Fluvoxamine: Difference between revisions

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__NOTOC__
{{DrugProjectFormSinglePage
{{Fluvoxamine}}
|authorTag=
{{CMG}}; {{AE}} {{PB}}


'''''For patient information about Fluvoxamine, click [[Fluvoxamine (patient information)|here]].'''''
{{VP}}
<!--Overview-->


{{SB}} LUVOX CR (fluvoxamine maleate) capsule, extended release<sup>®</sup>, Luvox<sup>®</sup>, Faverin<sup>®</sup>, Fevarin<sup>®</sup> and Dumyrox<sup>®</sup>
|genericName=


==Overview==
{{Drugbox|
|IUPAC_name = ''2-[(5-methoxy-1- [4-(trifluoromethyl) phenyl]pentylidene) amino]oxyethanamine''
| image=Fluvoxamine structure.svg
| width=140
| CAS_number=54739-18-3
| ATC_prefix=N06
| ATC_suffix=AB08
| ATC_supplemental=
| PubChem=5324346
| DrugBank=APRD00425
| C=15 | H=21 | F=3 | N=2 | O=2
| molecular_weight = 318.335
| bioavailability= 77%
| metabolism = [[Hepatic]]
| elimination_half-life= 15.6 hours
| excretion = [[Renal]]
| pregnancy_category = C
| legal_status = Schedule VI <small>[[US]]</small>
| routes_of_administration= Oral
}}
'''Fluvoxamine''' is an antidepressant which functions pharmacologically as a [[selective serotonin reuptake inhibitor]]. Though it is in the same class as other SSRI drugs, it is most often used to treat [[obsessive-compulsive disorder]].


==History==
Fluvoxamine was one of the first of the SSRI antidepressants to be launched (1984 - Switzerland) and was developed by [[Solvay (company)|Solvay Pharmaceuticals]]. It has been in use in clinical practice since 1983 and has a clinical trial database comprised of approximately 35,000 patients. It was launched in the US in December 1994 and in Japan in June 1999. As of the end of 1995, more than 10 million patients worldwide have been treated with fluvoxamine.<ref>{{cite journal | first = | last =  | date = 1999 | title = | journal = Fluvoxamine Product Monograph | volume = | issue = | pages = }}</ref>


Fluvoxamine was the first SSRI to be registered for the treatment of [[Obsessive Compulsive Disorder]] in children by FDA in 1997.<ref>{{cite journal | first = | last = | date = | title = Luvox Approved For Obsessive Compulsive Disorder in Children and Teens | journal = http://www.pslgroup.com/dg/2261a.htm | volume = | issue = | pages = }}</ref>
|aOrAn=
 
a
 
|drugClass=
 
 
 
|indication=
 
[[obsessive compulsive disorder]] (OCD)
 
|hasBlackBoxWarning=
 
Yes
 
|adverseReactions=
 
nausea, somnolence, insomnia, asthenia, nervousness, dyspepsia, abnormal ejaculation, sweating, anorexia, tremor, and vomiting
 
<!--Black Box Warning-->
 
|blackBoxWarningTitle=
WARNING
 
|blackBoxWarningBody=
<i><span style="color:#FF0000;"> SUICIDALITY AND ANTIDEPRESSANT DRUGS </span></i>
 
*Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluvoxamine maleate tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Fluvoxamine maleate tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD).
 
<!--Adult Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
 
|offLabelAdultGuideSupport=
 
=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
|fdaLIADPed=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
 
|offLabelPedGuideSupport=
 
=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
 
|offLabelPedNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
 
|contraindications=
 
* Condition1
 
<!--Warnings-->
 
|warnings=
 
* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
 
|clinicalTrials=
 
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
 
|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
=====Metabolic and Nutritional=====
 
 
 
=====Musculoskeletal=====
 
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
=====Special Senses=====
 
 
 
=====Urogenital=====
 
 
 
=====Miscellaneous=====
 
 
 
