3)
• Adults: Efficacy as an adjunct to antidepressants was established in two 6-week trials in patients with MDD who had an inadequate response to an antidepressant alone (14.3)
DOSAGE AND ADMINISTRATION
SEROQUEL XR Tablets should be swallowed whole and not split, chewed or crushed. SEROQUEL XR should be taken without food or with a light meal (approx. 300 calories). SEROQUEL XR should be administered once daily, preferably in the evening.
*
After initial dosing, adjustments can be made upwards or downwards, if necessary, within the dose range depending upon the clinical response and tolerance of the patient.
Indication
Dosing Instructions*
Recommended Dose / Dose Range
Schizophrenia-(2.1)
Day 1: 300 mg/day
Dose increases can be made at intervals as short as 1 day and in increments of up to 300 mg/day.
400-800 mg/day
Schizophrenia Maintenance (Monotherapy) (2.1)
400 mg/day to 800 mg/day
400-800 mg/day
Bipolar Mania-
Acute monotherapy or as an adjunct to lithium or divalproex (2.2)
Day 1: 300 mg.
Day 2: 600 mg.
Day 3: between 400 mg and 800 mg
400-800 mg/day
Depressive Episodes Associated with Bipolar Disorder (2.2)
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
Bipolar I Disorder-
Maintenance Treatment as an adjunct to lithium or divalproex (2.2)
400 mg/day to 800 mg/day
400-800 mg/day
Major Depressive Disorder, Adjunctive Therapy with Antidepressants (2.3)
Day 1 and 2: 50 mg
Day 3 and 4: 150 mg
150-300 mg/day
DOSAGE FORMS AND STRENGTHS
Extended-Release Tablets: 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Antipsychotic drugs, including quetiapine, are associated with an increased risk of death; causes of death are variable. (5.1)
Suicidality and Antidepressant Drugs: Increased the risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder and other psychiatric disorders (5.2)
Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring. (5.3)
Hyperglycemia and Diabetes Mellitus (DM): Ketoacidosis, hyperosmolar coma and death have been reported in patients treated with atypical antipsychotics, including quetiapine. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. When starting treatment, patients with diabetes or risk factors for diabetes should undergo blood glucose testing before and during treatment. (5.4)
Hyperlipidemia: Undesirable alterations in lipids have been observed. Increases in total cholesterol, LDL-cholesterol and triglycerides and decreases in HDL-cholesterol have been reported in clinical trials. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatment. (5.5)
Weight Gain: Patients should receive regular monitoring of weight. (5.6)
Tardive Dyskinesia: Discontinue if clinically appropriate. (5.7)
Orthostatic Hypotension