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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section and/or refer to product labeling for additional detail.
Medication Safety Issues
Sound-alike/look-alike issues:
Fluvoxamine may be confused with flavoxate, fluoxetine
Luvox may be confused with Lasix®, Levoxyl®, Lovenox®
Pronunciation
(floo VOKS a meen)
U.S. Brand Names
Index Terms
Generic Available
Yes: Excludes controlled release capsule
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of obsessive-compulsive disorder (OCD); treatment of social anxiety disorder
Use: Unlabeled/Investigational
Treatment of major depression; panic disorder; anxiety disorders in children; treatment of mild dementia-associated agitation in nonpsychotic patients
Restrictions
An FDA-approved medication guide concerning the use of antidepressants in children, adolescents, and young adults must be distributed when dispensing an outpatient prescription (new or refill) where this medication is to be used without direct supervision of a healthcare provider. Medication guides are available at http://www.fda.gov/cder/Offices/ODS/medication_guides.htm. Dispense to parents or guardians of children and adolescents receiving this medication.
Pregnancy Risk Factor
C
Pregnancy Considerations
Due to adverse effects observed in animal studies, fluvoxamine is classified as pregnancy category C. Fluvoxamine crosses the human placenta. Nonteratogenic effects in the newborn following SSRI exposure late in the third trimester include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo- or hypertonia, hyper-reflexia, jitteriness, irritability, constant crying, and tremor. An increased risk of low birth weight and low APGAR scores has also been reported. Exposure to SSRIs after the twentieth week of gestation has been associated with persistent pulmonary hypertension of the newborn (PPHN). Adverse effects may be due to toxic effects of the SSRI or drug withdrawal due to discontinuation. The long-term effects of in utero SSRI exposure on infant development and behavior are not known.Women treated for major depression and who are euthymic prior to pregnancy are more likely to experience a relapse when medication is discontinued as compared to pregnant women who continue taking antidepressant medications. The ACOG recommends that therapy with SSRIs or SNRIs during pregnancy be individualized; treatment of depression during pregnancy should incorporate the clinical expertise of the mental health clinician, obstetrician, primary healthcare provider, and pediatrician (ACOG, 2007). If treatment during pregnancy is required, consider tapering therapy during the third trimester in order to prevent withdrawal symptoms in the infant. If this is done and the woman is considered to be at risk from her major depressive disorder, the medication can be restarted following delivery, although the dose should be readjusted to that required before pregnancy.
Lactation
Enters breast milk/consider risk:benefit (AAP rates “of concern”)
Breast-Feeding Considerations
Fluvoxamine is excreted in breast milk. Based on case reports, the dose the infant receives is relatively small and adverse events have not been observed. According to the manufacturer, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother. The AAP considers fluvoxamine to be a "drug for which the effect on the nursing infant is unknown, but may be of concern."
The long-term effects on development and behavior have not been studied; therefore, fluvoxamine should be prescribed to a mother who is breast-feeding only when the benefits outweigh the potential risks.
Contraindications
Hypersensitivity to fluvoxamine or any component of the formulation; concurrent use with alosetron, pimozide, thioridazine, or tizanidine; use with or within 14 days of MAO inhibitors
Warnings/Precautions
Boxed warnings:
• Suicidal thinking/behavior: See “Major psychiatric warnings” below.
Major psychiatric warnings:
•[U.S. 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; consider risk prior to prescribing. Short-term studies did not show an increased risk in patients >24 years of age and showed a decreased risk in patients ?65 years. Closely monitor patients for clinical worsening, suicidality, or unusual changes in behavior, particularly during the initial 1-2 months of therapy or during periods of dosage adjustments (increases or decreases); the patient's family or caregiver should be instructed to closely observe the patient and communicate condition with healthcare provider. A medication guide concerning the use of antidepressants should be dispensed with each prescription. Fluvoxamine is FDA approved for the treatment of OCD in children ?8 years of age; controlled release capsules are not FDA approved for use in children.
