HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LUVOX CR® (Fluvoxamine Maleate) Extended-Release Capsules safely and effectively. See full prescribing information for LUVOX CR Capsules.
LUVOX CR(Fluvoxamine Maleate) Extended-Release Capsules for oral administration
Initial U.S. Approval: 2008
WARNING: SUICIDALITY and ANTIDEPRESSANTSSee 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 disorder and other psychiatric disorders (5.1).
RECENT MAJOR CHANGES
Warnings and Precautions (5.3)             07/2014
INDICATIONS AND USAGE
LUVOX CR Capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) (1).
Efficacy was demonstrated in:
• One 12-week study with LUVOX CR Capsules in adults (14.1).
• Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents (14.1, 14.3).
• One maintenance study with IR fluvoxamine tablets (14.2).
DOSAGE AND ADMINISTRATION
• Adults: Recommended starting dose is 100 mg at bedtime, with weekly increases of 50 mg as tolerated to maximum effect, not to exceed 300 mg/day (2.1).
• Pediatric patients naïve to fluvoxamine maleate: The lowest available dose of LUVOX CR Capsules may not be appropriate (2.2).
• Hepatically impaired: Decreased clearance may require modified dose and titration (2.3).
• Extended treatment: Adjust dose to maintain lowest effective dose; reassess patients periodically (2.4).
• Discontinuation: Gradual dose reduction is recommended ( 2.7, see Warnings and Precautions [5.9]).
DOSAGE FORMS AND STRENGTHS
• 100 mg and 150 mg Extended-Release Capsules (3)
CONTRAINDICATIONS
• Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon (4).
• Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with LUVOX CR Capsules or within 14 days of stopping treatment with LUVOX CR Capsules. Do not use LUVOX CR Capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start LUVOX CR Capsules in a patient who is being treated with linezolid or intravenous methylene blue (4.1).
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 (5.1).
• Bipolar Disorder: Screen for bipolar disorder (5.1).
• Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including LUVOX CR Capsules, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort). If such symptoms occur, discontinue LUVOX CR Capsules and initiate supportive treatment. If concomitant use of LUVOX CR Capsules with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for s