quetiapine 400 mg

1 INDICATIONS & 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 [ 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 [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 [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. 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.

Macleods Pharmaceuticals Limited

FDA Reported Adverse Reactions
[1] drug ineffective    [2] fatigue    [3] nausea    [4] off label use    [5] pain    [6] diarrhoea    [7] dyspnoea    [8] headache    [9] alopecia    [10] vomiting