1 INDICATIONS AND USAGE
Quetiapine Fumarate Tablets is an atypical antipsychotic indicated for the:
Treatment of schizophrenia (1.1)
Adults: Efficacy was established in three 6 week clinical trials 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 12 week monotherapy trials and in one 3 week adjunctive 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 8 week 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
Quetiapine fumarate tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6 week trials in adults. The effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)].
Pediatric use information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LPs quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LPs marketing exclusivity rights; this drug product is not labeled for use in those adolescent patients.
1.2 Bipolar Disorder
Quetiapine fumarate tablets are 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 [see Clinical Studies
(14.2)].
Quetiapine fumarate tablets are 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)].
Quetiapine fumarate tablets are 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 quetiapine fumarate tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies
(14.2)].
Pediatric use information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LPs quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LPs marketing exclusivity rights; this drug product is not labeled for use in those pediatric patients.
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric use information in patients (13 to 17 years of age) with schizophrenia, and patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LPs quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LPs marketing exclusivity rights; this drug product is not labeled for use in those patients.