HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use SEROQUEL XR safely and effectively. See full prescribing information for SEROQUEL XR.
SEROQUEL XR®(quetiapine fumarate) Extended-Release Tablets
Initial U.S. Approval: 1997
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning.
Antipsychotic drugs are associated with an increased risk of death. (5.1)
Quetiapine is not approved for elderly patients with Dementia-Related Psychosis. (5.1)
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning.
Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder and other psychiatric disorders. (5.2)
RECENT MAJOR CHANGES
Indications and Usage, Schizophrenia (1.1), 12/2009
Indications and Usage, Bipolar Disorder (1.2), 12/2009
Indications and Usage, Major Depressive Disorder (MDD), Adjunctive Treatment with Antidepressants (1.3), 12/2009
Dosage and Administration, Schizophrenia (2.1), 12/2009
Dosage and Administration, Bipolar Disorder (2.2), 12/2009
Dosage and Administration, Major Depressive Disorder (MDD), Adjunctive Treatment with Antidepressants (2.3), 12/2009
Warnings and Precautions, Hyperglycemia (5.4), 12/2009
Warnings and Precautions, Hyperlipidemia (5.5), 12/2009
Warnings and Precautions, Weight Gain (5.6), 12/2009
Warnings and Precautions, Increases in Blood Pressure (Children and Adolescents) (5.9), 12/2009
Warnings and Precautions, Hypothyroidism (5.13), 01/2009
Warnings and Precautions, Hyperprolactinemia (5.14), 01/2009
Warnings and Precautions, Potential for Cognitive and Motor Impairment (5.16), 12/2009
Warnings and Precautions, Suicide (5.20), 12/2009
Warnings and Precautions, Withdrawal (5.21), 12/2009
INDICATIONS AND USAGE
SEROQUEL XR is an atypical antipsychotic indicated for the:
Treatment of schizophrenia (1.1)
• Adults: Efficacy was established with SEROQUEL XR in one 6-week and one maintenance trial in patients with schizophrenia as well as in three 6-week trials with SEROQUEL in patients with schizophrenia (14.1)
Acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex (1.2)
• Adults: Efficacy was established with SEROQUEL XR in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder as well as two 12-week monotherapy trials and one 3-week adjunctive trial with SEROQUEL in patients with manic episodes associated with bipolar I disorder (14.2)
Acute treatment of depressive episodes associated with bipolar disorder (1.2)
• Adults: Efficacy was established with SEROQUEL XR in one 8-week trial in patients with bipolar I or II disorder as well as two 8-week trials with SEROQUEL in patients with bipolar I or II disorder (14.2)
Maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex (1.2)
• Adults: Efficacy was established with SEROQUEL in two maintenance trials in patients with bipolar I disorder (14.2)
Adjunctive treatment of major depressive disorder (MDD) (1.
