Country: United States
Language: English
Source: NLM (National Library of Medicine)
Testosterone (UNII: 3XMK78S47O) (Testosterone - UNII:3XMK78S47O)
Upsher-Smith Laboratories, LLC
Testosterone
Testosterone 50 mg in 5 g
TOPICAL
PRESCRIPTION DRUG
Testosterone gel is indicated for 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 levels 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 levels but have gonadotropins in the normal or low range. Limitations of Use: - Safety and efficacy of testosterone gel in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
Testosterone gel is supplied in unit-dose tubes in cartons of 30 and unit-dose packets in cartons of 30. Each tube or packet contains 50 mg testosterone in 5 g of gel. Testosterone gel is also supplied in a metered-dose pump that delivers 12.5 mg of testosterone per complete pump actuation. Each 88 g metered-dose pump is capable of dispensing 75 g of gel or 60-metered pump actuations. Each pump actuation delivers 1.25 g of gel. The metered-dose pump is supplied in cartons of 2. Testosterone gel is available as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Used testosterone gel tubes, packets or pumps should be discarded 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 Authorized Generic
TESTOSTERONE- TESTOSTERONE GEL, METERED Upsher-Smith Laboratories, LLC ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 5/2020 MEDICATION GUIDE Testosterone (tes-TOS-te-rōn) Gel, CIII for topical use What is the most important information I should know about testosterone gel? 1. Testosterone gel 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 gel 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 gel. Children Signs and symptoms of early puberty in a child when they come in direct contact with Testosterone gel 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 gel may include: • changes in body hair. • an abnormal increase in pimples (acne). Stop using testosterone gel 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 gel. 2. To lower the risk of transfer of testosterone gel from your body to others, follow these important instructions: • Apply testosterone gel 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 testosterone gel. • 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 ski Read the complete document
TESTOSTERONE- TESTOSTERONE GEL TESTOSTERONE- TESTOSTERONE GEL, METERED UPSHER-SMITH LABORATORIES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TESTOSTERONE GEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TESTOSTERONE GEL. 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) 05/2020 INDICATIONS AND USAGE Testosterone gel 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 (congenital or acquired). (1) Limitations of Use: Safety and efficacy of testosterone gel in men with age-related hypogonadism have not been established (1) Safety and efficacy of testosterone gel 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 testosterone gel, 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 or one packet or 4 pump actuations) applied topically once daily at approximately the same time each day. (2.1) Apply to clean, dry, intact skin of t Read the complete document