FAVERIN 100/MG FC TAB 30/FC TAB

Indications

Approved Uses

Major depressive disorder, Obsessive-compulsive disorder (OCD)

Off-Label Uses

Common off‑label/other-evidence uses include: panic disorder, social anxiety disorder, generalized anxiety disorder, PTSD, and body dysmorphic disorder.

Dosage & Administration

Dosing by Condition

Obsessive‑compulsive disorder (adults): start 50 mg once daily at bedtime; increase by 50 mg increments every 4-7 days as tolerated; usual range 100-300 mg/day; maximum 300 mg/day; if >100 mg/day, divide into 2 doses (larger at bedtime). Depression (where used/approved in some guidelines/regions): similar titration; typical range 100-200 mg/day; maximum 300 mg/day; if >100 mg/day, divide doses.

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

Dose Adjustment Notes

Hepatic impairment and elderly: start at a lower dose and titrate more slowly with close monitoring; if total daily dose is >100 mg/day, give in divided doses.

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 >100 mg/day, administer in 2 divided doses (morning and bedtime), with the larger dose at bedtime.

Safety & Warnings

Contraindications

Contraindicated with: MAOIs (and within 14 days of stopping an MAOI; and allow adequate washout when switching), tizanidine, thioridazine, pimozide, alosetron; and in patients with hypersensitivity to fluvoxamine/excipients.

Warnings & Precautions

Key precautions: monitor for suicidality/clinical worsening (especially early and in younger patients), serotonin syndrome risk with serotonergic drugs, increased bleeding risk with NSAIDs/aspirin/anticoagulants, screen for bipolar disorder/mania risk, seizure risk, hyponatremia/SIADH (esp. elderly/diuretics), hepatic impairment-lower start/slow titration, discontinuation syndrome-taper, and significant CYP-mediated drug interactions (notably CYP1A2/CYP2C19 inhibition); caution in narrow-angle glaucoma.

Age Restriction

Approved for pediatric use for OCD in children ≥8 years; not approved for pediatric major depressive disorder (MDD).

Drug Interactions

Drug Interactions

Major/contraindicated: MAOIs, tizanidine, thioridazine, pimozide, alosetron. Other clinically important: warfarin/anticoagulants (↑INR), theophylline (↓clearance

Interaction Severity

MAJOR/contraindicated: MAOIs (and within required washout periods), tizanidine, thioridazine, pimozide. Clinically significant (avoid/adjust/monitor closely): theophylline, warfarin/other anticoagulants, clozapine, certain benzodiazepines (e.g., alprazolam, diazepam), methadone, TCAs, triptans/other serotonergic agents; increased bleeding risk with NSAIDs/antiplatelets. Minor: caffeine (reduced clearance-limit intake).

Food Interaction

No restriction.

Special Populations

Pregnancy

Category C

Children

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

Elderly

Start at lower dose (50mg/day), titrate slowly, and use lower maintenance doses. Monitor for hyponatremia and drug interactions. Maximum dose in elderly is generally 150-200mg/day.

Liver Impairment

Start at a lower dose and titrate slowly with close monitoring in hepatic impairment; consider lower maximum doses (avoid aggressive titration in severe impairment).

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually (commonly over at least 2-4 weeks, individualized) to reduce discontinuation symptoms (e.g., dizziness, irritability/anxiety, insomnia, sensory disturbances, nausea, headache).

Overdose

Overdose may cause GI symptoms (nausea/vomiting/diarrhea), CNS depression (somnolence/dizziness), cardiovascular effects (tachycardia/bradycardia, hypotension, ECG changes), seizures, coma; management is urgent supportive care (airway/ventilation as needed), activated charcoal if appropriate, cardiac/neurologic monitoring-no specific antidote.

Patient Counseling

Take exactly as prescribed (often at bedtime); swallow tablets whole; may take with or without food; do not stop abruptly-taper with prescriber; expect several weeks for full benefit; caution with driving/alcohol due to possible sedation; report suicidality or unusual behavior changes; avoid/consult before using other serotonergic drugs (including St John’s wort) and due to many drug interactions; seek urgent care for serotonin syndrome symptoms; store below 25°C.

Monitoring Requirements

Monitor for clinical worsening/suicidality (especially early and after dose changes); monitor for serotonin syndrome when combined with serotonergic drugs; consider serum sodium in elderly/at-risk patients (hyponatremia/SIADH); monitor INR/bleeding if used with warfarin/anticoagulants or NSAIDs/antiplatelets; consider liver function monitoring 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 high affinity for sigma‑1 receptors.

Half-Life

Approximately 15-20 hours after a single dose; may increase to ~20-26 hours at steady state (range varies with dose and patient factors).

Bioavailability

Approximately 53% (subject to first‑pass metabolism).

Metabolism

Extensive hepatic metabolism mainly via CYP2D6 and CYP1A2 (also CYP2C19/3A4 contributions); metabolites are not clinically active; fluvoxamine is a potent inhibitor of CYP1A2 and CYP2C19 (and inhibits CYP3A4/2D6 to a lesser extent).

Excretion

Primarily renal excretion of metabolites (majority), with minimal unchanged drug in urine.

Protein Binding

Approximately 80%.

Product Information

Available Dosage Forms

Film‑coated tablet (oral).

Composition per Dose

Each film-coated tablet: 100mg fluvoxamine as maleate salt

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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