Australia - English - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - aripiprazole, quantity: 2 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; magnesium stearate; iron oxide yellow; maize starch; microcrystalline cellulose; hyprolose; indigo carmine aluminium lake; colloidal anhydrous silica - aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - aripiprazole, quantity: 30 mg - tablet, uncoated - excipient ingredients: maize starch; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; microcrystalline cellulose; hyprolose - aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

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

avpak - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole oral tablets are indicated for the treatment of: • schizophrenia [see clinical studies ( 14.1 )] additional pediatric use information is approved for otsuka america pharmaceutical, inc.'s abilify ® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole tablets are 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)] . teratogenic effects pregnancy category c: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole 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 aripiprazole tablets) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. adequate and well controlled studies with aripiprazole tablets have not been conducted in pregnant women. animal reproduction studies were conducted with aripiprazole in rats and rabbits during organogenesis, and in rats during the pre- and post-natal period. oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses higher than 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 higher than the maximum recommended human dose (mrhd) produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival. administer aripiprazole tablets during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 aripiprazole tablets) 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. data 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 (1, 3, and 10 times the maximum recommended human dose [mrhd] on a mg/m 2 basis) of aripiprazole during the period of organogenesis. gestation was slightly prolonged at 30 mg/kg/day. treatment at the high dose of 30 mg/kg/day caused a slight delay in fetal development (decreased fetal weight), undescended testes, and delayed skeletal ossification (also seen at 10 mg/kg/day). there were no adverse effects on embryofetal or pup survival. delivered offspring had decreased body weights (10 and 30 mg/kg/day), and increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia at 30 mg/kg (the other dose groups were not examined for these findings). postnatally, delayed vaginal opening was seen at 10 and 30 mg/kg/day and impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) was seen at 30 mg/kg/day. some maternal toxicity was seen at 30 mg/kg/day however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity. pregnant rabbits were treated with oral doses of 10, 30, and 100 mg/kg/day (2, 3, and 11 times human exposure at mrhd based on auc and 6, 19, and 65 times the mrhd based on mg/m 2 ) of aripiprazole during the period of organogenesis. at the high dose of 100 mg/kg/day decreased maternal food consumption, and increased abortions were seen as well as increased fetal mortality, decreased fetal weight (also seen at 30 mg/kg/day), increased incidence of a skeletal abnormality (fused sternebrae) (also seen at 30 mg/kg/day). in a study in which rats were treated peri- and post-natally with oral doses of 3, 10, and 30 mg/kg/day (1, 3, and 10 times the mrhd on a mg/m 2 basis) of aripiprazole from day 17 through day 21 postpartum, slight maternal toxicity, slightly prolonged gestation an increase in stillbirths and, decreases in pup weight (persisting into adulthood) and survival were seen at 30 mg/kg/day. the effect of aripiprazole tablets on labor and delivery in humans is unknown. aripiprazole is present in human breast milk. because of the potential for serious adverse reactions in nursing infants from aripiprazole tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the pharmacokinetics of aripiprazole and dehydro-aripiprazole in pediatric patients, 10 to 17 years of age, were similar to those in adults after correcting for the differences in body weight [see clinical pharmacology ( 12.3)]. schizophrenia safety and effectiveness in pediatric patients with schizophrenia were established in a 6-week, placebo-controlled clinical trial in 202 pediatric patients aged 13 to 17 years [see dosage and administration ( 2.1), adverse reactions ( 6.1), and clinical studies ( 14.1)]. although maintenance efficacy in pediatric patients has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. information describing a clinical study in which efficacy was not demonstrated in patients ages 6 to 17 years is approved for otsuka america pharmaceutical, inc.'s abilify® (aripiprazole). additional pediatric use information in patients ages 6 to 18 years is approved for otsuka america pharmaceutical, inc.'s abilify® (aripiprazole) product.  however, due to otsuka america pharmaceutical, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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, 40mg/kg/day from weaning (21 days old) through maturity (80 days old). at 40mg/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 10mg/kg/day, there is no safety margin relative to the systemic exposures (auc 0 to 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 (auc 0 to 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. no dosage adjustment is recommended for elderly patients [see  boxed warning, warnings and precautions ( 5.1), and clinical pharmacology ( 12.3)]. of the 13,543 patients treated with oral aripiprazole tablets in clinical trials, 1073 (8%) were ≥65 years old and 799 (6%) were ≥75 years old. placebo-controlled studies of oral aripiprazole in schizophrenia, other indications did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. aripiprazole tablets are not approved for the treatment of patients with psychosis associated with alzheimer's disease [see  boxed warningand 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 ( 2.7) and clinical pharmacology ( 12.3)]. no dosage adjustment for aripiprazole tablets 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 aripiprazole tablets are required on the basis of a patient's sex, race, or smoking status [see clinical pharmacology ( 12.3)] aripiprazole tablet is not a controlled substance. aripiprazole tablet has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of aripiprazole tablets misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). in physical dependence studies in monkeys, withdrawal symptoms were observed upon abrupt cessation of dosing. 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - aripiprazole, quantity: 30 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; hyprolose; magnesium stearate - aripiprazole gh is indicated for: ? the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy; ? acute treatment of manic or mixed episodes associated with bipolar i disorder in adults as monotherapy and in combination with lithium or valproate. ? maintenance treatment of manic or mixed episodes in bipolar i disorder in adults as monotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - aripiprazole, quantity: 20 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; hyprolose; magnesium stearate - aripiprazole gh is indicated for: ? the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy; ? acute treatment of manic or mixed episodes associated with bipolar i disorder in adults as monotherapy and in combination with lithium or valproate. ? maintenance treatment of manic or mixed episodes in bipolar i disorder in adults as monotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - aripiprazole, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; hyprolose; magnesium stearate - aripiprazole gh is indicated for: ? the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy; ? acute treatment of manic or mixed episodes associated with bipolar i disorder in adults as monotherapy and in combination with lithium or valproate. ? maintenance treatment of manic or mixed episodes in bipolar i disorder in adults as monotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - aripiprazole, quantity: 5 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; indigo carmine aluminium lake; croscarmellose sodium; tartaric acid; magnesium stearate - aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.,acute treatment of manic or mixed episodes associated with bipolar i disorder in adults as monotherapy and in combination with lithium or valproate;,maintenance treatment of manic or mixed episodes in bipolar i disorder in adults as monotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - aripiprazole, quantity: 15 mg - tablet, uncoated - excipient ingredients: iron oxide yellow; microcrystalline cellulose; croscarmellose sodium; tartaric acid; magnesium stearate - aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.,acute treatment of manic or mixed episodes associated with bipolar i disorder in adults as monotherapy and in combination with lithium or valproate;,maintenance treatment of manic or mixed episodes in bipolar i disorder in adults as monotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - aripiprazole, quantity: 5 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; iron oxide yellow; hyprolose; croscarmellose sodium; magnesium stearate - aripiprazole-teva is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - aripiprazole, quantity: 10 mg - tablet, uncoated - excipient ingredients: tartaric acid; microcrystalline cellulose; croscarmellose sodium; iron oxide red; magnesium stearate - aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.,acute treatment of manic or mixed episodes associated with bipolar i disorder in adults as monotherapy and in combination with lithium or valproate;,maintenance treatment of manic or mixed episodes in bipolar i disorder in adults as monotherapy.