DEPO-TESTOSTERONE- testosterone cypionate injection, solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Pharmacia and Upjohn Company LLC

INN (الاسم الدولي):

TESTOSTERONE CYPIONATE

تركيب:

TESTOSTERONE CYPIONATE 100 mg in 1 mL

طريقة التعاطي:

INTRAMUSCULAR

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired )-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired )- gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of DEPO-Testosterone (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) DEPO-Testosterone Injection contains testosterone, a Schedule III controlled substan

ملخص المنتج:

DEPO-Testosterone Injection is available as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

DEPO-TESTOSTERONE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION
PHARMACIA AND UPJOHN COMPANY LLC
----------
DEPO
-TES TOS TERONE
TESTOSTERONE CYPIONATE INJECTION, USP CIII
DESCRIPTION
DEPO-Testosterone 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)-, (17ß)-. Its molecular formula is C
H O , and the molecular weight 412.61.
The structural formula is represented below:
DEPO-Testosterone Injection 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
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
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40
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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 a