Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)
Endo Pharmaceuticals Inc.
TESTOSTERONE
TESTOSTERONE 50 mg in 5 g
TRANSDERMAL
PRESCRIPTION DRUG
TESTIM is indicated for testosterone replacement therapy in adult males for 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, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. - Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of use: - Safety and efficacy of TESTIM in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been esta
TESTIM is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows: Store at 20°C to 25°C (68°F - 77°F). Excursions permitted to 15°C to 30°C (59°F - 86°F) [See USP Controlled Room Temperature]. Discard used TESTIM tubes in household trash in a manner that prevents accidental exposure of women, children, or pets [see Boxed Warning and Warnings and Precautions (5.2)]. Contents are flammable [see Warnings and Precautions (5.16)].
New Drug Application
Endo Pharmaceuticals Inc. ---------- MEDICATION GUIDE Testim® (TĔS tim) (testosterone gel) for topical use, CIII What is the most important information I should know about Testim? 1. Testim can transfer from your body to others including, children and women. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where Testim has been applied to your skin. Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used Testim. Children Signs and symptoms of early puberty in a child when they come in direct contact with Testim may include: Abnormal sexual changes: • enlarged penis or clitoris. • early growth of hair near the vagina or around the penis (pubic hair). • erections or acting out sexual urges (sex drive). Behavior problems: • acting aggressively, behaving in an angry or violent way. Women Signs and symptoms in women when they come in direct contact with Testim may include: • changes in body hair. • an abnormal increase in pimples (acne). Stop using Testim and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have happened through accidental touching of the area where you have placed Testim. 2. To lower the risk of transfer of Testim from your body to others, follow these important instructions: • Apply Testim only to the areas of your shoulders and upper arms that will be covered by a short sleeve t-shirt. • Wash your hands right away with soap and water after applying Testim. • After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered. • If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water. • If a child or woman touches the area where you have applied Testim, that area on the child or woman should be washed well with soap and water right read_full_document
TESTIM- TESTOSTERONE GEL ENDO PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TESTIM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TESTIM . TESTIM (TESTOSTERONE GEL) FOR TOPICAL USE, CIII INITIAL U.S. APPROVAL: 1953 WARNING: SECONDARY EXPOSURE TO TESTOSTERONE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ VIRILIZATION HAS BEEN REPORTED IN CHILDREN WHO WERE SECONDARILY EXPOSED TO TESTOSTERONE GEL (5.2, 6.2) CHILDREN SHOULD AVOID CONTACT WITH UNWASHED OR UNCLOTHED APPLICATION SITES IN MEN USING TESTOSTERONE GEL (2.2, 5.2) HEALTHCARE PROVIDERS SHOULD ADVISE PATIENTS TO STRICTLY ADHERE TO RECOMMENDED INSTRUCTIONS FOR USE (2.2, 5.2, 17) RECENT MAJOR CHANGES Contraindications (4) 11/2020 INDICATIONS AND USAGE TESTIM is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary Hypogonadism (Congenital or Acquired) (1) Hypogonadotropic Hypogonadism (1) Limitations of Use: Safety and efficacy of TESTIM in men with “age-related hypogonadism” have not been established. (1) Safety and efficacy of TESTIM in males less than 18 years old have not been established. (8.4) Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. (1, 12.3) DOSAGE AND ADMINISTRATION Prior to initiating TESTIM, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range. (2) Recommended starting dose for adult males: 50 mg of testosterone (one tube) applied topically once daily. (2.1) Apply to clean, dry, intact skin of the shoulders and/or upper arms. Do NOT apply TESTIM to the genitals or abdomen. (2.1, 2.2) If morning pre-dose serum testosterone concentration is below normal range, increase dose to 100 mg. (2.1) read_full_document