Clinical monitoring, including baseline and periodic follow-up lipid evaluations in patients using Symbyax, is recommended In an analysis of 7 controlled clinical studies, 2 of which were placebo-controlled, with treatment duration up to 12 weeks, Symbyax-treated patients had an increase from baseline in mean random total cholesterol of 12.1 mg/dL compared to an increase from baseline in mean random total cholesterol of 4.8 mg/dL for olanzapine-treated patients and a decrease in mean random total cholesterol of 5.5 mg/dL for placebo-treated patients.
In addition, in vitro studies have shown ketoconazole, a potent inhibitor of CYP3A activity, to be at least 100 times more potent than fluoxetine or norfluoxetine as an inhibitor of the metabolism of several substrates for this enzyme, including astemizole, cisapride, and midazolam. Mixed-drug ingestion or other methods of suicide complicated all 6 overdoses in children that resulted in fatalities. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. Sleepiness. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding.
In neither patient was there an unequivocal diagnosis, but 1 was considered to have a leukocytoclastic vasculitis, and the other, a severe desquamating syndrome that was considered variously to be a vasculitis or erythema multiforme. Plasma fluoxetine and norfluoxetine concentration decrease gradually at the conclusion of therapy, which may minimize the risk of discontinuation symptoms with this drug The following adverse reactions are discussed in more detail in other sections of the labeling:Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice.The data in the tables represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed.
In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
The importance of the drug to the mother should be considered.Take Symbyax exactly as prescribed. You may report side effects to the FDA at 1-800-FDA-1088.Tell your doctor about all the medicine you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Symbyax should be discontinued before initiating treatment with the MAOI If concomitant use of Symbyax with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamines, and St. John's Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.Treatment with Symbyax and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.In Symbyax premarketing controlled clinical studies, the overall incidence of rash or allergic reactions in Symbyax-treated patients [4.6% (26/571)] was similar to that of placebo [5.2% (25/477)].