Class: Selective Serotonin-reuptake Inhibitors
VA Class: CN609
Chemical Name: O-(2-aminoethyl)oxime 5-methoxy-1-(4-(trifluoromethyl)phenyl)-1-pentanone (Z)-2-butenedioate (1:1)
Molecular Formula: C15H21F3N2O2•C4H4O4
CAS Number: 61718-82-9
- Suicidality
Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.1 b c Fluvoxamine is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder.1 a (See Pediatric Use under Cautions.)
In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.b c
Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.b c d
Appropriately monitor and closely observe all patients who are started on fluvoxamine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.1 b c d (See Worsening of Depression and Suicidality Risk under Cautions.)
Introduction
Antidepressant; selective serotonin-reuptake inhibitor (SSRI).1 7
Uses for Fluvoxamine Maleate
Obsessive-Compulsive Disorder (OCD)
Management of OCD;1 2 4 7 8 9 10 11 12 13 14 reduces but does not eliminate obsessions and compulsions.1 2 4 7 12 14
Bulimia Nervosa
Has been used in the management of bulimia nervosa†.19 20
Fluvoxamine Maleate Dosage and Administration
General
Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of fluvoxamine therapy and vice versa.1
Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.1 a b c d (See Worsening of Depression and Suicidality Risk under Cautions.)
Sustained therapy may be required; monitor periodically for need for continued therapy.1
Avoid abrupt discontinuance of therapy.1 a To avoid withdrawal reactions, taper dosage gradually.1 a (See Worsening of Depression and Suicidality Risk and also see Withdrawal of Therapy under Cautions.)
Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery.1 30 a (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Administration
Oral Administration
Administer orally once or twice daily without regard to meals.1 5 7
Administer dosages ≤100 mg daily in adults or ≤50 mg in pediatric patients as a single daily dose at bedtime; higher dosages generally are given as 2 divided doses, either as equally divided doses or as unequal doses with the larger dose given at bedtime.1 5
Dosage
Available as fluvoxamine maleate; dosage is expressed in terms of the salt.1
Pediatric Patients
OCD
Oral
Children >8 years of age: Initially, 25 mg at bedtime.1 Increase dosages in 25-mg increments every 4–7 days, as tolerated, until maximum therapeutic benefit is achieved or up to a maximum dosage of 200 mg daily in children ≤11 years of age or 300 mg daily in adolescents ≥12 years of age.1 37 Girls ≤11 years of age may require lower dosages.1 37 a
Optimum duration of therapy not established; may require several months of sustained drug therapy.1 Use the lowest possible dosage and periodically reassess need for continued therapy.1
Adults
OCD
Oral
Initially, 50 mg at bedtime.1 Increase dosages in 50-mg increments every 4–7 days, as tolerated, until maximum therapeutic benefit is achieved or up to a maximum dosage of 300 mg daily.1
Optimum duration of therapy not established; may require several months of sustained drug therapy.1 Use the lowest possible dosage and periodically reassess need for continued therapy.1
Prescribing Limits
Pediatric Patients
OCD
Oral
Children ≤11 years of age: Maximum 200 mg daily.1 37
Adolescents ≥12 years of age: Maximum 300 mg daily.1 37
Adults
OCD
Oral
Maximum 300 mg daily.1
Special Populations
Hepatic Impairment
OCD
Oral
Use lower initial dosage19 and titrate dosage slowly.1
Renal Impairment
OCD
Oral
Limited evidence indicates that dosage modification is not necessary.1 18 19
Geriatric Patients
Initially, 25 mg daily;19 titrate dosage slowly.1
Cautions for Fluvoxamine Maleate
Contraindications
Concomitant therapy with alosetron, astemizole (no longer commercially available in the US), cisapride, pimozide, terfenadine (no longer commercially available in the US), thioridazine, or tizanidine.1 34 35 36 42 a (See Specific Drugs under Interactions.)
Known hypersensitivity to fluvoxamine or any ingredient in the formulation.1
Warnings/Precautions
Warnings
Worsening of Depression and Suicidality Risk
Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients, whether or not they are taking antidepressants; may persist until clinically important remission occurs.1 b c d e However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.b c d
Appropriately monitor and closely observe patients receiving fluvoxamine for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.1 b c d (See Boxed Warning and also see Pediatric Use under Cautions.)
Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.c d Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.1 b c d If decision is made to discontinue therapy, taper fluvoxamine dosage as rapidly as is feasible but consider risks of abrupt discontinuance.c (See Withdrawal of Therapy under Cautions.)
Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.1 c
Observe these precautions for patients with psychiatric (e.g., major depressive disorder, OCD) or nonpsychiatric disorders.1 c
Bipolar Disorder
May unmask bipolar disorder.1 c (See Activation of Mania or Hypomania under Cautions.) Fluvoxamine is not approved for use in treating bipolar depression.1 a
Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.1 c
Fetal/Neonatal Morbidity and Mortality
Possible complications, sometimes severe and requiring prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care reported in neonates exposed to fluvoxamine, other SSRIs, or SNRIs late in the third trimester; may arise immediately upon delivery.1 27 28 29 30 31 32 33
Increased risk of persistent pulmonary hypertension of the newborn (PPHN) in infants exposed to SSRIs during late pregnancy; PPHN is associated with substantial neonatal morbidity and mortality.f h
Carefully consider potential risks and benefits of treatment when used during third trimester of pregnancy.1 28 29 30 33 Consider cautiously tapering dosage during third trimester prior to delivery.1 30 (See Pregnancy under Cautions.)
Drug Interactions
Concomitant use with MAO inhibitors associated with serious, sometimes fatal reactions, including manifestations resembling serotonin syndrome (e.g., hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes) or neuroleptic malignant syndrome (NMS).1 a (See Serotonin Syndrome under Cautions and also see Specific Drugs under Interactions.)
May increase the risk of QT prolongation and/or ventricular tachycardia of the torsades de pointes type associated with elevated plasma concentrations of astemizole (no longer commercially available in the US), cisapride, pimozide, terfenadine (no longer commercially available in the US), or thioridazine.1 a (See Interactions.)
Serotonin Syndrome
Potentially life-threatening serotonin syndrome reported during concurrent therapy with SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs) and other serotonergic drugs (e.g., 5-HT1 receptor agonists [“triptans”] or drugs that impair serotonin metabolism (e.g., MAO inhibitors).1 43 44 Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).43 44 (See Specific Drugs under Interactions.)
Sensitivity Reactions
Hypersensitivity Reactions
Possible allergic reaction, anaphylaxis, angioedema, or Stevens-Johnson syndrome.a
General Precautions
Withdrawal of Therapy
Possibly severe withdrawal reactions (e.g., dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania); avoid abrupt discontinuance of therapy.1 a Taper dosage gradually (e.g., over a period of several weeks).1 a
Abnormal Bleeding
Possible increased risk of bleeding, including upper GI bleeding; use with caution.1 39 41 a
Concomitant use of an NSAIA (e.g., aspirin) or warfarin may potentiate such risk.1 39 41 a (See Interactions.)
Activation of Mania or Hypomania
Possible activation of mania and hypomania; use with caution in patients with a history of mania.1 a (See Bipolar Disorder under Cautions.)
Seizures
Possible risk of seizures;1 a use with caution in patients with a history of seizures.1 a Discontinue if seizures occur during therapy.1 a
Hyponatremia
Possible hyponatremia in older patients, patients with depleted fluid volume, those receiving diuretics, or with concomitant conditions (e.g., SIADH) that might cause hyponatremia; monitor serum electrolytes (especially sodium), BUN, and plasma creatinine regularly in patients considered at risk.1 a
Concomitant Diseases
Experience in patients with concomitant diseases is limited.1 a Use with caution in patients with altered metabolism or hemodynamics.1 a
Not studied in patients with recent MI or unstable heart disease.1 a
Cognitive/Physical Impairment
Risk of impaired mental alertness or physical coordination required for performing hazardous tasks (e.g., driving, operating machinery).1 a
Electroconvulsive Therapy (ECT)
Effects of concomitant use with ECT have not been systematically evaluated.a
Specific Populations
Pregnancy
Category C.1 a (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Increased risk of depression relapse observed in women who discontinued antidepressant therapy during pregnancy compared with those who remained on antidepressant therapy.f g
Lactation
Distributed into milk; discontinue nursing or the drug.1 a
Pediatric Use
Safety and efficacy not established in children <8 years of age for OCD22 or in pediatric patients with conditions other than OCD.1
Safety and efficacy in OCD established in a small 10-week, placebo-controlled trial in children and adolescents 8–17 years of age; 1 21 a majority of patients continued receiving fluvoxamine therapy for up to 1–3 years longer in an open-label extension.1 a Adverse effects generally similar to those reported in adults.1 21 No substantial differences in efficacy in treatment of OCD in children ≥8 years of age relative to adults.a
Risks associated with extended use in children and adolescents with OCD not systematically evaluated.1 a Evidence of safety derived from relatively short-term clinical studies and from extrapolation of experience gained with adult patients.1 Effects on growth, development, and maturation of children and adolescents unknown.1 a Regularly monitor weight and growth of children receiving long-term fluvoxamine therapy.1 a
FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, OCD, or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).1 c However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.e No suicides occurred in these pediatric trials.1 c e
Carefully consider these findings when assessing potential benefits and risks of fluvoxamine in a child or adolescent for any clinical use.1 b c d e (See Worsening of Depression and Suicidality Risk under Cautions.)