• The possibility of a suicide attempt is inherent in major depression and may persist until remission occurs. Patients treated with antidepressants should be observed for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Worsening depression and severe abrupt suicidality that are not part of the presenting symptoms may require discontinuation or modification of drug therapy. Use caution in high-risk patients during initiation of therapy.
• Prescriptions should be written for the smallest quantity consistent with good patient care. The patient's family or caregiver should be alerted to monitor patients for the emergence of suicidality and associated behaviors such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania; patients should be instructed to notify their healthcare provider if any of these symptoms or worsening depression or psychosis occur.
• May worsen psychosis in some patients or precipitate a shift to mania or hypomania in patients with bipolar disorder. Monotherapy in patients with bipolar disorder should be avoided. Patients presenting with depressive symptoms should be screened for bipolar disorder. Fluvoxamine is not FDA approved for the treatment of bipolar depression.
Concerns related to adverse effects:
• Anticholinergic effects: Relatively devoid of these side effects.
• Bleeding risk: May impair platelet aggregation resulting in increased risk of bleeding events, particularly if used concomitantly with aspirin, NSAIDs, warfarin or other anticoagulants. Bleeding related to SSRI use has been reported to range from relatively minor bruising and epistaxis to life-threatening hemorrhage.
• CNS depression: Has a low potential to impair cognitive or motor performance; caution operating hazardous machinery or driving.
• Neuroleptic malignant syndrome (NMS): Use with or without concomitant antipsychotic therapy has been rarely associated with NMS; monitor for mental status changes, fever, muscle rigidity, and/or autonomic instability (risk may be increased in patients with Parkinson's disease or Lewy body dementia).
• Sexual dysfunction: May cause or exacerbate sexual dysfunction.
• SIADH and hyponatremia: SSRIs and SNRIs have been associated with the development of SIADH; hyponatremia has been reported rarely (including severe cases with serum sodium <110 mmol/L), predominately in the elderly. Volume depletion and/or concurrent use of diuretics likely increases risk.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular disease; fluvoxamine has not been systemically evaluated in patients with a recent history of MI or unstable heart disease.
• Hepatic impairment: Use with caution in patients with hepatic impairment; clearance is decreased and plasma concentrations are increased; a lower dosage may be needed.
• Seizure disorder: Use with caution in patients with a previous seizure disorder or condition predisposing to seizures such as brain damage or alcoholism.
Concurrent drug therapy issues:
• Agents which lower seizure threshold: Use caution with concurrent use of drugs which lower the seizure threshold.
• Alosetron: Fluvoxamine may significantly increase alosetron concentrations; concurrent use contraindicated.
• Anticoagulants/Antiplatelets: Use caution with concomitant use of NSAIDs, ASA, or other drugs that affect coagulation; the risk of bleeding may be potentiated.
• CNS depressants: Use caution with concomitant therapy.
• MAO inhibitors: Potential for severe reaction when used with MAO inhibitors; autonomic instability, coma, death, delirium, diaphoresis, hyperthermia, mental status changes/agitation, muscular rigidity, myoclonus, neuroleptic malignant syndrome features, and seizures may occur.
• Serotonin syndrome: Symptoms of agitation, confusion, hallucinations, hyper-reflexia, myoclonus, shivering, and tachycardia may occur with concomitant proserotonergic drugs (ie, SSRIs/SNRIs or triptans) or agents which reduce fluvoxamine's metabolism. Concurrent use of serotonin precursors (eg, tryptophan) is not recommended.
• Thioridazine and pimozide: Potential for QTc prolongation and arrhythmia; concurrent use of fluvoxamine with either of these agents is contraindicated.
• Tizanidine: Concomitant use may cause a significant decrease in blood pressure and increase in drowsiness; concurrent use is contraindicated.
Special populations:
• Elderly: Use caution in elderly patients; clearance may be decreased and half-life may be increased compared to younger adults. Risk of hyponatremia and other adverse events may be increased.
• Smokers: Fluvoxamine levels may be lower in patients who smoke.
