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

amneal pharma australia pty ltd - quetiapine fumarate -

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

amneal pharma australia pty ltd - quetiapine fumarate -

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

amneal pharma australia pty ltd - quetiapine fumarate -

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

redpharm drug, inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 100 mg - 1.1 schizophrenia quetiapine is indicated for the treatment of schizophrenia. the efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1)]. 1.2 bipolar disorder quetiapine is indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies (14.2)]. quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adult patients with bipolar i and b

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

direct rx - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 50 mg - - 1.1 schizophrenia quetiapine fumarate tablet is indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see clinical studies (14.1)] 1.2 bipolar disorder quetiapine fumarate tablet is indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [ see clinical studies (14.2)] . quetiapine fumarate tablet is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. effica

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

accord healthcare inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 50 mg - quetiapine extended-release tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated with quetiapine tablets [see clinical studies (14.1)]. quetiapine extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. the efficacy of quetiapine extended-release tablets in manic or mixed episodes of bipolar i disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar i disorder. efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar i disorder as well as one 3-week monotherapy trial in children and adolescents (10 to 17 years) with manic episodes associated with bipolar i disorder treated with quetiapine tablets [see clinical studies (14.2)]. quetiapine extended-release tablets are indicated for the acute treatment of depressive episodes associated with bipolar disorder. the efficacy of quetiapine extended-release tablets were established in one 8-week trial in adults with bipolar i or ii disorder and supported by two 8-week trials in adults with bipolar i or ii disorder treated with quetiapine tablets [see clinical studies (14.2)]. quetiapine extended-release tablets are indicated for the maintenance treatment of bipolar i disorder, as an adjunct to lithium or divalproex. efficacy was extrapolated from two maintenance trials in adults with bipolar i disorder treated with quetiapine tablets. the effectiveness of monotherapy for the maintenance treatment of bipolar i disorder has not been systematically evaluated in controlled clinical trials [see clinical studies (14.2)]. quetiapine extended-release tablets are indicated for use as adjunctive therapy to antidepressants for the treatment of mdd. the efficacy of quetiapine extended-release tablets as adjunctive therapy to antidepressants in mdd was established in two 6-week trials in adults with mdd who had an inadequate response to antidepressant treatment [see clinical studies (14.3)]. 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, 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 is indicated as part of a total treatment program that often includes psychological, educational and social interventions. hypersensitivity to quetiapine or to any excipients in the quetiapine extended-release tablets formulation. anaphylactic reactions have been reported in patients treated with quetiapine extended-release tablets. pregnancy pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including quetiapine extended-release tablets, 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, including quetiapine extended-release tablets, 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 quetiapine 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, bipolar i, or major depressive disorder, and with exposure to antipsychotics, including, quetiapine extended-release tablets during pregnancy (see clinical considerations) . in animal studies, embryo-fetal toxicity occurred including delays in skeletal ossification at approximately 1 and 2 times the maximum recommended human dose (mrhd) of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the mrhd. in addition, fetal weights were decreased in both species. maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the mrhd in rats and approximately 1 to 2 times the mrhd in rabbits. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, 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/or 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. a prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. the women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. 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 quetiapine extended-release tablets, during the third trimester of pregnancy. these symptoms 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 retrospective cohort study from a medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk of major birth defects. animal data when pregnant rats and rabbits were exposed to quetiapine during organogenesis, there was no teratogenic effect in fetuses. doses were 25, 50 and 200 mg/kg in rats and 25, 50 and 100 mg/kg in rabbits which are approximately 0.3, 0.6 and 2-times (rats) and 0.6, 1 and 2-times (rabbits) the mrhd, for schizophrenia of 800 mg/day based on mg/m 2 body surface area. however, there was evidence of embryo-fetal toxicity, including delays in skeletal ossification at approximately 1 and 2 times the mrhd of 800 mg/day in both rats and rabbits and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the mrhd. in addition, fetal weights were decreased in both species. maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the mrhd in rats and at approximately 1 to 2 times the mrhd (all doses tested) in rabbits. in a peri/postnatal reproductive study in rats, no drug-related effects were observed when pregnant dams were treated with quetiapine at doses 0.01, 0.1, and 0.2 times the mrhd of 800 mg/day based on mg/m 2 body surface area. however, in a preliminary peri/postnatal study, there were increases in fetal and pup death, and decreases in mean litter weight at 3 times the mrhd. risk summary limited data from published literature report the presence of quetiapine in human breast milk at relative infant dose of < 1% of the maternal weight-adjusted dosage. there are no consistent adverse events that have been reported in infants exposed to quetiapine through breast milk. there is no information on the effects of quetiapine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for quetiapine extended-release tablets and any potential adverse effects on the breastfed child from quetiapine extended-release tablets or from the mother’s underlying condition. infertility females based on the pharmacologic action of quetiapine (d2 antagonism), treatment with quetiapine extended-release tablets 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)] . safety and effectiveness of quetiapine extended-release tablets are supported by studies of quetiapine tablets for schizophrenia in adolescent patients 13 to 17 years of age and in bipolar mania in children and