Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
TESTOSTERONE CYPIONATE (UNII: M0XW1UBI14) (TESTOSTERONE - UNII:3XMK78S47O)
A-S Medication Solutions
TESTOSTERONE CYPIONATE
TESTOSTERONE CYPIONATE 100 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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)- gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of DEPO-Testosterone (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 or who may become pregnant - Patients with serious cardiac, hepatic or renal disease DEPO-Testosterone Injection contains testosterone, a Schedule III controlled substance in the Controlled Substan
Product: 50090-0746 NDC: 50090-0746-0 10 mL in a VIAL
Abbreviated New Drug Application
DEPO-TESTOSTERONE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION A-S MEDICATION SOLUTIONS ---------- 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 organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair distribution, such as beard, ® 27 40 3 pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution. Drugs in this class also cause retention of nitrogen, sodium, potassium, and phosphorous, 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 respo Đọc toàn bộ tài liệu