Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
TESTOSTERONE CYPIONATE (UNII: M0XW1UBI14) (TESTOSTERONE - UNII:3XMK78S47O)
Dispensing Solutions, Inc.
INTRAMUSCULAR
PRESCRIPTION DRUG
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. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. - Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. - Known hypersensitivity to the drug Known hypersensitivity to the drug - Males with carcinoma of the breast Males with carcinoma of the breast - Males with known or suspected carc
Testosterone Cypionate Injection USP, 200 mg/mL is available in: 10 mL multiple dose vials, individually boxed. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Literature revised: July 2010 Product No.: 0256-10 Manufactured by: Hikma Farmaceutica (Portugal) S.A. 2705-906 Terrugem SNT, Portugal Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA PIN230-WAT/1
Abbreviated New Drug Application
TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION DISPENSING SOLUTIONS, INC. ---------- TESTOSTERONE CYPIONATE INJECTION USP FOR INTRAMUSCULAR USE ONLY C-III RX ONLY 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: Each mL contains: Testosterone Cypionate 200 mg, Benzyl Benzoate 20%, with Benzyl Alcohol 0.9% as preservative in Cottonseed Oil q.s. 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 prostate, seminal vesicles, penis, and scrotum; development of male hair distribution, such as beard, pubic, chest and axillary hair; laryngeal enlargement, vocal chord thickening, and alterations in body musculature and fat distribution. Drugs in this class also cause retention of nitrogen, sodium, potassium, and phosphorus, 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 for the growth spurt of adolescence and for eventual termination of linear growth, brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates, but may cause disproportionate advancement in bone maturation. Use over lo read_full_document