erotonim syndrome, particularly during treatment initiation and dose increases (5.2).
• Angle Closure Glaucome: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants ( 5.3).
• Other Potentially Important Drug Interactions: Benzodiazepines: Use with caution. Coadministration with diazepam is generally not advisable (5.9). Clozapine: Clozapine levels may be increased and produce orthostatic hypotension or seizures (5.9). Methadone: Coadministration may produce opioid intoxication. Discontinuation of fluvoxamine may produce opioid withdrawal (5.9). Mexiletine: Monitor serum mexiletine levels (5.9). Theophylline: Clearance decreased; reduce theophylline dose by one-third (5.9). Warfarin: Plasma concentrations increased and prothrombin times prolonged; monitor prothrombin time and adjust warfarin dose accordingly (5.9).
• Discontinuation: Symptoms associated with discontinuation have been reported (5.10). 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 (5.11).
• Activation of Mania/Hypomania has occurred (5.12).
• Seizures: Avoid administering fluvoxamine in patients with unstable epilepsy; monitor patients with controlled epilepsy; discontinue treatment if seizures occur or frequency increases (5.13).
• Hyponatremia: May occur with SSRIs and SNRIs, including LUVOX CR Capsules. The elderly may be at increased risk. Consider discontinuing in patients with symptomatic hyponatremia (5.14).
• 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 ( 5.15 ).
ADVERSE REACTIONS
Most common reactions in controlled trials with OCD patients and patients from another studied population (incidence ≥5% and at least twice that for placebo) were abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating and tremor (6.2). The following additional reactions occurred: anxiety, decreased libido, myalgia, pharyngitis, and vomiting in the OCD population; and dyspepsia, dizziness, insomnia, and yawning in another studied population.
To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals, Inc., at 1-800-520-5568 phone; 1-510-595-8183 fax; jazzsafety@jazzpharma.com; or FDA at 1-800-FDA-1088 or www.fda.gov/Medwatch.
DRUG INTERACTIONS
Drug Interactions (not described in Contraindications or Warnings and Precautions) include the following:
Drugs Inhibiting or Metabolized by Cytochrome P450: Fluvoxamine inhibits several cytochrome P450 isoenzymes (CYP1A2, CYP2C9, CYP3A4, and CYP2C19) (7.1). Carbamazepine: Elevated carbamazepine levels and symptoms of toxicity with coadministration (7.2). Sumatriptan: Rare postmarketing reports of weakness, hyperreflexia, and incoordination following use of an SSRI and sumatriptan. Monitor appropriately if concomitant treatment is clinically warranted (7.2). Tacrine: Coadministration increased tacrine Cmax and AUC five- and eight-fold and caused nausea, vomiting, sweating, and diarrhea (7.2). Tricyclic Antidepressants (TCAs): Coadminist |
