Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
TESTOSTERONE ENANTHATE (UNII: 7Z6522T8N9) (TESTOSTERONE - UNII:3XMK78S47O)
Hikma Pharmaceuticals USA Inc.
TESTOSTERONE ENANTHATE
TESTOSTERONE ENANTHATE 200 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
Testosterone Enanthate Injection, USP is indicated for replacement therapy in conditions associated with a 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) – Gonadotropin or luteinizing hormone‑releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. Safety and efficacy of Testost
Testosterone Enanthate Injection, USP 200 mg/mL is available as: 5 mL Multiple Dose vial, Cartons of 1 vial NDC 0143-9750-01
Abbreviated New Drug Application
TESTOSTERONE ENANTHATE- TESTOSTERONE ENANTHATE INJECTION, SOLUTION HIKMA PHARMACEUTICALS USA INC. ---------- TESTOSTERONE ENANTHATE INJECTION, USP RX ONLY CIII DESCRIPTION Testosterone Enanthate Injection, USP provides Testosterone Enanthate, USP, a derivative of the primary endogenous androgen testosterone, for intramuscular administration. In their active form, androgens have a 17-beta-hydroxy group. Esterification of the 17-beta-hydroxy group increases the duration of action of testosterone; hydrolysis to free testosterone occurs _in vivo_. Each mL of sterile, colorless to pale yellow, solution provides 200 mg Testosterone Enanthate, USP in sesame oil with 5 mg chlorobutanol (chloral derivative) as a preservative. Testosterone Enanthate, USP is designated chemically as androst-4-en-3-one, 17-[(1- oxoheptyl)-oxy]-, (17β)-. Structural formula: CLINICAL PHARMACOLOGY Endogenous androgens are responsible for the 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; alterations in body musculature; and fat distribution. Androgens 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 the eventual termination of linear growth which is brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates but may cause a disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. And read_full_document