Quetiapinedosage

Swallow tablets whole and do not split, chew or crush

Take without food or with a light meal (approx. 300 calories)

Administer once daily, preferably in the evening

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 (50 mg/day) and slower titration may be needed Indication Initial Dose Recommended Dose Maximum Dose Schizophrenia - Adults 300 mg/day 400-800 mg/day 800 mg/day Schizophrenia - Adolescents (13 to 17 years) 50 mg/day 400-800 mg/day 800 mg/day Bipolar I Disorder manic or mixed - Acute monotherapy or adjunct to lithium or divalproex - Adults 300 mg/day 400-800 mg/day 800 mg/day Bipolar I Disorder, manic Acute monotherapy - Children and Adolescents (10 to 17 years) 50 mg/day 400-600 mg/day 600 mg/day Bipolar Disorder, Depressive Episodes - Adults 50 mg/day 300 mg/day 300 mg/day Major Depressive Disorder, Adjunctive Therapy with Antidepressants - Adults 50 mg/day 150-300 mg/day 300 mg/day

2.1 Important

Administration Instructions 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). SEROQUEL XR should be administered once daily, preferably in the evening.

2.2 Recommended

Dosing The recommended initial dose, titration, dose range and maximum SEROQUEL XR dose for each approved indication is displayed in Table 1 below. 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 XR Indication Initial Dose and Titration Recommended Dose Maximum Dose Schizophrenia - Adults 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 800 mg/day Schizophrenia - Adolescents (13 to 17 years) Day 1: 50 mg/day Day 2: 100 mg/day Day 3: 200 mg/day Day 4: 300 mg/day Day 5: 400 mg/day 400-800 mg/day 800 mg/day Schizophrenia Maintenance - Monotherapy - Adults Not applicable 400-800 mg/day 800 mg/day Bipolar I Disorder manic or mixed - Acute monotherapy or adjunct to lithium or divalproex - Adults Day 1: 300 mg/day Day 2: 600 mg/day Day 3: between 400 and 800 mg/day 400-800 mg/day 800 mg/day Bipolar I Disorder, manic - Acute monotherapy - Children and Adolescents (10 to 17 years) Day 1: 50 mg/day Day 2: 100 mg/day Day 3: 200 mg/day Day 4: 300 mg/day Day 5: 400 mg/day 400-600 mg/day 600 mg/day Bipolar Disorder, Depressive Episodes - Adults Day 1: 50 mg/day Day 2: 100 mg/day Day 3: 200 mg/day Day 4: 300 mg/day 300 mg/day 300 mg/day Bipolar I Disorder Maintenance - Adjunct to lithium or divalproex - Adults Not applicable 400-800 mg/day 800 mg/day Major Depressive Disorder - Adjunctive Therapy with Antidepressants - Adults Day 1: 50 mg/day Day 2: 50 mg/day Day 3: 150 mg/day 150-300 mg/day 300 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 XR 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 SEROQUEL XR 50 mg/day. The dose can be increased daily in increments of 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 XR 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 XR should be increased by 6-fold.

2.6 Dose Modifications when used with CYP3A4

Inducers SEROQUEL XR 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 tolerance of the individual patient. When the CYP3A4 inducer is discontinued, the dose of SEROQUEL XR 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 XR for more than one-week, the initial dosing schedule should be followed. When restarting patients who have been off SEROQUEL XR for less than one-week, gradual dose escalation may not be required and the maintenance dose may be re-initiated.

2.8 Switching

Patients from SEROQUEL Tablets to SEROQUEL XR Tablets Patients who are currently being treated with SEROQUEL (immediate release formulation) may be switched to SEROQUEL XR at the equivalent total daily dose taken once daily. Individual dosage adjustments may be necessary.

2.9 Switching from

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