TESTOSTERONE CYPIONATE injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Sun Pharmaceutical Industries, Inc.

INN (mednarodno ime):

TESTOSTERONE CYPIONATE

Sestava:

TESTOSTERONE CYPIONATE 100 mg in 1 mL

Pot uporabe:

INTRAMUSCULAR

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Testosterone cypionate injection, USP is available as follows: 100 mg/mL          10 mL Multiple-dose vials      NDC 62756-017-40 200 mg/mL 1 mL Single-dose vials           NDC 62756-015-40 10 mL Multiple-dose vials      NDC 62756-016-40 Vials should be store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

TESTOSTERONE CYPIONATE - TESTOSTERONE CYPIONATE INJECTION, SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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 maint