TESTOSTERONE CYPIONATE injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Xiromed LLC

Οδός χορήγησης:

INTRAMUSCULAR

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Testosterone Cypionate 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 Testosterone Cypionate Injection 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) Testosterone Cypionate Injection contains testosterone, a Schedule III controlled substanc

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION
XIROMED LLC
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TESTOSTERONE CYPIONATE INJECTION, USP CIII
DESCRIPTION
Testosterone Cypionate Injection, USP, 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, USP 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
732.79 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
556.24 mg
Benzyl alcohol (as preservative)
9.45 mg
27
40
3
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