TESTOSTERONE CYPIONATE injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

A-S Medication Solutions

Via de administração:

INTRAMUSCULAR

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 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 substance in the C

Resumo do produto:

Product: 50090-4446 NDC: 50090-4446-0 10 mL in a VIAL, MULTI-DOSE / 1 in a CARTON

Status de autorização:

Abbreviated New Drug Application

Características técnicas

TESTOSTERONE CYPIONATE - TESTOSTERONE CYPIONATE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
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TESTOSTERONE CYPIONATE INJECTION C-III
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, USP is available in two strengths,
100 mg/mL and 200
mg/mL testosterone cypionate, USP.
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
27
40
3
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 s