FEVERIN 50/MG FC TAB 60/FC TAB

Indications

Approved Uses

Obsessive‑Compulsive Disorder (OCD).

Off-Label Uses

Off-label (varies by guideline): social anxiety disorder, panic disorder, PTSD, body dysmorphic disorder, and some eating disorders.

Dosage & Administration

Dosing by Condition

OCD (adults): start 50 mg once daily at bedtime; increase by 50 mg every 4-7 days as tolerated; usual range 100-300 mg/day; max 300 mg/day; divide doses when total daily dose is >100-150 mg/day (larger dose at bedtime). Pediatric OCD (8-17 years): start 25 mg once daily at bedtime; titrate by 25-50 mg every 4-7 days; max 200 mg/day (8-11 years) and 300 mg/day (12-17 years); divide doses when total daily dose is >50 mg/day.

Initial Dose

50mg once daily at bedtime.

Maintenance Dose

100-200mg/day (depression); 100-300mg/day (OCD)

Maximum Dose

300mg per day.

Children's Dosage

OCD in children 8-17 years: Initial 25mg once daily at bedtime; increase by 25mg every 4-7 days; max 200mg/day in children 8-11 years, max 300mg/day in adolescents 12-17 years. Not approved for depression in children.

Dose Adjustment Notes

Hepatic impairment/elderly: start low and titrate slowly with close monitoring. If higher total daily doses are used (commonly >100-150 mg/day), administer in 2 divided doses; increase dose no more frequently than every 4-7 days as tolerated.

How to Take

Oral: swallow the film‑coated tablet whole with water; may be taken with or without food. Usually given once daily at bedtime; if the total daily dose is higher (commonly >100-150 mg/day), divide into 2 doses (larger portion at bedtime).

Side Effects

Common Side Effects

Common: nausea/GI upset (including diarrhea or constipation), headache, somnolence or insomnia, dizziness, dry mouth, sweating, asthenia/fatigue, decreased appetite, tremor/anxiety/nervousness.

Side Effect Frequency

Very common (>10%): nausea, somnolence, insomnia, headache. Common (1-10%): asthenia/fatigue, dizziness, anxiety/nervousness, dry mouth, diarrhea, decreased appetite/anorexia, sweating, tremor (and other GI/CNS effects may occur).

Safety & Warnings

Contraindications

Contraindicated with MAOIs (including within 14 days of stopping an MAOI; and allow adequate washout after stopping fluvoxamine before starting an MAOI), and with thioridazine, pimozide, tizanidine, and alosetron; contraindicated in hypersensitivity to fluvoxamine.

Warnings & Precautions

Key warnings/precautions: monitor for suicidality/clinical worsening (especially early and in patients <25), serotonin syndrome with serotonergic agents, increased bleeding risk with NSAIDs/aspirin/anticoagulants, mania/hypomania activation (screen for bipolar disorder), seizures (use caution), hyponatremia/SIADH (higher risk in elderly/diuretics), angle-closure glaucoma risk in susceptible patients, significant CYP-mediated drug interactions (notably CYP1A2/2C19 inhibition), and taper to avoid discontinuation symptoms.

Age Restriction

Not approved for children <8 years; for OCD it is approved in pediatric patients ≥8 years, while for depression it is not approved in patients <18 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major/contraindicated: MAOIs, thioridazine, pimozide, tizanidine, alosetron. Clinically significant: warfarin/other anticoagulants and NSAIDs/aspirin (bleeding risk), theophylline and clozapine (↑ levels via CYP1A2 inhibition), benzodiazepines (notably alprazolam/triazolam/diazepam-↑ sedation/levels), other serotonergic drugs (triptans, tramadol, other SSRIs/SNRIs, linezolid, etc.-serotonin syndrome risk). Ramelteon: avoid/contraindicated due to markedly increased exposure.

Interaction Severity

MAJOR/contraindicated: MAOIs (and within 14 days), tizanidine, thioridazine, pimozide, alosetron. Clinically significant (monitor/adjust): warfarin/other anticoagulants (bleeding/INR), theophylline (↑ levels via CYP1A2 inhibition), clozapine (↑ levels), benzodiazepines such as alprazolam/triazolam (↑ levels), other serotonergic drugs (e.g., tramadol, triptans, linezolid) (serotonin syndrome risk), NSAIDs/aspirin (↑ bleeding risk).

Food Interaction

No restriction.

Special Populations

Pregnancy

Category C

Children

OCD in children 8-17 years: Initial 25mg once daily at bedtime; increase by 25mg every 4-7 days; max 200mg/day in children 8-11 years, max 300mg/day in adolescents 12-17 years. Not approved for depression in children.

Elderly

Start at 50mg once daily at bedtime; titrate more slowly than in younger adults; lower maintenance doses may be sufficient; monitor for hyponatremia and drug interactions

Liver Impairment

Hepatic impairment: start at a lower dose and titrate slowly with close monitoring; consider lower maximum doses, and avoid or use extreme caution in severe hepatic impairment.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually (typically over at least 2-4 weeks, individualized) to reduce discontinuation symptoms (e.g., dizziness, nausea, irritability, anxiety, paresthesia).

Overdose

Overdose may cause GI upset (nausea/vomiting/diarrhea), CNS depression (somnolence/dizziness), seizures, and cardiovascular effects (tachy/bradycardia, hypotension, ECG changes), with possible coma and liver function disturbances; management is immediate emergency care with supportive treatment, airway/cardiac monitoring, and activated charcoal when appropriate-no specific antidote.

Patient Counseling

Take exactly as prescribed (often at bedtime); may take with or without food; do not stop abruptly-taper with prescriber guidance. Expect benefit after several weeks (often 2-4 weeks; full effect may take longer, especially for OCD). Avoid alcohol and use caution with driving until effects are known. Seek urgent care for serotonin syndrome symptoms; report worsening mood/suicidal thoughts. Inform providers about all medicines (notably MAOIs, tizanidine, anticoagulants/NSAIDs, theophylline, clozapine, benzodiazepines).

Monitoring Requirements

Monitor for clinical worsening/suicidality (especially early and after dose changes); monitor for serotonin syndrome when combined with serotonergic agents; consider sodium (hyponatremia risk) in older adults or symptomatic patients; monitor INR/bleeding if used with warfarin/anticoagulants; consider LFTs in hepatic impairment or if clinically indicated.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI) that inhibits SERT to increase synaptic serotonin; also has notable sigma‑1 receptor affinity.

Duration of Effect

Dosing interval is typically once daily (or divided twice daily) with ~24‑hour coverage; clinical symptom control is maintained with continued daily therapy.

Half-Life

Approximately 15-22 hours (may be ~22 hours at steady state with repeated dosing).

Metabolism

Extensive hepatic metabolism primarily via CYP1A2 and CYP2D6 (with contributions from other CYPs such as CYP2C19/CYP3A4), producing largely inactive metabolites.

Product Information

Available Dosage Forms

Film‑coated tablet (50 mg), oral.

Composition per Dose

Each film-coated tablet: 50mg fluvoxamine as maleate salt

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-SSRI

Controlled Substance

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 09-06-2026