Increased Blood Pressure in Children and Adolescents: Blood pressure should be measured at the beginning of, and periodically during treatment in children and adolescents. SEROQUEL XR has not been eva luated in pediatric patients. (5.9)

Leukopenia, Neutropenia and Agranulocytosis: have been reported with atypical antipsychotics including SEROQUEL XR. Patients with a pre-existing low white cell count (WBC) or a history of leukopenia/neutropenia should have complete blood count (CBC) monitored frequently during the first few months of treatment and should discontinue SEROQUEL XR at the first sign of a decline in WBC in absence of other causative factors. (5.10)

Cataracts: Lens changes have been observed in patients during long-term quetiapine treatment. Lens examination is recommended when starting treatment and at 6-month intervals during chronic treatment. (5.11)

Suicide: The possibility of a suicide attempt is inherent in schizophrenia, bipolar disorder and depression and close supervision of high risk patients should accompany drug therapy. (5.20)

See Full Prescribing Information for additional WARNINGS and PRECAUTIONS.

ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5% and twice placebo) in decreasing frequency are: somnolence, dry mouth, constipation, dizziness, increased appetite, dyspepsia, weight gain, fatigue, dysarthria, and nasal congestion. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
P450 3A Inhibitors: May decrease the clearance of quetiapine. Lower doses of quetiapine may be required. (7.1)

Hepatic Enzyme Inducers: May increase the clearance of quetiapine. Higher doses of quetiapine may be required with phenytoin or other inducers. (7.1)

Centrally Acting Drugs: Caution should be used when quetiapine is used in combination with other CNS acting drugs. (7)

Antihypertensive Agents: Quetiapine may add to the hypotensive effects of these agents. (7)

Levodopa and Dopamine Agents: Quetiapine may antagonize the effect of these drugs. (7)
USE IN SPECIFIC POPULATIONS
Geriatric Use: Consider a lower starting dose (50 mg/day), slower titration, and careful monitoring during the initial dosing period in the elderly. (2.3 and 8.5)

Hepatic Impairment: Lower starting doses (50 mg/day) and slower titration may be needed. (2.3, 8.7, 12.3)

Pregnancy: Limited human data. Based on animal data, may cause fetal harm. (8.1)

Nursing Mothers: Caution should be exercised when administered to a nursing woman. (8.3)

Pediatric Use: Safety and effectiveness have not been established. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide 
Revised: 12/2009
--------------------------------------------------------------------------------
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Recent Major Changes
1 INDICATIONS AND USAGE
1.1 Schizophrenia
1.2 Bipolar Disorder
1.3 Adjuncti