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quetiapine 400 mg

1 INDICATIONS AND USAGE Quetiapine extended-release tablets are 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 quetiapine tablets [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 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 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 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) ]. 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.

ACI Healthcare USA, Inc.


2 hours ago OVAL WHITE 384 quetiapine 400 mg

OVAL WHITE 384

16 HOW SUPPLIED/STORAGE AND HANDLING 50 mg Tablets peach, film coated, capsule-shaped, biconvex embossed tablet with “380” on one side and plain on the other are supplied in Bottles of 60 tablets: NDC 71093-135-02 150 mg Tablets white, film coated, capsule-shaped, biconvex embossed tablet with “381” on one side and plain on the other are supplied in Bottles of 60 tablets: NDC 71093-136-02 200 mg Tablets yellow, film coated, capsule-shaped, biconvex embossed tablet with “382” on one side and plain on the other are supplied in Bottles of 60 tablets: NDC 71093-137-02 300 mg Tablets pale yellow, film coated, capsule-shaped, biconvex embossed tablet with “383” on one side and plain on the other are supplied in Bottles of 60 tablets: NDC 71093-138-02 400 mg Tablets white, film coated, capsule-shaped, biconvex embossed tablet with “384” on one side and plain on the other are supplied in Bottles of 60 tablets: NDC 71093-139-02 Store

QUETIAPINE extended-release tablets at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [See USP Controlled Room Temperature].

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