SEROQUEL XR

SEROQUEL XR- quetiapine fumarate tablet, extended release
Physicians Total Care, Inc.

WARNING: 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. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. SEROQUEL XR is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].

SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of SEROQUEL XR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SEROQUEL XR is not approved for use in pediatric patients [see Warnings and Precautions (5.2)].

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 as well by extrapolation from three 6-week trials in adults with schizophrenia 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 as well by extrapolation from two 12-week monotherapy and one 3-week adjunctive trial in adults 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 as well as extrapolation from 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 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)].

2 DOSAGE AND ADMINISTRATION

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)].

2.1 Schizophrenia

Dose Selection—SEROQUEL XR should be administered once daily, preferably in the evening. The recommended initial dose is 300 mg/day. Patients should be titrated within a dose range of 400 mg/day – 800 mg/day depending on the response and tolerance of the individual patient [see Clinical Studies (14.1)]. Dose increases can be made at intervals as short as 1 day and in increments of up to 300 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.

Maintenance Treatment—A maintenance trial in adult patients with schizophrenia treated with SEROQUEL XR has shown this drug to be effective in delaying time to relapse in patients who were stabilized on SEROQUEL XR at doses of 400 mg/day to 800 mg/day for 16 weeks. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.1)].

2.2 Bipolar Disorder

Bipolar Mania

Usual Dose for Acute Monotherapy or Adjunct Therapy (with lithium or divalproex)

Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), SEROQUEL XR should be administered once daily in the evening starting with 300 mg on Day 1 and 600 mg on Day 2. SEROQUEL XR can be adjusted between 400 mg and 800 mg beginning on Day 3 depending on the response and tolerance of the individual patient.

Recommended Dosing Schedule

Day

Day 1

Day 2

Day 3

SEROQUEL XR

300 mg

600 mg

400 mg to 800 mg

Depressive Episodes Associated with Bipolar Disorder

Usual Dose—SEROQUEL XR should be administered once daily in the evening to reach 300 mg/day by Day 4.

Recommended Dosing Schedule

Day

Day 1

Day 2

Day 3

Day 4

SEROQUEL XR

50 mg

100 mg

200 mg

300 mg

Maintenance Treatment for Bipolar I Disorder

Maintenance Treatment—Maintenance of efficacy in bipolar I disorder was demonstrated with SEROQUEL (administered twice daily totaling 400 mg/day to 800 mg/day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].

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