INDICATIONS AND USAGE
SEROQUEL is indicated for the treatment of schizophrenia.
The efficacy of SEROQUEL in schizophrenia was established in short-term (6-week) controlled trials of schizophrenic inpatients (See CLINICAL PHARMACOLOGY). The effectiveness of SEROQUEL in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use SEROQUEL for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (See DOSAGE AND ADMINISTRATION). CONTRAINDICATIONS
DOSAGE AND ADMINISTRATION
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.