Spojené štáty - angličtina - NLM (National Library of Medicine)

padagis us llc - testosterone cypionate (unii: m0xw1ubi14) (testosterone - unii:3xmk78s47o) - testosterone cypionate 200 mg in 1 ml - testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. safety and efficacy of testosterone cypionate in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. 1. known hypersensitivity to the drug 2. males with carcinoma of the breast 3. males with known or suspected carcinoma of the prostate gland 4. women who are pregnant (see precautions, pregnancy) 5. patients with serious cardiac, hepatic or renal disease (see warnings) testosterone cypionate injection 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.

Spojené štáty - angličtina - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - testosterone cypionate (unii: m0xw1ubi14) (testosterone - unii:3xmk78s47o) - testosterone cypionate 100 mg in 1 ml - testosterone cypionate 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)- gonadotropin or lhrh deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - known hypersensitivity to the drug - males with carcinoma of the breast - males with known or suspected carcinoma of the prostate gland - women who are pregnant (see precautions, pregnancy) - patients with serious cardiac, hepatic or renal disease (see warnings) testosterone cypionate injection contains testosterone, a schedule iii controlled substance in the c

Spojené štáty - angličtina - NLM (National Library of Medicine)

proficient rx lp - testosterone cypionate (unii: m0xw1ubi14) (testosterone - unii:3xmk78s47o) - testosterone cypionate 200 mg in 1 ml - testosterone cypionate injection, usp is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. testosterone is a controlled substance under the anabolic steroids control act, and testosterone cypionate injection has been assigned to schedule iii.

Spojené štáty - angličtina - NLM (National Library of Medicine)

encube ethicals private 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-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%: testosterone gel, 1% comes in a pump or in packets. - 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. if you are using the testosterone gel, 1% pump: - before using a new bottle of testosterone gel, 1% for the first time, you will need to prime the pump. to prime the testosterone gel, 1% pump, slowly push the pump all the way down 3 times, over the sink drain. do not use any testosterone gel, 1% that came out while priming. wash it down the sink to avoid accidental exposure to others. your testosterone gel, 1% pump is ready to use. - remove the cap from the pump. then, position the nozzle over the palm of your hand and slowly push the pump all the way down. apply testosterone gel, 1% to the application site. you may also apply testosterone gel, 1% from the pump 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. if you are using testosterone gel, 1% packets: - 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. - 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%. - apply testosterone gel, 1% to the application site. you may also apply testosterone gel, 1% from the packet directly to the application site. 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. manufactured by: encube ethicals pvt. ltd. plot no. c-1, madkaim industrial estate, madkaim, post: mardol, ponda, goa - 403 404, india. distributed by: encube ethicals, inc. 200 meredith drive,suite 202 durham, nc 27713 usa rev.02/2024

Spojené štáty - angličtina - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - 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: 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

Spojené štáty - angličtina - NLM (National Library of Medicine)

northstar rx llc - 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: 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 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: 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) 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%: if you are using testosterone gel, 1.62% pump: 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. find your dose as prescribed by your healthcare provider application method 1 pump 20.25 mg apply 1 pump of testosterone gel, 1.62% to 1 upper arm and shoulder. 2 pumps 40.5 mg apply 1 pump of testosterone gel, 1.62% to 1 upper arm and shoulder and then apply 1 pump of testosterone gel, 1.62% to the opposite upper arm and shoulder. 3 pumps 60.75 mg apply 2 pumps of testosterone gel, 1.62% to 1 upper arm and shoulder and then apply 1 pump of testosterone gel, 1.62% to the opposite upper arm and shoulder. 4 pumps 81 mg apply 2 pumps of testosterone gel, 1.62% to 1 upper arm and shoulder and then apply 2 pumps of testosterone gel, 1.62% to the opposite upper arm and shoulder. if you are using testosterone gel, 1.62% packets: find your dose as prescribed by your healthcare provider application method one 20.25 mg packet 20.25 mg apply 1 packet of testosterone gel, 1.62% to 1 upper arm and shoulder. one 40.5 mg packet 40.5 mg apply half of the 40.5 mg packet of testosterone gel, 1.62% to 1 upper arm and shoulder and then apply the remaining packet contents to the opposite upper arm and shoulder. one 40.5 mg packet and one 20.25 mg packet 60.75 mg apply one 40.5 mg packet of testosterone gel, 1.62% to 1 upper arm and shoulder and then apply one 20.25 mg packet of testosterone gel, 1.62% to the opposite upper arm and shoulder. two 40.5 mg packets 81 mg apply one 40.5 mg packet of testosterone gel, 1.62% to 1 upper arm and shoulder and then apply one 40.5 mg packet of testosterone gel, 1.62% to the opposite upper arm and shoulder. how should i store testosterone gel, 1.62%? 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. medication guides available at www.northstarrxllc.com/products or call 1-800-206-7821. manufactured for: northstar rx llc, memphis, tn 38141. manufactured by: padagis® , yeruham, israel. rev date: 12/2023

Spojené štáty - angličtina - 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: 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

Spojené štáty - angličtina - 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

Spojené štáty - angličtina - NLM (National Library of Medicine)

alembic 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. - 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 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 precautions(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.

Spojené štáty - angličtina - NLM (National Library of Medicine)

remedyrepack inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - 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 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 in men with "age-related hypogonadism" (also referred to as "late-onset hypog