Geriatric Use
No substantial differences in safety and efficacy relative to younger adults.a
Hyponatremia reported.a (See Hyponatremia under Cautions.)
In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.b c (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)
Hepatic Impairment
Use with caution.1 a (See Hepatic Impairment under Dosage and Administration and see Elimination: Special Populations, under Pharmacokinetics.)
Common Adverse Effects
Somnolence, insomnia, nervousness, tremor, nausea, dyspepsia, anorexia, vomiting, abnormal ejaculation, asthenia, sweating, dry mouth, decreased libido, urinary frequency, anorgasmia, rhinitis, taste perversion, agitation, depression, dysmenorrhea, flatulence, hyperkinesia, rash.1 a
Interactions for Fluvoxamine Maleate
Extensively metabolized in the liver, principally by CYP1A2, 2C9, 2D6, and 3A4.1 Inhibits CYP1A2, 2C9, and 3A4; weak inhibitor of CYP2D6.1 a
Drugs Metabolized by Hepatic Microsomal Enzymes
Potential pharmacokinetic interaction (increased plasma concentrations of CYP1A2, 2C9, 2D6, and 3A4 substrate) with drugs metabolized by these CYP isoenzymes.1
Drugs Affecting Hemostasis
Potential pharmacologic interaction (increased risk of bleeding) with concomitant use of drugs that affect coagulation; use with caution.1 39 41 a
Drugs Associated with Serotonin Syndrome
Potential pharmacologic interaction (serotonin syndrome) with serotonergic agents.a 43 Avoid such use or use with caution.a 43 (See Serotonin Syndrome under Cautions.)
Specific Drugs
Drug
|
Interaction
|
Comment
|
|---|
Alcohol
|
Pharmacokinetic or pharmacologic interaction unlikelya
|
Avoid concomitant use a
|
Alosetron
|
Increased plasma alosetron concentrations and prolonged alosetron half-life1 34
|
Concomitant use contraindicated1 34
|
Alprazolam
|
Increased plasma alprazolam concentrations1
|
Reduce initial alprazolam dosage by ≥50%; titrate to lowest effective dosage1
|
Antidepressants, tricyclic (TCAs) (e.g., amitriptyline, clomipramine, imipramine)
|
Increased plasma TCA concentrationsa
|
Use with caution.a May need to monitor plasma TCA concentration and reduce TCA dosage.a
|
Astemizole (no longer commercially available in the US)
|
Increased risk of QT interval prolongation1
|
Concomitant use contraindicated1
|
Atenolol
|
Pharmacokinetic interaction unlikelya
|
|
Benzodiazepines
|
Decreased benzodiazepine clearance with benzodiazepines metabolized by hepatic oxidation (e.g., alprazolam, midazolam, triazolam)1
Pharmacokinetic interaction unlikely with benzodiazepines metabolized by glucuronidation (e.g., lorazepam, oxazepam, temazepam)1
|
Use with caution1
|
Carbamazepine
|
Increased plasma carbamazepine concentrations and symptoms of toxicity reporteda
|
|
Cisapride
|
Increased risk of QT interval prolongation1
|
Concomitant use contraindicated1
|
Clozapine
|
Increased plasma clozapine concentrations reported; increased risk of seizures and orthostatic hypotensiona
|
Monitor for clozapine toxicitya
|
Diazepam
|
Decreased clearance of diazepam and its active metabolite1
|
Avoid concomitant use1
|
Digoxin
|
Pharmacokinetic interaction unlikelya
|
|
Diltiazem
|
Bradycardia reporteda
|
|
5-HT1 receptor agonists (“triptans”)
|
Potentially life-threatening serotonin syndromea 43
|
Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiateda 43
|
Linezolid
|
Possible serotonin syndromek
|
Use with cautionk
|
Lithium
|
Enhances fluvoxamine’s serotonergic effects;a seizures reporteda
|
Use with cautiona
|
Lorazepam
|
Pharmacokinetic interaction unlikelya
|
|
MAO inhibitors
|
Increased risk of potentially fatal serotonin syndromea
|
Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of fluvoxamine therapy and vice versa1