adolescent patients 10 to 17 years of age [see clinical studies ( 14.1and 14.2)]. in general, the adverse reactions observed in children and adolescents during the clinical trials with quetiapine tablets were similar to those in the adult population with few exceptions. increases in systolic and diastolic blood pressure occurred in children and adolescents and did not occur in adults. orthostatic hypotension occurred more frequently in adults (4 to 7%) compared to children and adolescents (< 1%) [see warnings and precautions (5.7)and adverse reactions (6.1)]. bipolar depression the effectiveness of quetiapine extended-release tablets for the treatment of bipolar depression in patients under the age of 18 years has not been established. one 8-week trial was conducted to evaluate the safety and efficacy of quetiapine extended-release tablets in the treatment of bipolar depression in pediatric patients 10 to 17 years of age. the primary objective of the study was to evaluate whether quetiapine extended-release tablets at a dose of 150 to 300 mg/day demonstrated superior efficacy (as measured by change in cdrs-r total score from baseline to end of 8 weeks) compared to placebo in children and adolescents 10 to 17 years of age with bipolar depression. a total of 193 patients with bipolar depression were randomized to placebo or quetiapine extended-release tablets. the primary results of this study did not show a difference between quetiapine extended-release tablets and placebo in decreasing depression symptoms in children and adolescents with bipolar disorder. in this study, patients treated with quetiapine extended-release tablets exhibited metabolic changes, weight gain, increases in blood pressure and increases in heart rate [see warnings and precautions ( 5.5, 5.9) and adverse reactions (6.1)]. some differences in the pharmacokinetics of quetiapine were noted between children/adolescents (10 to 17 years of age) and adults. when adjusted for weight, the auc and cmax of quetiapine were 41% and 39% lower, respectively, in children and adolescents compared to adults. the pharmacokinetics of the active metabolite, norquetiapine, were similar between children/adolescents and adults after adjusting for weight [see clinical pharmacology (12.3)]. schizophrenia the efficacy and safety of quetiapine extended-release tablets in the treatment of schizophrenia in adolescents aged 13 to 17 years is supported by one 6-week, double-blind, placebo-controlled trial with quetiapine tablets [see indications and usage (1.1), dosage and administration (2.2), adverse reactions (6.1), and clinical studies (14.1)]. safety and effectiveness of quetiapine extended-release tablets in pediatric patients less than 13 years of age with schizophrenia have not been established. the safety and effectiveness of quetiapine extended-release tablets in the maintenance treatment of schizophrenia has not been established in patients less than 18 years of age. bipolar mania the efficacy and safety of quetiapine extended-release tablets in the treatment of bipolar mania in children and adolescents ages 10 to 17 years is supported by one 3-week, double-blind, placebo controlled trial with quetiapine tablets [see indications and usage (1.2), dosage and administration (2.2), adverse reactions (6.1), and clinical studies (14.2)]. safety and effectiveness of quetiapine extended-release tablets in pediatric patients less than 10 years of age with bipolar mania have not been established. the safety and effectiveness of quetiapine extended-release tablets in the maintenance treatment of bipolar disorder has not been established in patients less than 18 years of age. sixty-eight patients in clinical studies with quetiapine extended-release tablets were 65 years of age or over. in general, there was no indication of any different tolerability of quetiapine extended-release tablets in the elderly compared to younger adults. nevertheless, the presence of factors that might decrease pharmacokinetic clearance, increase the pharmacodynamic response to quetiapine extended-release tablets, or cause poorer tolerance or orthostasis, should lead to consideration of a lower starting dose, slower titration, and careful monitoring during the initial dosing period in the elderly. the mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients [see dosage and administration (2.3)and clinical pharmacology (12.3)]. clinical experience with quetiapine extended-release tablets in patients with renal impairment is limited [see clinical pharmacology (12.3)]. since quetiapine is extensively metabolized by the liver, higher plasma levels are expected in patients with hepatic impairment. in this population, a low starting dose of 50 mg/day is recommended and the dose may be increased in increments of 50 mg/day [see dosage and administration (2.4)and clinical pharmacology (12.3) ]. quetiapine extended-release tablets are not a controlled substance. quetiapine extended-release tablets 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 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 quetiapine extended-release tablets (e.g., development of tolerance, increases in dose, drug-seeking behavior).

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

sciegen pharmaceuticals, inc - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 150 mg - quetiapine extended-release tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated with quetiapine tablets [see clinical studies (14.1)]. quetiapine extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. the efficacy of quetiapine extended-release tablets in manic or mixed episodes of bipolar i disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar i disorder. efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in ad

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

marlex pharmaceuticals inc - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 150 mg - quetiapine extended-release tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated with quetiapine tablets [see clinical studies ( 14.1 )]. quetiapine extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. the efficacy of quetiapine extended-release tablets in manic or mixed episodes of bipolar i disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar i disorder. efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar i disorder as

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

redpharm drug, inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 100 mg - 1.1 schizophrenia quetiapine is indicated for the treatment of schizophrenia. the efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1)]. 1.2 bipolar disorder quetiapine is indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies (14.2)]. quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adult patients with bipolar i and b

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

aci healthcare usa, inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 150 mg - quetiapine extended-release tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated with quetiapine tablets [see clinical studies (14.1)]. quetiapine extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. the efficacy of quetiapine extended-release tablets in manic or mixed episodes of bipolar i disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar i disorder. efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar i disorder as wel