<!--Drug Interactions-->
 
|drugInteractions=
 
* Drug
:* Description
 
<!--Use in Specific Populations-->
 
|useInPregnancyFDA=
* '''Pregnancy Category'''
 
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
 
|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
 
|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
 
|useInPed=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
 
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
 
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
 
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
 
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
 
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
 
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
 
|administration=
 
* Oral
 
* Intravenous
 
|monitoring=
 
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Description
 
<!--IV Compatibility-->
 
|IVCompat=
 
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
 
|overdose=
 
===Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
 
|drugBox=
 
 
 
<!--Mechanism of Action-->
 
|mechAction=
 
*
 
<!--Structure-->
 
|structure=
 
*
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Pharmacodynamics-->


Fluvoxamine was the first drug approved for the treatment of social anxiety disorder in Japan in 2005.<ref>{{cite journal | first = | last =  | date = | title = Solvay’s Fluvoxamine maleate is first drug approved for the treatment of social anxiety disorder in Japan | journal = http://www.solvaypress.com/pressreleases/0,,33713-2-83,00.htm | volume = | issue = | pages = }}</ref>
|PD=


==Indication==
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
===Approved===
Fluvoxamine is widely prescribed to treat [[Clinical depression|depression]], and [[anxiety disorder]]s such as [[Obsessive-Compulsive Disorder]], [[Obsessive-Compulsive Spectrum Disorder]], [[Panic Disorder]], [[Social Phobia]], and [[Post-Traumatic Stress Disorder]].<ref>{{cite journal | first = David P. Figgit | last = Karen J. McClellan | date = Drugs Oct 2000 | title = Fluvoxamine An Updated Review of its Use in the Management of Adults with Anxiety Disorders | journal = Adis Drug Evaluation | volume = 60 | issue = 4 | pages = 925-954}}</ref>


Fluvoxamine is indicated for children and adolescents with OCD.<ref>{{cite journal | first = | last = | date = March 2005 | title = US-FDA Fluvoxamine Product Insert | journal = | volume = | issue = | pages = }}</ref>
<!--Pharmacokinetics-->


===Unapproved/Off-label/Investigational===
|PK=
Fluvoxamine is also used for the treatment of children and adolescents with social phobia, [[separation anxiety disorder]], or [[generalized anxiety disorder]].<ref>{{cite journal | first = Michael J. Labelarte MD et.al. | last = John T Walker MD | date = April 26, 2001 | title = Fluvoxamine for the treatment of anxiety disorders in children and adolescents | journal = The New England Journal of Medicine | volume = 344 | issue = | pages = 1279-1285}}</ref>


Fluvoxamine may help in the treatment of [[Irritable Bowel Syndrome]].<ref>{{cite journal | first = et al. | last = Emmanuel | date = 1997 | title = Treatment of Irritable Bowel Syndrome with Fluvoxamine | journal = Am J Psychiatry | volume = 154 | issue = | pages = 711-712}}</ref>
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
==Category==


==FDA Package Insert==
<!--Nonclinical Toxicology-->
==LUVOX CR (fluvoxamine maleate) capsule, extended release==


'''  [[LUVOX CR (fluvoxamine maleate) capsule, extended release indications and usage|Indications and Usage]]'''
|nonClinToxic=
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release dosage and administration|Dosage and Administration]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release dosage forms and strengths|Dosage Forms and Strengths]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release contraindications|Contraindications]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release warnings and precautions|Warnings and Precautions]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release adverse reactions|Adverse Reactions]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release drug interactions|Drug Interactions]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release use in specific populations|Use in Specific Populations]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release overdosage|Overdosage]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release description|Description]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release clinical pharmacology|Clinical Pharmacology]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release nonclinical toxicology|Nonclinical Toxicology]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release clinical studies|Clinical Studies]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release patient counseling information|Patient Counseling Information]]'''
'''| [[LUVOX CR (fluvoxamine maleate) capsule, extended release labels and packages|Labels and Packages]]'''


==Mechanism of Action==
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
Fluvoxamine is one of the few SSRI class of drugs to have a monocyclic structure.


