DOSE IS RESTRICTED TO 30 MG IN PATIENTS KNOWN TO BE OF CYP2D6 POOR METABOLIZER GENOTYPE OR IN PATIENTS CONCOMITANTLY TREATED WITH POTENT CYP2D6 & MODERATE CYP3A4 INHIBITORS. THIORIDAZINE (CYP 2D6 INHIBITOR) ADMINISTRATION ALONE PRODUCES PROLONGATION OF THE QTC INTERVAL, WHICH IS ASSOCIATED WITH SERIOUS VENTRICULAR ARRHYTHMIAS. CONCOMITANT TREATMENT IS CONTRAINDICATED WITH MONOAMINE OXIDASE INHIBITORS (MAOIS), THIORIDAZINE SEROTONIN REUPTAKE INHIBITORS [SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS), SEROTONIN-NOREPINEPHRINE REUPTAKE INHIBITORS (SNRIS), TRICYCLIC ANTIDEPRESSANTS (TCAS)] OR OTHER MEDICINAL/HERBAL PRODUCTS WITH SEROTONERGIC EFFECTS [E.G., L-TRYPTOPHAN, TRIPTANS, TRAMADOL, LINEZOLID, LITHIUM, ST. JOHN'S WORT (HYPERICUM PERFORATUM)] OR WITHIN 14 DAYS OF DISCONTINUING TREATMENT WITH THESE DRUGS. SIMILARLY, THESE DRUGS SHOULD NOT BE ADMINISTERED WITHIN 7 DAYS AFTER DAPOXETINE HAS BEEN DISCONTINUED.
CONCOMITANT TREATMENT OF POTENT CYP3A4 INHIBITORS SUCH AS KETOCONAZOLE, ITRACONAZOLE, RITONAVIR, SAQUINAVIR, TELITHROMYCIN, NEFAZADONE, NELFINAVIR, ATAZANAVIR, ETC IS AVOIDED. RECREATIONAL DRUGS WITH SEROTONERGIC ACTIVITY SUCH AS KETAMINE, METHYLENEDIOXYMETHAMPHETAMINE (MDMA) AND LYSERGIC ACID DIETHYLAMIDE (LSD) MAY LEAD TO POTENTIALLY SERIOUS REACTIONS IF COMBINED WITH DAPOXETINE. THESE REACTIONS INCLUDE, BUT ARE NOT LIMITED TO, ARRHYTHMIA, HYPERTHERMIA, AND SEROTONIN SYNDROME. COMBINING ALCOHOL WITH DAPOXETINE MAY INCREASE ALCOHOL-RELATED NEUROCOGNITIVE EFFECTS. THERE HAVE BEEN REPORTS OF BLEEDING ABNORMALITIES WITH SSRIS. CAUTION IS ADVISED IN PATIENTS TAKING DAPOXETINE, PARTICULARLY IN CONCOMITANT USE WITH MEDICINAL PRODUCTS KNOWN TO AFFECT PLATELET FUNCTION (E.G., ATYPICAL ANTIPSYCHOTICS AND PHENOTHIAZINES, ACETYLSALICYLIC ACID, NONSTEROIDAL ANTI-INFLAMMATORY DRUGS [NSAIDS], ANTI-PLATELET AGENTS) OR ANTICOAGULANTS (E.G., WARFARIN), AS WELL AS IN PATIENTS WITH A HISTORY OF BLEEDING OR COAGULATION DISORDERS.