|
Methadone
|
Increased methadone (plasma concentration:dose) ratios; symptoms of opioid intoxication or withdrawal possiblea
|
|
Metoprolol
|
Bradycardia and hypotension (including orthostatic hypotension) reporteda
|
Reduce initial metoprolol dosage and titrate dosages slowlya
|
Mexiletine
|
Reduced mexiletine clearance1 38
|
Monitor patient closely and monitor serum mexiletine concentrations 1 38
|
NSAIAs (e.g., aspirin)
|
Increased risk of bleeding1 39 41 a
|
Use with caution1 a
|
Phenytoin
|
Possible altered phenytoin metabolism
|
Monitor plasma phenytoin concentrations and pharmacodynamicsa
|
Pimozide
|
Increased risk of QT interval prolongation1
|
Concomitant use contraindicated1
|
Propranolol
|
Increased plasma propranolol concentrations; potentiates propranolol-induced reductions in heart rate and exercise diastolic pressurea
|
Reduce initial propranolol dosage and titrate dosages slowlya
|
Sibutramine
|
Possible serotonin syndrome43
|
Use with caution43
|
Smoking
|
Increased fluvoxamine metabolisma
|
|
|
|
|
Tacrine
|
Increased plasma tacrine concentrations; increased cholinergic effects (e.g., diarrhea, nausea, sweating, vomiting)a
|
|
Terfenadine (no longer commercially available in the US)
|
Increased risk of QT interval prolongation1
|
Concomitant use contraindicated1
|
Theophylline
|
Decreased theophylline clearance1
|
Reduce theophylline dosage to approximately one-third usual daily maintenance dosage; monitor plasma theophylline concentrations1
|
Thioridazine
|
Increased risk of QTc interval prolongation1
|
Concomitant use contraindicated1
|
Tizanidine
|
Markedly increased plasma concentrations, elimination half-life, and AUC of tizanidine 1 35 42
Increased risk of adverse cardiovascular (e.g., substantial hypotension) and CNS effects (e.g., drowsiness, psychomotor impairment)1 35 36 42
|
Concomitant use contraindicated1 35 36 42
|
Tryptophan and other serotonin precursors
|
Possible serotonin syndromea i j
|
Concomitant use with SSRIs generally not recommendedi j
|
Warfarin
|
Increased PT and plasma warfarin concentrations1 a
|
Use with caution; monitor PT and adjust dosages as needed1 a
|
Fluvoxamine Maleate Pharmacokinetics
Absorption
Bioavailability
Absolute bioavailability is 53%.a
Onset
OCD therapeutic response evident within 2–3 weeks, with maximal effects after several months.4 8 9 12 14
Food
Food does not affect GI absorption or oral bioavailability.1 17 a
Special Populations
In children 6–11 years of age, steady-state plasma fluvoxamine concentrations are twofold to threefold higher than those in adolescents 12–17 years of age.1 37 a
In girls 6–11 years of age, AUC and peak plasma fluvoxamine concentrations were substantially higher than those in boys 6–11 years of age.1 37 a
In geriatric patients, mean peak plasma fluvoxamine concentrations are approximately 40% higher than those in younger adults.a
Distribution
Plasma Protein Binding
Approximately 80%, principally albumin.a
Elimination
Metabolism
Extensively metabolized in the liver, principally via oxidative demethylation and deamination, to several inactive metabolites.a
Metabolized principally by CYP1A2, 2C9, 2D6, and 3A4.a
Elimination Route
Eliminated principally in urine (94%); approximately 2% as unchanged drug.a
Half-life
Mean plasma half-life following multiple oral doses is 15.6 hours.a
Special Populations
Hepatic impairment may reduce clearance by 30%.a
In geriatric patients, elimination half-life is increased by 28–65% and clearance is reduced by 50%.a
Stability
Storage
Oral
Tablets
Tight, light-resistant containers at 15–30°C.a
ActionsActions
Mechanism of action in the management of OCD not clearly established, but may involve inhibition of serotonergic activity.1 2 7 9
