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

actavis pharma, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone gel 1% 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 testosterone gel 1% in men with “age-related hypogonadism” (also referred to as “late-onset hypogon

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

bryant ranch prepack - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. limitations of use: pregnancy category x [see contraindications (4) ] — testosterone topical solution is contraindicated during pregnancy or in women who may become pregnant. testosterone is teratogenic and may cause fetal harm. exposure of a female fetus to androgens may result in varying degrees of virilization. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. although it is not known how much testosterone transfers into human milk, testosterone topical solution is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. testosterone and other androgens may adversely affect lactation. [see contraindications (4) ]. safety and efficacy of testosterone topical solution has not been establis

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

deseret biologicals, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 6 [hp_x] in 1 ml - indications:   for temporary relief of symptoms related to testosterone sensitivity including gastritis, weak libido, prostatitis, stress, memory loss, infertility, stomach discomfort, impotence and general joint pain.** **these statements are based upon homeopathic principles. they have not been reviewed by the food and drug administration. indications:   for temporary relief of symptoms related to testosterone sensitivity including gastritis, weak libido, prostatitis, stress, memory loss, infertility, stomach discomfort, impotence and general joint pain.** **these statements are based upon homeopathic principles. they have not been reviewed by the food and drug administration.

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

par pharmaceutical, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone gel 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 testosterone gel in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”

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

alembic pharmaceuticals inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone gel, 1.62% 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, 1.62% in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. - safety and efficacy of testosterone gel, 1.62% 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 [see indications and usage (1), and clinical pharmacology (12.3)]. - 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 testosterone gel, 1.62% is not indicated for use in women. infertility testis disorder, testicular atrophy, and oligospermia have been identified during use of testosterone gel, 1.62% [see adverse reactions (6.1, 6.2)]. during treatment with large doses of exogenous androgens, including testosterone gel, 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. 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.

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

bryant ranch prepack - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone gel, 1.62% 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, 1.62% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - safety and efficacy of testosterone gel, 1.62% 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 [see indications and usage ( 1 ), and clinical pharmacology (12.3 )]. - 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 pregnant women. testosterone is teratogenic and may cause fetal harm when administered to a pregnanat 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 femail and male offspring. these studies did not meet current standards for nonclinical develpment 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, 1.62% 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 testosterone gel, 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. 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. instructions for use testosterone (tes tos' ter one) gel, 1.62%, ciii 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. how should i store testosterone gel, 1.62%? - store testosterone gel, 1.62% at room temperature between 68ºf to 77ºf (20ºc to 25ºc). - 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. revised 10/2019 ifu112-00

