|
1 Indications And Usage Quetiapine Fumarate 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 Fumarate Extended-Release Tablet Is Indicated For The Treatment Of Schizophrenia. The Efficacy Of Quetiapine Fumarate 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 Quetiapine Fumarate Tablet [See Clinical Studies ( 14.1 )] . 1.2 Bipolar Disorder Quetiapine Fumarate 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 Fumarate 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 Quetiapine Fumarate Tablet [See Clinical Studies ( 14.2 )] . Quetiapine Fumarate Extended-Release Tablet Is Indicated For The Acute Treatment Of Depressive Episodes Associated With Bipolar Disorder. The Efficacy Of Quetiapine Fumarate 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 Quetiapine Fumarate Tablet [See Clinical Studies ( 14.2 )]. Quetiapine Fumarate 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 Quetiapine Fumarate Tablet. 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 Tablet Is Indicated For Use As Adjunctive Therapy To Antidepressants For The Treatment Of Mdd. The Efficacy Of Quetiapine Fumarate 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.
|