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

otsuka america pharmaceutical, inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - abilify (aripiprazole) oral tablets, orally-disintegrating tablets, and oral solution are indicated for the treatment of: - schizophrenia - acute treatment of manic and mixed episodes associated with bipolar i disorder - adjunctive treatment of major depressive disorder - irritability associated with autistic disorder - treatment of tourette's disorder abilify injection is indicated for the treatment of: - agitation associated with schizophrenia or bipolar mania abilify is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including abilify, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhea

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

otsuka pharmaceutical factory, inc. - tolvaptan - blue tablet, major axis : 7.7 mm, minor axis: 4.4 mm, thickness: 2.6 mm

Egypt - English - EDA (Egyptian Drug Authority)

otsuka egypt - sachet

Egypt - English - EDA (Egyptian Drug Authority)

otsuka egypt - infusion

Egypt - English - EDA (Egyptian Drug Authority)

otsuka pharmaceutical-japan - tablet - 15 mg

Egypt - English - EDA (Egyptian Drug Authority)

otsuka pharmaceutical-japan - tablet - 10 mg

Egypt - English - EDA (Egyptian Drug Authority)

otsuka pharmaceutical-japan - coated tablet - 100 mg

Egypt - English - EDA (Egyptian Drug Authority)

otsuka pharmaceutical-japan - tablet - 100 mg

Egypt - English - EDA (Egyptian Drug Authority)