Although all SSRIs inhibit the reuptake of serotonin, fluvoxamine has different pharmacological and side effects profiles from other drugs in its class. Fluvoxamine has been shown to be selective for serotonin reuptake, and has little effect on dopamine and noradrenaline uptake systems compared to other SSRI. For this reason, fluvoxamine can be of benefit to patients who experience unusual or limiting [[Adverse drug reaction|side-effects]] from other antidepressants. It appears to cause fewer side effects than other SSRIs. In addition, these differences also are a result of the lack of direct effects at other [[neurotransmitter receptor]]s compared to other SSRIs. Affinity for these receptors, for example [[cholinergic]] [[muscarinic]] (dry mouth, constipation) sites, [[histaminergic]] (sedation) sites, [[alpha]] (postural hypertension) sites and [[dopamine]] ([[extrapyramidal]])sites, leads to many side effects. Compared to other SSRIs, fluvoxamine has a very low affinity to all of these sites.<ref>{{cite journal | first = Hyttel | last = J. | date = 1993 | title = Comparative pharmacology of selective serotonin reuptake inhibitors (SSRIs) | journal = Nordisk Journal of Psychiatric | volume = 47 | issue = Suppl 30 | pages = 5-12 }}</ref>
<!--Clinical Studies-->


Among the SSRIs, fluvoxamine has the highest affinity for [[sigma receptor]] subtype 1 (σ<sub>1</sub>receptors)<ref>{{cite journal | first = Narita N | last = Hashimoto K et al. | date = 1996 | title = Interactions of selective reuptake inhibitors with subtypes of sigma receptor in rat brain | journal = Eur J Pharmacol| volume = 307 | issue = | pages = 117-9}}</ref>
|clinicalStudies=
, suggesting that it may have particular benefits in the treatment of depressed patients who show features of anxiety/stress and for whom memory impairment is particularly undesirable (such as in depressed elderly patients, and also in treating psychotic depression).<ref>{{cite journal | first = Carrasco JL | last = C.Sandner | date = December 2005 | title = Clinical effects of pharmacological variations in selective serotonin reuptake inhibitors: an overview | journal = International Journal of Clinical Practice | volume = 59 | issue = 12 | pages = 1428-1434}}</ref>


==Pharmacokinetics==
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
===Absorption===
The oral absorption of fluvoxamine is equal to or more than 94%.


===Distribution===
<!--How Supplied-->
The plasma protein binding is only about 77%.


===Metabolism===
|howSupplied=
Fluvoxamine is extensively metabolised in the liver. It has no active metabolites.


===Elimination===
*
Fluvoxamine has the shortest [[half-life]] of all the SSRIs.  Its mean [[serum]] half-life is 15 hours after a single dose, and 17 to 22 hours after repeated doses.


==Dosage & Administration==
<!--Patient Counseling Information-->
The normal dosage for depression and anxiety starts at 50mg per day, rising to 100mg after a few days.  It may be raised after evaluation of the effects by a doctor.


Fluvoxamine has shown generally effective for OCD at 150mg and above, and dosages can reach 300mg or more for some patients.
|fdaPatientInfo=