Other warnings/precautions:
• Electroconvulsive therapy: May increase the risks associated with electroconvulsive therapy; consider discontinuing, when possible, prior to ECT treatment.
• Withdrawal syndrome: May cause dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. Upon discontinuation of fluvoxamine therapy, gradually taper dose. If intolerable symptoms occur following a decrease in dosage or upon discontinuation of therapy, then resuming the previous dose with a more gradual taper should be considered.
Adverse Reactions
Frequency varies by dosage form and indication. Adverse reactions reported as a composite of all indications.
>10%:
Central nervous system: Headache (22% to 35%), insomnia (21% to 35%), somnolence (22% to 27%), dizziness (11% to 15%), nervousness (10% to 12%)
Gastrointestinal: Nausea (34% to 40%), diarrhea (11% to 18%), xerostomia (10% to 14%), anorexia (6% to 14%)
Genitourinary: Ejaculation abnormal (8% to 11%)
Neuromuscular & skeletal: Weakness (14% to 26%)
1% to 10%:
Cardiovascular: Chest pain (3%), palpitation (3%), vasodilation (2% to 3%), hypertension (1% to 2%), edema (?1%), hypotension (?1%), syncope (?1%), tachycardia (?1%)
Central nervous system: Pain (10%), anxiety (5% to 8%), abnormal dreams (3%), abnormal thinking (3%), agitation (2% to 3%), apathy (?1% to 3%), chills (2%), CNS stimulation (2%), depression (2%), neurosis (2%), amnesia, malaise, manic reaction, psychotic reaction
Dermatologic: Bruising (4%), acne (2%)
Endocrine & metabolic: Libido decreased (2% to 10%; incidence higher in males), anorgasmia (2% to 5%), sexual function abnormal (2% to 4%), menorrhagia (3%)
Gastrointestinal: Dyspepsia (8% to 10%), constipation (4% to 10%), vomiting (4% to 6%), abdominal pain (5%), flatulence (4%), taste perversion (2% to 3%), tooth disorder (2% to 3%), dysphagia (2%), gingivitis (2%), weight loss (?1% to 2%), weight gain
Genitourinary: Polyuria (2% to 3%), impotence (2%), urinary tract infection (2%), urinary retention (1%)
Hepatic: Liver function tests abnormal (?1% to 2%)
Neuromuscular & skeletal: Tremor (5% to 8%), myalgia (5%), paresthesia (3%), hypertonia (2%), twitching (2%), hyper-/hypokinesia, myoclonus
Ocular: Amblyopia (2% to 3%)
Respiratory: Upper respiratory infection (9%), pharyngitis (6%), yawn (2% to 5%), laryngitis (3%), bronchitis (2%), dyspnea (2%), epistaxis (2%), cough increased, sinusitis
Miscellaneous: Diaphoresis (6% to 7%), flu-like syndrome (3%), viral infection (2%)
<1%, postmarketing, and/or case reports (limited to important or life-threatening): Acute renal failure, agranulocytosis, akinesia, allergic reaction, amenorrhea, anaphylactic reaction, anemia, angina, angioedema, anuria, aplastic anemia, apnea, asthma, ataxia, AV block, bradycardia, bullous eruption, cardiomyopathy, cerebrovascular accident, cholecystitis, cholelithiasis, colitis, conduction delay, coronary artery disease, deafness, delirium, diplopia, dyskinesia, dystonia, extrapyramidal syndrome, embolus, GI bleeding, goiter, hallucinations, heart failure, hematemesis, hematuria, Henoch-Schönlein purpura, hepatitis, hemoptysis, hypercholesterolemia, hyper-/hypoglycemia, hypokalemia, hyponatremia, hypothyroidism, ileus, intestinal obstruction, jaundice, laryngismus, leukopenia, leukocytosis, lymphadenopathy, melena, MI, myasthenia, myopathy, neuralgia, neuroleptic malignant syndrome, neuropathy, pancreatitis, paralysis, pericarditis, porphyria, priapism, purpura, retinal detachment, serotonin syndrome, ST segment changes, seizure, Stevens-Johnson syndrome, suicidal tendencies, supraventricular extrasystoles, tardive dyskinesia, thrombocytopenia, toxic epidermal necrolysis, vasculitis, ventricular tachycardia (including torsade de pointes)
Metabolism/Transport Effects
Substrate (major) of CYP1A2, 2D6; Inhibits CYP1A2 (strong), 2B6 (weak), 2C9 (weak), 2C19 (strong), 2D6 (weak), 3A4 (weak)
Drug Interactions
