o other antidepressant therapy was superior to antidepressant alone in reduction of MADRS total score in both trials. SEROQUEL XR 150 mg once daily as adjunctive treatment was superior to antidepressant therapy alone in reduction of MADRS total score in one trial.
15 REFERENCES
None
16 HOW SUPPLIED/STORAGE AND HANDLING
50 mg Tablets (NDC 0310-0280) peach, film coated, capsule-shaped, biconvex, intagliated tablet with “XR 50” on one side and plain on the other are supplied in bottles of 60 tablets and 500 tablets and hospital unit dose packages of 100 tablets.
150 mg Tablets (NDC 0310-0281) white, film-coated, capsule-shaped, biconvex, intagliated tablet with ‘XR 150’ on one side and plain on the other are supplied in bottles of 60 tablets and 500 tablets and hospital unit dose packages of 100 tablets.
200 mg Tablets (NDC 0310-0282) yellow, film coated, capsule-shaped, biconvex, intagliated tablet with “XR 200” on one side and plain on the other are supplied in bottles of 60 tablets and 500 tablets and hospital unit dose packages of 100 tablets.
300 mg Tablets (NDC 0310-0283) pale yellow, film coated, capsule-shaped, biconvex, intagliated tablet with “XR 300” on one side and plain on the other are supplied in bottles of 60 tablets and 500 tablets and hospital unit dose packages of 100 tablets.
400 mg Tablets (NDC 0310-0284) white, film coated, capsule-shaped, biconvex, intagliated tablet with “XR 400” on one side and plain on the other are supplied in bottles of 60 tablets 500 mg tablets and hospital unit dose packages of 100 tablets.
Store SEROQUEL XR at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [See USP].
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
[see Medication Guide]
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with SEROQUEL XR and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for SEROQUEL XR. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking SEROQUEL XR.
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Patients and caregivers should be advised that elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. Quetiapine is not approved for elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1)].
Clinical Worsening and Suicide Risk
Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypoma
