DOSAGE AND ADMINISTRATION
Bipolar Disorder
Depression
Usual Dose: SEROQUEL should be administered once daily at bedtime to reach 300 mg/day by day 4.
Recommended Dosing Schedule |
Day
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Day 1
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Day 2
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Day 3
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Day 4
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SEROQUEL
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50 mg
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100 mg
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200 mg
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300 mg
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In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for days 1-4 respectively. Patients receiving 600 mg increased to 400 mg on day 5 and 600 mg on day 8 (Week 1). Antidepressant efficacy was demonstrated with SEROQUEL at both 300 mg and 600 mg however, no additional benefit was seen in the 600 mg group.
Mania
Usual Dose: When used as monotherapy or adjunct therapy (with lithium or divalproex), SEROQUEL should be initiated in bid doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in bid divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicates that the majority of patients responded between 400 to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Schizophrenia
Usual Dose: SEROQUEL should generally be administered with an initial dose of 25 mg bid, with increases in increments of 25-50 mg bid or tid on the second and third day, as tolerated, to a target dose range of 300 to 400 mg daily by the fourth day, given bid or tid. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for SEROQUEL would not be achieved for approximately 1-2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25-50 mg bid are recommended. Most efficacy data with SEROQUEL were obtained using tid regimens, but in one controlled trial 225 mg bid was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 to 750 mg/day in the clinical trials supporting the effectiveness of SEROQUEL. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400-500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Dosing in Special Populations
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 (see CLINICAL PHARMACOLOGY). When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25-50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
The elimination of quetiapine was enhanced in the presence of phenytoin. Higher maintenance doses of quetiapine may be required when it is coadministered with phenytoin and other enzyme inducers such as carbamazepine and phenobarbital (See Drug Interactions under PRECAUTIONS).
Maintenance Treatment: While there is no body of evidence available to answer the question of how long the patient treated with SEROQUEL should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Reinitiation of Treatment in Patients Previously Discontinued: Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off SEROQUEL, titration of SEROQUEL is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off SEROQUEL for more than one week, the initial titration schedule should be followed.
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 reevaluated periodically.
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