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If the decision has been made to discontinue treatmentmedication should be taperedas rapidly as is feasiblebut with recognition that abrupt discontinuation can be associated with certain symptomssee Discontinuation of Treatment

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicityThe risk increases if you are also taking other drugs that increase serotoninso tell your doctor or pharmacist of all the drugs you takesee Drug Interactions sectionGet medical help right away if you develop some of the following symptomsfast heartbeathallucinationsloss of coordinationsevere dizzinesssevere nausea/vomiting/diarrheatwitching musclesunexplained feverunusual agitation/restlessness.

Patientstheir familiesand their caregivers should be encouraged to be alert to the emergence of anxietyagitationpanic attacksinsomniairritabilityhostilityaggressivenessimpulsivityakathisiapsychomotor restlessnesshypomaniamaniaother unusual changes in behaviorworsening of depressionand suicidal ideationespecially early during antidepressant treatment and when the dose is adjusted up or downFamilies and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basissince changes may be abruptSuch symptoms should be reported to the patient’s prescriber or health professionalespecially if they are severeabrupt in onsetor were not part of the patient’s presenting symptomsSymptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medicationsee BOXED WARNING and WARNINGS AND PRECAUTIONS

Concomitant use of SARAFEMfluoxetinein patients taking MAOIs is contraindicatedThere have been reports of serioussometimes fatalreactionsincluding hyperthermiarigiditymyoclonusautonomic instability with possible rapid fluctuations of vital signsand mental status changes that include extreme agitation progressing to delirium and comain patients receiving fluoxetine in combination with a monoamine oxidase inhibitorMAOIand in patients who have recently discontinued fluoxetine and are then started on an MAOISome cases presented with features resembling neuroleptic malignant syndromeThereforefluoxetineincluding SARAFEMshould not be used in combination with an MAOIor within a minimum of 14 days of discontinuing therapy with an MAOIsee CONTRAINDICATIONSSince fluoxetine and its major metabolite have very long elimination half-livesat least 5 weeksperhaps longerespecially if fluoxetine has been prescribed chronically and/or at higher dosesshould be allowed after stopping fluoxetine before starting an MAOIsee DOSAGE AND ADMINISTRATIONCONTRAINDICATIONSWARNINGS AND PRECAUTIONSand CLINICAL PHARMACOLOGY

Because fluoxetine is tightly bound to plasma proteinsthe administration of fluoxetine to a patient taking another drug that is tightly bound to proteinfor examplewarfarindigitoxinmay cause a shift in plasma concentrations potentially resulting in an adverse effectsee CLINICAL PHARMACOLOGY

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