Fluvoxamine

Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD). Obsessive-Compulsive Disorder 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. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.

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 has been shown to be a potent inhibitor of the serotonin reuptake transporter in preclinical studies, both in vitro and in vivo.

• 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.

Coadministration Coadministration of tizanidine, thioridazine, alosetron, or pimozide with Fluvoxamine Maleate Tablets is contraindicated. Serotonin Syndrome and Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with Fluvoxamine Maleate Tablets or within 14 days of stopping treatment with Fluvoxamine Maleate Tablets is contraindicated because of an increased risk of serotonin syndrome. The use of Fluvoxamine Maleate Tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.

Boxed 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. • 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.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. • 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. 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.

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). Carbamazepine: Elevated carbamazepine levels and symptoms of toxicity with coadministration. Sumatriptan: Rare postmarketing reports of weakness, hyperreflexia, and incoordination following use of an SSRI and sumatriptan. Monitor appropriately if concomitant treatment is clinically warranted. Tacrine: Coadministration increased tacrine C max and AUC five- and eight-fold and caused nausea, vomiting, sweating, and diarrhea. Tricyclic Antidepressants (TCAs): Coadministration significantly increased plasma TCA levels. Use caution, monitor plasma TCA levels, reduce TCA dose if indicated. Tryptophan: Severe vomiting with coadministration.

Fluvoxamine Maleate Tablets should be protected from high humidity and stored at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).