otsuka pharmaceutical-japan - tablet - 50 mg

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

otsuka america pharmaceutical, inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 300 mg in 1.5 ml - abilify maintena (aripiprazole) is indicated for: - treatment of schizophrenia in adults [see clinical studies (14.1)] - maintenance monotherapy treatment of bipolar i disorder in adults [see clinical studies (14.2)] abilify maintena is contraindicated in patients with a known hypersensitivity to aripiprazole. hypersensitivity reactions ranging from pruritus/urticaria to anaphylaxis have been reported in patients receiving aripiprazole [see adverse reactions (6.1 and 6.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abilify 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 exposed to antipsychotic drugs, including abilify maintena, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. there are insufficient data with abilify maintena use in pregnant women to inform a drug-associated risk. in animal reproduction studies, oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses 10 and 11 times, respectively, the maximum recommended human dose (mrhd) produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia. oral and intravenous aripiprazole administration during the pre- and post-natal period in rats at doses 10 times the mrhd produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival. consider the benefits and risks of abilify maintena and possible risks to the fetus when prescribing abilify maintena to a pregnant woman. advise pregnant women of potential fetal risk. the background risk of major birth defects and miscarriage for the indicated population are unknown. 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 (including oral aripiprazole) 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 exhibiting extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. animal data in animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits. pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day which are approximately 1 to 10 times the mrhd of 30 mg/day on mg/m2 basis of aripiprazole during the period of organogenesis. treatment at the highest dose caused a slight prolongation of gestation and delay in fetal development, as evidenced by decreased fetal weight and undescended testes. delayed skeletal ossification was observed at 3 and 10 times the oral mrhd on mg/m2 basis. at 3 and 10 times the oral mrhd on mg/m2 basis, delivered offspring had decreased body weights. increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia were observed in offspring from the highest dose group (the other dose groups were not examined for these findings). postnatally, delayed vaginal opening was seen at 3 and 10 times the oral mrhd on mg/m2 basis and impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) along with some maternal toxicity were seen at the highest dose; however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity. in pregnant rats treated with aripiprazole intravenously at doses of 3, 9, and 27 mg/kg/day, which are 1 to 9 times the oral mrhd on mg/m2 basis, during the period of organogenesis, decreased fetal weight and delayed skeletal ossification were seen at the highest dose which also caused maternal toxicity. in pregnant rabbits treated with oral doses of 10, 30, and 100 mg/kg/day which are 2 to 11 times human exposure at the oral mrhd based on auc and 6 to 65 times the oral mrhd of aripiprazole on mg/m2 basis during the period of organogenesis, decreased maternal food consumption and increased abortions were seen at the highest dose as well as increased fetal mortality. decreased fetal weight and increased incidence of fused sternebrae were observed at 3 and 11 times the mrhd based on auc. in pregnant rabbits receiving aripiprazole injection intravenously at doses of 3, 10, and 30 mg/kg/day, which are 2 to 19 times the oral mrhd on mg/m2 basis during the period of organogenesis, the highest dose caused pronounced maternal toxicity that resulted in decreased fetal weight, increased fetal abnormalities (primarily skeletal), and decreased fetal skeletal ossification. the fetal no-effect dose was 5 times the human exposure at the oral mrhd based on auc and is 6 times the oral mrhd on mg/m2 basis. in rats treated with oral doses of 3, 10, and 30 mg/kg/day, which are 1 to 10 times the oral mrhd of aripiprazole on a mg/m2 basis, peri- and post-natally (from day 17 of gestation through day 21 postpartum), slight maternal toxicity and slightly prolonged gestation were seen at the highest dose. an increase in stillbirths and decreases in pup weight (persisting into adulthood) and survival were also seen at this dose. in rats treated with aripiprazole intravenously at doses of 3, 8, and 20 mg/kg/day which are 1 to 6 times the oral mrhd on mg/m2 basis from day 6 of gestation through day 20 postpartum, increased stillbirths were seen at 3 and 6 times the mrhd on mg/m2 basis, and decreases in early postnatal pup weight and survival were seen at the highest dose; these doses produced some maternal toxicity. there were no effects on postnatal behavioral and reproductive development. risk summary aripiprazole is present in human breast milk; however, there are insufficient data to assess the amount in human milk, the effects on the breastfed infant, or the effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for abilify maintena and any potential adverse effects on the breastfed infant from abilify maintena or from the underlying maternal condition. abilify maintena has not been studied in children 18 years of age or younger. however, juvenile animal studies have been conducted in rats and dogs. juvenile animal studies aripiprazole in juvenile rats caused mortality, cns clinical signs, impaired memory and learning, and delayed sexual maturation when administered at oral doses of 10, 20, 40 mg/kg/day from weaning (21 days old) through maturity (80 days old). at 40 mg/kg/day, mortality, decreased activity, splayed hind limbs, hunched posture, ataxia, tremors and other cns signs were observed in both genders. in addition, delayed sexual maturation was observed in males. at all doses and in a dose-dependent manner, impaired memory and learning, increased motor activity, and histopathology changes in the pituitary (atrophy), adrenals (adrenocortical hypertrophy), mammary glands (hyperplasia and increased secretion), and female reproductive organs (vaginal mucification, endometrial atrophy, decrease in ovarian corpora lutea) were observed. the changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. a no observed adverse effect level (noael) could not be determined and, at the lowest tested dose of 10 mg/kg/day, there is no safety margin relative to the systemic exposures (auc0-24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. all drug-related effects were reversible after a 2-month recovery period, and most of the drug effects in juvenile rats were also observed in adult rats from previously conducted studies. aripiprazole in juvenile dogs (2 months old) caused cns clinical signs of tremors, hypoactivity, ataxia, recumbency and limited use of hind limbs when administered orally for 6 months at 3, 10, 30 mg/kg/day. mean body weight and weight gain were decreased up to 18% in females in all drug groups relative to control values. a noael could not be determined and, at the lowest tested dose of 3 mg/kg/day, there is no safety margin relative to the systemic exposures (auc0-24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. all drug-related effects were reversible after a 2-month recovery period. clinical studies of oral aripiprazole did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience and pharmacokinetic data [see clinical pharmacology (12.3)] have not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in single-dose and multiple-dose pharmacokinetic studies, there was no detectable age effect in the population pharmacokinetic analysis of oral aripiprazole in schizophrenia patients [see clinical pharmacology (12.3)] . no dosage adjustments are recommended based on age alone. abilify maintena is not approved for the treatment of patients with dementia-related psychosis [see also boxed warning and warnings and precautions (5.1)]. dosage adjustment is recommended in known cyp2d6 poor metabolizers due to high aripiprazole concentrations. approximately 8% of caucasians and 3% to 8% of black/african americans cannot metabolize cyp2d6 substrates and are classified as poor metabolizers (pm) [see dosage and administration (2.3) and clinical pharmacology (12.3)] . no dosage adjustment for abilify maintena is required on the basis of a patient's hepatic function (mild to severe hepatic impairment, child-pugh score between 5 and 15), or renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 ml/minute) [see clinical pharmacology (12.3)] . no dosage adjustment for abilify maintena is required on the basis of a patient's sex, race, or smoking status [see clinical pharmacology (12.3)] .