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
Alosetron: Fluvoxamine may decrease the metabolism of Alosetron. Risk X: Avoid combination
Analgesics (Opioid): May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Risk C: Monitor therapy
Anticoagulants: Antiplatelet Agents may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy
Antidepressants (Serotonin Reuptake Inhibitor/Antagonist): Selective Serotonin Reuptake Inhibitors may enhance the serotonergic effect of Antidepressants (Serotonin Reuptake Inhibitor/Antagonist). This may cause serotonin syndrome. Risk C: Monitor therapy
Antiplatelet Agents: May enhance the anticoagulant effect of other Antiplatelet Agents. Risk C: Monitor therapy
Aspirin: Selective Serotonin Reuptake Inhibitors may enhance the antiplatelet effect of Aspirin. Risk C: Monitor therapy
Bendamustine: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Bendamustine. Concentrations of the active metabolites of bendamustine may be decreased. Risk C: Monitor therapy
Benzodiazepines (metabolized by oxidation): Selective Serotonin Reuptake Inhibitors may decrease the metabolism of Benzodiazepines (metabolized by oxidation). Risk C: Monitor therapy
BusPIRone: May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Selective Serotonin Reuptake Inhibitors may decrease the metabolism of BusPIRone. Risk C: Monitor therapy
CarBAMazepine: Selective Serotonin Reuptake Inhibitors may decrease the metabolism of CarBAMazepine. Specifically those SSRIs that inhibit CYP3A4 isoenzymes. CarBAMazepine may increase the metabolism of Selective Serotonin Reuptake Inhibitors. Specifically those agents metabolized via CYP1A2, 2C, and/or 3A4 isoenzymes. Risk D: Consider therapy modification
Cimetidine: May decrease the metabolism of Selective Serotonin Reuptake Inhibitors. Risk D: Consider therapy modification
Clozapine: Selective Serotonin Reuptake Inhibitors may decrease the metabolism of Clozapine. Risk D: Consider therapy modification
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy
CYP1A2 Inducers (Strong): May increase the metabolism of CYP1A2 Substrates. Risk C: Monitor therapy
CYP1A2 Inhibitors (Moderate): May decrease the metabolism of CYP1A2 Substrates. Risk C: Monitor therapy
CYP1A2 Inhibitors (Strong): May decrease the metabolism of CYP1A2 Substrates. Risk D: Consider therapy modification
CYP1A2 Substrates: CYP1A2 Inhibitors (Strong) may decrease the metabolism of CYP1A2 Substrates. Risk D: Consider therapy modification
CYP2C19 Substrates: CYP2C19 Inhibitors (Strong) may decrease the metabolism of CYP2C19 Substrates. Risk D: Consider therapy modification
CYP2D6 Inhibitors (Moderate): May decrease the metabolism of CYP2D6 Substrates. Risk C: Monitor therapy
CYP2D6 Inhibitors (Strong): May decrease the metabolism of CYP2D6 Substrates. Risk D: Consider therapy modification
Cyproheptadine: May diminish the therapeutic effect of Selective Serotonin Reuptake Inhibitors. Risk C: Monitor therapy
Dasatinib: May enhance the anticoagulant effect of Antiplatelet Agents. Risk C: Monitor therapy
Desmopressin: Selective Serotonin Reuptake Inhibitors may enhance the adverse/toxic effect of Desmopressin. Risk C: Monitor therapy
Drotrecogin Alfa: Antiplatelet Agents may enhance the adverse/toxic effect of Drotrecogin Alfa. Bleeding may occur. Risk D: Consider therapy modification
DULoxetine: Fluvoxamine may decrease the metabolism of DULoxetine. Risk C: Monitor therapy
Haloperidol: Selective Serotonin Reuptake Inhibitors may decrease the metabolism of Haloperidol. Risk C: Monitor therapy
Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Antiplatelet Agents. Bleeding may occur. Risk D: Consider therapy modification
Ibritumomab: Antiplatelet Agents may enhance the adverse/toxic effect of Ibritumomab. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Risk C: Monitor therapy
Lithium: Selective Serotonin Reuptake Inhibitors may enhance the adverse/toxic effect of Lithium. Risk C: Monitor therapy
