কানাডা - ইংরেজি - Health Canada

eugia pharma inc. - fulvestrant - solution - 50mg - fulvestrant 50mg

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

remedyrepack inc. - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperidone is indicated for the treatment of schizophrenia. efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see clinical studies ( 14.1)]. monotherapy risperidone is indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see clinical studies ( 14.2)] . adjunctive therapy risperidone adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in one short-term trial in adults [see clinical studies ( 14.3)] . risperidone is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see clinical studies ( 14.4)]. risperidone is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the risperidone formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. paliperidone is a metabolite of risperidone. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including risperidone, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-andresearch-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see clinical considerations). overall, available data from published epidemiologic studies of pregnant women exposed to risperidone have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are risks to the mother associated with untreated schizophrenia or bipolar i disorder and with exposure to antipsychotics, including risperidone, during pregnancy (see clinical considerations). oral administration of risperidone to pregnant mice caused cleft palate at doses 3 to 4 times the maximum recommended human dose (mrhd) with maternal toxicity observed at 4-times mrhd based on mg/m 2 body surface area. risperidone was not teratogenic in rats or rabbits at doses up to 6-times the mrhd based on mg/m 2 body surface area. increased stillbirths and decreased birth weight occurred after oral risperidone administration to pregnant rats at 1.5-times the mrhd based on mg/m 2 body surface area. learning was impaired in offspring of rats when the dams were dosed at 0.6-times the mrhd and offspring mortality increased at doses 0.1 to 3 times the mrhd based on mg/m 2 body surface area. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk there is a risk to the mother from untreated schizophrenia or bipolar i disorder, including increased risk of relapse, hospitalization, and suicide. schizophrenia and bipolar i disorder are associated with increased adverse perinatal outcomes, including preterm birth. it is not known if this is a direct result of the illness or other comorbid factors. fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including risperidone, during the third trimester of pregnancy. these symptoms have varied in severity. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. data human data published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. a prospective observational study including 6 women treated with risperidone demonstrated placental passage of risperidone. a retrospective cohort study from a medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects. there was a small increase in the risk of major birth defects (rr=1.26, 95% ci 1.02-1.56) and of cardiac malformations (rr=1.26, 95% ci 0.88-1.81) in a subgroup of 1566 women exposed to risperidone during the first trimester of pregnancy; however, there is no mechanism of action to explain the difference in malformation rates. animal data oral administration of risperidone to pregnant mice during organogenesis caused cleft palate at 10 mg/kg/day which is 3 times the mrhd of 16 mg/day based on mg/m 2 body surface area: maternal toxicity occurred at 4 times the mrhd. risperidone was not teratogenic when administered orally to rats at 0.6 to 10 mg/kg/day and rabbits at 0.3 to 5 mg/kg/day, which are up to 6 times the mrhd of 16 mg/day risperidone based on mg/m 2 body surface area. learning was impaired in offspring of rats dosed orally throughout pregnancy at 1 mg/kg/day which is 0.6 times the mrhd and neuronal cell death increased in fetal brains of offspring of rats dosed during pregnancy at 1 and 2 mg/kg/day which are 0.6 and 1.2 times the mrhd based on mg/m 2 body surface area; postnatal development and growth of the offspring were also delayed. rat offspring mortality increased during the first 4 days of lactation when pregnant rats were dosed throughout gestation at 0.16 to 5 mg/kg/day which are 0.1 to 3 times the mrhd of 16 mg/day based on mg/m 2 body surface area. it is not known whether these deaths were due to a direct effect on the fetuses or pups or to effects on the dams; a no-effect dose could not be determined. the rate of stillbirths was increased at 2.5 mg/kg or 1.5 times the mrhd based on mg/m 2 body surface area. in a rat cross-fostering study the number of live offspring was decreased, the number of stillbirths increased, and the birth weight was decreased in offspring of drug-treated pregnant rats. in addition, the number of deaths increased by day 1 among offspring of drug-treated pregnant rats, regardless of whether or not the offspring were cross-fostered. risperidone also appeared to impair maternal behavior in that offspring body weight gain and survival (from day 1 to 4 of lactation) were reduced in offspring born to control but reared by drug-treated dams. all of these effects occurred at 5 mg/kg which is 3 times the mrhd based on mg/m 2 and the only dose tested in the study. risk summary limited data from published literature reports the presence of risperidone and its metabolite, 9-hydroxyrisperidone, in human breast milk at relative infant dose ranging between 2.3% and 4.7% of the maternal weight-adjusted dosage. there are reports of sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) in breastfed infants exposed to risperidone (see clinical considerations). there is no information on the effects of risperidone on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for risperidone and any potential adverse effects on the breastfed child from risperidone or from the mother’s underlying condition. clinical considerations infants exposed to risperidone through breastmilk should be monitored for excess sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements). infertility females based on the pharmacologic action of risperidone (d 2 receptor antagonism), treatment with risperidone may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see warnings and precautions ( 5.6)]. approved pediatric indications schizophrenia the efficacy and safety of risperidone in the treatment of schizophrenia were demonstrated in 417 adolescents, aged 13 to 17 years, in two short-term (6 and 8 weeks, respectively) double-blind controlled trials [see indications and usage (1.1) , adverse reactions (6.1) , and clinical studies (14.1)]. additional safety and efficacy information was also assessed in one long-term (6-month) open-label extension study in 284 of these adolescent patients with schizophrenia. safety and effectiveness of risperidone in children less than 13 years of age with schizophrenia have not been established. bipolar i disorder the efficacy and safety of risperidone in the short-term treatment of acute manic or mixed episodes associated with bipolar i disorder in 169 children and adolescent patients, aged 10 to 17 years, were demonstrated in one double-blind, placebo-controlled, 3-week trial [see indications and usage (1.2) , adverse reactions (6.1) , and clinical studies (14.2)] . safety and effectiveness of risperidone in children less than 10 years of age with bipolar disorder have not been established. autistic disorder the efficacy and safety of risperidone in the treatment of irritability associated with autistic disorder were established in two 8-week, double-blind, placebo-controlled trials in 156 children and adolescent patients, aged 5 to 16 years [see indications and usage (1.3) , adverse reactions (6.1)and clinical studies (14.4)] . additional safety information was also assessed in a long-term study in patients with autistic disorder, or in short- and long-term studies in more than 1200 pediatric patients with psychiatric disorders other than autistic disorder, schizophrenia, or bipolar mania who were of similar age and weight, and who received similar dosages of risperidone as patients treated for irritability associated with autistic disorder. a third study was a 6-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of a lower than recommended dose of risperidone in subjects 5 to 17 years of age with autistic disorder and associated irritability, and related behavioral symptoms. there were two weight-based, fixed doses of risperidone (high-dose and low-dose). the high dose was 1.25 mg per day for patients weighing 20 to < 45 kg, and it was 1.75 mg per day for patients weighing ≥ 45 kg. the low dose was 0.125 mg per day for patients for patients weighing 20 to < 45 kg, and it was 0.175 mg per day for patients weighing ≥ 45 kg. the study demonstrated the efficacy of high-dose risperidone, but it did not demonstrate efficacy for low-dose risperidone. adverse reactions in pediatric patients tardive dyskinesia in clinical trials in 1885 children and adolescents treated with risperidone, 2 (0.1%) patients were reported to have tardive dyskinesia, which resolved on discontinuation of risperidone treatment [see also warnings and precautions (5.4)] . weight gain weight gain has been observed in children and adolescents during treatment with risperidone. clinical monitoring of weight is recommended during treatment. data derive from short-term placebo-controlled trials and longer-term uncontrolled studies in pediatric patients (ages 5 to 17 years) with schizophrenia, bipolar disorder, autistic disorder, or other psychiatric disorders. in the short-term trials (3 to 8 weeks), the mean weight gain for risperidone-treated patients was 2 kg, compared to 0.6 kg for placebo-treated patients. in these trials, approximately 33% of the risperidone group had weight gain ≥7%, compared to 7% in the placebo group. in longer-term, uncontrolled, open-label pediatric studies, the mean weight gain was 5.5 kg at week 24 and 8 kg at week 48 [see warnings and precautions (5.5)and adverse reactions (6.1)]. somnolence somnolence was frequently observed in placebo-controlled clinical trials of pediatric patients with autistic disorder. most cases were mild or moderate in severity. these events were most often of early onset with peak incidence occurring during the first two weeks of treatment, and transient with a median duration of 16 days. somnolence was the most commonly observed adverse reaction in the clinical trial of bipolar disorder in children and adolescents, as well as in the schizophrenia trials in adolescents. as was seen in the autistic disorder trials, these adverse reactions were most often of early onset and transient in duration [see adverse reactions (6.1and 6.2)] . patients experiencing persistent somnolence may benefit from a change in dosing regimen [ see dosage and administration (2.1 , 2.2 , and 2.3)] . hyperprolactinemia risperidone has been shown to elevate prolactin levels in children and adolescents as well as in adults [see warnings and precautions (5.6)] . in double-blind, placebo-controlled studies of up to 8 weeks duration in children and adolescents (aged 5 to 17 years) with autistic disorder or psychiatric disorders other than autistic disorder, schizophrenia, or bipolar mania, 49% of patients who received risperidone had elevated prolactin levels compared to 2% of patients who received placebo. similarly, in placebo-controlled trials in children and adolescents (aged 10 to 17 years) with bipolar disorder, or adolescents (aged 13 to 17 years) with schizophrenia, 82–87% of patients who received risperidone had elevated levels of prolactin compared to 3-7% of patients on placebo. increases were dose-dependent and generally greater in females than in males across indications. in clinical trials in 1885 children and adolescents, galactorrhea was reported in 0.8% of risperidone-treated patients and gynecomastia was reported in 2.3% of risperidone-treated patients. growth and sexual maturation the long-term effects of risperidone on growth and sexual maturation have not been fully evaluated in children and adolescents. juvenile animal studies juvenile dogs were treated with oral risperidone from weeks 10 to 50 of age (equivalent to the period of childhood through adolescence in humans), at doses of 0.31, 1.25, or 5 mg/kg/day, which are 1.2, 3.4, and 13.5 times the mrhd of 6 mg/day for children, based on mg/m 2 body surface area. bone length and density were decreased with a no-effect dose of 0.31 mg/kg/day; this dose produced plasma auc of risperidone plus its active metabolite paliperidone (9-hydroxy-risperidone) that were similar to those in children and adolescents receiving the mrhd of 6 mg/day. in addition, sexual maturation was delayed at all doses in both males and females. the above effects showed little or no reversibility in females after a 12 week drug-free recovery period. juvenile rats, treated with oral risperidone from days 12 to 50 of age (equivalent to the period of infancy through adolescence in humans) showed impaired learning and memory performance (reversible only in females), with a no-effect dose of 0.63 mg/kg/day which is 0.5 times the mrhd of 6 mg/day for children, based on mg/m 2 body surface area. this dose produced plasma auc of risperidone plus paliperidone about half the exposure observed in humans at the mrhd. no other consistent effects on neurobehavioral or reproductive development were seen up to the highest tested dose of 1.25 mg/kg/day which is 1 time the mrhd and produced plasma auc of risperidone plus paliperidone that were about two thirds of those observed in humans at the mrhd of 6 mg/day for children. clinical studies of risperidone in the treatment of schizophrenia did not include sufficient numbers of patients aged 65 and over to determine whether or not they respond differently than younger patients. other reported clinical experience has not identified differences in responses between elderly and younger patients. in general, a lower starting dose is recommended for an elderly patient, reflecting a decreased pharmacokinetic clearance in the elderly, as well as a greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)and dosage and administration (2.4, 2.5)] . while elderly patients exhibit a greater tendency to orthostatic hypotension, its risk in the elderly may be minimized by limiting the initial dose to 0.5 mg twice daily followed by careful titration [see warnings and precautions (5.7)] . monitoring of orthostatic vital signs should be considered in patients for whom this is of concern. this drug is substantially excreted by the kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.4)] . in patients with moderate