What it's for (Indications)
- Fluvoxamine maleate is used to treat the symptoms of depressive illness, including Major Depressive Disorder (MDD), characterized by persistent feelings of sadness, loss of interest, and disruption in daily tasks.
- It is also indicated for Obsessive Compulsive Disorder (OCD) and other psychiatric disorders.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | For adults with OCD, the recommended starting dose is 100 mg orally once daily at bedtime. The dose can be increased weekly by 50 mg as tolerated, up to a maximum of 300 mg per day. For pediatric patients naive to fluvoxamine maleate, the lowest available dose may not be appropriate, and careful consideration and titration are required. In patients with hepatic impairment, decreased clearance may necessitate modified dosage and titration. For extended treatment, the dose should be adjusted to maintain the lowest effective dose, and patients should be periodically reassessed. Capsules should not be crushed or chewed. Gradual dose reduction is recommended when discontinuing the medication. |
Safety & Warnings
Common Side Effects
- Common reactions include nausea, vomiting, diarrhea, gastrointestinal disturbances (e.
- g.
- , dyspepsia), somnolence, insomnia, anorexia, asthenia, sweating, tremor, anxiety, dizziness, myalgia, pharyngitis, and yawning.
- Sexual dysfunction such as abnormal ejaculation, anorgasmia, and decreased libido may also occur.
- More serious or less common effects reported include tachycardia, palpitations, hyponatremia (low sodium levels), and neuroleptic malignant syndrome (a life-threatening reaction).
Serious Warnings
- Black Box Warning: 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. Anyone considering the use of fluvoxamine maleate extended-release capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.
- Patients, particularly children, adolescents, and young adults, must be monitored for suicidal ideation and behavior, especially at the beginning of treatment or following dose adjustments.
- The medication should be withdrawn gradually to avoid discontinuation symptoms.
- Use with caution in patients with hepatic (liver) and renal (kidney) dysfunction (dose modification and titration may be required for hepatic impairment), a history of epilepsy, bleeding disorders, heart diseases, diabetes, mania, and those at risk of narrow-angle glaucoma.
- The effects of this medicine in pregnant females are undetermined, and pregnant patients should consult their doctor before use.
- Lactation is a contraindication for this medication.
How it Works (Mechanism of Action)
Fluvoxamine maleate is classified as a selective serotonin reuptake inhibitor (SSRI). Its primary therapeutic action involves the potent and selective inhibition of serotonin (5-hydroxytryptamine, 5-HT) reuptake by the presynaptic neuronal membrane in the central nervous system. By blocking the serotonin transporter (SERT) protein, fluvoxamine prevents the reabsorption of serotonin from the synaptic cleft back into the presynaptic neuron. This blockade results in an increased concentration of serotonin in the synaptic space, leading to enhanced and prolonged stimulation of postsynaptic serotonin receptors. This augmentation of serotonergic neurotransmission is considered the fundamental mechanism by which fluvoxamine exerts its antidepressant, anxiolytic, and anti-obsessional effects. Furthermore, fluvoxamine exhibits minimal affinity for other neurotransmitter receptors, including alpha-adrenergic, histamine H1, muscarinic cholinergic, and dopamine receptors, contributing to a more favorable tolerability profile compared to non-selective agents. Chronic administration is believed to induce adaptive changes in serotonin receptor sensitivity and neuronal signaling pathways, further solidifying its therapeutic impact.