==Drug Interactions==
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
Fluvoxamine has a low potential for [[drug interaction]]s. In terms of inhibition of enzyme [[Cytochrome P450]] [[CYP2D6]], fluvoxamine is the cleanest among all the SSRI because importantly it does not inhibit CYP2D6.<ref>{{cite journal | first = Baumann | last = P. | date = 1996 | title = Pharmacokinetic-pharmacodynamic relationship of the Selective serotonin reuptake inhibitors | journal = Clinical Pharmacokinetics | volume = 31 | issue = | pages = 444-469}}</ref><ref>{{cite journal | first = DeVane CL | last = Gill HS | date = 1997 | title = Clinical Pharmacokinetics of Fluvoxamine: applications to dosage regime design | journal = Journal of Clinical Psychiatric | volume = 58 | issue = Suppl 5 | pages = 7-14}}</ref><ref>{{cite journal | first =  CL | last = DeVane| date = 1998 | title = Translational pharmacokinetics: current issues with newer antidepressants | journal = Depression and Anxiety | volume = 8 | issue = Suppl 1 | pages = 64-70}}</ref>
Drugs that interacts with CYP2D6 will have more interactions with TCAs, antiarrythmics, B-blockers, phenytoin, opiates (eg. codeine, dextromethophon, morphine, tramadol) and neuroleptics (eg. haloperidol, risperidon). It does, however, inhibit Cytochrome P450 enzyme [[CYP1A2]], which metabolises [[theophylline]], [[caffeine]], [[phenacetin]], [[tacrine]], [[clozapine]], and [[olanzapine]],  . These substances can cause increased serum levels when administered together with fluvoxamine. It has only modest effects on [[CYP2C]] and [[CYP3A3/4]]. Therefore, different SSRI have different level of drug interactions depending on the inhibition of Cytochrome P450 enzymez.  


In addition, fluvoxamine has relatively short plasma half life, roughly 15 hours, and has no active metabolites. With these properties, fluvoxamine has less of a chance of drug accumulations and interactions.
<!--Precautions with Alcohol-->


The plasma protein binding of fluvoxamine is only about 77%. Drugs with low protein binding are less likely to displace other protein bound drugs, and therefore have a lower potential to cause drug interactions.
|alcohol=


==Side effects==
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Fluvoxamine has the least incidence of side effects on sexual dysfunctions, or loss of sex drive of all the SSRIs.<ref>{{cite journal | first = Waldinger MD | last = Hengeveld VW et al. | date = 1998 | title = Effect of SSRI antidepressants on ejaculation: a double blind, randomised, placebo-controlled study with fluoxetine, fluvoxamine, paroxetine and sertraline | journal = Journal of Clinical Psychopharmacology | volume = 18 | issue = | pages = 274-281}}</ref>


Side effects of fluvoxamine can include:
<!--Brand Names-->
common
decreased sex drive or ability, drowsiness, tiredness, diarrhea, dizziness or light-headedness, [[constipation]],  [[headache]], [[nausea]], [[nervousness]], [[sleep]] problems, increased [[sweating]], [[tremors]], serious [[skin rash]] and other allergic problems such as difficulty breathing, fever, confusion, severe weakness,  intense agitation or anxiety, restlessness, [[hypomania]], [[mania]],  [[seizures]].


==Historical relevance==
|brandNames=
In [[1999]], fluvoxamine came under great public scrutiny after it was discovered that [[Eric Harris and Dylan Klebold|Eric Harris]], one of the two teenaged shooters involved in the [[Columbine High School massacre]], had been taking the drug as treatment for depression.  Many immediately pointed fingers at fluvoxamine and its manufacturer Solvay Pharmaceuticals (which sells fluvoxamine under the widely known brandname Luvox), since Solvay's own clinical trials indicated the drug had the propensity to induce mania in 4% of the youth who took it. What was not made public however was that Solvay concealed from the public the fact that a homicide occurred during the clinical trials involving adults.  Solvay, while acknowledging the risks inherent in taking an SSRI medication like fluvoxamine, downplayed any role the drug may have had in the killings.  The [[American Psychiatric Association]] (A.P.A.) took a similar stance; Rodrigo Munoz, M.D., President of the A.P.A., said: "Despite a decade of research, there is little valid evidence to prove a causal relationship between the use of anti-depressant medications and destructive behavior. On the other hand, there is ample evidence that undiagnosed and untreated mental illness exacts a heavy toll on those who suffer from these disorders as well as those around them."  It was also pointed out by many that Luvox was often safer than the other SSRI medications available--for example, fluoxetine (Prozac) caused mania in 6% of youth tested on the drug (versus fluvoxamine's 4%).  Nonetheless, the reputation of Luvox was irreparably damaged.  Sales fell, and Solvay withdrew the medication from the U.S. market in 2002; the company maintains, however, that this move had nothing to do with the safety profile of fluvoxamine, which they still sell in many countries around the world.  In the United States, fluvoxamine can only be purchased generically.