to severe (clcr 59 to 15 ml/min) renal disease, clearance of the sum of risperidone and its active metabolite decreased by 60%, compared to young healthy subjects. risperidone doses should be reduced in patients with renal disease [see dosage and administration (2.4)] . while the pharmacokinetics of risperidone in subjects with liver disease were comparable to those in young healthy subjects, the mean free fraction of risperidone in plasma was increased by about 35% because of the diminished concentration of both albumin and α 1 -acid glycoprotein. risperidone doses should be reduced in patients with liver disease [see dosage and administration (2.4)] . patients with parkinson's disease or dementia with lewy bodies can experience increased sensitivity to risperidone. manifestations can include confusion, obtundation, postural instability with frequent falls, extrapyramidal symptoms, and clinical features consistent with neuroleptic malignant syndrome. risperidone is not a controlled substance. risperidone has not been systematically studied in animals or humans for its potential for abuse. while the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of risperidone misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). risperidone has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

proficient rx lp - lurasidone hydrochloride (unii: o0p4i5851i) (lurasidone - unii:22ic88528t) - lurasidone hydrochloride tablets are indicated for: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride during pregnancy. for more information, contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-andresearch-programs/pregnancyregistry/ . risk summary neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery [see clinical considerations] . there are no studies of lurasidone hydrochloride use in pregnant women. the limited available data are not sufficient to inform a drug-associated risk of birth defects or miscarriage. in animal reproduction studies, no teratogenic effects were seen in pregnant rats and rabbits given lurasidone during the period of organogenesis at doses approximately 1.5- and 6-times, the maximum recommended human dose (mr

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

remedyrepack inc. - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperidone is indicated for the treatment of schizophrenia. efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see clinical studies ( 14.1)]. monotherapy risperidone is indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see clinical studies ( 14.2)] . adjunctive therapy risperidone adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in one short-term trial in adults [see clinical studies ( 14.3)] . risperidone is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see clinical studies ( 14.4)]. risperidone is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the risperidone formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. paliperidone is a metabolite of risperidone. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including risperidone, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-andresearch-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see clinical considerations). overall, available data from published epidemiologic studies of pregnant women exposed to risperidone have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are risks to the mother associated with untreated schizophrenia or bipolar i disorder and with exposure to antipsychotics, including risperidone, during pregnancy (see clinical considerations). oral administration of risperidone to pregnant mice caused cleft palate at doses 3 to 4 times the maximum recommended human dose (mrhd) with maternal toxicity observed at 4-times mrhd based on mg/m 2 body surface area. risperidone was not teratogenic in rats or rabbits at doses up to 6-times the mrhd based on mg/m 2 body surface area. increased stillbirths and decreased birth weight occurred after oral risperidone administration to pregnant rats at 1.5-times the mrhd based on mg/m 2 body surface area. learning was impaired in offspring of rats when the dams were dosed at 0.6-times the mrhd and offspring mortality increased at doses 0.1 to 3 times the mrhd based on mg/m 2 body surface area. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk there is a risk to the mother from untreated schizophrenia or bipolar i disorder, including increased risk of relapse, hospitalization, and suicide. schizophrenia and bipolar i disorder are associated with increased adverse perinatal outcomes, including preterm birth. it is not known if this is a direct result of the illness or other comorbid factors. fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including risperidone, during the third trimester of pregnancy. these symptoms have varied in severity. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. data human data published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. a prospective observational study including 6 women treated with risperidone demonstrated placental passage of risperidone. a retrospective cohort study from a medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects. there was a small increase in the risk of major birth defects (rr=1.26, 95% ci 1.02-1.56) and of cardiac malformations (rr=1.26, 95% ci 0.88-1.81) in a subgroup of 1566 women exposed to risperidone during the first trimester of pregnancy; however, there is no mechanism of action to explain the difference in malformation rates. animal data oral administration of risperidone to pregnant mice during organogenesis caused cleft palate at 10 mg/kg/day which is 3 times the mrhd of 16 mg/day based on mg/m 2 body surface area: maternal toxicity occurred at 4 times the mrhd. risperidone was not teratogenic when administered orally to rats at 0.6 to 10 mg/kg/day and rabbits at 0.3 to 5 mg/kg/day, which are up to 6 times the mrhd of 16 mg/day risperidone based on mg/m 2 body surface area. learning was impaired in offspring of rats dosed orally throughout pregnancy at 1 mg/kg/day which is 0.6 times the mrhd and neuronal cell death increased in fetal brains of offspring of rats dosed during pregnancy at 1 and 2 mg/kg/day which are 0.6 and 1.2 times the mrhd based on mg/m 2 body surface area; postnatal development and growth of the offspring were also delayed. rat offspring mortality increased during the first 4 days of lactation when pregnant rats were dosed throughout gestation at 0.16 to 5 mg/kg/day which are 0.1 to 3 times the mrhd of 16 mg/day based on mg/m 2 body surface area. it is not known whether these deaths were due to a direct effect on the fetuses or pups or to effects on the dams; a no-effect dose could not be determined. the rate of stillbirths was increased at 2.5 mg/kg or 1.5 times the mrhd based on mg/m 2 body surface area. in a rat cross-fostering study the number of live offspring was decreased, the number of stillbirths increased, and the birth weight was decreased in offspring of drug-treated pregnant rats. in addition, the number of deaths increased by day 1 among offspring of drug-treated pregnant rats, regardless of whether or not the offspring were cross-fostered. risperidone also appeared to impair maternal behavior in that offspring body weight gain and survival (from day 1 to 4 of lactation) were reduced in offspring born to control but reared by drug-treated dams. all of these effects occurred at 5 mg/kg which is 3 times