Prescribing Information
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Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death, compared to placebo (sugar pill). Seroquel XR is not approved for treating these patients.
Antidepressants have increased the risk of suicidal thoughts and actions in some children, teenagers, and young adults. Patients of all ages starting treatment should be watched closely for worsening of depression, suicidal thoughts or actions, unusual changes in behavior, agitation, and irritability. Families and caregivers should watch patients daily and report these symptoms immediately to the physician. Seroquel XR is not approved for patients under the age of 18 years.
This is not a complete summary of safety information. Please discuss the full Prescribing Information with your health care provider.
Seroquel XR is a once-daily tablet approved to treat acute depressive episodes in bipolar disorder; acute manic or mixed episodes in bipolar disorder alone or when added to lithium or divalproex; long-term maintenance of bipolar disorder when added to lithium or divalproex; and schizophrenia.
Click here to see Prescribing Information for Seroquel XR, including Boxed Warnings.
Please see the last page of the Prescribing Information for the Medication Guide.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Patient photos are intended to be representative of typical patients with bipolar disorder and are not of actual patients.
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