The FDA currently issues the following warning with Luvox:
* ®<ref>{{Cite web | title =  | url =  }}</ref>
Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger.[http://www.fda.gov/cder/drug/infopage/fluvoxamine/default.htm]
The UK and Health Canada have taken similar actions.


<!--
<!--Look-Alike Drug Names-->
==Appearance in popular culture==


The drug was given visibility in the American television series [[The Sopranos]] produced by [[HBO]], in the second season, episode 10. Dr. [[Jennifer Melfi]], the psychiatrist treating the character named [[Tony Soprano]], is prescribed Luvox by her own psychiatrist, to treat a strong inclination toward alcohol.
|lookAlike=


The Columbine killer [[Eric Harris]] had taken Luvox, which reports claimed may have been the cause for his shooting rampage, along with [[Dylan Klebold]].
* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


"Stuttering" John Melendez, formerly of The Howard Stern Show, had taken Luvox for a period of time before his departure from the show.
<!--Drug Shortage Status-->
--><ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = LUVOX CR (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [JAZZ PHARMACEUTICALS, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e57814e3-9507-4a2f-858f-a845ad18f029 | publisher =  | date =  | accessdate = }}</ref>


==References==
|drugShortage=
}}


{{Reflist|2}}
<!--Pill Image-->


<div class="references-small">{{reflist|2}}</div>
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|fileName=No image.jpg|This image is provided by the National Library of Medicine.
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==External links==
<!--Label Display Image-->
* [http://www.rxlist.com/cgi/generic/fluvox.htm RxList.com - Fluvoxamine]
* [http://www.drugs.com/cons/Fluvoxamine.html Drugs.com - Fluvoxamine]
* [http://www.solvay.com/solvayproducts/pharmaceuticals/psychiatry/0,,1532-2-0,00.htm Solvay S.A. Mental Health Pharmaceuticals - Luvox®]


{{Antidepressants}}
{{LabelImage
[[Category:Selective serotonin reuptake inhibitors]]
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}
 
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


{{Antimigraine preparations}}
<!--Category-->
[[Category:Drugs]]


[[fr:Fluvoxamine]]
[[Category:Drug]]
[[it:Fluvoxamina]]
[[ja:フルボキサミン]]
[[no:Fluvoksamin]]
[[pt:Fluvoxamina]]
[[ru:Флувоксамин]]

Revision as of 14:57, 24 December 2014

Fluvoxamine
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

Disclaimer

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Black Box Warning

WARNING
See full prescribing information for complete Boxed Warning.
SUICIDALITY AND ANTIDEPRESSANT DRUGS
  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluvoxamine maleate tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Fluvoxamine maleate tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD).

Overview

Fluvoxamine is a that is FDA approved for the {{{indicationType}}} of obsessive compulsive disorder (OCD). There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, somnolence, insomnia, asthenia, nervousness, dyspepsia, abnormal ejaculation, sweating, anorexia, tremor, and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Fluvoxamine in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluvoxamine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Fluvoxamine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Fluvoxamine in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluvoxamine in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNING
See full prescribing information for complete Boxed Warning.
SUICIDALITY AND ANTIDEPRESSANT DRUGS
  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluvoxamine maleate tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Fluvoxamine maleate tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD).
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Fluvoxamine in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Fluvoxamine in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fluvoxamine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Fluvoxamine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Fluvoxamine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Fluvoxamine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Fluvoxamine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Fluvoxamine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fluvoxamine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Fluvoxamine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Fluvoxamine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fluvoxamine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fluvoxamine in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Fluvoxamine in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Fluvoxamine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Fluvoxamine in the drug label.

Pharmacology

There is limited information regarding Fluvoxamine Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Fluvoxamine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Fluvoxamine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Fluvoxamine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Fluvoxamine in the drug label.

How Supplied

Storage

There is limited information regarding Fluvoxamine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Fluvoxamine in the drug label.

Precautions with Alcohol

  • Alcohol-Fluvoxamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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