1 INDICATIONS & USAGE
Quetiapine Fumarate Extended-release Tablets USP 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 Fumarate Extended-release Tablets USPis indicated for the treatment of schizophrenia. The efficacy of Quetiapine Fumarate Extended-release Tablets USPin 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 (13-17 years) treated with quetiapine fumarate tablets [see Clinical Studies (14.1)].
1.2 Bipolar Disorder
Quetiapine Fumarate Extended-release Tablets USP 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 Fumarate Extended-release Tablets USPin 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
17 years) with manic episodes associated with bipolar I disorder treated with quetiapine fumarate tablets [see Clinical Studies (14.2)].
Quetiapine Fumarate Extended-release TabletsUSPis indicated for the acute treatment of depressive episodes associated with bipolar disorder. The efficacy of Quetiapine Fumarate Extended-release TabletsUSPwas 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 fumarate tablets [see Clinical Studies (14.2)].
Quetiapine Fumarate Extended-release Tablets USP 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 quetiapine fumarate 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 Fumarate Extended-release Tablets USPis indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. The efficacy of Quetiapine Fumarate Extended-release Tablets USP 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.