Amerika Serikat - Inggris - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperdal ® (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 risperdal ® 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 risperdal ® 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)] . risperdal ® is indicated for the

Amerika Serikat - Inggris - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperdal ® (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 risperdal ® 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 risperdal ® 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)] . risperdal ® is indicated for the

Amerika Serikat - Inggris - NLM (National Library of Medicine)

remedyrepack inc. - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperdal ® (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 risperdal ® 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 risperdal ® 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)] . risperdal ® is indicated for the

Amerika Serikat - Inggris - NLM (National Library of Medicine)

remedyrepack inc. - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperdal ® (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 risperdal ® 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 risperdal ® 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)] . risperdal ® is indicated for the

Amerika Serikat - Inggris - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperidone 12.5 mg in 2 ml - risperdal consta ® (risperidone) is indicated for the treatment of schizophrenia [see clinical studies (14.1)]. risperdal consta ® is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar i disorder [see clinical studies (14.2 , 14.3)] . risperdal consta ® is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the risperdal consta ® 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 risperdal consta ® , 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-and-research-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 risperdal consta ® , during pregnancy (see clinical considerations) . risperidone has been detected in plasma in adult subjects up to 8 weeks after a single-dose administration of risperdal consta ® [see clinical pharmacology (12.3)] . the clinical significance of risperdal consta ® administered before pregnancy or anytime during pregnancy is not known. 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 the 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 risperdal consta ® , 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 major of 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). risperidone has been detected in plasma in adult subjects up to 8 weeks after a single-dose administration of risperdal consta ® [see clinical pharmacology (12.3)] , and the clinical significance on the breastfed infant is not known. 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 risperdal consta ® and any potential adverse effects on the breastfed child from risperdal consta ® or from the mother's underlying condition. clinical considerations infants exposed to risperdal consta ® 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 risperdal consta ® 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)]. safety and effectiveness of risperdal consta ® in pediatric patients have not been established. however, juvenile animal toxicology studies have been conducted with oral risperidone. 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. in an open-label study, 57 clinically stable, elderly patients (≥ 65 years old) with schizophrenia or schizoaffective disorder received risperdal consta ® every 2 weeks for up to 12 months. in general, no differences in the tolerability of risperdal consta ® were observed between otherwise healthy elderly and nonelderly patients. therefore, dosing recommendations for otherwise healthy elderly patients are the same as for nonelderly patients. because elderly patients exhibit a greater tendency to orthostatic hypotension than nonelderly patients, elderly patients should be instructed in nonpharmacologic interventions that help to reduce the occurrence of orthostatic hypotension (e.g., sitting on the edge of the bed for several minutes before attempting to stand in the morning and slowly rising from a seated position). in addition, monitoring of orthostatic vital signs should be considered in elderly patients for whom orthostatic hypotension is of concern [see warnings and precautions (5.7)] . concomitant use with furosemide in elderly patients with dementia-related psychosis in two of four placebo-controlled trials in elderly patients with dementia-related psychosis, a higher incidence of mortality was observed in patients treated with furosemide plus oral risperidone when compared to patients treated with oral risperidone alone or with oral placebo plus furosemide. no pathological mechanism has been identified to explain this finding, and no consistent pattern for cause of death was observed. an increase of mortality in elderly patients with dementia-related psychosis was seen with the use of oral risperidone regardless of concomitant use with furosemide. risperdal consta ® is not approved for the treatment of patients with dementia-related psychosis. [see boxed warning and warnings and precautions (5.1)] . in patients with renal or hepatic impairment, carefully titrate with oral risperidone prior to initiating treatment with risperdal consta ® [see dosage and administration (2.4)]. patients with renal impairment may have less ability to eliminate risperidone than patients with normal renal function. patients with impaired hepatic function may have an increase in the free fraction of risperidone, possibly resulting in an enhanced effect [see clinical pharmacology (12.3)] . patients with parkinson's disease or dementia with lewy bodies can experience increased sensitivity to risperdal consta ® . manifestations can include confusion, obtundation, postural instability with frequent falls, extrapyramidal symptoms, and clinical features consistent with neuroleptic malignant syndrome. risperdal consta ® (risperidone) is not a controlled substance. risperdal consta ® has not been systematically studied in animals or humans for its potential for abuse. because risperdal consta ® is to be administered by health care professionals, the potential for misuse or abuse by patients is low. risperdal consta ® has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.

Israel - Inggris - Ministry of Health

j-c health care ltd - risperidone - powder for suspension for injection - risperidone 25 mg/vial - risperidone - risperidone - risperdal consta is indicated for the treatment of schizophrenia and schizoaffective disorders.risperdal consta is indicated as monotherapy for the maintenance treatment of bipolar i disorder to delay occurrence of mood episodes.risperdal consta is indicated for adjunctive maintenance treatment to delay occurrence of mood episodes in patients with frequently relapsing bipolar disorder.

Israel - Inggris - Ministry of Health

j-c health care ltd - risperidone - powder for suspension for injection - risperidone 25 mg/vial - risperidone - risperidone - risperdal consta is indicated for the treatment of schizophrenia and schizoaffective disorders.risperdal consta is indicated as monotherapy for the maintenance treatment of bipolar i disorder to delay occurrence of mood episodes.risperdal consta is indicated for adjunctive maintenance treatment to delay occurrence of mood episodes in patients with frequently relapsing bipolar disorder.

Israel - Inggris - Ministry of Health

j-c health care ltd - risperidone - powder for suspension for injection - risperidone 37.5 mg/vial - risperidone - risperidone - risperdal consta is indicated for the treatment of schizophrenia and schizoaffective disorders.risperdal consta is indicated as monotherapy for the maintenance treatment of bipolar i disorder to delay occurrence of mood episodes.risperdal consta is indicated for adjunctive maintenance treatment to delay occurrence of mood episodes in patients with frequently relapsing bipolar disorder.

Israel - Inggris - Ministry of Health

j-c health care ltd - risperidone - powder for suspension for injection - risperidone 37.5 mg/vial - risperidone - risperidone - risperdal consta is indicated for the treatment of schizophrenia and schizoaffective disorders.risperdal consta is indicated as monotherapy for the maintenance treatment of bipolar i disorder to delay occurrence of mood episodes.risperdal consta is indicated for adjunctive maintenance treatment to delay occurrence of mood episodes in patients with frequently relapsing bipolar disorder.

Israel - Inggris - Ministry of Health

j-c health care ltd - risperidone - powder for suspension for injection - risperidone 50 mg/vial - risperidone - risperidone - risperdal consta is indicated for the treatment of schizophrenia and schizoaffective disorders.risperdal consta is indicated as monotherapy for the maintenance treatment of bipolar i disorder to delay occurrence of mood episodes.risperdal consta is indicated for adjunctive maintenance treatment to delay occurrence of mood episodes in patients with frequently relapsing bipolar disorder.