the mrhd based on mg/m 2 and the only dose tested in the study. risk summary limited data from published literature reports the presence of risperidone and its metabolite, 9-hydroxyrisperidone, in human breast milk at relative infant dose ranging between 2.3% and 4.7% of the maternal weight-adjusted dosage. there are reports of sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) in breastfed infants exposed to risperidone (see clinical considerations). there is no information on the effects of risperidone on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for risperidone and any potential adverse effects on the breastfed child from risperidone or from the mother’s underlying condition. clinical considerations infants exposed to risperidone through breastmilk should be monitored for excess sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements). infertility females based on the pharmacologic action of risperidone (d 2 receptor antagonism), treatment with risperidone may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see warnings and precautions ( 5.6)]. approved pediatric indications schizophrenia the efficacy and safety of risperidone in the treatment of schizophrenia were demonstrated in 417 adolescents, aged 13 to 17 years, in two short-term (6 and 8 weeks, respectively) double-blind controlled trials [see indications and usage (1.1) , adverse reactions (6.1) , and clinical studies (14.1)]. additional safety and efficacy information was also assessed in one long-term (6-month) open-label extension study in 284 of these adolescent patients with schizophrenia. safety and effectiveness of risperidone in children less than 13 years of age with schizophrenia have not been established. bipolar i disorder the efficacy and safety of risperidone in the short-term treatment of acute manic or mixed episodes associated with bipolar i disorder in 169 children and adolescent patients, aged 10 to 17 years, were demonstrated in one double-blind, placebo-controlled, 3-week trial [see indications and usage (1.2) , adverse reactions (6.1) , and clinical studies (14.2)] . safety and effectiveness of risperidone in children less than 10 years of age with bipolar disorder have not been established. autistic disorder the efficacy and safety of risperidone in the treatment of irritability associated with autistic disorder were established in two 8-week, double-blind, placebo-controlled trials in 156 children and adolescent patients, aged 5 to 16 years [see indications and usage (1.3) , adverse reactions (6.1)and clinical studies (14.4)] . additional safety information was also assessed in a long-term study in patients with autistic disorder, or in short- and long-term studies in more than 1200 pediatric patients with psychiatric disorders other than autistic disorder, schizophrenia, or bipolar mania who were of similar age and weight, and who received similar dosages of risperidone as patients treated for irritability associated with autistic disorder. a third study was a 6-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of a lower than recommended dose of risperidone in subjects 5 to 17 years of age with autistic disorder and associated irritability, and related behavioral symptoms. there were two weight-based, fixed doses of risperidone (high-dose and low-dose). the high dose was 1.25 mg per day for patients weighing 20 to < 45 kg, and it was 1.75 mg per day for patients weighing ≥ 45 kg. the low dose was 0.125 mg per day for patients for patients weighing 20 to < 45 kg, and it was 0.175 mg per day for patients weighing ≥ 45 kg. the study demonstrated the efficacy of high-dose risperidone, but it did not demonstrate efficacy for low-dose risperidone. adverse reactions in pediatric patients tardive dyskinesia in clinical trials in 1885 children and adolescents treated with risperidone, 2 (0.1%) patients were reported to have tardive dyskinesia, which resolved on discontinuation of risperidone treatment [see also warnings and precautions (5.4)] . weight gain weight gain has been observed in children and adolescents during treatment with risperidone. clinical monitoring of weight is recommended during treatment. data derive from short-term placebo-controlled trials and longer-term uncontrolled studies in pediatric patients (ages 5 to 17 years) with schizophrenia, bipolar disorder, autistic disorder, or other psychiatric disorders. in the short-term trials (3 to 8 weeks), the mean weight gain for risperidone-treated patients was 2 kg, compared to 0.6 kg for placebo-treated patients. in these trials, approximately 33% of the risperidone group had weight gain ≥7%, compared to 7% in the placebo group. in longer-term, uncontrolled, open-label pediatric studies, the mean weight gain was 5.5 kg at week 24 and 8 kg at week 48 [see warnings and precautions (5.5)and adverse reactions (6.1)]. somnolence somnolence was frequently observed in placebo-controlled clinical trials of pediatric patients with autistic disorder. most cases were mild or moderate in severity. these events were most often of early onset with peak incidence occurring during the first two weeks of treatment, and transient with a median duration of 16 days. somnolence was the most commonly observed adverse reaction in the clinical trial of bipolar disorder in children and adolescents, as well as in the schizophrenia trials in adolescents. as was seen in the autistic disorder trials, these adverse reactions were most often of early onset and transient in duration [see adverse reactions (6.1and 6.2)] . patients experiencing persistent somnolence may benefit from a change in dosing regimen [ see dosage and administration (2.1 , 2.2 , and 2.3)] . hyperprolactinemia risperidone has been shown to elevate prolactin levels in children and adolescents as well as in adults [see warnings and precautions (5.6)] . in double-blind, placebo-controlled studies of up to 8 weeks duration in children and adolescents (aged 5 to 17 years) with autistic disorder or psychiatric disorders other than autistic disorder, schizophrenia, or bipolar mania, 49% of patients who received risperidone had elevated prolactin levels compared to 2% of patients who received placebo. similarly, in placebo-controlled trials in children and adolescents (aged 10 to 17 years) with bipolar disorder, or adolescents (aged 13 to 17 years) with schizophrenia, 82–87% of patients who received risperidone had elevated levels of prolactin compared to 3-7% of patients on placebo. increases were dose-dependent and generally greater in females than in males across indications. in clinical trials in 1885 children and adolescents, galactorrhea was reported in 0.8% of risperidone-treated patients and gynecomastia was reported in 2.3% of risperidone-treated patients. growth and sexual maturation the long-term effects of risperidone on growth and sexual maturation have not been fully evaluated in children and adolescents. juvenile animal studies juvenile dogs were treated with oral risperidone from weeks 10 to 50 of age (equivalent to the period of childhood through adolescence in humans), at doses of 0.31, 1.25, or 5 mg/kg/day, which are 1.2, 3.4, and 13.5 times the mrhd of 6 mg/day for children, based on mg/m 2 body surface area. bone length and density were decreased with a no-effect dose of 0.31 mg/kg/day; this dose produced plasma auc of risperidone plus its active metabolite paliperidone (9-hydroxy-risperidone) that were similar to those in children and adolescents receiving the mrhd of 6 mg/day. in addition, sexual maturation was delayed at all doses in both males and females. the above effects showed little or no reversibility in females after a 12 week drug-free recovery period. juvenile rats, treated with oral risperidone from days 12 to 50 of age (equivalent to the period of infancy through adolescence in humans) showed impaired learning and memory performance (reversible only in females), with a no-effect dose of 0.63 mg/kg/day which is 0.5 times the mrhd of 6 mg/day for children, based on mg/m 2 body surface area. this dose produced plasma auc of risperidone plus paliperidone about half the exposure observed in humans at the mrhd. no other consistent effects on neurobehavioral or reproductive development were seen up to the highest tested dose of 1.25 mg/kg/day which is 1 time the mrhd and produced plasma auc of risperidone plus paliperidone that were about two thirds of those observed in humans at the mrhd of 6 mg/day for children. clinical studies of risperidone in the treatment of schizophrenia did not include sufficient numbers of patients aged 65 and over to determine whether or not they respond differently than younger patients. other reported clinical experience has not identified differences in responses between elderly and younger patients. in general, a lower starting dose is recommended for an elderly patient, reflecting a decreased pharmacokinetic clearance in the elderly, as well as a greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)and dosage and administration (2.4, 2.5)] . while elderly patients exhibit a greater tendency to orthostatic hypotension, its risk in the elderly may be minimized by limiting the initial dose to 0.5 mg twice daily followed by careful titration [see warnings and precautions (5.7)] . monitoring of orthostatic vital signs should be considered in patients for whom this is of concern. this drug is substantially excreted by the kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.4)] . in patients with moderate to severe (clcr 59 to 15 ml/min) renal disease, clearance of the sum of risperidone and its active metabolite decreased by 60%, compared to young healthy subjects. risperidone doses should be reduced in patients with renal disease [see dosage and administration (2.4)] . while the pharmacokinetics of risperidone in subjects with liver disease were comparable to those in young healthy subjects, the mean free fraction of risperidone in plasma was increased by about 35% because of the diminished concentration of both albumin and α 1 -acid glycoprotein. risperidone doses should be reduced in patients with liver disease [see dosage and administration (2.4)] . patients with parkinson's disease or dementia with lewy bodies can experience increased sensitivity to risperidone. manifestations can include confusion, obtundation, postural instability with frequent falls, extrapyramidal symptoms, and clinical features consistent with neuroleptic malignant syndrome. risperidone is not a controlled substance. risperidone has not been systematically studied in animals or humans for its potential for abuse. while the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of risperidone misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). risperidone has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

remedyrepack inc. - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperidone is indicated for the treatment of schizophrenia. efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see clinical studies ( 14.1)]. monotherapy risperidone is indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see clinical studies ( 14.2)] . adjunctive therapy risperidone adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in one short-term trial in adults [see clinical studies ( 14.3)] . risperidone is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see clinical studies ( 14.4)]. risperidone is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the risperidone formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. paliperidone is a metabolite of risperidone. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including risperidone, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-andresearch-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see clinical considerations). overall, available data from published epidemiologic studies of pregnant women exposed to risperidone have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are risks to the mother associated with untreated schizophrenia or bipolar i disorder and with exposure to antipsychotics, including risperidone, during pregnancy (see clinical considerations). oral administration of risperidone to pregnant mice caused cleft palate at doses 3 to 4 times the maximum recommended human dose (mrhd) with maternal toxicity observed at 4-times mrhd based on mg/m 2 body surface area. risperidone was not teratogenic in rats or rabbits at doses up to 6-times the mrhd based on mg/m 2 body surface area. increased stillbirths and decreased birth weight occurred after oral risperidone administration to pregnant rats at 1.5-times the mrhd based on mg/m 2 body surface area. learning was impaired in offspring of rats when the dams were dosed at 0.6-times the mrhd and offspring mortality increased at doses 0.1 to 3 times the mrhd based on mg/m 2 body surface area. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk there is a risk to the mother from untreated schizophrenia or bipolar i disorder, including increased risk of relapse, hospitalization, and suicide. schizophrenia and bipolar i disorder are associated with increased adverse perinatal outcomes, including preterm birth. it is not known if this is a direct result of the illness or other comorbid factors. fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including risperidone, during the third trimester of pregnancy. these symptoms have varied in severity. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. data human data published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. a prospective observational study including 6 women treated with risperidone demonstrated placental passage of risperidone. a retrospective cohort study from a medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects. there was a small increase in the risk of major birth defects (rr=1.26, 95% ci 1.02-1.56) and of cardiac malformations (rr=1.26, 95% ci 0.88-1.81) in a subgroup of 1566 women exposed to risperidone during the first trimester of pregnancy; however, there is no mechanism of action to explain the difference in malformation rates. animal data oral administration of risperidone to pregnant mice during organogenesis caused cleft palate at 10 mg/kg/day which is 3 times the mrhd of 16 mg/day based on mg/m 2 body surface area: maternal toxicity occurred at 4 times the mrhd. risperidone was not teratogenic when administered orally to rats at 0.6 to 10 mg/kg/day and rabbits at 0.3 to 5 mg/kg/day, which are up to 6 times the mrhd of 16 mg/day risperidone based on mg/m 2 body surface area. learning was impaired in offspring of rats dosed orally throughout pregnancy at 1 mg/kg/day which is 0.6 times the mrhd and neuronal cell death increased in fetal brains of offspring of rats dosed during pregnancy at 1 and 2 mg/kg/day which are 0.6 and 1.2 times the mrhd based on mg/m 2 body surface area; postnatal development