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Patients on stable doses of phenytoin and carbamazepine have developed elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation of concomitant fluoxetine treatment.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongationBefore using fluoxetinetell your doctor or pharmacist of all the drugs you take and if you have any of the following conditionscertain heart problemsheart failureslow heartbeatQT prolongation in the EKGfamily history of certain heart problemsQT prolongation in the EKGsudden cardiac death

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worseningsuicidalityand unusual changes in behaviorespecially during the initial few months of a course of drug therapyor at times of dos e changeseither increases or decreases

In US placebo-controlled clinical trials of fluoxetine for other approved indicationsanxietynervousnessand insomnia have been among the most commonly reported adverse reactionssee Table 6 and ADVERSE REACTIONS

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Because fluoxetine is excreted in human milknursing while on SARAFEM is not recommendedIn one breast-milk samplethe concentration of fluoxetine plus norfluoxetine was 70.4 ng/mLThe concentration in the mother’s plasma was 295.0 ng/mLNo adverse effects on the infant were reportedIn another casean infant nursed by a mother on fluoxetine developed cryingsleep disturbancevomitingand watery stoolsThe infant’s plasma drug levels were 340 ng/mL of fluoxetine and 208 ng/mL of norfluoxetine on the second day of feeding.

Table 6 enumerates the most common treatment-emergent adverse reactions associated with the use of fluoxetine up to 80 mgincidence of at least 2for fluoxetine and greater than placeboin female patients ages 18 to 45 years from US placebo-controlled clinical trials in the treatment of depressionOCDand bulimia.

Patients should be advised to notify their physician if they develop a rash or hivessee WARNINGS AND PRECAUTIONSPatients should also be advised of the signs and symptoms associated with a severe allergic reactionincluding swelling of the faceeyesor mouthor trouble breathingPatients should be cautioned to seek medical care immediately if they experience these symptoms.

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