dose vials. Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature]. Warming and rotating the vial between the palms of the hands will redissolve any crystals that may have formed during storage at low temperatures. For Prescription Use Only Literature revised: December 2017 Manufactured by: Hikma Farmaceutica (Portugal) S.A. 2705-906 Terrugem SNT, Portugal Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 Medical Inquiries:  1-800-272-5525

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TESTOSTERONE ENANTHATE- TESTOSTERONE ENANTHATE INJECTION, SOLUTION
ACTAVIS PHARMA, INC.
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TESTOSTERONE ENANTHATE INJECTION, USP CIII
FOR INTRAMUSCULAR USE ONLY
RX ONLY
DESCRIPTION
Testosterone enanthate injection, USP provides testosterone enanthate,
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 in sesame
oil with 5 mg chlorobutanol
(chloral derivative) as a preservative.
Testosterone enanthate 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 cord
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. Andr