n and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline) is clinically warranted, appropriate observation of the patient is advised.
Tryptophan: Tryptophan may enhance the serotonergic effects of fluvoxamine, and the combination should, therefore, be used with caution. Severe vomiting has been reported with the coadministration of immediate-release fluvoxamine maleate tablets and tryptophan (see WARNINGS AND PRECAUTIONS [5.2]).
7.3 Other Drugs
Alosetron: See CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.7), and Lotronex® (alosetron) package insert.
Digoxin: Administration of immediate-release fluvoxamine maleate tablets 100 mg daily for 18 days (N=8) did not significantly affect the pharmacokinetics of a 1.25 mg single intravenous dose of digoxin.
Diltiazem: Bradycardia has been reported with the coadministration of immediate-release fluvoxamine maleate tablets and diltiazem.
Mexiletine: See WARNINGS AND PRECAUTIONS (5.9).
Propranolol and Other Beta-Blockers: Coadministration of immediate-release fluvoxamine maleate tablets 100 mg per day and propranolol 160 mg per day in normal volunteers resulted in a mean five-fold increase (range 2 to 17) in minimum propranolol plasma concentrations. In this study, there was a slight potentiation of the propranolol-induced reduction in heart rate and reduction in the exercise diastolic pressure.
One case of bradycardia and hypotension and a second case of orthostatic hypotension have been reported with the coadministration of immediate-release fluvoxamine maleate tablets and metoprolol.
If propranolol or metoprolol is coadministered with LUVOX CR Capsules, a reduction in the initial beta-blocker dose and more cautious dose titration are recommended. No dosage adjustment is required for LUVOX CR Capsules.
Coadministration of immediate-release fluvoxamine maleate tablets 100 mg per day with atenolol 100 mg per day (N=6) did not affect the plasma concentrations of atenolol. Unlike propranolol and metoprolol, which undergo hepatic metabolism, atenolol is eliminated primarily by renal excretion.
Theophylline: See WARNINGS AND PRECAUTIONS (5.9).
Warfarin and Other Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, etc.): See WARNINGS AND PRECAUTIONS (5.9, 5.11).
7.4 Effects of Smoking on Fluvoxamine Metabolism
Smokers had a 25% increase in the metabolism of fluvoxamine compared to nonsmokers.
7.5 Electroconvulsive Therapy (ECT)
There are no clinical studies establishing the benefits or risks of combined use of ECT and fluvoxamine maleate.
7.6 Monoamine Oxidase Inhibitors (MAOIs) Serotonergic Drugs See DOSAGE AND ADMINISTRATION (2.6, 2.7), CONTRADICTIONS (4.1), WARNINGS AND PRECAUTIONS (5.2).
7.7 Serotonergic Drugs
See DOSAGE AND ADMINISTRATION (2.6, 2.7), CONTRADICTIONS (4.1), WARNINGS AND PRECAUTIONS (5.2).
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Teratogenic Effects - Pregnancy Category C: When pregnant rats were given daily doses of fluvoxamine (60, 120, or 240 mg/kg) orally throughout the period of organogenesis, developmental toxicity in the form of increased embryofetal death and increased incidences of fetal eye abnormalities (folded retinas) was observed at doses of 120 mg/kg or greater. Decreased fetal bod |
