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Reference ID: 2870733 Coma and Death Have Been Reported in Patients Treated with Atypical

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HIGHLIGHTS OF PRESCRIBING INFORMATION years) (2.1) mg. These highlights do not include all the information needed to use SEROQUEL Day 3: Twice daily dosing totaling 200 safely and effectively. See full prescribing information for SEROQUEL. mg. SEROQUEL® (quetiapine fumarate) Tablets Day 4: Twice daily dosing totaling 300 Initial US Approval: 1997 mg. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS Day 5: Twice daily dosing totaling 400 WITH DEMENTIA-RELATED PSYCHOSIS See Full Prescribing mg. Information for complete boxed warning. Further adjustments should be in • Antipsychotic drugs are associated with an increased risk of death increments no greater than 100 mg/day (5.1) within the recommended dose range of • Quetiapine is not approved for elderly patients with Dementia- 400-800 mg/day. Related Psychosis (5.1) Based on response and tolerability, may WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS be administered three times daily. See Full Prescribing Information for complete boxed warning. • Increased risk of suicidal thinking and behavior in children, Bipolar Mania- Day 1: Twice daily dosing totaling 100 400– 800 adolescents and young adults taking antidepressants for major Adults mg. mg/day depressive disorder and other psychiatric disorders (5.2) Monotherapy or as Day 2: Twice daily dosing totaling 200 an adjunct to lithium mg. or divalproex (2.2) Day 3: Twice daily dosing totaling 300 mg. ----------------------------------RECENT MAJOR CHANGES--------------------------- Day 4: Twice daily dosing totaling 400 Boxed Warning: Suicidality and Antidepressant Drugs, 12/2009 mg. Indications and Usage, Schizophrenia (1.1), 12/2009 Further dosage adjustments up to 800 Indications and Usage, Bipolar Disorder (1.2), 12/2009 mg/day by Day 6 should be in Indications and Usage, Special Considerations in Treating Pediatric Patients with increments of no greater than 200 Schizophrenia and Bipolar I Disorder (1.3), 12/2009 mg/day. Dosage and Administration, Schizophrenia, Adolescents (2.1), 12/2009 Bipolar Mania- Day 1: 25 mg twice daily. 400-600 Dosage and Administration, Bipolar Mania, Children and Adolescents (2.2), Children and Day 2: Twice daily dosing totaling 100 mg/day 12/2009 Adolescents (10 to mg. Warnings and Precautions, Hyperglycemia (5.4),12/2009 17 years), Day 3: Twice daily dosing totaling 200 Warnings and Precautions, Hyperlipidemia (5.5), 12/2009 Monotherapy mg. Warnings and Precautions, Weight Gain (5.6), 12/2009 Day 4: Twice daily dosing totaling 300 Warnings and Precautions, Increases in Blood Pressure in Children and Adolescents mg. (5.9), 12/2009 Day 5: Twice daily dosing totaling 400 Warnings and Precautions, Use in Patients with Concomitant Illness (5.21), 01/2010 mg. Warnings and Precautions, Withdrawal (5.22), 05/2010 Further adjustments should be in --------------------------------INDICATIONS AND USAGE---------------------------- increments no greater than 100 mg/day SEROQUEL is an atypical antipsychotic indicated for the: within the recommended dose range of Treatment of schizophrenia (1.1) 400-600 mg/day. • Adults: Efficacy was established in three 6-week clinical trials in Based on response and tolerability, may patients with schizophrenia (14.1) be administered three times daily. • Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1) Bipolar Depression- Administer once daily at bedtime. 300 mg/day Acute treatment of manic episodes associated with bipolar I disorder, both as Adults Day 1: 50 mg monotherapy and as an adjunct to lithium or divalproex (1.2) Day 2: 100 mg • Adults: Efficacy was established in two 12-week monotherapy trials Day 3: 200 mg and in one 3-week adjunctive trial in patients with manic episodes Day 4: 300 mg associated with bipolar I disorder (14.2) Bipolar I Disorder Administer twice daily totaling 400-800 • Children and Adolescents (ages 10-17): Efficacy was established in one Maintenance mg/day as adjunct to lithium or 3-week monotherapy trial in patients with manic episodes associated Therapy- Adults divalproex. Generally, in the with bipolar I disorder (14.2) maintenance phase, patients continued on Acute treatment of depressive episodes associated with bipolar disorder (1.2) the same dose on which they were • Adults: Efficacy was established in two 8-week trials in patients with stabilized. bipolar I or II disorder (14.2) Maintenance treatment of bipolar disorder as an adjunct to lithium or divalproex *After initial dosing, adjustments can be made upwards or downwards, if (1.2) necessary, within the dose range depending upon the clinical response and • Adults: Efficacy was established in two maintenance trials in adults tolerance of the patient. (14.2) ----------------------------DOSAGE AND ADMINISTRATION------------------------ --------------------------DOSAGE FORMS AND STRENGTHS----------------- SEROQUEL can be taken with or without food. 