DEPO-TESTOSTERONE- testosterone cypionate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

TESTOSTERONE CYPIONATE

Composition:

TESTOSTERONE CYPIONATE 200 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)-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 DEPO-Testosterone Injection has been assigned to Schedule III.

Product summary:

DEPO-Testosterone Injection is available as follows: Vials should be stored at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEPO-TESTOSTERONE - TESTOSTERONE CYPIONATE INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
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)-
, (17β)-. 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 organ