More potent than clomipramine, desipramine, and fluoxetine as an SSRI3 4 6 7 with substantially greater selectivity in inhibiting serotonin versus norepinephrine reuptake than that of other SSRIs (e.g., fluoxetine, paroxetine, sertraline) and TCAs (e.g., clomipramine).3 4
Possesses virtually no affinity for α1- or α2-adrenergic, β-adrenergic, muscarinic, dopamine D2, histamine H1, GABA-benzodiazepine, opiate, 5-HT1, or 5-HT2 receptors.1 3 4 6
Advice to Patients
Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.1 b c d FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.1 b c d
Risk of sensitivity reactions (e.g., Stevens-Johnson syndrome); importance of notifying clinicians if rash, hives, or a related allergic phenomenon occurs during therapy.a
Risk of psychomotor impairment; importance of exercising caution while operating hazardous machinery, including automobile driving, until gain experience with the drug’s effects.a
Risk of concomitant use with alcohol.a
Importance of continuing fluvoxamine therapy even if improvement is evident within 2–3 weeks,4 8 9 12 14 unless directed otherwise by clinician.1
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 a
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 a
Importance of informing patients of risk of serotonin syndrome with concurrent use of fluvoxamine and 5-HT1 receptor agonists (“triptans”) or other serotonergic agents.43 Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.43
Importance of informing patients of other important precautionary information.1 a (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Fluvoxamine Maleate
Routes
|
Dosage Forms
|
Strengths
|
Brand Names
|
Manufacturer
|
|---|
Oral
|
Tablets, film-coated
|
25 mg*
|
Fluvoxamine Maleate Tablets
|
Apotex, Barr, Eon, Mylan, Sandoz, Synthon, Teva
|
|
|
50 mg*
|
Fluvoxamine Maleate Tablets
|
Apotex, Barr, Eon, Mylan, Sandoz, Synthon, Teva
|
|
|
100 mg*
|
Fluvoxamine Maleate Tablets
|
Apotex, Barr, Eon, Mylan, Sandoz, Synthon, Teva
|
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Fluvoxamine Maleate 100MG Tablets (SANDOZ): 50/$109.99 or 100/$205.96
Fluvoxamine Maleate 25MG Tablets (SANDOZ): 30/$53.99 or 90/$155.97
Fluvoxamine Maleate 50MG Tablets (BAY PHARMA): 30/$79.99 or 90/$199.96
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions December 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
1. Barr Laboratories, Inc. Fluvoxamine maleate tablets prescribing information. Ponoma, NY; 2005 Jan.
2. Anon. Fluvoxamine for obsessive-compulsive disorder. Med Lett Drug Ther. 1905; 37:13-6.
3. Wilde MI, Plosker GL, Benfield P. Fluvoxamine: an updated review of its pharmacology, and therapeutic use in depressive illness. Drugs. 1993; 45:895-24. [PubMed 7691497]
4. Palmer KJ, Benfield P. Fluvoxamine: an overview of its pharmacological properties and review of its therapeutic potential in non-depressive disorders. CNS Drugs. 1994; 1: 57-87.
5. Solvay Pharmaceuticals. Luvox (fluvoxamine maleate) tablets product monograph. Marietta, GA; 1993 Dec.
6. Richelson E. Pharmacology of antidepressants-characteristics of the ideal drug. Mayo Clin Proc. 1994; 69:1069-81. [IDIS 338485] [PubMed 7967761]
7. Perse TL, Greist JH, Jefferson JW et al. Fluvoxamine treatment of obsessive-compulsive disorder. Am J Psych. 1987; 144:1543-8.
8. Montgomery SA, Manceaux A. Fluvoxamine in the treatment of obsessive compulsive disorder. Int Clin Psychopharmacol. 1992; 7:5-9. [PubMed 1355499]
9. Jenike JA, Hyman S, Baer L et al. A controlled trial of fluvoxamine in obsessive-compulsive disorder: implications for a serotonergic theory. Am J Psych. 1990; 147:1209-15.