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

natco pharma usa llc - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - 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 cryptor chidism, 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 concentrations and gonadotropins (fsh, lh) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropic 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 established. - safety and efficacy of testosterone topical solution in males < 18 years old have not been established [see use in specific populations (8.4)] . - testosterone topical solution is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see warnings and precaution (5.1)] . - testosterone topical solution is contraindicated in women who are, or who may become pregnant, or who are breastfeeding. testosterone topical solution may cause fetal harm when administered to a pregnant woman. testosterone topical solution may cause serious adverse reactions in nursing infants. if a pregnant woman is exposed to testosterone topical solution, she should be apprised of the potential hazard to the fetus. [see use in specific populations (8.1, 8.3)] . pregnancy category x [see contraindications (4)] — testosterone topical solution is contraindicated during pregnancy or in women who may become pregnant. testosterone is teratogenic and may cause fetal harm. exposure of a female fetus to androgens may result in varying degrees of virilization. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. although it is not known how much testosterone transfers into human milk, testosterone topical solution is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. testosterone and other androgens may adversely affect lactation. [see contraindications (4)] . safety and efficacy of testosterone topical solution has not been established in males <18 years of age. 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 topical solution to determine whether efficacy in those over 65 years of age differs from younger patients. of the 155 patients enrolled in the pivotal clinical study utilizing testosterone topical solution, 21 were over 65 years of age. additionally, there were insufficient long-term safety data in these patients utilizing testosterone topical solution to assess a potential incremental risk of cardiovascular disease and prostate cancer. no formal studies were conducted involving patients with renal impairment. no formal studies were conducted involving patients with hepatic impairment. safety and efficacy of testosterone topical solution in males with bmi >35 kg/m2 has not been established. testosterone topical solution 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. instructions for use testosterone (tes-tos-te-rone) topical solution, for topical use ciii read this instructions for use for testosterone topical solution 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 topical solution - testosterone topical solution is to be applied to the armpits only. do not apply testosterone topical solution to any other parts of your body such as your stomach area (abdomen), penis, scrotum, shoulders or upper arms. - do not apply testosterone topical solution with your fingers or hands. - apply testosterone topical solution at about the same time each morning. testosterone topical solution should be applied after showering and bathing. - avoid swimming or bathing for at least 2 hours after you apply testosterone topical solution. - you can use an antiperspirant or deodorant before applying testosterone topical solution. if you use antiperspirant or deodorant, then it should be applied at least 2 minutes before you apply testosterone topical solution. - testosterone topical solution is flammable until dry. let testosterone topical solution dry before smoking or going near an open flame. - avoid splashing in the eyes. in case of contact with eyes, flush thoroughly with water. if irritation persists, seek medical advice. testosterone topical solution figure 1 - before using a new bottle of testosterone topical solution for the first time, you will need to prime the pump. to prime the testosterone topical solution pump gently push down on the pump 3 times. do not use any testosterone topical solution that came out while priming. wash it down the sink to avoid accidental exposure to others. your testosterone topical solution pump is now ready to use. - use testosterone topical solution exactly as your healthcare provider tells you to use it. your healthcare provider will tell you the dose of testosterone topical solution that is right for you. apply your dose correctly by following the application instructions in the table below. - before applying testosterone topical solution, make sure that your armpit is clean, dry and that there is no broken skin. figure 2 remove the cap and the applicator cup from the pump. then, position the nozzle over the applicator cup and gently press down on (depress) the pump (see figure 2). figure 3 - to apply the testosterone topical solution, keep the applicator upright, place it up into the armpit application site and wipe steadily down and up. (see figure 3). - if testosterone topical solution drips or runs, wipe it back up with the applicator cup. do not rub in the solution with your fingers or hand after it has been applied. - let the application site dry completely for 3 minutes before putting on a shirt. - after you have finished applying testosterone topical solution, rinse the applicator cup with room temperature running water, and then pat it dry with a tissue. carefully replace the applicator cup and cap back onto the bottle and make sure you store the bottle safely. - clean up any spilled solution from surfaces such as the sink or floor to make sure others do not come into contact with it. - wash your hands with soap and water right away. how should i store testosterone topical solution? - store testosterone topical solution upright at room temperature between 68ºf to 77ºf (20ºc to 25ºc). - when it is time to throw away the bottle, safely throw away all parts of the testosterone topical solution dispenser including the bottle applicator cup and cap into the household trash. - be careful to prevent accidental exposure of children or pets. - keep testosterone topical solution away from fire. keep testosterone topical solution 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: 04/2021

