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

arrotex pharmaceuticals pty ltd - olanzapine, quantity: 15 mg - tablet, orally disintegrating - excipient ingredients: mannitol; sucralose; microcrystalline cellulose; colloidal anhydrous silica; carmellose calcium; magnesium stearate - - treatment of schizophrenia and related psychoses;. - short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar i disorder;. - preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

arrotex pharmaceuticals pty ltd - olanzapine, quantity: 20 mg - tablet, orally disintegrating - excipient ingredients: sucralose; carmellose calcium; magnesium stearate; microcrystalline cellulose; mannitol; colloidal anhydrous silica - - treatment of schizophrenia and related psychoses;. - short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar i disorder;. - preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

arrotex pharmaceuticals pty ltd - olanzapine, quantity: 10 mg - tablet, orally disintegrating - excipient ingredients: microcrystalline cellulose; carmellose calcium; sucralose; mannitol; magnesium stearate; colloidal anhydrous silica - - treatment of schizophrenia and related psychoses;. - short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar i disorder;. - preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

arrotex pharmaceuticals pty ltd - olanzapine, quantity: 10 mg - tablet, orally disintegrating - excipient ingredients: colloidal anhydrous silica; sodium stearylfumarate; mannitol; aspartame; crospovidone; polacrilin potassium; microcrystalline cellulose; flavour - for the treatment of schizophrenia and related psychoses. alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder. for preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

arrotex pharmaceuticals pty ltd - olanzapine, quantity: 15 mg - tablet, orally disintegrating - excipient ingredients: mannitol; sodium stearylfumarate; polacrilin potassium; colloidal anhydrous silica; aspartame; crospovidone; microcrystalline cellulose; flavour - for the treatment of schizophrenia and related psychoses. alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder. for preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

arrotex pharmaceuticals pty ltd - olanzapine, quantity: 5 mg - tablet, orally disintegrating - excipient ingredients: mannitol; aspartame; microcrystalline cellulose; crospovidone; sodium stearylfumarate; polacrilin potassium; colloidal anhydrous silica; flavour - for the treatment of schizophrenia and related psychoses. alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder. for preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

arrotex pharmaceuticals pty ltd - olanzapine, quantity: 20 mg - tablet, orally disintegrating - excipient ingredients: polacrilin potassium; colloidal anhydrous silica; mannitol; sodium stearylfumarate; crospovidone; aspartame; microcrystalline cellulose; flavour - for the treatment of schizophrenia and related psychoses. alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder. for preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

avpak - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - olanzapine 5 mg -            oral olanzapine is indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial [see clinical studies (14.1)] .            when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions (5.5)] .             monotherapy — oral olanzapine is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy w

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

teva pharmaceuticals usa, inc. - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - olanzapine 5 mg - olanzapine orally disintegrating tablets are indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial [see clinical studies (14.1)]. when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions (5.5)]. monotherapy — olanzapine orally disintegrating tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clin

