nt of MDD. The efficacy of SEROQUEL XR as adjunctive therapy to antidepressants in MDD was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant treatment [see Clinical Studies (14.3)].
2 DOSAGE AND ADMINISTRATION
SEROQUEL XR tablets should be swallowed whole and not split, chewed or crushed.
It is recommended that SEROQUEL XR be taken without food or with a light meal (approximately 300 calories) [see Clinical Pharmacology (12.3)].
2.1 Schizophrenia
Dose Selection—SEROQUEL XR should be administered once daily, preferably in the evening. The recommended initial dose is 300 mg/day. Patients should be titrated within a dose range of 400 mg/day – 800 mg/day depending on the response and tolerance of the individual patient [see Clinical Studies (14.1)]. Dose increases can be made at intervals as short as 1 day and in increments of up to 300 mg/day. The safety of doses above 800 mg/day has not been eva luated in clinical trials.
Maintenance Treatment—A maintenance trial in adult patients with schizophrenia treated with SEROQUEL XR has shown this drug to be effective in delaying time to relapse in patients who were stabilized on SEROQUEL XR at doses of 400 mg/day to 800 mg/day for 16 weeks. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.1)].
2.2 Bipolar Disorder
Bipolar Mania
Usual Dose for Acute Monotherapy or Adjunct Therapy (with lithium or divalproex)
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), SEROQUEL XR should be administered once daily in the evening starting with 300 mg on Day 1 and 600 mg on Day 2. SEROQUEL XR can be adjusted between 400 mg and 800 mg beginning on Day 3 depending on the response and tolerance of the individual patient.
Recommended Dosing Schedule Day
Day 1
Day 2
Day 3
SEROQUEL XR
300 mg
600 mg
400 mg to 800 mg
Depressive Episodes Associated with Bipolar Disorder
Usual Dose—SEROQUEL XR should be administered once daily in the evening to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day
Day 1
Day 2
Day 3
Day 4
SEROQUEL XR
50 mg
100 mg
200 mg
300 mg
Maintenance Treatment for Bipolar I Disorder
Maintenance Treatment—Maintenance of efficacy in bipolar I disorder was demonstrated with SEROQUEL (administered twice daily totaling 400 mg/day to 800 mg/day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Major Depressive Disorder, Adjunctive Therapy with Antidepressants
Dose Selection—SEROQUEL XR in a dose range of 150 mg/day to 300 mg/day was demonstrated to be effective as adjunctive therapy to antidepressants. Begin with 50 mg once daily in the evening. On Day 3, the dose can be increased to 150 mg once daily in the evening. There were dose-dependent increases in adverse reactions in the recommended dose ra