Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
TESTOSTERONE CYPIONATE (UNII: M0XW1UBI14) (TESTOSTERONE - UNII:3XMK78S47O)
Xiromed LLC
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. 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 Injection 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 substanc
Testosterone Cypionate Injection, USP is available as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.
Abbreviated New Drug Application
TESTOSTERONE CYPIONATE- TESTOSTERONE CYPIONATE INJECTION, SOLUTION XIROMED LLC ---------- TESTOSTERONE CYPIONATE INJECTION, USP CIII DESCRIPTION Testosterone Cypionate Injection, USP, 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. Each mL of the 100 MG/ML solution contains: Testosterone cypionate 100 mg Benzyl benzoate 0.1 mL Cottonseed oil 732.79 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 556.24 mg Benzyl alcohol (as preservative) 9.45 mg 27 40 3 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 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 responsible Baca dokumen lengkap