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

remedyrepack inc. - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - olanzapine 5 mg - oral olanzapine tablets are indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13-17), efficacy was established in one 6-week trial [see clinical studies ( 14.1)].  when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions ( 5.5)]. monotherapy — oral olanzapine tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clinical trials in adult patients with manic or mixed episodes of bipolar i disorder: two 3- to 4-week trials and one monotherapy maintenance trial. in adolescent patients with manic or mixed episodes associated with bipolar i disorder (ages 13-17), efficacy was established in one 3-week trial [see clinical studies ( 14.2)]. when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions ( 5.5)]. adjunctive therapy to lithium or valproate — oral olanzapine tablets are indicated for the treatment of manic or mixed episodes associated with bipolar i disorder as an adjunct to lithium or valproate. efficacy was established in two 6-week clinical trials in adults. the effectiveness of adjunctive therapy for longer-term use has not been systematically evaluated in controlled trials [see clinical studies ( 14.2)]. pediatric schizophrenia and bipolar i disorder are serious mental disorders; however, diagnosis can be challenging. for pediatric schizophrenia, symptom profiles can be variable, and for bipolar i disorder, pediatric patients may have variable patterns of periodicity of manic or mixed symptoms. it is recommended that medication therapy for pediatric schizophrenia and bipolar i disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. medication treatment for both pediatric schizophrenia and bipolar i disorder should be part of a total treatment program that often includes psychological, educational and social interventions. oral olanzapine and fluoxetine in combination is indicated for the treatment of depressive episodes associated with bipolar i disorder, based on clinical studies.  when using olanzapine and fluoxetine in combination, refer to the clinical studies section of the package insert for symbyax. olanzapine monotherapy is not indicated for the treatment of depressive episodes associated with bipolar i disorder. oral olanzapine and fluoxetine in combination is indicated for the treatment of treatment resistant depression (major depressive disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode), based on clinical studies in adult patients. when using olanzapine and fluoxetine in combination, refer to the clinical studies section of the package insert for symbyax. olanzapine monotherapy is not indicated for the treatment of treatment resistant depression. • none with olanzapine tablets monotherapy. • when using olanzapine and fluoxetine in combination, also refer to the contraindications section of the package insert for symbyax. • for specific information about the contraindications of lithium or valproate, refer to the contraindications section of the package inserts for these other products.  when using olanazapine and fluoxetine in combination, also refer to the use in specific populations section of the package insert for symbyax. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including olanzapine, 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://womensmentalhealth.org/clinical-and-researchprograms/ pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs, including olanzapine, during the third trimester 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 olanzapine 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 olanzapine, during pregnancy (see clinical considerations). olanzapine was not teratogenic when administered orally to pregnant rats and rabbits at doses that are 9- and 30-times the daily oral maximum recommended human dose (mrhd), based on mg/m2 body surface area; some fetal toxicities were observed at these doses (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations 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. clinical considerations disease-associated maternal and 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 olanzapine, 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 placental passage has been reported in published study reports; however, the placental passage ratio was highly variable ranging between 7% to 167% at birth following exposure during pregnancy. the clinical relevance of this finding is unknown. published data from observational studies, birth registries, and case reports that have evaluated the use of atypical antipsychotics during pregnancy do not establish an increased risk of major birth defects. 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. animal data in oral reproduction studies in rats at doses up to 18 mg/kg/day and in rabbits at doses up to 30 mg/kg/day (9 and 30 times the daily oral mrhd based on mg/m2 body surface area, respectively), no evidence of teratogenicity was observed. in an oral rat teratology study, early resorptions and increased numbers of nonviable fetuses were observed at a dose of 18 mg/kg/day (9 times the daily oral mrhd based on mg/m2 body surface area), and gestation was prolonged at 10 mg/kg/day (5 times the daily oral mrhd based on mg/m body surface area). in an oral rabbit teratology study, fetal toxicity manifested as increased resorptions and decreased fetal weight, occurred at a maternally toxic dose of 30 mg/kg/day (30 times the daily oral mrhd based on mg/m 2 body surface area). risk summary olanzapine is present in human milk. there are reports of excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed to olanzapine through breast milk (see clinical considerations). there is no information on the effects of olanzapine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for olanzapine and any potential adverse effects on the breastfed child from olanzapine or from the mother’s underlying condition. clinical considerations infants exposed to olanzapine should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements). infertility females based on the pharmacologic action of olanzapine (d2 receptor antagonism), treatment with olanzapine 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 ( 5.15)]. the safety and effectiveness of oral olanzapine in the treatment of schizophrenia and manic or mixed episodes associated with bipolar i disorder were established in short-term studies in adolescents (ages 13 to 17 years). use of olanzapine in adolescents is supported by evidence from adequate and well-controlled studies of olanzapine in which 268 adolescents received olanzapine in a range of 2.5 to 20 mg/day [ see clinical studies ( 14.1, 14.2) ]. recommended starting dose for adolescents is lower than that for adults [ see dosage and administration ( 2.1, 2.2) ]. compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, ldl cholesterol, prolactin and hepatic aminotransferase levels [ see warnings and precautions ( 5.5, 5.15, 5.17) and adverse reactions ( 6.1) ]. when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [ see indications and usage ( 1.1, 1.2) ]. safety and effectiveness of olanzapine in children <13 years of age have not been established [ see patient counseling information ( 17 ) ] safety and efficacy of olanzapine and fluoxetine in combination in children and adolescents (10 to 17 years of age) have been established for the acute treatment of depressive episodes associated with bipolar i disorder. safety and effectiveness of olanzapine and fluoxetine in combination in children <10 years of age have not been established. of the 2500 patients in premarketing clinical studies with oral olanzapine, 11% (263) were 65 years of age or over. in patients with schizophrenia, there was no indication of any different tolerability of olanzapine in the elderly compared to younger patients. studies in elderly patients with dementia-related psychosis have suggested that there may be a different tolerability profile in this population compared to younger patients with schizophrenia. elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo. in placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis, there was a higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) in patients treated with olanzapine compared to patients treated with placebo. in 5 placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis (n=1184), the following adverse reactions were reported in olanzapine-treated patients at an incidence of at least 2% and significantly greater than placebo-treated patients: falls, somnolence, peripheral edema, abnormal gait, urinary incontinence, lethargy, increased weight, asthenia, pyrexia, pneumonia, dry mouth and visual hallucinations. the rate of discontinuation due to adverse reactions was greater with olanzapine than placebo (13% vs 7%). elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo. olanzapine is not approved for the treatment of patients with dementia-related psychosis [see boxed warning, warnings and precautions ( 5.1), and patient counseling information ( 17)]. olanzapine is not approved for the treatment of patients with dementia-related psychosis. also, the presence of factors that might decrease pharmacokinetic clearance or increase the pharmacodynamic response to olanzapine should lead to consideration of a lower starting dose for any geriatric patient [see boxed warning, dosage and administration ( 2.1), and warnings and precautions ( 5.1)]. clinical studies of olanzapine and fluoxetine in combination did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently from younger patients. in studies prospectively designed to assess abuse and dependence potential, olanzapine was shown to have acute depressive cns effects but little or no potential of abuse or physical dependence in rats administered oral doses up to 15 times the daily oral mrhd (20 mg) and rhesus monkeys administered oral doses up to 8 times the daily oral mrhd based on mg/m 2 body surface area. olanzapine has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. 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. consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of olanzapine (e.g., development of tolerance, increases in dose, drug-seeking behavior).