WARNING
SERENTIL® (MESORIDAZINE BESYLATE) HAS BEEN SHOWN TO PROLONG THE QTc INTERVAL IN A DOSE RELATED MANNER, AND DRUGS WITH THIS POTENTIAL, INCLUDING SERENTIL, HAVE BEEN ASSOCIATED WITH TORSADE DE POINTES-TYPE ARRHYTHMIAS AND SUDDEN DEATH. DUE TO ITS POTENTIAL FOR SIGNIFICANT, POSSIBLY LIFE-THREATENING, PROARRHYTHMIC EFFECTS, SERENTIL SHOULD BE RESERVED FOR USE IN THE TREATMENT OF SCHIZOPHRENIC PATIENTS WHO FAIL TO SHOW AN ACCEPTABLE RESPONSE TO ADEQUATE COURSES OF TREATMENT WITH OTHER ANTIPSYCHOTIC DRUGS, EITHER BECAUSE OF INSUFFICIENT EFFECTIVENESS OR THE INABILITY TO ACHIEVE AN EFFECTIVE DOSE DUE TO INTOLERABLE ADVERSE EFFECTS FROM THOSE DRUGS. (SEE WARNINGS, CONTRAINDICATIONS, AND INDICATIONS.)
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SERENTIL SUMMARY
Serentil®
SERENTIL® (mesoridazine besylate), the besylate salt of a metabolite of thioridazine, is a phenothiazine antipsychotic. Serentil is 10-[2(1-methyl-2-piperidyl)ethyl]-2-(methyl-sulfinyl)-phenothiazine [as the besylate].
Serentil® (mesoridazine besylate) is indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Due to the risk of significant, potentially life-threatening, proarrhythmic effects with Serentil treatment, Serentil should be used only in patients who have failed to respond adequately to treatment with appropriate courses of other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. Consequently, before initiating treatment with Serentil, it is strongly recommended that a patient be given at least two trials, each with a different antipsychotic drug product at an adequate dose, and for an adequate duration (see WARNINGS and CONTRAINDICATIONS).
However, the prescriber should be aware that Serentil has not been systematically evaluated in controlled trials in treatment of refractory schizophrenic patients and its efficacy in such patients is unknown.
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