Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
TESTOSTERONE CYPIONATE (UNII: M0XW1UBI14) (TESTOSTERONE - UNII:3XMK78S47O)
Physicians Total Care, Inc.
TESTOSTERONE CYPIONATE
TESTOSTERONE CYPIONATE 100 mg in 1 mL
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. - 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. - 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 Testosterone is a controlled substance under the Anabolic Steroid Control Act, and testosterone cypionate injection, USP has been assigned to Schedule III.
Testosterone cypionate injection, USP is available as follows: 100 mg/mL: NDC 54868-3669-0 – 10 mL multidose vial Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light. 03-2009M U1006824 Manufactured in Canada by Sandoz Canada Inc. for Sandoz Inc., Princeton, NJ 08540 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146
Abbreviated New Drug Application
TESTOSTERONE CYPIONATE - TESTOSTERONE CYPIONATE INJECTION, SOLUTION PHYSICIANS TOTAL CARE, INC. ---------- TESTOSTERONE CYPIONATE INJECTION, USP 100 MG/ML AND 200 MG/ML 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 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 27 40 3 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 protei Läs hela dokumentet