Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
TESTOSTERONE CYPIONATE (UNII: M0XW1UBI14) (TESTOSTERONE - UNII:3XMK78S47O)
ASP Cares
INTRAMUSCULAR
PRESCRIPTION DRUG
Testosterone Cypionate Injection, USP 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 luteinizing hormone-releasing hormone (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. 1. Known hypersensitivity to the drug 2. Males with carcinoma of the breast 3. Males with known or suspected carcinoma of the prostate gland 4. Women who are or who may become pregnant 5. Patients with serious cardiac, hepatic or renal disease Controlled Substa
Testosterone Cypionate Injection, USP, 200 mg/mL is a clear, pale yellow oleaginous viscous, sterile solution intended for intramuscular or subcutaneous administration available as: 30 mL Multiple Dose Vials, Cartons of 1 vial NDC 72833-678-30 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect From Light. Manufactured by: ASP Cares 2414 Babcock Rd Ste 106 San Antonio, TX 78229
unapproved drug other
TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION ASP CARES _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- DES CRIPTION Testosterone Cypionate Injection, USP for intramuscular injection, contains testosterone cypionate, USP which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP 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, USP is androst-4-en-3-one,17-(3-cyclopentyl-1- oxopropoxy)-, (17b)-. Its molecular formula is C27H40O3 and the molecular weight 412.61. The structural formula is represented below: Each mL of the 200 mg/mL solution contains: Testosterone Cypionate, USP 200 mg Benzyl Benzoate, USP 0.25 mL Benzyl Alcohol, USP 0.02 mL Grape Seed Oil 0.50 mL 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, 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 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 chi Baca dokumen lengkap