Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
METHYLTESTOSTERONE (UNII: V9EFU16ZIF) (METHYLTESTOSTERONE - UNII:V9EFU16ZIF)
Amneal Pharmaceuticals of New York LLC
METHYLTESTOSTERONE
METHYLTESTOSTERONE 10 mg
ORAL
PRESCRIPTION DRUG
Androgens are 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 torsions, 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 methyltestosterone in men with “ag
Methyltestosterone Capsules USP, 10 mg are capsules with red translucent body and cap imprinted with “AA1” in black ink; containing white to off-white powder. They are available as follows: Bottles of 30: NDC 0115-1408-08 Bottles of 100: NDC 0115-1408-01 Bottles of 1000: NDC 0115-1408-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed, light-resistant container as defined in the USP, with a child-resistant closure, as required. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2018-00
Abbreviated New Drug Application
METHYLTESTOSTERONE- METHYLTESTOSTERONE CAPSULE AMNEAL PHARMACEUTICALS OF NEW YORK LLC ---------- METHYLTESTOSTERONE CAPSULES, USP, CIII (10 MG) RX ONLY DESCRIPTION The androgens are steroids that develop and maintain primary and secondary male sex characteristics. Androgens are derivatives of cyclopentanoper-hydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. In their active form, all drugs in the class have a 17-beta hydroxy group. 17- alpha alkylation (methyltestosterone) increases the pharmacologic activity per unit weight compared to testosterone when given orally. Methyltestosterone, a synthetic derivative of testosterone, is an androgenic preparation given by the oral route in a capsule form. It has the following structural formula: C H O M.W. 302.46 17-β-hydroxy-17-methylandrost-4-en-3-one Methyltestosterone, USP occurs as white or creamy white crystals or powder, which is soluble in various organic solvents but is practically insoluble in water. Each capsule, for oral administration, contains 10 mg of methyltestosterone, USP. In addition, each capsule contains the following inactive ingredients: corn starch, D&C Yellow #10, gelatin, FD&C Blue #1, FD&C Red #40, and magnesium stearate. Additionally, the capsule printing inks contain D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac. 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 the growth and maturation of prostate, seminal vesicles, penis, and scrotum. The 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. Drugs in this class also cause retention of nitrogen, sodium, potassium, phosphorus, and decrease Lees het volledige document