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

bryant ranch prepack - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone gel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [fsh], luteinizing hormone [lh]) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of testosterone gel 1% in men with “age-related hypogonadism” (also referred to as “late-onset

United States - English - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - testosterone undecylate 40mg - soft gelatin capsule - 40 mg - active: testosterone undecylate 40mg excipient: caprylic/capric triglyceride gelatin glycerol methyl hydroxybenzoate opacode white nsp-78-18022 p-hydroxybenzoic acid purified water sorbitol sunset yellow fcf - testosterone replacement therapy for primary or secondary hypogonadal disorders, for example: - after castration - eunuchoidism - hypopituitarism - endocrine impotence - male climacteric symptoms such as decreased libido and decreased feeling of general well-being and fitness - certain types of infertility due to spermatogenesis disorders. moreover, in men testosterone therapy may be indicated in osteoporosis due to androgen deficiency.

Canada - English - Health Canada

taro pharmaceuticals inc - testosterone undecanoate - capsule - 40mg - testosterone undecanoate 40mg - androgens

Ireland - English - HPRA (Health Products Regulatory Authority)

organon laboratories limited - testosterone propionate testosterone phenylpropionate testosterone isocaproate - solution for injection - 20/40/40 mg/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

organon laboratories limited - testosterone propionate testosterone phenylpropionate testosterone isocaproate testosterone decanoate - solution for injection - 30/60/60/1 mg/ml

Canada - English - Health Canada

sandoz canada incorporated - testosterone cypionate - liquid - 100mg - testosterone cypionate 100mg - androgens

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

jurox pty limited - testosterone propionate - parenteral liquid/solution/suspension - testosterone propionate steroid-anabolic active 50.0 mg/ml - endocrine system - cattle | dog | dog - female (bitch) | horse | beef | bitch | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf - cryptorchidism | impotence | inhibit lactation | mammary tumours | reduced libido | undescended testes

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)

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