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

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

hikma pharmaceuticals usa inc. - 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. - 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. 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 testoster

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

actavis pharma, inc. - 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. 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 luteinizing hormone-releasing hormone (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. 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) test

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

physicians total care, inc. - testosterone cypionate (unii: m0xw1ubi14) (testosterone - unii:3xmk78s47o) - testosterone cypionate 100 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. - primary hypogonadism (congenital or acquired) testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. - 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 steroid control act, and testosterone cypionate injection, usp has been assigned to schedule iii.

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

hospira, 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 injection 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 substan

United States - English - 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.

United States - English - 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

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

amneal pharmaceuticals of new york llc - methyltestosterone (unii: v9efu16zif) (methyltestosterone - unii:v9efu16zif) - methyltestosterone 10 mg - androgens are 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 torsions, 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 methyltestosterone in men with “ag

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

actavis pharma, inc. - testosterone enanthate (unii: 7z6522t8n9) (testosterone - unii:3xmk78s47o) - testosterone enanthate 200 mg in 1 ml - males testosterone enanthate injection 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 testo

United States - English - 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