Quetiapinedosage

SEROQUEL can be taken with or without food Indication Initial Dose Recommended Dose Maximum Dose Schizophrenia - Adults 25 mg twice daily 150-750 mg/day 750 mg/day Schizophrenia - Adolescents (13-17 years) 25 mg twice daily 400-800 mg/day 800 mg/day Bipolar Mania - Adults Monotherapy or as an adjunct to lithium or divalproex 50 mg twice daily 400-800 mg/day 800 mg/day Bipolar Mania - Children and Adolescents (10-17 years), Monotherapy 25 mg twice daily 400-600 mg/day 600 mg/day Bipolar Depression - Adults 50 mg once daily at bedtime 300 mg/day 300 mg/day

Geriatric Use: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly

Hepatic Impairment: Lower starting dose (25 mg/day) and slower titration may be needed

2.1 Important

Administration Instructions SEROQUEL can be taken with or without food.

2.2 Recommended

Dosing The recommended initial dose, titration, dose range and maximum SEROQUEL dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient.

Table 1: Recommended Dosing for SEROQUEL Indication Initial Dose and Titration Recommended Dose Maximum Dose Schizophrenia - Adults Day 1: 25 mg twice daily. Increase in increments of 25 mg-50 mg divided two or three times on Days 2 and 3 to range of 300-400 mg by Day 4. Further adjustments can be made in increments of 25–50 mg twice a day, in intervals of not less than 2 days. 150-750 mg/day 750 mg/day Schizophrenia - Adolescents (13-17 years) Day 1: 25 mg twice daily.

Day 2: Twice daily dosing totaling 100 mg.

Day 3: Twice daily dosing totaling 200 mg.

Day 4: Twice daily dosing totaling 300 mg.

Day 5: Twice daily dosing totaling 400 mg. Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400-800 mg/day. Based on response and tolerability, may be administered three times daily. 400-800 mg/day 800 mg/day Schizophrenia - Maintenance Not applicable. 400-800 mg/day 800 mg/day Bipolar Mania - Adults Monotherapy or as an adjunct to lithium or divalproex Day 1: Twice daily dosing totaling 100 mg.

Day 2: Twice daily dosing totaling 200 mg.

Day 3: Twice daily dosing totaling 300 mg.

Day 4: Twice daily dosing totaling 400 mg. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400-800 mg/day 800 mg/day Bipolar Mania - Children and Adolescents (10 to 17 years), Monotherapy Day 1: 25 mg twice daily.

Day 2: Twice daily dosing totaling 100 mg.

Day 3: Twice daily dosing totaling 200 mg.

Day 4: Twice daily dosing totaling 300 mg.

Day 5: Twice daily dosing totaling 400 mg. Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400-600 mg/day. Based on response and tolerability, may be administered three times daily. 400-600 mg/day 600 mg/day Bipolar Depression - Adults Administer once daily at bedtime.

Day 1: 50 mg Day 2: 100 mg Day 3: 200 mg Day 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy - Adults Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized. 400-800 mg/day 800 mg/day Maintenance Treatment for Schizophrenia and Bipolar I Disorder Maintenance Treatment – Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.

2.3 Dose Modifications in

Elderly Patients Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions. When indicated, dose escalation should be performed with caution in these patients. Elderly patients should be started on SEROQUEL 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.

2.4 Dose Modifications in

Hepatically Impaired Patients Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day - 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.

2.5 Dose Modifications when used with CYP3A4

Inhibitors SEROQUEL dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of SEROQUEL should be increased by 6-fold.

2.6 Dose Modifications when used with CYP3A4

Inducers SEROQUEL dose should be increased up to 5-fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7-14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of SEROQUEL should be reduced to the original level within 7-14 days.

2.7 Re-initiation of

Treatment in Patients Previously Discontinued Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off SEROQUEL for more than one-week, the initial dosing schedule should be followed. When restarting patients who have been off SEROQUEL for less than one-week, gradual dose escalation may not be required and the maintenance dose may be re-initiated.

2.8 Switching from

Antipsychotics There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to SEROQUEL, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate SEROQUEL therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.