Ireland - English - HPRA (Health Products Regulatory Authority)

norton waterford - paliperidone; paliperidone - prolonged-release suspension for injection - 150 mg + 100 milligram(s) - paliperidone

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

remedyrepack inc. - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone 9 mg - paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)] . the efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)] . the efficacy of paliperidone extended-release tablets in schizoaffective disorder was established in two 6-week trials in adults. paliperidone extended-release tablets are contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone extended-release tablets formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and

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

actavis pharma, inc. - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone 1.5 mg - paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies ( 14.1 )] . the efficacy of paliperidone in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies ( 14.2 )] . the efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults. paliperidone is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone extended-release tablet 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 paliperidone, 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 paliperidone 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 and with exposure to antipsychotics, including paliperidone, during pregnancy (see clinical considerations) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, 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% to 4% and 15% to 20%, respectively. in animal reproduction studies, there were no increases in fetal abnormalities when pregnant rats and rabbits were treated with paliperidone during the period of organogenesis with up to 8 times the maximum recommended human dose (mrhd) based on mg/m2 body surface area. additional reproduction toxicity studies were conducted with orally administered risperidone, which is extensively converted to paliperidone (see animal data) . clinical considerations disease-associated maternal and/or embryo/fetal risk there is a risk to the mother from untreated schizophrenia, including increased risk of relapse, hospitalization, and suicide. schizophrenia 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 paliperidone, 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, the parent compound of paliperidone, demonstrated placental passage of risperidone and paliperidone. 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 to 1.56) and of cardiac malformations (rr=1.26, 95% ci 0.88 to 1.81) in a subgroup of 1566 women exposed to the parent compound of paliperidone, risperidone, during the first trimester of pregnancy; however, there is no mechanism of action to explain the difference in malformation rates. animal data in animal reproduction studies, there were no increases in fetal abnormalities when pregnant rats and rabbits were treated with paliperidone during the period of organogenesis with up to 8 times the mrhd of 12 mg based on mg/m2 body surface area. additional reproduction toxicity studies were conducted with orally administered risperidone, which is extensively converted to paliperidone. cleft palate was observed in the offspring of pregnant mice treated with risperidone at 3 to 4 times the mrhd of 16 mg based on mg/m2 body surface area; maternal toxicity occurred at 4 times the mrhd. there was no evidence of teratogenicity in embryo-fetal developmental toxicity studies with risperidone in rats and rabbits at doses up to 6 times the mrhd of 16 mg/day risperidone based on mg/m2 body surface area. when the offspring of pregnant rats, treated with risperidone at 0.6 times the mrhd based on mg/m2 body surface area, reached adulthood, learning was impaired. increased neuronal cell death occurred in the fetal brains of the offspring of pregnant rats treated at 0.5 to 1.2 times the mrhd; the postnatal development and growth of the offspring was delayed. in rat reproduction studies with risperidone, pup deaths occurred at oral doses which are less than the mrhd of risperidone based on mg/m2 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 (see risperdal®  package insert) . risk summary limited data from published literature report the presence of paliperidone in human breast milk. there is no information on the effects on the breastfed infant, or the effects on milk production; however, there are reports of sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) in breastfed infants exposed to paliperidone’s parent compound, risperidone (see clinical considerations) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for paliperidone and any potential adverse effects on the breastfed child from paliperidone or from the mother’s underlying condition. clinical considerations infants exposed to paliperidone 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 paliperidone (d2 receptor antagonism), treatment with paliperidone 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 (5.7)] . safety and effectiveness of paliperidone in the treatment of schizophrenia were evaluated in 150 adolescent subjects 12 to 17 years of age with schizophrenia who received paliperidone in the dose range of 1.5 mg to 12 mg/day in a 6-week, double-blind, placebo-controlled trial. safety and effectiveness of paliperidone for the treatment of schizophrenia in patients ˂ 12 years of age have not been established. safety and effectiveness of paliperidone for the treatment of schizoaffective disorder in patients ˂ 18 years of age have not been studied. juvenile animal studies in a study in which juvenile rats were treated with oral paliperidone from days 24 to 73 of age, a reversible impairment of performance in a test of learning and memory was seen, in females only, with a no-effect dose of 0.63 mg/kg/day, which produced plasma levels (auc) of paliperidone similar to those in adolescents at mrhd of 12 mg/day. no other consistent effects on neurobehavioral or reproductive development were seen up to the highest dose tested (2.5 mg/kg/day), which produced plasma levels of paliperidone 2 to 3 times those in adolescents. juvenile dogs were treated for 40 weeks with oral risperidone, which is extensively metabolized to paliperidone in animals and humans, at doses of 0.31, 1.25, or 5 mg/kg/day. decreased bone length and density were seen with a no-effect dose of 0.31 mg/kg/day, which produced plasma levels (auc) of risperidone plus paliperidone which were similar to those in children and adolescents receiving the mrhd of risperidone. in addition, a delay in sexual maturation was seen 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. the long-term effects of paliperidone on growth and sexual maturation have not been fully evaluated in children and adolescents. the safety, tolerability, and efficacy of paliperidone were evaluated in a 6-week placebo-controlled study of 114 elderly subjects with schizophrenia (65 years of age and older, of whom 21 were 75 years of age and older). in this study, subjects received flexible doses of paliperidone (3 mg to 12 mg once daily). in addition, a small number of subjects 65 years of age and older were included in the 6-week placebo-controlled studies in which adult schizophrenic subjects received fixed doses of paliperidone (3 mg to 15 mg once daily) [see clinical studies (14)] . there were no subjects ≥ 65 years of age in the schizoaffective disorder studies. overall, of the total number of subjects in schizophrenia clinical studies of paliperidone (n=1796), including those who received paliperidone or placebo, 125 (7.0%) were 65 years of age and older and 22 (1.2%) were 75 years of age and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. this drug is known to be substantially excreted by the kidney and clearance is decreased in patients with moderate to severe renal impairment [see clinical pharmacology ( 12.3 )] , who should be given reduced doses. 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 ( 2.5 )] . dosing must be individualized according to the patient’s renal function status [see dosage and administration ( 2.5 )] . no dosage adjustment is required in patients with mild to moderate hepatic impairment. paliperidone has not been studied in patients with severe hepatic impairment. patients with parkinson’s disease or dementia with lewy bodies can experience increased sensitivity to paliperidone. manifestations can include confusion, obtundation, postural instability with frequent falls, extrapyramidal symptoms, and clinical features consistent with neuroleptic malignant syndrome. paliperidone is not a controlled substance. paliperidone has not been systematically studied in animals or humans for its potential for abuse. it is not possible to predict 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 paliperidone misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). paliperidone has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.

