TESTOSTERONE CYPIONATE injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

Testosterone Cypionate (UNII: M0XW1UBI14) (Testosterone - UNII:3XMK78S47O)

Boleh didapati daripada:

Physicians Total Care, Inc.

Laluan pentadbiran:

INTRAMUSCULAR

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Testosterone cypionate injection 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 Steroids Control Act, and Testosterone Cypionate Injection has been assigned to Schedule III.

Ringkasan produk:

Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows: 1 mL vials                     NDC 54868-3618-1 10 mL vials                   NDC 54868-3618-0 Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

TESTOSTERONE CYPIONATE - TESTOSTERONE CYPIONATE INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, 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)-, (17β)-. 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 one strength, 200
mg/mL testosterone cypionate. Each
mL of the 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,
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 growth spurt of adolescence and for
eventual termination of linear
growth, brought about by fusion of the epiphyseal growth centers. In
children, exogenous androgens
accelerate