Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)
Padagis Israel Pharmaceuticals Ltd
TOPICAL
PRESCRIPTION DRUG
Testosterone Gel, 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Limitations of use: Risk Summary Testosterone Gel, 1.62% is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action [see Contraindications (4) and Clinical Pharmacology (12.1)] . Exposure of a female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. Data Animal Data In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone dur
Testosterone Gel, 1.62% is supplied in non-aerosol, metered-dose pumps that deliver 20.25 mg of testosterone per complete pump actuation. The pumps are composed of plastic and stainless steel and an LDPE/aluminum foil inner liner encased in rigid plastic with a polypropylene cap. Each 88 g metered-dose pump is capable of dispensing 75 g of gel or 60-metered pump actuations; each pump actuation dispenses 1.25 g of gel. Testosterone Gel, 1.62% is also supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 1.25 g or 2.5 g gel contains 20.25 mg or 40.5 mg testosterone, respectively. NDC 45802-754 -01 88 g pump (each pump dispenses 60 metered pump actuations with each pump actuation containing 20.25 mg of testosterone in 1.25 g of gel) NDC 45802-281 -03 Each unit dose packet contains 20.25 mg of testosterone provided in 1.25 g of gel NDC 45802-281 -39 30 packets (each unit dose packet contains 20.25 mg of testosterone provided in 1.25 g of gel) NDC 45802-366 -02 Each unit dose packet contains 40.5 mg of testosterone provided in 2.5 g of gel NDC 45802-366 -65 30 packets (each unit dose packet contains 40.5 mg of testosterone provided in 2.5 g of gel) Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature]. Used Testosterone Gel, 1.62% pumps or used Testosterone Gel, 1.62% packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.
Abbreviated New Drug Application
TESTOSTERONE- TESTOSTERONE GEL Padagis Israel Pharmaceuticals Ltd ---------- MEDICATION GUIDE Testosterone (tes-TOS-te-rone) Gel, 1.62% for topical use CIII What is the most important information I should know about Testosterone Gel, 1.62%? 1. Testosterone Gel, 1.62% 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, 1.62% 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, 1.62%. Children Signs and symptoms of early puberty in a child when they come in direct contact with Testosterone Gel, 1.62% 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, 1.62% may include: • changes in body hair. • an abnormal increase in pimples (acne). Stop using Testosterone Gel, 1.62% 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, 1.62%. 2. To lower the risk of transfer of Testosterone Gel, 1.62% from your body to others, follow these important instructions: • Apply Testosterone Gel, 1.62% only to 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, 1.62%. • 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 p Izlasiet visu dokumentu
TESTOSTERONE- TESTOSTERONE GEL PADAGIS ISRAEL PHARMACEUTICALS LTD ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TESTOSTERONE GEL, 1.62% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TESTOSTERONE GEL, 1.62%. TESTOSTERONE GEL, FOR TOPICAL USE CIII INITIAL U.S. APPROVAL: 1953 WARNING: SECONDARY EXPOSURE TO TESTOSTERONE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • 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). INDICATIONS AND USAGE Testosterone Gel, 1.62% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: • • Limitations of use: • • • DOSAGE AND ADMINISTRATION • • • • • 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). Primary hypogonadism (congenital or acquired) (1) Hypogonadotropic hypogonadism (congenital or acquired) (1) Safety and efficacy of Testosterone Gel, 1.62% in men with “age-related hypogonadism” have not been established. (1) Safety and efficacy of Testosterone Gel, 1.62% in males less than 18 years old have not been established. (1, 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 FOR TESTOSTERONE GEL, 1.62% DIFFERS FROM TESTOSTERONE GEL, 1%. FOR DOSAGE AND ADMINISTRATION OF TESTOSTERONE GEL, 1% REFER TO ITS FULL PRESCRIBING INFORMATION. (2) Prior to initiating Testosterone Gel, 1.62%, confirm t Izlasiet visu dokumentu