quetiapine fumarate 300 mg

1 INDICATIONS AND USAGE Quetiapine extended-release tablet 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 tablet is indicated for the treatment of Schizophrenia. The efficacy of quetiapine extended-release tablet 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 tablet is 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 tablet 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 tablet is indicated for the acute treatment of depressive episodes associated with bipolar disorder. The efficacy of quetiapine extended-release tablet 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 tablet is 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 tablet is indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. The efficacy of quetiapine extended-release tablet 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.

Lupin Pharmaceuticals, Inc.

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