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Table 5Most Common Treatment-Emergent Adverse ReactionsIncidence in PMDD PlaceboControlled Clinical Trials.
In a study of 19 healthy male subjectswhich included 6 slow and 13 rapid hydroxylators of debrisoquina single 25 mg oral dose of thioridazine produced a 2.4-fold higher Cmax and a 4.5-fold higher AUC for thioridazine in the slow hydroxylators compared with the rapid hydroxylatorsThe rate of debrisoquin hydroxylation is felt to depend on the level of CYP2D6 isozyme activityThusthis study suggests that drugs which inhibit CYP2D6such as certain SSRIsincluding fluoxetinewill produce elevated plasma levels of thioridazine.
Healthcare providers should instruct their patients to read the Medication Guide before starting therapy with SARAFEM and to reread it each time the prescription is renewed.
Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of SARAFEM and other serotonergic agents including triptanstricyclic antidepressantsfentanyllithiumtramadolbuspironetryptophanand StJohn’s Wortsee CONTRAINDICATIONSWARNINGS AND PRECAUTIONSand DRUG INTERACTIONS
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