SEROQUEL XR
SEROQUEL XR- quetiapine fumarate tablet, extended release
AstraZeneca Pharmaceuticals LP
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1)]. SEROQUEL XR is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].
Suicidal Thoughts and Behaviors
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.2)].
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.2)].
SEROQUEL XR is not approved for use in pediatric patients under ten years of age [see Use in Specific Populations (8.4)].
1 INDICATIONS AND USAGE
1.1 Schizophrenia
SEROQUEL XR is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL XR 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 (13-17 years) treated with SEROQUEL [see Clinical Studies (14.1)].
1.2 Bipolar Disorder
SEROQUEL XR 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 SEROQUEL XR 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 — 17 years) with manic episodes associated with bipolar I disorder treated with SEROQUEL [see Clinical Studies (14.2)].
SEROQUEL XR is indicated for the acute treatment of depressive episodes associated with bipolar disorder. The efficacy of SEROQUEL XR 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 SEROQUEL [see Clinical Studies (14.2)].
SEROQUEL XR 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 SEROQUEL. 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)
SEROQUEL XR is indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. The efficacy of SEROQUEL XR 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.
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
SEROQUEL XR tablets should be swallowed whole and not split, chewed, or crushed.
It is recommended that SEROQUEL XR be taken without food or with a light meal (approximately 300 calories) [see Clinical Pharmacology (12.3)].
SEROQUEL XR should be administered once daily, preferably in the evening.
2.2 Recommended Dosing
The recommended initial dose, titration, dose range and maximum SEROQUEL XR dose for each approved indication is displayed in Table 1 below. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1, 14.2 and 14.3)].
Indication | Initial Dose and Titration | Recommended Dose | Maximum Dose |
Schizophrenia — Adults | Day 1: 300 mg/day Dose increases can be made at intervals as short as 1 day and in increments of up to 300 mg/day | 400-800 mg/day | 800 mg/day |
Schizophrenia — Adolescents (13 to 17 years) | Day 1: 50 mg/day Day 2: 100 mg/day Day 3: 200 mg/day Day 4: 300 mg/day Day 5: 400 mg/day | 400-800 mg/day | 800 mg/day |
Schizophrenia Maintenance — Monotherapy — Adults | Not applicable | 400-800 mg/day | 800 mg/day |
Bipolar I Disorder manic or mixed — Acute monotherapy or adjunct to lithium or divalproex — Adults | Day 1: 300 mg/day Day 2: 600 mg/day Day 3: between 400 and 800 mg/day | 400-800 mg/day | 800 mg/day |
Bipolar I Disorder, manic — Acute monotherapy — Children and Adolescents (10 to 17 years) | Day 1: 50 mg/day Day 2: 100 mg/day Day 3: 200 mg/day Day 4: 300 mg/day Day 5: 400 mg/day | 400-600 mg/day | 600 mg/day |
Bipolar Disorder, Depressive Episodes — Adults | Day 1: 50 mg/day Day 2: 100 mg/day Day 3: 200 mg/day Day 4: 300 mg/day | 300 mg/day | 300 mg/day |
Bipolar I Disorder Maintenance — Adjunct to lithium or divalproex — Adults | Not applicable | 400-800 mg/day | 800 mg/day |
Major Depressive Disorder — Adjunctive Therapy with Antidepressants — Adults | Day 1: 50 mg/day Day 2: 50 mg/day Day 3: 150 mg/day | 150-300 mg/day | 300 mg/day |
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment —Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.1, 14.2)].
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