United States - English - NLM (National Library of Medicine)

strides pharma science limited - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone gel 1% 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 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 (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 testosterone gel 1% in men with "age-

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone gel, 1% 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 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 (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 testosterone gel, 1% in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. - safety and efficacy of testosterone gel, 1% in males less than 18 years old have not been established [ see use in specific populations ( 8.4) ]. - topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure ( 1, 12.3). - testosterone gel, 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see warnings and precautions ( 5.1), adverse reactions ( 6.1), and nonclinical toxicology ( 13.1)] . -  testosterone gel, 1% is contraindicated in women who are pregnant. testosterone gel, 1% can cause virilization of the female fetus when administered to a pregnant woman. pregnant women need to be aware of the potential for transfer of testosterone from men treated with testosterone gel, 1%. if a pregnant woman is exposed to testosterone gel, 1%, she should be apprised of the potential hazard to the fetus [see warnings and precautions ( 5.2) and use in specific populations ( 8.1)] . risk summary testosterone gel, 1% 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 during the period of organogenesis. testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. structural impairments observed in females included increased ano-genital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. increased pituitary weight was seen in both sexes. testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy. risk summary testosterone gel, 1% is not indicated for use in women. infertility testis disorder, testicular atrophy, and oligospermia have been identified during use of testosterone gel, 1% [see adverse reactions ( 6.1, 6.2)] . during treatment with large doses of exogenous androgens, including testosterone gel, 1%, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see warnings and precautions ( 5.8)] . reduced fertility is observed in some men taking testosterone replacement therapy. testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [see drug abuse and dependence ( 9.2)] . with either type of use, the impact on fertility may be irreversible. the safety and efficacy of testosterone gel, 1% in pediatric patients less than 18 years old has not been established. improper use may result in acceleration of bone age and premature closure of epiphyses. there have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone gel, 1% to determine whether efficacy in those over 65 years of age differs from younger subjects. additionally, there is insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer. geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of bph. no studies were conducted in patients with renal impairment. no studies were conducted in patients with hepatic impairment. testosterone gel, 1% contains testosterone, a schedule iii controlled substance in the controlled substances act. drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. abuse and misuse of testosterone are seen in male and female adults and adolescents. testosterone, often in combination with other anabolic androgenic steroids (aas), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. there have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. abuse-related adverse reactions serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. the following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. the following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. the following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. behaviors associated with addiction continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: - taking greater dosages than prescribed - continued drug use despite medical and social problems due to drug use - spending significant time to obtain the drug when supplies of the drug are interrupted - giving a higher priority to drug use than other obligations - having difficulty in discontinuing the drug despite desires and attempts to do so - experiencing withdrawal symptoms upon abrupt discontinuation of use physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. drug dependence in individuals using approved doses of testosterone for approved indications has not been documented. testosterone gel, 1% (tes tos ter one jel) ciii for topical use read this instructions for use for testosterone gel, 1% before you start using it and each time you get a refill. there may be new information. this leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. applying testosterone gel, 1%: - before applying testosterone gel, 1%, make sure that your shoulders, upper arms or stomach are clean, dry, and there is no broken skin. - the application sites for testosterone gel, 1% are the shoulders, upper arms or stomach area (abdomen) that will be covered by a short sleeve t-shirt (see figure a). do not apply testosterone gel, 1% to any other parts of your body such as your penis, scrotum, chest, armpits (axillae), knees, or back. - tear open the packet completely at the dotted line. squeeze from the bottom of the packet to the top. - squeeze all of the testosterone gel, 1% out of the packet into the palm of your hand. - apply testosterone gel, 1% to the application site. you may also apply testosterone gel, 1% from the packet directly to the application site. - let the application areas dry completely before putting on a t-shirt. - testosterone gel, 1% is flammable until dry. let testosterone gel, 1% dry before smoking or going near an open flame. - wash your hands with soap and water right away after applying testosterone gel, 1%. - avoid showering, swimming, or bathing for at least 5 hours after you apply testosterone gel, 1%. how should i store testosterone gel, 1%? - store testosterone gel, 1% at room temperature between 68ºf to 77ºf (20ºc to 25ºc). - safely throw away used testosterone gel, 1% in the household trash. be careful to prevent accidental exposure of children or pets. - keep testosterone gel, 1% away from fire. keep testosterone gel, 1% and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. revised: 09/2020

Ireland - English - HPRA (Health Products Regulatory Authority)

merck sharp & dohme ireland (human health) limited - testosterone undecanoate - capsule, soft - 40 milligram(s) - 3-oxoandrosten (4) derivatives; testosterone

Ireland - English - HPRA (Health Products Regulatory Authority)

bayer limited - testosterone undecanoate - solution for injection - 1000 milligram(s) - 3-oxoandrosten (4) derivatives; testosterone

Ireland - English - HPRA (Health Products Regulatory Authority)

grunenthal pharma ltd - testosterone undecanoate - solution for injection - 3-oxoandrosten (4) derivatives; testosterone

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - testosterone undecanoate, quantity: 1000 mg - injection - excipient ingredients: benzyl benzoate; castor oil - testosterone replacement in primary and secondary male hypogonadism.

