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

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.