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

twi pharmaceuticals, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. limitations of use: pregnancy category x [see contraindications (4) ] — testosterone topical solution is contraindicated during pregnancy or in women who may become pregnant. testosterone is teratogenic and may cause fetal harm. exposure of a female fetus to androgens may result in varying degrees of virilization. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. although it is not known how much testosterone transfers into human milk, testosterone topical solution is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. testosterone and other androgens may adversely affect lactation. [see contraindications (4) ]. safety and efficacy of testosterone topical solution has not been established in males <18 years of age. 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 topical solution to determine whether efficacy in those over 65 years of age differs from younger patients. of the 155 patients enrolled in the pivotal clinical study utilizing testosterone topical solution, 21 were over 65 years of age. additionally, there were insufficient long-term safety data in these patients utilizing testosterone topical solution to assess a potential incremental risk of cardiovascular disease and prostate cancer. no formal studies were conducted involving patients with renal impairment. no formal studies were conducted involving patients with hepatic impairment. safety and efficacy of testosterone topical solution in males with bmi >35 kg/m2 has not been established. testosterone topical solution 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: 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 (tes-tos-te-rone) topical solution, usp, for topical use ciii read this instructions for use for testosterone topical solution 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 topical solution: - testosterone topical solution is to be applied to the armpits only. do not apply testosterone topical solution to any other parts of your body such as your stomach area (abdomen), penis, scrotum, shoulders or upper arms. - do not apply testosterone topical solution with your fingers or hands. - apply testosterone topical solution at about the same time each morning. testosterone topical solution should be applied after showering or bathing. - avoid swimming or bathing for at least 2 hours after you apply testosterone topical solution. - you can use an antiperspirant or deodorant before applying testosterone topical solution. if you use antiperspirant or deodorant, then it should be applied at least 2 minutes before you apply testosterone topical solution. - testosterone topical solution is flammable until dry. let testosterone topical solution dry before smoking or going near an open flame. - avoid splashing in the eyes. in case of contact with eyes, flush thoroughly with water. if irritation persists, seek medical advice. - before using a new bottle of testosterone topical solution for the first time, you will need to prime the pump. to prime the testosterone topical solution pump gently push down on the pump 3 times. do not use any testosterone topical solution that came out while priming. wash it down the sink to avoid accidental exposure to others. your testosterone topical solution pump is now ready to use. - use testosterone topical solution exactly as your healthcare provider tells you to use it. your healthcare provider will tell you the dose of testosterone topical solution that is right for you. apply your dose correctly by following the application instructions in the table below. find your dose as prescribed by your healthcare provider each application equals 1 press (depression) of the pump. 30 mg apply 1 application one time, to one armpit only (left or right). 60 mg apply 2 applications: one to the left armpit and then one to the right armpit. 90 mg apply 3 applications: one to the left and one to the right armpit, wait for the product to dry, and then apply again one to the left or right armpit. 120 mg apply 4 applications: one to the left and one to the right armpit, wait for the product to dry, and then apply again one to the left and one to the right armpit. - before applying testosterone topical solution, make sure that your armpit is clean, dry and that there is no broken skin. - remove the caps from the applicator cup and the pump. then, position the nozzle over the applicator cup and gently press down on (depress) the pump. (see figure 2 ). - to apply the testosterone topical solution, keep the applicator upright, place it up into the armpit application site and wipe steadily down and up (see figure 3 ). - if testosterone topical solution drips or runs, wipe it back up with the applicator cup. do not rub in the solution with your fingers or hand after it has been applied. - let the application site dry completely for 3 minutes before putting on a shirt. - after you have finished applying testosterone topical solution, rinse the applicator cup with room temperature running water, and then pat it dry with a tissue. carefully replace the cup cap and bottle cap back onto the applicator cup and bottle, respectively, and make sure you store the bottle safely.  - clean up any spilled solution from surfaces such as the sink or floor to make sure others do not come into contact with it. - wash your hands with soap and water right away. how should i store testosterone topical solution? - store testosterone topical solution upright at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. - when it is time to throw away the bottle, safely throw away all parts of the testosterone topical solution dispenser including the bottle applicator cup and cap into the household trash. - be careful to prevent accidental exposure of children or pets. - keep testosterone topical solution away from fire. keep testosterone topical solution 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: 09/2021 tlm-087-01

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

slayback pharma llc - testosterone cypionate (unii: m0xw1ubi14) (testosterone - unii:3xmk78s47o) - testosterone cypionate injection is indicated for testosterone replacement therapy in males in 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; or orchiectomy, klinefelter’s syndrome, or toxic damage from alcohol or heavy metals, 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 [see dosage and administration (2.2) ]. • 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 [see dosage and admi

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

hikma pharmaceuticals usa inc. - testosterone enanthate (unii: 7z6522t8n9) (testosterone - unii:3xmk78s47o) - testosterone enanthate 200 mg in 1 ml - testosterone enanthate injection, usp is indicated for replacement therapy in 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, or orchidectomy. hypogonadotropic hypogonadism (congenital or acquired) –  gonadotropin or luteinizing hormone‑releasing hormone (lhrh) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) if the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. safety and efficacy of testost