and growth of the offspring were also delayed. rat offspring mortality increased during the first 4 days of lactation when pregnant rats were dosed throughout gestation at 0.16 to 5 mg/kg/day which are 0.1 to 3 times the mrhd of 16 mg/day based on mg/m 2 body surface area. it is not known whether these deaths were due to a direct effect on the fetuses or pups or to effects on the dams; a no-effect dose could not be determined. the rate of stillbirths was increased at 2.5 mg/kg or 1.5 times the mrhd based on mg/m 2 body surface area. in a rat cross-fostering study the number of live offspring was decreased, the number of stillbirths increased, and the birth weight was decreased in offspring of drug-treated pregnant rats. in addition, the number of deaths increased by day 1 among offspring of drug-treated pregnant rats, regardless of whether or not the offspring were cross-fostered. risperidone also appeared to impair maternal behavior in that offspring body weight gain and survival (from day 1 to 4 of lactation) were reduced in offspring born to control but reared by drug-treated dams. all of these effects occurred at 5 mg/kg which is 3 times the mrhd based on mg/m 2 and the only dose tested in the study. risk summary limited data from published literature reports the presence of risperidone and its metabolite, 9-hydroxyrisperidone, in human breast milk at relative infant dose ranging between 2.3% and 4.7% of the maternal weight-adjusted dosage. there are reports of sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) in breastfed infants exposed to risperidone (see clinical considerations). there is no information on the effects of risperidone on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for risperidone and any potential adverse effects on the breastfed child from risperidone or from the mother’s underlying condition. clinical considerations infants exposed to risperidone through breastmilk should be monitored for excess sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements). infertility females based on the pharmacologic action of risperidone (d 2 receptor antagonism), treatment with risperidone may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see warnings and precautions ( 5.6)]. approved pediatric indications schizophrenia the efficacy and safety of risperidone in the treatment of schizophrenia were demonstrated in 417 adolescents, aged 13 to 17 years, in two short-term (6 and 8 weeks, respectively) double-blind controlled trials [see indications and usage (1.1) , adverse reactions (6.1) , and clinical studies (14.1)]. additional safety and efficacy information was also assessed in one long-term (6-month) open-label extension study in 284 of these adolescent patients with schizophrenia. safety and effectiveness of risperidone in children less than 13 years of age with schizophrenia have not been established. bipolar i disorder the efficacy and safety of risperidone in the short-term treatment of acute manic or mixed episodes associated with bipolar i disorder in 169 children and adolescent patients, aged 10 to 17 years, were demonstrated in one double-blind, placebo-controlled, 3-week trial [see indications and usage (1.2) , adverse reactions (6.1) , and clinical studies (14.2)] . safety and effectiveness of risperidone in children less than 10 years of age with bipolar disorder have not been established. autistic disorder the efficacy and safety of risperidone in the treatment of irritability associated with autistic disorder were established in two 8-week, double-blind, placebo-controlled trials in 156 children and adolescent patients, aged 5 to 16 years [see indications and usage (1.3) , adverse reactions (6.1)and clinical studies (14.4)] . additional safety information was also assessed in a long-term study in patients with autistic disorder, or in short- and long-term studies in more than 1200 pediatric patients with psychiatric disorders other than autistic disorder, schizophrenia, or bipolar mania who were of similar age and weight, and who received similar dosages of risperidone as patients treated for irritability associated with autistic disorder. a third study was a 6-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of a lower than recommended dose of risperidone in subjects 5 to 17 years of age with autistic disorder and associated irritability, and related behavioral symptoms. there were two weight-based, fixed doses of risperidone (high-dose and low-dose). the high dose was 1.25 mg per day for patients weighing 20 to < 45 kg, and it was 1.75 mg per day for patients weighing ≥ 45 kg. the low dose was 0.125 mg per day for patients for patients weighing 20 to < 45 kg, and it was 0.175 mg per day for patients weighing ≥ 45 kg. the study demonstrated the efficacy of high-dose risperidone, but it did not demonstrate efficacy for low-dose risperidone. adverse reactions in pediatric patients tardive dyskinesia in clinical trials in 1885 children and adolescents treated with risperidone, 2 (0.1%) patients were reported to have tardive dyskinesia, which resolved on discontinuation of risperidone treatment [see also warnings and precautions (5.4)] . weight gain weight gain has been observed in children and adolescents during treatment with risperidone. clinical monitoring of weight is recommended during treatment. data derive from short-term placebo-controlled trials and longer-term uncontrolled studies in pediatric patients (ages 5 to 17 years) with schizophrenia, bipolar disorder, autistic disorder, or other psychiatric disorders. in the short-term trials (3 to 8 weeks), the mean weight gain for risperidone-treated patients was 2 kg, compared to 0.6 kg for placebo-treated patients. in these trials, approximately 33% of the risperidone group had weight gain ≥7%, compared to 7% in the placebo group. in longer-term, uncontrolled, open-label pediatric studies, the mean weight gain was 5.5 kg at week 24 and 8 kg at week 48 [see warnings and precautions (5.5)and adverse reactions (6.1)]. somnolence somnolence was frequently observed in placebo-controlled clinical trials of pediatric patients with autistic disorder. most cases were mild or moderate in severity. these events were most often of early onset with peak incidence occurring during the first two weeks of treatment, and transient with a median duration of 16 days. somnolence was the most commonly observed adverse reaction in the clinical trial of bipolar disorder in children and adolescents, as well as in the schizophrenia trials in adolescents. as was seen in the autistic disorder trials, these adverse reactions were most often of early onset and transient in duration [see adverse reactions (6.1and 6.2)] . patients experiencing persistent somnolence may benefit from a change in dosing regimen [ see dosage and administration (2.1 , 2.2 , and 2.3)] . hyperprolactinemia risperidone has been shown to elevate prolactin levels in children and adolescents as well as in adults [see warnings and precautions (5.6)] . in double-blind, placebo-controlled studies of up to 8 weeks duration in children and adolescents (aged 5 to 17 years) with autistic disorder or psychiatric disorders other than autistic disorder, schizophrenia, or bipolar mania, 49% of patients who received risperidone had elevated prolactin levels compared to 2% of patients who received placebo. similarly, in placebo-controlled trials in children and adolescents (aged 10 to 17 years) with