Name Fluvoxamine Maleate
Classes Central Nervous System Agent
Psychotherapeutic Agent
Serotonin Reuptake Inhibitor (SRI)
Diseases CNS Disorder
Depression
Obsessive Compulsive Disorder (OCD)
Phobia

Fluvoxamine Maleate

Fluvoxamine is a selective serotonin reuptake inhibitor that is used orally (SSRI). Fluvoxamine's antidepressant mechanism is thought to be linked to potentiation of serotonergic activity in the central nervous system (CNS) as a result of its suppression of serotonin neuronal reuptake (5-HT). 

Fluvoxamine is indicated for the treatment of:

  • Major depressive episode
  • Obsessive Compulsive Disorder (OCD)
  • Adults: The recommended starting dose is 50 mg at bedtime, followed by 50 mg increases every to days as tolerated to achieve maximum effect, not to exceed 300 mg/day. Doses greater than 100mg per day should be divided.
  • Children and adolescents (8-17 years): The recommended starting dose is 25 mg at bedtime, with increases of 25 mg every to days as tolerated to achieve maximum effect, withmaximum daily dose of 200 mg (8-11 years) or 300 mg/day (12-17 years). Doses greater than 50mg per day should be divided.
  • Hepatically impaired: Reduced clearance may necessitate dose modification and titration. Adjust the dose to maintain the lowest effective dose; reassess patients on regular basis.
  • Extended treatment:  Adjust dose to maintain lowest effective dose; reassess patients periodically.
  • Discontinuation: A gradual dose reduction is advised.

Most common reactions in controlled trials with adult OCD and depression patients were-

  • nausea
  • somnolence
  • insomnia
  • asthenia
  • nervousness
  • dyspepsia
  • abnormal ejaculation
  • sweating
  • anorexia
  • tremor
  • vomiting
  • 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 (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John's Wort). If such symptoms occur, discontinue Fluvoxamine Maleate Tablets 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.
  • Drug Interactions:
    • Benzodiazepines: Use with caution. Coadministration with diazepam is generally not advisable 
    • Clozapine: Clozapine levels may be increased and produce orthostatic hypotension or seizures (5.7). Methadone: Coadministration may produce opioid intoxication. Discontinuation of fluvoxamine may produce opioid withdrawal
    • Mexiletine: Monitor serum mexiletine levels 
    • Ramelteon: Should not be used in combination with fluvoxamine
    • Theophylline: Clearance decreased; reduce theophylline dose by one-third
    • Warfarin: Plasma concentrations increased and prothrombin times prolonged; monitor prothrombin time and adjust warfarin dose accordingly 
    • Other Drugs Affecting Hemostasis: Increased risk of bleeding with concomitant use of NSAIDs, aspirin, or other drugs affecting coagulation 
  • Discontinuation: Symptoms associated with discontinuation have been reported. Abrupt discontinuation not recommended. 
  • Activation of mania/hypomania has occurred
  • Seizures: Avoid administering fluvoxamine in patients with unstable epilepsy; monitor patients with controlled epilepsy; discontinue treatment if seizures occur or frequency increases
  • Hyponatremia: May occur with SSRIs and SNRIs, including Fluvoxamine Maleate Tablets. The elderly may be at increased risk. Consider discontinuing in patients with symptomatic hyponatremia 
  • 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.

Contraindication

  • Coadministration of the following drugs is contraindicated-
  • 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. Examples of MAOIs include-
  • Contraindicated in patients hypersensitive to Fluvoxamine.