Bandaríkin - enska - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - iloperidone (unii: vpo7kj050n) (iloperidone - unii:vpo7kj050n) - iloperidone tablets are indicated for the treatment of schizophrenia in adults. when deciding among the alternative treatments available for this condition, the prescriber should consider the finding that iloperidone tablets are associated with prolongation of the qtc interval [see warnings and precautions (5.3)] . prolongation of the qtc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death. in many cases this would lead to the conclusion that other drugs should be tried first. whether iloperidone tablets will cause torsade de pointes or increase the rate of sudden death is not yet known. patients must be titrated to an effective dose of iloperidone tablets. thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require a similar titration. prescribers should be mindful of this delay when

Bandaríkin - enska - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - iloperidone (unii: vpo7kj050n) (iloperidone - unii:vpo7kj050n) - iloperidone 1 mg - iloperidone tablets are indicated for the treatment of schizophrenia in adults. when deciding among the alternative treatments available for this condition, the prescriber should consider the finding that iloperidone is associated with prolongation of the qtc interval [see warnings and precautions (5.3)] . prolongation of the qtc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death. in many cases this would lead to the conclusion that other drugs should be tried first. whether iloperidone tablets will cause torsade de pointes or increase the rate of sudden death is not yet known. patients must be titrated to an effective dose of iloperidone tablets. thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require a similar titration. prescribers should be mindful of this delay when selecti

Bandaríkin - enska - NLM (National Library of Medicine)

vanda pharmaceuticals inc. - iloperidone (unii: vpo7kj050n) (iloperidone - unii:vpo7kj050n) - iloperidone 1 mg - fanapt®  is indicated for: - treatment of schizophrenia in adults [see clinical studies (14.1)]. - acute treatment of manic or mixed episodes associated with bipolar i disorder in adults [see clinical studies (14.2)] . fanapt is contraindicated in individuals with a known hypersensitivity reaction to the product. anaphylaxis, angioedema, and other hypersensitivity reactions have been reported [see adverse reactions (6.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to fanapt during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . risk summary neonates whose mothers are exposed to antipsychotic drugs, including fanapt, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery [see clinical considerations] . the limited available data with fanapt in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. iloperidone was not teratogenic when administered orally to pregnant rats during organogenesis at doses up to 26 times the maximum recommended human dose of 24 mg/day on mg/m2 basis. however, it prolonged the duration of pregnancy and parturition, increased still births, early intrauterine deaths, increased incidence of developmental delays, and decreased post-partum pup survival. iloperidone was not teratogenic when administered orally to pregnant rabbits during organogenesis at doses up to 20-times the mrhd on mg/m2 basis. however, it increased early intrauterine deaths and decreased fetal viability at term at the highest dose which was also a maternally toxic dose [see data] . the background risk of major birth defects and miscarriage for the indicated population is unknown. 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. 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 whose mothers 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 in an embryo-fetal development study, pregnant rats were given 4, 16, or 64 mg/kg/day (1.6, 6.5, and 26 times the maximum recommended human dose (mrhd) of 24 mg/day on a mg/m2 basis) of iloperidone orally during the period of organogenesis. the highest dose caused increased early intrauterine deaths, decreased fetal weight and length, decreased fetal skeletal ossification, and an increased incidence of minor fetal skeletal anomalies and variations; this dose also caused decreased maternal food consumption and weight gain. in an embryo-fetal development study, pregnant rabbits were given 4, 10, or 25 mg/kg/day (3, 8, and 20 times the mrhd on a mg/m2 basis) of iloperidone during the period of organogenesis. the highest dose caused increased early intrauterine deaths and decreased fetal viability at term; this dose also caused maternal toxicity. in additional studies in which rats were given iloperidone at doses similar to the above beginning from either pre-conception or from day 17 of gestation and continuing through weaning, adverse reproductive effects included prolonged pregnancy and parturition, increased stillbirth rates, increased incidence of fetal visceral variations, decreased fetal and pup weights, and decreased post-partum pup survival. there were no drug effects on the neurobehavioral or reproductive development of the surviving pups. no-effect doses ranged from 4 to 12 mg/kg except for the increase in stillbirth rates which occurred at the lowest dose tested of 4 mg/kg, which is 1.6 times the mrhd on a mg/m2 basis. maternal toxicity was seen at the higher doses in these studies. the iloperidone metabolite p95, which is a major circulating metabolite of iloperidone in humans but is not present in significant amounts in rats, was given to pregnant rats during the period of organogenesis at oral doses of 20, 80, or 200 mg/kg/day. no teratogenic effects were seen. delayed skeletal ossification occurred at all doses. no significant maternal toxicity was produced. plasma levels of p95 (auc) at the highest dose tested were 2 times those in humans receiving the mrhd of iloperidone. risk summary there is no information regarding the presence of iloperidone or its metabolites in human milk, the effects of iloperidone on a breastfed child, nor the effects of iloperidone on human milk production. iloperidone is present in rat milk [see data ]. because of the potential for serious adverse reactions in breastfed infants, advise a woman not to breastfeed during treatment with fanapt. data the transfer of radioactivity into the milk of lactating rats was investigated following a single dose of [14c] iloperidone at 5 mg/kg. the concentration of radioactivity in milk at 4 hours post-dose was near 10-fold greater than that in plasma at the same time. however, by 24 hours after dosing, concentrations of radioactivity in milk had fallen to values slightly lower than plasma. the metabolic profile in milk was qualitatively similar to that in plasma. safety and effectiveness of fanapt have not been established in pediatric patients. clinical studies of fanapt in the treatment of schizophrenia did not include sufficient numbers of patients aged 65 years and over to determine whether or not they respond differently than younger adult patients. of the 3,210 patients with schizophrenia treated with fanapt in clinical trials, 25 (0.5%) were ≥65 years old and there were no patients ≥75 years old. of the 206 patients with bipolar mania treated with fanapt in a clinical trial, 2 (0.1%) were 65 years old and there were no patients were >65 years old. elderly patients with dementia-related psychosis treated with fanapt are at an increased risk of death compared to placebo. fanapt is not approved for the treatment of patients with dementia-related psychosis [see boxed warning and warnings and precautions (5.1, 5.2)] . no dose adjustment to fanapt is needed in patients with mild hepatic impairment (child-pugh class a). patients with moderate hepatic impairment (child-pugh class b) may require dose reduction. fanapt is not recommended for patients with severe hepatic impairment (child-pugh class c) [see dosage and administration (2.3), clinical pharmacology (12.3)] . fanapt is not a controlled substance. fanapt has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. while the clinical trials did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this experience the extent to which a cns active drug, fanapt, 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 fanapt misuse or abuse (e.g. development of tolerance, increases in dose, drug-seeking behavior).