MAO Inhibitors: May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Risk X: Avoid combination
Methadone: Selective Serotonin Reuptake Inhibitors may decrease the metabolism of Methadone. Fluvoxamine appears to be the only interacting SSRI. Risk D: Consider therapy modification
Mexiletine: Selective Serotonin Reuptake Inhibitors may decrease the metabolism of Mexiletine. Risk D: Consider therapy modification
NSAID (COX-2 Inhibitor): Selective Serotonin Reuptake Inhibitors may enhance the antiplatelet effect of NSAID (COX-2 Inhibitor). Risk D: Consider therapy modification
NSAID (Nonselective): Selective Serotonin Reuptake Inhibitors may enhance the antiplatelet effect of NSAID (Nonselective). Risk D: Consider therapy modification
OLANZapine: Fluvoxamine may decrease the metabolism of OLANZapine. Risk D: Consider therapy modification
Omega-3-Acid Ethyl Esters: May enhance the antiplatelet effect of Antiplatelet Agents. Risk C: Monitor therapy
Pentosan Polysulfate Sodium: May enhance the adverse/toxic effect of Antiplatelet Agents. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Risk C: Monitor therapy
Phenytoin: Selective Serotonin Reuptake Inhibitors may decrease the metabolism of Phenytoin. Risk D: Consider therapy modification
Pimozide: Selective Serotonin Reuptake Inhibitors may enhance the adverse/toxic effect of Pimozide. Risk X: Avoid combination
Propranolol: Fluvoxamine may increase the serum concentration of Propranolol. Management: Use a lower initial propranolol dose and be cautious with propranolol dose titration. Risk D: Consider therapy modification
Prostacyclin Analogues: May enhance the antiplatelet effect of Antiplatelet Agents. Risk C: Monitor therapy
QuiNIDine: Selective Serotonin Reuptake Inhibitors may decrease the metabolism of QuiNIDine. Fluvoxamine appears to be the only SSRI of concern. Risk D: Consider therapy modification
Ramelteon: Fluvoxamine may decrease the metabolism of Ramelteon. Risk X: Avoid combination
Ropivacaine: Fluvoxamine may decrease the metabolism of Ropivacaine. Risk C: Monitor therapy
Salicylates: Antiplatelet Agents may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Risk C: Monitor therapy
Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Risk D: Consider therapy modification
Sibutramine: May enhance the serotonergic effect of Serotonin Modulators. This may cause serotonin syndrome. Risk X: Avoid combination
Tacrine: Fluvoxamine may decrease the metabolism of Tacrine. Risk D: Consider therapy modification
Theophylline Derivatives: Fluvoxamine may decrease the metabolism of Theophylline Derivatives. Exceptions: Dyphylline. Risk D: Consider therapy modification
Thioridazine: Fluvoxamine may increase the serum concentration of Thioridazine. Risk X: Avoid combination
Thrombolytic Agents: Antiplatelet Agents may enhance the anticoagulant effect of Thrombolytic Agents. Risk C: Monitor therapy
TiZANidine: Fluvoxamine may decrease the metabolism of TiZANidine. Risk X: Avoid combination
Tositumomab and Iodine I 131 Tositumomab: Antiplatelet Agents may enhance the adverse/toxic effect of Tositumomab and Iodine I 131 Tositumomab. Specifically, the risk of bleeding-related adverse events may be increased. Risk C: Monitor therapy
TraMADol: Selective Serotonin Reuptake Inhibitors may enhance the neuroexcitatory and/or seizure-potentiating effect of TraMADol. TraMADol may enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Risk D: Consider therapy modification
Tricyclic Antidepressants: Selective Serotonin Reuptake Inhibitors may decrease the metabolism of Tricyclic Antidepressants. Risk D: Consider therapy modification
Tryptophan: May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Selective Serotonin Reuptake Inhibitors may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol. Patients with depression should avoid/limit intake.
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).
Storage
Protect from high humidity and store at controlled room temperature 25°C (77°F).
Mechanism of Action
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
Pharmacodynamics/Kinetics
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)
Dosage
Oral:
Obsessive-compulsive disorder:
Children 8-17 years: Immediate release: Initial: 25 mg once daily at bedtime; may be increased in 25 mg increments at 4- to 7-day intervals, as tolerated, to maximum therapeutic benefit; usual dose range: 50-200 mg/day. Note: When total daily dose exceeds 50 mg, the dose should be given in 2 divided doses with larger portion administered at bedtime.
Maximum: Children: 8-11 years: 200 mg/day, adolescents: 300 mg/day; lower doses may be effective in female versus male patients
Adults:
Immediate release: Initial: 50 mg once daily at bedtime; may be increased in 50 mg increments at 4- to 7-day intervals, as tolerated; usual dose range: 100-300 mg/day; maximum dose: 300 mg/day. Note: When total daily dose exceeds 100 mg, the dose should be given in 2 divided doses with larger portion administered at bedtime.
Controlled release: Initial: 100 mg once daily at bedtime; may be increased in 50 mg increments at intervals of at least 1 week; usual dosage range: 100-300 mg/day; maximum dose: 300 mg/day
Social anxiety disorder: Adults: Controlled release: Initial: 100 mg once daily at bedtime; may be increased in 50 mg increments at intervals of at least 1 week; usual dosage range: 100-300 mg/day; maximum dose: 300 mg/day
Elderly: Reduce dose, titrate slowly
Dosage adjustment in hepatic impairment: Reduce dose, titrate slowly
Administration: Oral
May be administered with or without food. Do not crush, open, or chew controlled release capsules.
Monitoring Parameters
Mental status for depression, suicidal ideation (especially at the beginning of therapy or when doses are increased or decreased), anxiety, social functioning, mania, panic attacks; akathisia, weight gain or loss, nutritional intake, sleep; liver function assessment prior to beginning drug therapy
Dietary Considerations
May be taken with or without food.
Patient Education
Take exactly as directed; do not increase dose or frequency. It may take 2-3 weeks to achieve desired results. Avoid alcohol, caffeine, and other prescription or OTC medications unless approved by prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. You may experience drowsiness, lightheadedness, impaired coordination, dizziness, or blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, or anorexia (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); constipation (increased exercise, fluids, fruits, or fiber may help); diarrhea (buttermilk, yogurt, or boiled milk may help); postural hypotension (use caution when climbing stairs or changing position from lying or sitting to standing); or decreased sexual function or libido (reversible). Report persistent CNS effects (nervousness, restlessness, insomnia, anxiety, excitation, suicide ideation, headache, sedation, seizures, mania, abnormal thinking); rash or skin irritation; muscle cramping, tremors, or change in gait; chest pain or palpitations; change in urinary pattern; or worsening of condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.
