1 INDICATIONS AND USAGE
SEROQUEL is an atypical antipsychotic indicated for the:
Treatment of schizophrenia (1.1)
Adults: Efficacy was established in three 6week clinical trials in patients with schizophrenia (14.1)
Adolescents (ages 1317): Efficacy was established in one 6week trial in patients with schizophrenia (14.1)
Acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex (1.2)
Adults: Efficacy was established in two 12week monotherapy trials and in one 3week adjunctive trial in patients with manic episodes associated with bipolar I disorder (14.2)
Children and Adolescents (ages 1017): Efficacy was established in one 3week monotherapy trial 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 in two 8week trials 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 in two maintenance trials in adults (14.2)
1.1 Schizophrenia
SEROQUEL is indicated for the treatment of schizophrenia.
The efficacy of SEROQUEL in schizophrenia was established in three 6-week trials in adults and one 6week trial in adolescents (1317 years). The effectiveness of SEROQUEL for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)].
1.2 Bipolar Disorder
SEROQUEL is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex.
Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10-17 years)
[see Clinical Studies
(14.2)].
SEROQUEL is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder.
Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see Clinical Studies
(14.2)].
SEROQUEL is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex.
Efficacy was established in two maintenance trials in adults.
The effectiveness of SEROQUEL as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials
[see Clinical Studies
(14.2)].
1.3 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.