TESTOSTERONE CYPIONATE injection, solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Bryant Ranch Prepack

Stjórnsýsluleið:

INTRAMUSCULAR

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 Testosterone Cypionate Injection contains testosterone, a Sched

Vörulýsing:

Testosterone Cypionate Injection, USP, 200 mg/mL is a clear, pale yellow oleaginous viscous, sterile solution intended for intramuscular administration available as:    1 mL Vial, Cartons of 1 vial NDC 63629-8705-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION
BRYANT RANCH PREPACK
----------
TESTOSTERONE CYPIONATE INJECTION, USP
CIII
RX ONLY
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)-, (17ß)-. 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:
1. Testosterone Cypionate, USP 200 mg
2. Benzyl Benzoate, USP 0.2 mL
3. Cottonseed Oil, USP 560 mg
4. 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;
laryngeal enlargement, vocal cord thickening, and alterations in body
musculature and
27
40
3
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