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

mylan institutional inc. - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone 3 mg - paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)] . the efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)] . the efficacy of paliperidone extended-release tablets in schizoaffective disorder was established in two 6-week trials in adults. paliperidone extended-release tablets are contraindicated in patients with a

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

mylan pharmaceuticals inc. - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone 1.5 mg - paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)] . the efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)] . the efficacy of paliperidone extended-release tablets in schizoaffective disorder was established in two 6-week trials in adults. paliperidone extended-release tablets are contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone extended-release tablets formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in

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

patriot pharmaceuticals, llc - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone 3 mg - paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)] . the efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)] . the efficacy of paliperidone extended-release tablets in schizoaffective disorder was established in two 6-week trials in adults. paliperidone extended-release tablets are contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone extended-release tablets formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients t

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

carilion materials management - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone 6 mg - paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)]. the efficacy of paliperidone in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)] . the efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults.  hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone and paliperidone. paliperidone is a metabolite of risperidone and is therefore contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in paliperidone extended-release tablets. pregnancy category c . there are no

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

remedyrepack inc. - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)] . the efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)] . the efficacy of paliperidone extended-release tablets in schizoaffective disorder was established in two 6-week trials in adults. paliperidone extended-release tablets are contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone extended-release tablets formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and

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

remedyrepack inc. - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)] . the efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)] . the efficacy of paliperidone extended-release tablets in schizoaffective disorder was established in two 6-week trials in adults. paliperidone extended-release tablets are contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone extended-release tablets formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and

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

inventia healthcare limited - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)]. the efficacy of paliperidone in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)]. the efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults. paliperidoneis contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone 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 reg