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg (3) -------------------------CONTRAINDICATIONS--------------------------- Indication Dosing Instructions* Recommended None (4) Dose / Dose ---------------------WARNINGS AND PRECAUTIONS----------------- Range • Increased Mortality in Elderly Patients with Dementia-Related Schizophrenia- Day 1: 25 mg twice daily. 150-750 Psychosis: Atypical antipsychotic drugs, including quetiapine, are associated Adults (2.1) Increase in increments of 25 mg-50 mg mg/day with an increased risk of death; causes of death are variable. (5.1) divided two or three times on Days 2 and • Suicidality and Antidepressant Drugs: Increased the risk of suicidal 3 to range of 300-400 mg by Day 4. thinking and behavior in children, adolescents and young adults taking Further adjustments can be made in antidepressants for major depressive disorder and other psychiatric disorders. increments of 25–50 mg twice a day, in (5.2) intervals of not less than 2 days. • Neuroleptic Malignant Syndrome (NMS): Manage with immediate Schizophrenia- Day 1: 25 mg twice daily. 400-800 discontinuation and close monitoring. (5.3) Adolescents (13-17 Day 2: Twice daily dosing totaling 100 mg/day • Hyperglycemia and Diabetes Mellitus (DM): Ketoacidosis, hyperosmolar Reference ID: 2870733 coma and death have been reported in patients treated with atypical antipsychotics, including quetiapine. Any patient treated with atypical To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca antipsychotics should be monitored for symptoms of hyperglycemia including at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. polydipsia, polyuria, polyphagia, and weakness. When starting treatment, patients -----------------------DRUG INTERACTIONS—-------------------- with diabetes or risk factors for diabetes should undergo blood glucose testing • P450 3A Inhibitors: May decrease the clearance of quetiapine. Lower before and during treatment. (5.4) doses of quetiapine may be required. (7.1) • Hyperlipidemia: Undesirable alterations in lipids have been observed. • Hepatic Enzyme Inducers: May increase the clearance of quetiapine. Increases in total cholesterol, LDL-cholesterol and triglycerides and decreases in Higher doses of quetiapine may be required with phenytoin or other inducers. HDL-cholesterol have been reported in clinical trials. Appropriate clinical (7.1) monitoring is recommended, including fasting blood lipid testing at the beginning • Centrally Acting Drugs: Caution should be used when quetiapine is used of, and periodically during treatment. (5.5) in combination with other CNS acting drugs. (7) • Weight Gain: Patients should receive regular monitoring of weight. (5.6) • Antihypertensive Agents: Quetiapine may add to the hypotensive effects • Tardive Dyskinesia: Discontinue if clinically appropriate. (5.7) of these agents. (7) • Orthostatic Hypotension: Associated dizziness, tachycardia and syncope may • Levodopa and Dopamine Agents: Quetiapine may antagonize the effect occur especially during the initial dose titration period. (5.8) of these drugs. (7) • Increased Blood Pressure in Children and Adolescents: Blood pressure should be measured at the beginning of, and periodically during treatment in • Drugs known to cause electrolyte imbalance or increase QT interval: children and adolescents. (5.9) Caution should be used when quetiapine is used concomitantly with these • Leukopenia, Neutropenia and Agranulocytosis have been reported with drugs. (7) atypical antipsychotics including SEROQUEL. Patients with a pre-existing low • Interference with Urine Drug Screens: False positive urine drug screens white cell count (WBC) or a history of leukopenia/neutropenia should have for methadone or tricyclic antidepressants (TCAs) in patients taking complete blood count (CBC) monitored frequently during the first few months of quetiapine have been reported. (7). treatment and should discontinue SEROQUEL at the first sign of a decline in WBC in absence of other causative factors. (5.10) -------------USE IN SPECIFIC POPULATIONS-------- • Cataracts: Lens changes have been observed in patients during long-term • Geriatric Use: Consider a lower starting dose (50 mg/day), slower quetiapine treatment. Lens examination is recommended when starting treatment titration, and careful monitoring during the initial dosing period. (8.5) and at 6-month intervals during chronic treatment. (5.11) • Hepatic Impairment: Lower starting doses (25 mg/day) and slower • Suicide: The possibility of a suicide attempt is inherent in schizophrenia and titration may be needed. (2.3, 12.3) bipolar disorder, and close supervision
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