United States - English - NLM (National Library of Medicine)

twi pharmaceuticals, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - 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). - testosterone gel 1.62% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see warnings and precautions (5.1) and adverse reactions (6.1)]. - testosterone gel 1.62% is contraindicated in women who are pregnant. testosterone gel 1.62% can cause virilization of the female fetus when administered to a pregnant woman. pregnant women need to be aware of the potential for transfer of testosterone from men treated with testosterone gel 1.62%. if a pregnant woman is exposed to testosterone gel 1.62%, she should be apprised of the potential hazard to the fetus [see warnings and precautions (5.2) and use in specific populations (8.1)] . 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 during the period of organogenesis. testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. structural impairments observed in females included increased ano-genital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. increased pituitary weight was seen in both sexes. testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy. risk summary androgel 1.62% is not indicated for use in women. infertility testis disorder, testicular atrophy, and oligospermia have been identified during use of androgel 1.62% [see adverse reactions (6.1, 6.2)] . during treatment with large doses of exogenous androgens, including androgel 1.62%, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see warnings and precautions (5.8)] . reduced fertility is observed in some men taking testosterone replacement therapy. testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [see drug abuse and dependence (9.2)] . with either type of use, the impact on fertility may be irreversible. the safety and effectiveness of testosterone gel 1.62% in pediatric patients less than 18 years old has not been established. improper use may result in acceleration of bone age and premature closure of epiphyses. there have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone gel 1.62% to determine whether efficacy in those over 65 years of age differs from younger subjects. of the 234 patients enrolled in the clinical trial utilizing testosterone gel 1.62%, 21 were over 65 years of age. additionally, there is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer. geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of bph. no studies were conducted involving patients with renal impairment. no studies were conducted in patients with hepatic impairment. testosterone gel 1.62% contains testosterone, a schedule iii controlled substance in the controlled substances act. drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. abuse and misuse of testosterone are seen in male and female adults and adolescents. testosterone, often in combination with other anabolic androgenic steroids (aas), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. there have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. the following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. the following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. the following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: - taking greater dosages than prescribed - continued drug use despite medical and social problems due to drug use - spending significant time to obtain the drug when supplies of the drug are interrupted - giving a higher priority to drug use than other obligations - having difficulty in discontinuing the drug despite desires and attempts to do so - experiencing withdrawal symptoms upon abrupt discontinuation of use physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. drug dependence in individuals using approved doses of testosterone for approved indications has not been documented. instruction for use testosterone (tes-tos-ter-one) gel ciii 1.62% for topical use read this instructions for use for testosterone gel 1.62% before you start using it and each time you get a refill. there may be new information. this leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. applying testosterone gel 1.62%: - testosterone gel 1.62% comes in a pump. - before applying testosterone gel 1.62% make sure that your shoulders and upper arms are clean, dry, and that there is no broken skin. - testosterone gel 1.62% is to be applied to the area of your shoulders and upper arms that will be covered by a short sleeve t-shirt (see figure a). do not apply testosterone gel 1.62% to any other parts of your body such as your stomach area (abdomen), penis, scrotum, chest, armpits (axillae), or knees. (figure a) if you are using testosterone gel 1.62% pump: - before using a new bottle of testosterone gel 1.62 % for the first time, you will need to remove the cap and then prime the pump. to prime the testosterone gel 1.62% pump, slowly push the pump all the way down 3 times, over the sink drain. do not use any testosterone gel 1.62% that came out while priming. wash it down the sink to avoid accidental exposure to others. your testosterone gel 1.62% pump is now ready to use. - remove the cap from the pump. then, put the spout opening at the top of the pump where the medicine comes out over the palm of your hand and slowly push the pump all the way down. apply testosterone gel 1.62% to the application site. you may also apply testosterone gel 1.62% directly to the application site. your healthcare provider will tell you the number of times to press the pump for each dose. - wash your hands with soap and water right away. find your dose as prescribed by your healthcare provider how should i store testosterone gel 1.62%? - store testosterone gel 1.62% at room temperature between 59ºf to 86ºf (15ºc to 30ºc). - when it is time to throw away the pump, safely throw away used testosterone gel 1.62% in household trash. be careful to prevent accidental exposure of children or pets. - keep testosterone gel 1.62% away from fire. keep testosterone gel 1.62% and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration manufactured for: twi pharmaceuticals usa, inc. paramus, nj 07652 manufactured by: twi pharmaceuticals, inc. taoyuan city, 32063, taiwan revised: 07/22

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - testosterone cypionate (unii: m0xw1ubi14) (testosterone - unii:3xmk78s47o) - testosterone cypionate 200 mg in 1 ml - depo-testosterone injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or lhrh deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. - known hypersensitivity to the drug - males with carcinoma of the breast - males with known or suspected carcinoma of the prostate gland - women who are or who may become pregnant - patients with serious cardiac, hepatic or renal disease testosterone is a controlled substance under the anabolic steroids control act, and depo-testosterone injection has been assigned to schedule iii.

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 50 mg in 5 g - 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 levels and gonadotropins (fsh, lh) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): idiopathic 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. testim® has not been clinically evaluated in males under 18 years of age. androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. testim® is not indica

United States - English - NLM (National Library of Medicine)

prasco laboratories - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 50 mg in 5 g