bipolar disorder, or adolescents (aged 13 to 17 years) with schizophrenia, 82–87% of patients who received risperidone had elevated levels of prolactin compared to 3-7% of patients on placebo. increases were dose-dependent and generally greater in females than in males across indications. in clinical trials in 1885 children and adolescents, galactorrhea was reported in 0.8% of risperidone-treated patients and gynecomastia was reported in 2.3% of risperidone-treated patients. growth and sexual maturation the long-term effects of risperidone on growth and sexual maturation have not been fully evaluated in children and adolescents. juvenile animal studies juvenile dogs were treated with oral risperidone from weeks 10 to 50 of age (equivalent to the period of childhood through adolescence in humans), at doses of 0.31, 1.25, or 5 mg/kg/day, which are 1.2, 3.4, and 13.5 times the mrhd of 6 mg/day for children, based on mg/m 2 body surface area. bone length and density were decreased with a no-effect dose of 0.31 mg/kg/day; this dose produced plasma auc of risperidone plus its active metabolite paliperidone (9-hydroxy-risperidone) that were similar to those in children and adolescents receiving the mrhd of 6 mg/day. in addition, sexual maturation was delayed at all doses in both males and females. the above effects showed little or no reversibility in females after a 12 week drug-free recovery period. juvenile rats, treated with oral risperidone from days 12 to 50 of age (equivalent to the period of infancy through adolescence in humans) showed impaired learning and memory performance (reversible only in females), with a no-effect dose of 0.63 mg/kg/day which is 0.5 times the mrhd of 6 mg/day for children, based on mg/m 2 body surface area. this dose produced plasma auc of risperidone plus paliperidone about half the exposure observed in humans at the mrhd. no other consistent effects on neurobehavioral or reproductive development were seen up to the highest tested dose of 1.25 mg/kg/day which is 1 time the mrhd and produced plasma auc of risperidone plus paliperidone that were about two thirds of those observed in humans at the mrhd of 6 mg/day for children. clinical studies of risperidone in the treatment of schizophrenia did not include sufficient numbers of patients aged 65 and over to determine whether or not they respond differently than younger patients. other reported clinical experience has not identified differences in responses between elderly and younger patients. in general, a lower starting dose is recommended for an elderly patient, reflecting a decreased pharmacokinetic clearance in the elderly, as well as a greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)and dosage and administration (2.4, 2.5)] . while elderly patients exhibit a greater tendency to orthostatic hypotension, its risk in the elderly may be minimized by limiting the initial dose to 0.5 mg twice daily followed by careful titration [see warnings and precautions (5.7)] . monitoring of orthostatic vital signs should be considered in patients for whom this is of concern. this drug is substantially excreted by the kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.4)] . in patients with moderate to severe (clcr 59 to 15 ml/min) renal disease, clearance of the sum of risperidone and its active metabolite decreased by 60%, compared to young healthy subjects. risperidone doses should be reduced in patients with renal disease [see dosage and administration (2.4)] . while the pharmacokinetics of risperidone in subjects with liver disease were comparable to those in young healthy subjects, the mean free fraction of risperidone in plasma was increased by about 35% because of the diminished concentration of both albumin and α 1 -acid glycoprotein. risperidone doses should be reduced in patients with liver disease [see dosage and administration (2.4)] . patients with parkinson's disease or dementia with lewy bodies can experience increased sensitivity to risperidone. manifestations can include confusion, obtundation, postural instability with frequent falls, extrapyramidal symptoms, and clinical features consistent with neuroleptic malignant syndrome. risperidone is not a controlled substance. risperidone has not been systematically studied in animals or humans for its potential for abuse. while the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of risperidone misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). risperidone has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

a-s medication solutions - lurasidone hydrochloride (unii: o0p4i5851i) (lurasidone - unii:22ic88528t) - lurasidone hydrochloride tablets are indicated for: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride during pregnancy. for more information, contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-andresearch-programs/pregnancyregistry/ . risk summary neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery [see clinical considerations] . there are no studies of lurasidone hydrochloride use in pregnant women. the limited available data are not sufficient to inform a drug-associated risk of birth defects or miscarriage. in animal reproduction studies, no teratogenic effects were seen in pregnant rats and rabbits given lurasidone during the period of organogenesis at doses approximately 1.5- and 6-times, the maximum recommended human dose (mrhd) of 160 mg/day, respectively based on mg/m2 body surface area [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy. these symptoms have varied in severity. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. data animal data pregnant rats were treated with oral lurasidone at doses of 3, 10, and 25 mg/kg/day during the period of organogenesis. these doses are 0.2, 0.6, and 1.5 times the mrhd of 160 mg/day based on mg/m2 body surface area. no teratogenic or embryo-fetal effects were observed up to 1.5 times the mrhd of 160 mg/day, based on mg/m2 . pregnant rabbits were treated with oral lurasidone at doses of 2, 10, and 50 mg/kg/day during the period of organogenesis. these doses are 0.2, 1.2 and 6 times the mrhd of 160 mg/day based on mg/m2 . no teratogenic or embryo-fetal effects were observed up to 6 times the mrhd of 160 mg/day based on mg/m2 . pregnant rats were treated with oral lurasidone at doses of 0.4, 2, and 10 mg/kg/day during the periods of organogenesis and lactation. these doses are 0.02, 0.1 and 0.6 times the mrhd of 160 mg/day based on mg/m2 . no pre- and postnatal developmental effects were observed up to 0.6 times the mrhd of 160 mg/day, based on mg/m2 . risk summary lactation studies have not been conducted to assess the presence of lurasidone in human milk, the effects on the breastfed infant, or the effects on milk production. lurasidone is present in rat milk. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for lurasidone hydrochloride and any potential adverse effects on the breastfed infant from lurasidone hydrochloride or from the underlying maternal condition. schizophrenia the safety and effectiveness of lurasidone hydrochloride 40-mg/day and 80-mg/day for the treatment of schizophrenia in adolescents (13 to 17 years) was established in a 6-week, placebo-controlled clinical study in 326 adolescent patients [see dosage and administration (2.1), adverse reactions (6.1), and clinical studies (14.1)]. the safety and effectiveness of lurasidone hydrochloride has not been established in pediatric patients less than 13 years of age with schizophrenia. bipolar depression the safety and effectiveness of lurasidone hydrochloride 20 to 80 mg/day for the treatment of bipolar depression in pediatric patients (10 to 17 years) was established in a 6-week, placebo-controlled clinical study in 347 pediatric patients [see dosage and administration (2.2), adverse reactions (6.1), and clinical studies (14.2)] . the safety and effectiveness of lurasidone hydrochloride has not been established in pediatric patients less than 10 years of age with bipolar depression. irritability associated with autistic disorder the effectiveness of lurasidone hydrochloride in pediatric patients for the treatment of irritability associated with autistic disorder has not been established. efficacy was not demonstrated in a 6-week study evaluating lurasidone hydrochloride 20 mg/day and 60 mg/day for the treatment of pediatric patients 6 to 17 years of age with irritability associated with autistic disorder diagnosed by diagnostic and statistical manual of mental disorders, 4th ed., text revision [dsm-iv-tr] criteria. the primary objective of the study as measured by improvement from baseline in the irritability subscale of the aberrant behavior checklist (abc) at endpoint (week 6) was not met. a total of 149 patients were randomized to lurasidone hydrochloride or placebo. vomiting occurred at a higher rate than reported in other lurasidone hydrochloride studies (4/49 or 8% for 20 mg, 14/51 or 27% for 60 mg, and 2/49 or 4% for placebo), particularly in children ages 6 to 12 (13 out of 18 patients on lurasidone hydrochloride with vomiting). in a long‐term, open‐label study that enrolled pediatric patients (age 6 to 17 years) with schizophrenia, bipolar depression, or autistic disorder, from three short‐term, placebo‐controlled trials, 54% (378/701) received lurasidone for 104 weeks. there was one adverse event in this trial that was considered possibly drug‐related and has not been reported in adults receiving lurasidone: a 10 year old male experienced a prolonged, painful erection, consistent with priapism, that led to treatment discontinuation. in this trial, the mean increase in height from open‐label baseline to week 104 was 4.94 cm. to adjust for normal growth, z‐scores were derived (measured in standard deviations [sd]), which normalize for the natural growth of children and adolescents by comparisons to age‐ and sexmatched population standards. a z‐score change <0.5 sd is considered not clinically significant. in this trial, the mean change in height z‐score from open‐label baseline to week 104 was +0.05 sd, indicating minimal deviation from the normal growth curve. juvenile animal studies adverse effects were seen on growth, physical and neurobehavioral development at doses as low as 0.2 times the mrhd based on mg/m2 . lurasidone was orally administered to rats from postnatal days 21 through 91 (this period corresponds to childhood, adolescence, and young adulthood in humans) at doses of 3, 30, and 150 (males) or 300 (females) mg/kg/day which are 0.2 to 10 times (males) and 20 times (females) the maximum recommended adult human dose (mrhd) of 160 mg/day based on mg/m2 . the adverse effects included dose-dependent decreases in femoral length, bone mineral content, body and brain weights at 2 times the mrhd in both sexes, and motor hyperactivity at 0.2 and 2 times the mrhd in both sexes based on mg/m2 . in females, there was a delay in attainment of sexual maturity at 2 times the mrhd, associated with decreased serum estradiol. mortality occurred in both sexes during early post- weaning period and some of the male weanlings died after only 4 treatments at doses as low as 2 times the mrhd based on mg/m2 . histopathological findings included increased colloid in the thyroids and inflammation of the prostate in males at 10 times mrhd based on mg/m2 and mammary gland hyperplasia, increased vaginal mucification, and increased ovarian atretic follicles at doses as low as 0.2 times the mrhd based on mg/m2 . some of these findings were attributed to transiently elevated serum prolactin which was seen in both sexes at all doses. however, there were no changes at any dose level in reproductive parameters (fertility, conception indices, spermatogenesis, estrous cycle, gestation length, parturition, number of pups born). the no effect dose for neurobehavioral changes in males is 0.2 times the mrhd based on mg/m2 and could not be determined in females. the no effect dose for growth and physical development in both sexes is 0.2 times the mrhd based on mg/m2 . clinical studies with lurasidone hydrochloride did not include sufficient numbers of patients aged 65 and older to determine whether or not they respond differently from younger patients. in elderly patients with psychosis (65 to 85), lurasidone hydrochloride concentrations (20 mg/day) were similar to those in young subjects. it is unknown whether dose adjustment is necessary on the basis of age alone. elderly patients with dementia-related psychosis treated with lurasidone hydrochloride are at an increased risk of death compared to placebo. lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis [see boxed warning, warnings and precautions (5.1, 5.3)] . reduce the maximum recommended dosage in patients with moderate or severe renal impairment (clcr<50 ml/minute). patients with impaired renal function (clcr<50 ml/minute) had higher exposure to lurasidone than patients with normal renal function [see clinical pharmacology (12.3)] . greater exposure may increase the risk of lurasidone hydrochloride-associated adverse reactions [see dosage and administration (2.4)] . reduce the maximum recommended dosage in patients with moderate to severe hepatic impairment (child-pugh score ≥7). patients with moderate to severe hepatic impairment (child-pugh score ≥7) generally had higher exposure to lurasidone than patients with normal hepatic function [see clinical pharmacology (12.3)] . greater exposure may increase the risk of lurasidone hydrochloride-associated adverse reactions [see dosage and administration (2.5)] . no dosage adjustment for lurasidone hydrochloride is required on the basis of a patient’s sex, race, or smoking status [see clinical pharmacology (12.3)]. lurasidone hydrochloride is not a controlled substance. lurasidone hydrochloride has not been systematically studied in humans for its potential for abuse or physical dependence or its ability to induce tolerance. while clinical studies with lurasidone hydrochloride did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict the extent to which a cns-active drug will be misused, diverted and/or abused once it is marketed. patients should be evaluated carefully for a history of drug abuse, and such patients should be observed carefully for signs of lurasidone hydrochloride misuse or abuse (e.g., development of tolerance, drug-seeking behavior, increases in dose).

কানাডা - ইংরেজি - Health Canada

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কানাডা - ইংরেজি - Health Canada

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কানাডা - ইংরেজি - Health Canada

glaxosmithkline consumer healthcare ulc - ibuprofen - tablet - 200mg - ibuprofen 200mg - other nonsteroidal antiimflammatory agents

কানাডা - ইংরেজি - Health Canada

glaxosmithkline consumer healthcare ulc - ibuprofen - tablet - 200mg - ibuprofen 200mg - other nonsteroidal antiimflammatory agents