ve Treatment of Major Depressive Disorder (MDD)
2 DOSAGE AND ADMINISTRATION
2.1 Schizophrenia
2.2 Bipolar Disorder
2.3 Major Depressive Disorder, Adjunctive Therapy with Antidepressants
2.4 Dosing in Special Populations
2.5 Re-initiation of Treatment in Patients Previously Discontinued
2.6 Switching Patients from SEROQUEL Tablets to SEROQUEL XR Tablets
2.7 Switching from Antipsychotics
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis
5.2 Clinical Worsening and Suicide Risk
5.3 Neuroleptic Malignant Syndrome (NMS)
5.4 Hyperglycemia and Diabetes Mellitus
5.5 Hyperlipidemia
5.6 Weight Gain
5.7 Tardive Dyskinesia
5.8 Orthostatic Hypotension
5.9 Increases in Blood Pressure (Children and Adolescents)
5.10 Leukopenia, Neutropenia and Agranulocytosis
5.11 Cataracts
5.12 Seizures
5.13 Hypothyroidism
5.14 Hyperprolactinemia
5.15 Transaminase Elevations
5.16 Potential for Cognitive and Motor Impairment
5.17 Priapism
5.18 Body Temperature Regulation
5.19 Dysphagia
5.20 Suicide
5.21 Use in Patients with Concomitant Illness
5.22 Withdrawal
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Vital Signs and Laboratory Values
6.3 Post Marketing Experience
7 DRUG INTERACTIONS
7.1 The Effect of Other Drugs on Quetiapine
7.2 Effect of Quetiapine on Other Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
10 OVERDOSAGE
10.1 Human Experience
10.2 Management of Overdosage
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Schizophrenia
14.2 Bipolar Disorder
14.3 Major Depressive Disorder, Adjunctive Therapy to Antidepressants
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
17.2 MEDICATION GUIDE
PACKAGE LABEL PRINCIPAL DISPLAY PANEL
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FULL PRESCRIBING INFORMATION
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,
