Fluvoxamine Maleate

What it is and how it works

Mechanism of Action 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 .

Indications

Fluvoxamine maleate extended-release capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) . Efficacy was demonstrated in: One 12-week study fluvoxamine maleate extended-release capsules in adults . 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 . Obsessive Compulsive Disorder Fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV. 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 obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.

Dosage and administration (summary)

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 . Pediatric patients naïve to fluvoxamine maleate: The lowest available dose of fluvoxamine maleate extended-release capsules may not be appropriate . 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 ( 2.7 , see Warnings and Precautions [ 5.10 ] ).

Contraindications

Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated ( see WARNINGS AND PRECAUTIONS [ 5.4 - 5.8 ] ) . Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon .

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 . Bipolar Disorder: Screen for bipolar disorder . Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including fluvoxamine maleate extended-release capsules, both when taken alone, but especially when co-administered with other serotonergic agents. If such symptoms occur, discontinue fluvoxamine maleate extended-release capsules and serotonergic agents and initiate supportive treatment.

Pregnancy

Pregnancy Teratogenic Effects: When pregnant rats were given daily doses of fluvoxamine (60 mg/kg, 120 mg/kg, 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 greate…

Storage and supply

How Supplied Fluvoxamine maleate extended-release capsules are available in the following strengths, colors, imprints, and presentations: 100 mg Extended-Release Capsules : Available in an olive opaque/grey opaque hard gelatin capsules of size '2' imprinted with 'ap' logo on cap and 'FL 100' on body in black ink containing white to off white pellet…

Source: Fluvoxamine Maleate (Fluvoxamine Maleate) — US FDA prescribing information, 2025-11-04, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.