TESTOSTERONE CYPIONATE injection

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Cipla USA Inc.

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. - 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 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) Controlled Substance Testosterone cypionate injection contains testosterone, a Schedule III c

Povzetek izdelek:

Testosterone cypionate injection, USP is a clear colourless to pale yellow solution and is available as: 100 mg/mL 10 mL vials                                                  NDC 69097-536-37 200 mg/mL 1 mL vials                                                    NDC 69097-537-31 10 mL vials                                                  NDC 69097-537-37 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from light. This product's label may have been updated. For current full prescribing information, please visit www.ciplausa.com Rx only Manufactured by: Cipla Ltd. At M/s LSNE-Le n SLU C/Nicostrato Vela s/n 24009 Le n, Spain Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059 Revised: 01/2022

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION
CIPLA USA INC.
----------
TESTOSTERONE CYPIONATE INJECTION, USP C-III
DESCRIPTION
Testosterone cypionate, 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)-, (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 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
27
40
3
Benzyl benzoate
........................................................................................................0.2
mL
Cottonseed oil
...........................................................................................................560
mg
Benzyl alcohol (as preservative)
...............................................................................9.45
mg
CLINICAL PHARMACOLOGY
Endogenous androgens are responsible for normal gr