संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

maia pharmaceuticals, inc. - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide for injection is indicated in adults to: - stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. sincalide for injection is contraindicated in patients with: - a history of a hypersensitivity reaction to sulfites or sincalide. serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see warnings and precautions (5.1), adverse reactions (6)]. - intestinal obstruction. risk summary based on limited human data and mechanism of action, sincalide for inj

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

endo pharmaceuticals inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 2.5 mg - percocet is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve percocet for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia percocet is contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - hypersensitivity to oxycodone, acetaminophen, or any other component of the product (e.g., anaphylaxis) [see warnings, adverse reactions ] percocet contains oxycodone, a

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

par pharmaceutical, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 2.5 mg - endocet is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.  limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve endocet for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia endocet is contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - hypersensitivity to oxycodone, acetaminophen, or any other component of the product (e.g., anaphylaxis) [see warnings , adverse reactions ] endocet contains oxycodone, a

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

ferring pharmaceuticals inc. - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - endometrin® (progesterone) is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an assisted reproductive technology (art) treatment program for infertile women. endometrin is contraindicated in individuals with any of the following conditions: - previous allergic reactions to progesterone or any of the ingredients of endometrin [see description (11) ] - undiagnosed vaginal bleeding - known missed abortion or ectopic pregnancy - liver disease - known or suspected malignancy of the breast or genital organs - active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events endometrin has been used to support embryo implantation and maintain clinical pregnancy in one clinical study. the live birth outcomes of these pregnancies were as follows: - among the 404 subjects treated with endometrin twice daily, 143 subjects had live births consisting of 85 singletons, 56 twins, and 2 triplets. in this treatment group, 1

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

endo pharmaceuticals inc. - collagenase clostridium histolyticum (unii: 9x7o8v25it) (collagenase clostridium histolyticum - unii:9x7o8v25it) - collagenase clostridium histolyticum 0.9 mg - xiaflex is indicated for the treatment of adult patients with dupuytren’s contracture with a palpable cord. xiaflex is indicated for the treatment of adult men with peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. xiaflex is contraindicated in: - the treatment of peyronie’s plaques that involve the penile urethra due to potential risk to this structure. - patients with a history of hypersensitivity to xiaflex or to collagenase used in any other therapeutic application or application method [see warnings and precautions (5.4)] . pregnancy category b there are no adequate and well-controlled studies of xiaflex in pregnant women. because animal reproduction studies are not always predictive of human response, xiaflex should be used during pregnancy only if clearly needed. risk summary based on animal data, xiaflex is not predicted to increase the risk for major developmental abnormalities in humans. human data human pharmacokinetic studies

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

endo pharmaceuticals inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 10 mg in 0.5 g - fortesta 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, heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone [fsh] and 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 serum testosterone concentrations but have gonadotropins in the normal or low range. limitations of use - safety and efficacy of fortesta in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - safety and efficacy of fortesta in males <18 years old have not been established [see use in specific populations (8.4)] . - fortesta 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)] . - fortesta is contraindicated in women who are pregnant. testosterone can cause virilization of the female fetus when administered to a pregnant woman [see use in specific populations (8.1, 8.2)] . risk summary fortesta is contraindicated in pregnant women. testosterone is teratogenic and may cause fetal harm 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 anogenital 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 fortesta is not indicated for use in females. infertility during treatment with large doses of exogenous androgens, including fortesta, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see warnings and precautions (5.8)] , possibly leading to adverse effects on semen parameters including sperm count. 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 fortesta in pediatric patients <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 fortesta to determine whether efficacy in those over 65 years of age differs from younger subjects. of the 149 patients enrolled in the pivotal clinical study utilizing fortesta, 20 were over 65 years of age. additionally, there are 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. fortesta 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 of 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 fortesta® (for-tes-ta) ciii (testosterone) gel for topical use read this instructions for use for fortesta 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 fortesta: - apply fortesta only to areas that will be covered by shorts or pants. - fortesta should be applied to the front and inner part of your thighs only. do not apply fortesta to the area of the thigh closest to the scrotum. do not apply fortesta to any other parts of your body such as your stomach area (abdomen), penis, scrotum, shoulders or upper arms. - apply fortesta in the morning. if you shower or bathe, fortesta should be applied afterwards. - avoid swimming, showering, or bathing for at least 2 hours after you apply fortesta. - fortesta is flammable until dry. let fortesta dry before smoking or going near an open flame. - wash your hands with soap and water right after you apply fortesta. - before using a new canister of fortesta for the first time, you will need to prime the pump. to prime the fortesta pump, gently push down on the pump 8 times. do not use any fortesta that comes out while priming. wash it down the sink or throw it in the trash to avoid accidental exposure to others. your fortesta pump is now ready to use. - use fortesta exactly as your healthcare provider tells you to use it. your healthcare provider will tell you the dose of fortesta that is right for you. - press down on the pump to apply the medicine directly on clean, dry, skin that is not broken on the front and inner part of your thighs. use 1 finger to gently rub fortesta evenly onto the front and inner part of each thigh. - let the application site dry completely before putting on shorts or pants. - wash your hands right away with soap and water. how should i store fortesta? - store fortesta at room temperature between 68ºf to 77ºf (20ºc to 25ºc). - when it is time to throw away the canister, safely throw away used fortesta in the household trash. be careful to prevent accidental exposure of children or pets. - keep fortesta away from fire. - do not freeze fortesta. keep fortesta 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: 05/2019

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

endo pharmaceuticals inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 50 mg in 5 g - testim is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone 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 testim in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been esta

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

endo pharmaceuticals inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 10 mg in 1 g - voltaren gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. voltaren gel is contraindicated in the following patients: pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation risk summary use of nsaids, including voltaren gel, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including voltaren gel, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of voltaren gel in pregnant women. human and animal studies indicate that diclofenac crosses the placenta. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

endo pharmaceuticals inc. - testosterone undecanoate (unii: h16a5vct9c) (testosterone - unii:3xmk78s47o) - testosterone undecanoate 250 mg in 1 ml - aveed 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. aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pome

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

endo pharmaceuticals inc. - histrelin acetate (unii: qmg7hld1ze) (histrelin - unii:h50h3s3w74) - histrelin acetate 50 mg - supprelin la (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (cpp). children with cpp (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). they also show a significantly advanced bone age that can result in diminished adult height attainment. prior to initiation of treatment a clinical diagnosis of cpp should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (lh) and follicle stimulating hormone (fsh) following stimulation with a gnrh analog, and assessment of bone age versus chronological age. baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adre