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SARAFEM has the potential to impair judgmentthinkingor motor skillsPatients should be cautioned about operating hazardous machineryincluding automobilesuntil they are reasonably certain that the drug treatment does not affect them adversely.
Because fluoxetine is tightly bound to plasma proteinsadverse effects may result from displacement of protein-bound fluoxetine by other tightly bound drugssee CLINICAL PHARMACOLOGY
Patients should be advised of the signs and symptoms associated with serotonin syndrome that may include mental status changesfor exampleagitationhallucinationsdeliriumand comaautonomic instabilityfor exampletachycardialabile blood pressuredizzinessdiaphoresisflushinghyperthermianeuromuscular changesfor exampletremorrigiditymyoclonushyperreflexiaincoordinationseizuresand/or gastrointestinal symptomsfor examplenauseavomitingdiarrheaPatients should be cautioned to seek medical care immediately if they experience these symptoms.
Based on the mechanism of action of SNRIs and SSRIsincluding SARAFEMand the potential for serotonin syndromecaution is advised when SARAFEM is coadministered with other drugs that may affect the serotonergic neurotransmitter systemssuch as triptanslinezolidan antibiotic which is a reversible non-selective MAOIlithiumtramadolor StJohn’s Wortsee WARNINGS AND PRECAUTIONSThe concomitant use of SARAFEM with SNRIsSSRIsor tryptophan is not recommendedsee DOSAGE AND ADMINISTRATIONCONTRAINDICATIONSWARNINGS AND PRECAUTIONSand DRUG INTERACTIONS
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