10. Price LH, Goodman WK, Charney DS et al. Treatment of severe obsessive-compulsive disorder with fluvoxamine. Am J Psych. 1987; 144:1059-61.
11. Goodman WK, Price LH, Delgado PL et al. Specifity of serotonin reuptake inhibitors in the treatment of obsessive-compulsive disorder. Arch Gen Psych. 1990; 47:577-85.
12. Goodman WK, Price LH, Rasmussen SA et al. Efficacy of fluvoxamine in obsessive-compulsive disorder. Arch Gen Psych. 1989; 48:36-44.
13. Freeman CPL, Trimble MR, Deakin JFW et al. Fluvoxamine versus clomipramine in the treatment of obsessive compulsive disorder: a multicenter, randomized, double-blind, parallel group comparison. J Clin Psych. 1994; 55:301-5.
14. Greist JH, Jefferson JW, Kobalt KA et al. Efficacy and tolerability of serotonin transport inhibitors in obsessive-compulsive disorder. Arch Gen Psych. 1995; 52:53-60.
15. Edwards JG, Inman WHW, Wilton L et al. Prescription-event monitoring of 10401 patients treated with fluvoxamine. Br J Psych. 1994; 164:387-95.
16. Jefferson JW, Greist JH, Perse TL et al. Fluvoxamine-associated mania/hypomania in patients with obsessive-compulsive disorder. J Clin Psychopharmacol. 1991; 11:391. [IDIS 291655] [PubMed 1770160]
17. Van Den Brekel A, Harrington L. Toxic effects of theophylline caused by fluvoxamine. CMAJ. 1994; 151:1289-90. [IDIS 338576] [PubMed 7954177]
18. Van Harten J. Clinical pharmacokinetics of selective serotonin reuptake inhibitors. Clin Pharmacokinet. 1993; 24:203-20. [PubMed 8384945]
19. American Psychiatric Association. Practice guideline for the treatment of patients with eating disorders (revision). Am J Psychiatry. 2000; 157(Suppl 1):1-39.
20. Fichter MM, Kruger R, Rief W et al. Fluvoxamine in prevention of relapse in bulimia nervosa: effects on eating-specific psychopathology. J Clin Psychopharmacol. 1996; 16:9-18. [IDIS 362977] [PubMed 8834413]
21. Riddle MA, Reeve EA, Yaryura JA et al. Fluvoxamine for children and adolescents with obsessive-compulsive disorder: a randomized, controlled, multicenter trial. J Am Acad Child Adolesc Psychiatry. 2001; 40:222-9. [IDIS 458965] [PubMed 11211371]
22. Apotex corporation. Fluvoxamine maleate tablet prescribing information. Weston, FL; 2001 Jan.
23. Food and Drug Administration. Class suicidality labeling language for antidepressants. From the FDA website.
24. Food and Drug Administration. Public health advisory: suicidality in children and adolescents being treated with antidepressant medications. Rockville, MD; 2004 Oct 15. From the FDA website.
25. Food and Drug Administration. Medication guide: about using antidepressants in children or teenagers. Rockville, MD; 2005 Jan 16. From the FDA website.
26. Carrillo JA, Ramos SI, Herraiz AG et al. Pharmacokinetic interaction of fluvoxamine and thioridazine in schizophrenic patients. J Clin Psychopharmacol. 1999; 19:494-9. [IDIS 439348] [PubMed 10587283]
27. Morag I, Batash D, Keidar R et al. Paroxetine use throughout pregnancy: does it pose any risk to the neonate? J Toxicol Clin Toxicol. 2004; 42:97-100.
28. Haddad PM, Pal BR, Clarke P et al. Neonatal symptoms following maternal paroxetine treatment: serotonin toxicity or paroxetine discontinuation syndrome? J Psychopharmacol. 2005; 19:554-7.
29. Moses-Kolko EL, Bogen D, Perel J et al. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors: literature review and implications for clinical applications. JAMA. 2005; 293:2372-85. [PubMed 15900008]
30. Sanz EJ, De-Las-Cuevas C, Kiuru A et al. Selective serotonin reuptake inhibitors in pregnant women and neonatal wit
