Fluvoxamine

Therapeutic Class
 Antidepressant, Selective Serotonin Reuptake Inhibitor
Indications

Treatment of obsessive-compulsive disorder (OCD).

Unlabeled:
 Treatment of major depression; panic disorder; anxiety disorders in children; treatment of mild dementia-associated agitation in nonpsychotic patients; post-traumatic stress disorder (PTSD); social anxiety disorder (SAD).
Adult Doses

Oral
Depression
Initially, 50-100 mg daily, may increase gradually up to 300 mg daily, if necessary. Doses >150 mg should be given in 2 or 3 divided doses. 
Obsessive compulsive disorder
Adult: 50 mg once daily; may increase by 50 mg every 4-7 days. Daily doses >100 mg should be given in 2 divided doses. As modified-release preparation: Initial: 100 mg once daily. Max: 300 mg daily. 
Social anxiety disorder
Adult: As modified-release preparation: Initial: 100 mg once daily. Max: 300 mg daily.
Post-traumatic stress disorder (PTSD) (unlabeled use):
Immediate release:Oral: 75 mg twice daily

Elder Patient:
Reduce dose; titrate slowly.
Pediatric Doses

Oral
Obsessive compulsive disorder
Child: ≥8 yr: 25 mg once daily, may increase by 25 mg every 4-7 days. Doses >50 mg should be given in 2 divided doses. Reassess if no improvement after 10 wk of treatment. 
Maximum dose: Children: 8-11 years: 200 mg/day; Adolescents: 300 mg/day; lower doses may be effective in female versus male patients.
Doses in Hepatic impairment

Reduce dose; titrate slowly.
Contraindications

Hypersensitivity or any component of the formulation. Not to be used with thioridazine, terfenadine, astemizole, cisapride, pimozide, aloestron, tizanidine. Lactation.
Use with or within 14 days of MAO inhibitors.
Boxed Warning

Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (18-24 years of age) with major depressive disorder (MDD) and other psychiatric disorders.

Fluvoxamine is FDA approved for the treatment of OCD in children ≥8 years of age; extended release capsules are not FDA approved for use in children.
Warnings / Precautions

History of mania or seizures; liver dysfunction; presence of depressive symptoms; smokers. Treatment with MAOI should only be started at least 2 wk after stopping fluvoxamine treatment. Increased risk of suicidal ideation and behaviour when used in children, adolescents and young adults <24 yr. Pregnancy, elderly; operating hazardous machinery; withdraw gradually. Monitor prothrombin time in patients who are taking oral anticoagulants concurrently.
Adverse Reactions

Central nervous system: Headache, insomnia, somnolence, dizziness, nervousness, Pain, anxiety, abnormal dreams, abnormal thinking, agitation, apathy, chills, CNS stimulation, depression, neurosis, amnesia, malaise, manic reaction, psychotic reaction
Gastrointestinal: Nausea, diarrhea, xerostomia, anorexia, Dyspepsia, constipation, vomiting, abdominal pain, flatulence, taste perversion, toothache and dental caries, dysphagia, gingivitis, weight loss, weight gain
Genitourinary: Ejaculation abnormal, Polyuria, impotence, urinary tract infection, urinary retention
Neuromuscular & skeletal: Weakness, Tremor, myalgia, paresthesia, hypertonia, twitching, hyper-/hypokinesia, myoclonus
Cardiovascular: Chest pain, palpitation, vasodilation, hypertension, edema, hypotension, syncope, tachycardia
Dermatologic: Bruising, acne
Endocrine & metabolic: Libido decreased, anorgasmia, sexual function abnormal, menorrhagia
Hepatic: Liver function tests abnormal
Ocular: Amblyopia
Respiratory: Upper respiratory infection, pharyngitis, yawn, laryngitis, bronchitis, dyspnea, epistaxis, cough increased, sinusitis
Miscellaneous: Diaphoresis, flu-like syndrome, viral infection
Overdose Reactions

Symptoms include nausea, vomiting, diarrhoea, coma, hypokalemia, hypotension, respiratory difficulties, somnolence, tachycardia, bradycardia, ECG abnormalities (e.g. heart arrest, QT interval prolongation, 1st degree AV block, bundle branch block and junctional rhythm), convulsions, dizziness. Treatment includes general supportive measures. Ensure adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs. Activated charcoal may be used.
Drug Interactions

Co-admin with fluvoxamine may increase carbamazepine toxicity and serum levels of theophylline. Lithium enhances the serotonergic effects of fluvoxamine. Anticoagulants may require dosage adjustments. Diltiazem with fluvoxamine may lead to bradycardia. Avoid alcohol.
Potentially Fatal: Fluvoxamine should not be used in combination with MAOIs, or within 14 days of discontinuing treatment with MAOIs.
Food Interactions

Ethanol: May increase CNS depression; monitor for increased effects with coadministration. Caution patients about effects.

Food: The bioavailability of melatonin has been reported to be increased by fluvoxamine.

Herb/Nutraceutical: Avoid valerian, St John's wort, SAMe, kava kava (may increase risk of serotonin syndrome and/or excessive sedation). Avoid alfalfa, anise, bilberry, bladderwrack, bromelain, cat's claw, celery, chamomile, coleus, cordyceps, dong quai, evening primrose, fenugreek, feverfew, garlic, ginger, ginkgo biloba, ginseng (American), ginseng (Panax), ginseng (Siberian), grape seed, green tea, guggul, horse chestnuts, horseradish, licorice, prickly ash, red clover, reishi, SAMe (S-adenosylmethionine), sweet clover, turmeric, white willow (all have additional antiplatelet activity).
Mechanism of Actions

Inhibits CNS neuron serotonin uptake; minimal or no effect on reuptake of norepinephrine or dopamine; does not significantly bind to alpha-adrenergic, histamine or cholinergic receptors.
Metabolism

Substrate (major) of CYP1A2, 2D6;
Inhibits CYP1A2 (strong), 2B6 (weak), 2C9 (weak), 2C19 (strong), 2D6 (weak), 3A4 (weak)
Pharmacodynamics

Onset of action: Depression: The onset of action is within a week; however, individual response varies greatly and full response may not be seen until 8-12 weeks after initiation of treatment.

Absorption: Steady-state plasma concentrations have been noted to be 2-3 times higher in children than those in adolescents; female children demonstrated a significantly higher AUC than males

Distribution: Vd: ~25 L/kg

Protein binding: ~80%, primarily to albumin

Metabolism: Extensively hepatic via oxidative demethylation and deamination

Bioavailability: Immediate release: 53%; not significantly affected by food

Half-life elimination: 15-16 hours; 17-26 hours in the elderly

Time to peak, plasma: 3-8 hours

Excretion: Urine (~85% as metabolites; ~2% as unchanged drug)
Administration

May be taken with or without food.Do not crush, open, or chew extended release capsules.
Pregnancy Category

C: Drug Pregnancy Category Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Lactation

Enters breast milk/consider risk:benefit.
Storage Conditions

Oral: Store at 15-30°C.
ATC Classification
 N06AB08
GenericPedia Classification
    • Storage

    Oral: Store at 15-30°C.
    Available As
  • Fluvoxamine 100 mg
  • Fluvoxamine 50 mg

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