Fluvoxamine - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Fluvoxamine. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluvoxamine maleate extended-release capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. 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. Families and caregivers should be advised of the need for close observation and communication with the prescriber. ( See WARNINGS AND PRECAUTIONS-Clinical Worsening and Suicide Risk [ 5.1 ] and USE IN SPECIFIC POPULATIONS-Pediatric Use [ 8.4 ].) WARNING: SUICIDALITY and ANTIDEPRESSANTS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive diso
5 WARNINGS AND PRECAUTIONS Clinical Worsening/Suicide Risk: Monitor for clinical worsening of suicidal thoughts/behaviors especially during the initial months of therapy and at times of dose changes .
Bipolar Disorder: Screen for bipolar disorder .
Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including fluvoxamine maleate extended-release capsules, both when taken alone, but especially when co-administered with other serotonergic agents.
If such symptoms occur, discontinue fluvoxamine maleate extended-release capsules and serotonergic agents and initiate supportive treatment.
If concomitant use of fluvoxamine maleate extended-release capsules with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases .
Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants .
Other Potentially Important Drug Interactions: Benzodiazepines : Use with caution.
Coadministration with diazepam is generally not advisable .
Clozapine: Clozapine levels may be increased and produce orthostatic hypotension or seizures .
Methadone: Coadministration may produce opioid intoxication.
Discontinuation of fluvoxamine may produce opioid withdrawal .
Mexiletine: Monitor serum mexiletine levels .
Theophylline: Clearance decreased; reduce theophylline dose by one-third .
Warfarin: Plasma concentrations increased and prothrombin times prolonged; monitor prothrombin time and adjust warfarin dose accordingly .
Discontinuation: Symptoms associated with discontinuation have been reported .
In the absence of an emergency, abrupt discontinuation not recommended ( 2.7 , 5.2 ).
Abnormal Bleeding: May increase bleeding risk, especially when used with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation .
Activation of Mania/Hypomania has occurred .
Seizures: Avoid administering fluvoxamine in patients with unstable epilepsy; monitor patients with controlled epilepsy; discontinue treatment if seizures occur or frequency increases .
Hyponatremia: May occur with SSRIs and SNRIs, including fluvoxamine maleate extended-release capsules.
The elderly may be at increased risk.
Consider discontinuing in patients with symptomatic hyponatremia .
Concomitant Illness: Use caution in patients with diseases or conditions that affect hemodynamic responses or metabolism.
Patients with impaired liver function may require a lower starting dose and slower titration .
Sexual Dysfunction: Fluvoxamine may cause symptoms of sexual dysfunction .
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