Fluvoxamine Maleate Dosage & Rx Info

Fluvoxamine Maleate Generic Name & Formulations

Legal Class

General Description

Fluvoxamine maleate 25mg, 50mg+, 100mg+; tabs; +scored.

Pharmacological Class

SSRI.

How Supplied

Contact supplier

Manufacturer

Various generic manufacturers

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.

Fluvoxamine Maleate Indications

Indications

Obsessive-compulsive disorder.

Fluvoxamine Maleate Dosage and Administration

Adult

≥18yrs: initially 50mg at bedtime, increase in 50mg increments at 4–7 day intervals; range 100–300mg/day; max 300mg/day. Divide total daily doses >100mg into 2 doses; give larger portion at bedtime. Elderly, hepatic impairment: use lower initial dose and titrate more slowly.

Children

Females may respond to lower dose. <8yrs: not established. 8–17yrs: initially 25mg at bedtime, increase in 25mg increments at 4–7 day intervals; usual range 50–200mg/day. Max 8–11yrs: 200mg/day; 12–17yrs: 300mg/day. Divide total daily doses >50mg into 2 doses; give larger portion at bedtime. Hepatic impairment: use lower initial dose and titrate more slowly.

Fluvoxamine Maleate Contraindications

Contraindications

Concomitant alosetron, tizanidine, pimozide, thioridazine. During or within 14 days of MAOIs; do not start an MAOI during or within 14 days of fluvoxamine. Concomitant linezolid, IV methylene blue.

Fluvoxamine Maleate Boxed Warnings

Boxed Warning

Suicidality and antidepressants.

Fluvoxamine Maleate Warnings/Precautions

Warnings/Precautions

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes. Screen for bipolar disorder. Monitor for serotonin syndrome; discontinue if occurs. History of seizures (discontinue if occurs), mania/hypomania. ECT. Cardiovascular disease. Liver dysfunction. Risk for bleeding events. Angle-closure glaucoma. Conditions that affect metabolism or hemodynamic response. Hyponatremia (esp. in elderly). Sexual dysfunction. Reduced activity of CYP2D6. Reevaluate periodically. Write ℞ for smallest practical amount. Avoid abrupt cessation. Elderly. Labor & delivery. Pregnancy (esp. during 3^rd trimester). Nursing mothers: monitor infants.

Fluvoxamine Maleate Pharmacokinetics

Absorption

Absolute bioavailability: 53%. Maximum plasma concentrations at steady state occurred within 3–8 hours and reached concentrations averaging 88 ng/mL (100mg/day), 283 ng/mL (200mg/day), and 546 ng/mL (300mg/day).

Distribution

Mean apparent volume of distribution: ~25 L/kg. Plasma protein bound: ~80%.

Metabolism

Hepatic.

Elimination

Renal (94%). Half-life: 15.6 hours.

Fluvoxamine Maleate Interactions

Interactions

See Contraindications. Prolongation of QT interval with pimozide, thioridazine. Avoid alcohol. Concomitant ramelteon: not recommended. Increased risk of serotonin syndrome with other serotonergic drugs (eg, other SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue); monitor. Potentiates diazepam (not recommended), triazolam and alprazolam (reduce their doses by at least ½), midazolam, theophylline (reduce its dose by ⅔ and monitor), warfarin, carbamazepine, tricyclic antidepressants (reduce their doses and monitor), propranolol, metoprolol (reduce their doses), clozapine, methadone, tacrine. Caution with drugs that inhibit CYP2D6 (eg, quinidine) or 3A4, phenytoin, diltiazem. Increased risk of bleeding with concomitant NSAIDs, aspirin, warfarin, and others that affect coagulation. Monitor mexiletine levels. Smokers may have increased metabolism.

Fluvoxamine Maleate Adverse Reactions

Adverse Reactions

Nausea, somnolence, insomnia, asthenia, nervousness, dyspepsia, abnormal ejaculation, sweating, anorexia, tremor, vomiting, anorgasmia, decreased libido, dry mouth, rhinitis, taste perversion, urinary frequency. Children: also agitation, depression, dysmenorrhea, flatulence, hyperkinesia, rash.

Fluvoxamine Maleate Clinical Trials

See Literature

Fluvoxamine Maleate Note

Notes

Formerly known under the brand name Luvox.

Fluvoxamine Maleate Patient Counseling