ation
Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing SEROQUEL XR for patients who will be experiencing conditions which may contribute to an elevation in core body temperature, eg, exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration.
5.19 Dysphagia
Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia. SEROQUEL XR and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.
5.20 Suicide
The possibility of a suicide attempt is inherent in schizophrenia, bipolar disorder and depression; close supervision of high risk patients should accompany drug therapy. Prescriptions for SEROQUEL XR should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose.
In three, 6-week clinical studies in patients with schizophrenia (N=951) the incidence of treatment emergent suicidal ideation or suicide attempt was 0.6% (n=6) in SEROQUEL XR treated patients and 0.9% (n=3) in placebo-treated patients.
In an 8-week clinical study in patients with bipolar depression (N=137 for SEROQUEL XR and 140 for placebo) the incidence of treatment emergent suicidal ideation or suicide attempt was 0.7% (n=1) for SEROQUEL XR treated patients and 1.4% (n=2) for placebo.
In a 3-week clinical study in patients with bipolar mania (N=311, 151 for SEROQUEL XR and 160 for placebo) the incidence of treatment emergent suicidal ideation or suicide attempt was 1.3% (n=2) for SEROQUEL XR compared to 3.8% (n=6) for placebo.
In two, 6-week MDD adjunctive therapy trials (n=936, 627 on SEROQUEL XR and 309 on placebo) the incidence of treatment emergent suicidal ideation or suicide attempt was 0.5% (n=3) in SEROQUEL XR treated patients and 0.6% (n=2) in placebo.
5.21 Use in Patients with Concomitant Illness
Clinical experience with SEROQUEL XR in patients with certain concomitant systemic illnesses [see Pharmacokinetics (12.3)] is limited.
SEROQUEL XR has not been eva luated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from premarketing clinical studies. Because of the risk of orthostatic hypotension with SEROQUEL XR, caution should be observed in cardiac patients [see Warnings and Precautions (5.8)].
5.22 Withdrawal
Acute withdrawal symptoms, such as nausea, vomiting, and insomnia have very rarely been described after abrupt cessation of atypical antipsychotic drugs, including quetiapine fumarate. Gradual withdrawal is advised.
In short-term placebo-controlled, monotherapy clinical trials, in patients with MDD, which eva luated discontinuation symptoms, the aggregated incidence of discontinuation symptoms after abrupt cessation was 16.0% (89/556) for quetiapine and 7.3% (29/400) for placebo. The incidence of the individual adverse events (ie, insomnia, nausea, headache, diarrhea, vomiting, dizziness and irritability) did not exceed 6.7% in any treatment group and usually resolved after 1 week po
