Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)
Actavis Pharma, Inc.
TESTOSTERONE
TESTOSTERONE 30 mg in 1.5 mL
TOPICAL
PRESCRIPTION DRUG
Testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. - Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as 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 (FSH, 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 testosterone topical solution in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been establi
Testosterone topical solution is available as a metered-dose pump containing 110 mL of solution. The pump is capable of dispensing 90 mL of solution in 60 metered pump actuations. One actuation delivers 30 mg of testosterone in 1.5 mL of solution. Each metered-dose pump is supplied with an applicator. NDC Pump Type 0591-2114-81 Pump Actuated Keep testosterone topical solution out of reach of children. Store upright at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Used testosterone topical solution bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets. The bottle and the applicator cup are not made with natural rubber latex.
Abbreviated New Drug Application
Actavis Pharma, Inc. ---------- Medication Guide Testosterone (tes-TOS-te-rone) Topical Solution, For Topical Use CIII What is the most important information I should know about testosterone topical solution? 1. Testosterone topical solution 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 testosterone topical solution 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 testosterone topical solution. Children Signs and symptoms of early puberty in a child when they come in direct contact with testosterone topical solution 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 testosterone topical solution may include: • changes in body hair. • an abnormal increase in pimples (acne). Stop using testosterone topical solution 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 applied testosterone topical solution: 2. To lower the risk of transfer of testosterone topical solution from your body to others, follow these important instructions: • Apply testosterone topical solution only to your armpits. • Wash your hands right away with soap and water after applying testosterone topical solution. • After the solution 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 applicati Olvassa el a teljes dokumentumot
TESTOSTERONE- TESTOSTERONE SOLUTION ACTAVIS PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TESTOSTERONE TOPICAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TESTOSTERONE TOPICAL SOLUTION. TESTOSTERONE TOPICAL SOLUTION, 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 TOPICAL TESTOSTERONE PRODUCTS (5.2) CHILDREN SHOULD AVOID CONTACT WITH UNWASHED OR UNCLOTHED APPLICATION SITES IN MEN USING TESTOSTERONE TOPICAL SOLUTION (2.2, 5.2) HEALTHCARE PROVIDERS SHOULD ADVISE PATIENTS TO STRICTLY ADHERE TO RECOMMENDED INSTRUCTIONS FOR USE (2.2, 5.2, 17) INDICATIONS AND USAGE Testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) (1) Hypogonadotropic hypogonadism (congenital or acquired) (1) Limitations of use: Safety and efficacy of testosterone topical solution in men with “age-related hypogonadism” have not been established. (1) Safety and efficacy of testosterone topical solution in males less than 18 years old have not been established. (8.4) DOSAGE AND ADMINISTRATION Prior to initiating testosterone topical solution, 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). Starting testosterone topical solution dose is 60 mg of testosterone (1 pump actuation of 30 mg of testosterone to each axilla), applied once daily, at the same time each morning. (2.1) Apply to clean, dry intact skin of the axilla, not to any other parts of the body including the abdomen or genitals (2.2) Dose adjustment: The dose of testosterone may be decreased from 60 mg (2 p Olvassa el a teljes dokumentumot