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24 HR quetiapine 400 MG Extended Release Oral Tablet

1 INDICATIONS AND USAGE Quetiapine is an atypical antipsychotic indicated for the treatment of: Schizophrenia. ( 1.1 ) Bipolar I disorder, manic, or mixed episodes. ( 1.2 ) Bipolar disorder, depressive episodes. ( 1.2 ) Major depressive disorder, adjunctive therapy with antidepressants. ( 1.3 ) 1.1 Schizophrenia 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 SEROQUEL [ see Clinical Studies (14.1) ]. 1.2 Bipolar Disorder 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 SEROQUEL [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 was 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 SEROQUEL [ 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 SEROQUEL. 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) ]. 1.3 Adjunctive Treatment of Major Depressive Disorder (MDD) 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) ]. 1.4 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder 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.

Amneal Pharmaceuticals LLC


4 years ago OVAL WHITE AN431 24 HR quetiapine 400 MG Extended Release Oral Tablet

OVAL WHITE AN431

16 HOW SUPPLIED/STORAGE AND HANDLING

QUETIAPINE EXTENDED-RELEASE Tablets USP, 400 mg are supplied as white to off-white, film-coated, modified capsule shaped tablets debossed with ‘AN431’ on one side and plain on other side. They are available as follows: Bottles of 60: NDC 65162-431-06 Store

QUETIAPINE EXTENDED-RELEASE tablets at 20° to 25ºC (68° to 77ºF); excursions permitted between 15° to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature].


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