Geriatric Considerations
Given fluvoxamine's approved indication (OCD), the number of drug interactions, and the limited information available on its use in the elderly, it may be best to select a different agent when treating depression. The elderly are more prone to SSRI/SNRI-induced hyponatremia.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation) and abnormal taste. Problems with SSRI-induced bruxism have been reported and may preclude their use; clinicians attempting to evaluate any patient with bruxism or involuntary muscle movement, who is simultaneously being treated with an SSRI drug, should be aware of the potential association. See Dental Comment.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
Although caution should be used in patients taking tricyclic antidepressants, no interactions have been reported with vasoconstrictors and fluvoxamine, a nontricyclic antidepressant which acts to increase serotonin; no precautions appear to be needed
Dental Comment
Problems with SSRI-induced bruxism have been reported and may preclude their use. Clinicians attempting to evaluate any patient with bruxism or involuntary muscle movement, who is simultaneously being treated with an SSRI drug, should be aware of the potential association.
Mental Health: Child/Adolescent Considerations
Children 8-17 years of age with obsessive-compulsive disorder (OCD) received 50-200 mg/day for 10 weeks (Riddle, 2001). One hundred twenty-eight children 6-17 years of age with social phobia, separation anxiety disorder, or generalized anxiety disorder, who had received psychological treatment for 3 weeks without improvement, received fluvoxamine up to 300 mg/day for 8 weeks (Research Unit, 2001).
“Fluvoxamine for the Treatment of Anxiety Disorders in Children and Adolescents. The Research Unit on Pediatric Psychopharmacology Anxiety Study Group,” N Engl J Med, 2001, 344(17):1279-85.
Riddle MA, Reeve EA, Yaryura-Tobias JA, et al, “Fluvoxamine for Children and Adolescents With Obsessive-Compulsive Disorder: A Randomized, Controlled, Multicenter Trial,” J Am Acad Child Adolesc Psychiatry, 2001, 40(2):222-9.
Mental Health: Comment
The SSRIs as a class are generally considered to be safe and equally effective. For the management of depression, these drugs display a flat dose-response curve. Allow sufficient dose-response time (6-12 weeks). Differences lie in approved indications, receptor profiles, pharmacokinetics, and cytochrome P450 activity profile. Subtle differences exist in adverse effect profiles. All SSRIs have the potential to cause sexual dysfunction. Fluvoxamine is only approved in U.S. for obsessive-compulsive disorder (OCD), offers no advantage over other SSRIs, and is associated with significant CYP inhibitory properties.
Nursing: Physical Assessment/Monitoring
Assess other medications patient may be taking for effectiveness and interactions. Assess results of laboratory tests, therapeutic effectiveness, and adverse reactions at beginning of therapy and periodically with long-term use. Taper dosage slowly when discontinuing (allow 3-4 weeks between discontinuing Luvox® and starting another antidepressant). Assess mental status for depression, suicidal ideation, anxiety, social functioning, mania, or panic attack. Assess knowledge/teach patient appropriate use, interventions to reduce side effects, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, as maleate: 25 mg, 50 mg, 100 mg
Capsule, controlled release, as maleate:
Luvox® CR: 100 mg, 150 mg [gluten free]
Pricing: U.S. (www.drugstore.com)
Tablets (Fluvoxamine Maleate)
25 mg (30): $53.99
100 mg (50): $103.99
References
American Academy of Pediatrics Committee on Drugs, “The Transfer of Drugs and Other Chemicals Into Human Milk,” Pediatrics, 2001, 108(3):776-89.
American College of Obstetricians and Gynecologists, "ACOG Practice Bulletin No. 87 November 2007: Use of Psychiatric Medications During Pregnancy and Lactation" Obstet Gynecol, 2007, 110(5):1179-98.
Boyer EW and Shannon M, “The Serotonin Syndrome,” N Engl J Med, 2005, 352:1112-20.
Chambers CD, Hernandez-Diaz S, Van Marter LJ, et al, “Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn,” N Engl J Med, 2006, 354(6):579-87.
De Vries MH, Raghoebar M, Mathlener IS, et al, “Single and Multiple Oral Dose Fluvoxamine Kinetics in Young and Elderly Subjects,” Ther Drug Monit, 1992, 14(6):493-8.
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International Brand Names
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Last full review/revision September 2008
Content last modified September 2008
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