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pBased 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/ppPatientstheir 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/ppThe following adverse reactions have been identified during post approval use of fluoxetineBecause these reactions are reported voluntarily from a population of uncertain sizeit is difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure./ppAs with other SSRIsdecreased weight gain has been observed in association with the use of fluoxetine in children and adolescent patientsAfter 19 weeks of treatment in a clinical trialpediatric subjects treated with fluoxetine gained an average of 1.1 cm less in height and 1.1 kg less in weight than subjects treated with placeboIn additionfluoxetine treatment was associated with a decrease in alkaline phosphatase levelsThe safety of fluoxetine treatment for pediatric patients has not been systematically assessed for chronic treatment longer than several months in durationIn particularthere are no studies that directly evaluate the longer-term effects of fluoxetine on the growthdevelopment and maturation of children and adolescent patientsThereforeheight and weight should be monitored periodically in pediatric patients receiving fluoxetinesee WARNINGS AND PRECAUTIONS/ppHealthcare providers should inform patientstheir familiesand their caregivers about the benefits and risks associated with treatment with SARAFEM and should counsel them in its appropriate useHealthcare providers should instruct patientstheir familiesand their caregivers to read the Medication Guide and should assist them in understanding its contentsPatients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have./p

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