The mechanism of action of fluvoxamine maleate in obsessive compulsive disorder is presumed to be linked to its specific serotonin reuptake inhibition in brain neurons.

Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV.

Adults: Recommended starting dose is 50 mg at bedtime, with increases of 50 mg every 4 to 7 days as tolerated to maximum effect, not to exceed 300 mg/day. Daily doses over 100 mg should be divided. Children and adolescents (8 -17 years): Recommended starting dose is 25 mg at bedtime, with increases of 25 mg every 4 to 7 days as tolerated to maximum effect, not to exceed 200 mg/day (8 - 11 years) or 300 mg/day (12 -17 years). Daily doses over 50 mg should be divided. Hepatically impaired: Decreased clearance may require modified dose and titration. Extended treatment: Adjust dose to maintain lowest effective dose; reassess patients periodically. Discontinuation: Gradual dose reduction is recommended.

Most common reactions in controlled trials with adult OCD and depression patients (incidence ≥ 5% and at least twice that for placebo) were nausea, somnolence, insomnia, asthenia, nervousness, dyspepsia, abnormal ejaculation, sweating, anorexia, tremor, and vomiting (6.2). Using the above rule, the following events were also identified: anorgasmia, decreased libido, dry mouth, rhinitis, taste perversion, and urinary frequency in patients with OCD; and agitation, depression, dysmenorrhea, flatulence, hyperkinesia, and rash in pediatric patients with OCD.

Coadministration of tizanidine, thioridazine, alosteron, pimozide. Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with Fluvoxamine Maleate Tablets or within 14 days of stopping treatment with Fluvoxamine Maleate Tablets. Do not use Fluvoxamine Maleate Tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Fluvoxamine Maleate Tablets in a patient who is being treated with linezolid or intravenous methylene blue.

Suicidality: Monitor for clinical worsening and suicide risk. Bipolar disorder: Screen for bipolar disorder. Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including Fluvoxamine Maleate Tablets, both when taken alone, but especially when co-administered with other serotonergic agents. If such symptoms occur, discontinue Fluvoxamine Maleate Tablets and serotonergic agents and initiate supportive treatment. If concomitant use of Fluvoxamine Maleate Tablets 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. (See Full Prescribing Information.)