Bandaríkin - enska - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - iloperidone (unii: vpo7kj050n) (iloperidone - unii:vpo7kj050n) - iloperidone 1 mg

Bandaríkin - enska - NLM (National Library of Medicine)

avera mckennan hospital - iloperidone (unii: vpo7kj050n) (iloperidone - unii:vpo7kj050n) - iloperidone 4 mg - fanapt®  tablets are indicated for the treatment of adults with schizophrenia. efficacy was established in two short-term (4- and 6-week) placebo-and active-controlled studies of adult patients with schizophrenia [see clinical studies (14)] . when deciding among the alternative treatments available for this condition, the prescriber should consider the finding that fanapt is associated with prolongation of the qtc interval [see warnings and precautions (5.2)] . prolongation of the qtc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death. in many cases this would lead to the conclusion that other drugs should be tried first. whether fanapt will cause torsade de pointes or increase the rate of sudden death is not yet known. patients must be titrated to an effective dose of fanapt. thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared

Ísrael - enska - Ministry of Health

megapharm ltd - iloperidone - tablets - iloperidone 1 mg - iloperidone - iloperidone - fanapt is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults.

Ísrael - enska - Ministry of Health

megapharm ltd - iloperidone - tablets - iloperidone 2 mg - iloperidone - iloperidone - fanapt is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults.

Ísrael - enska - Ministry of Health

megapharm ltd - iloperidone - tablets - iloperidone 4 mg - iloperidone - iloperidone - fanapt is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults.

Ísrael - enska - Ministry of Health

megapharm ltd - iloperidone - tablets - iloperidone 6 mg - iloperidone - iloperidone - fanapt is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults.

Ísrael - enska - Ministry of Health

megapharm ltd - iloperidone - tablets - iloperidone 8 mg - iloperidone - iloperidone - fanapt is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults.