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Fluvoxamine

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Fluvoxamine, sold under the brand name Luvox among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.<ref name="U.S. Food and Drug Administration (FDA)-2015">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> It is primarily used to treat major depressive disorder and, perhaps more-especially, obsessive–compulsive disorder (OCD),<ref name="pmid20140100">Template:Cite journal</ref> but is also used to treat anxiety disorders<ref name="pmid11323729">Template:Cite journal</ref> such as panic disorder, social anxiety disorder, and post-traumatic stress disorder.<ref name="pmid11085201">Template:Cite journal</ref><ref name="pmid18568110"/><ref name="pmid11472786">Template:Cite journal</ref>

Fluvoxamine's side-effect profile is similar to that of other SSRIs. Common adverse effects include constipation, gastrointestinal problems, headache, anxiety, irritation, sexual problems, dry mouth, sleep problems and an increased risk of suicide at the start of treatment. These effects appear to be significantly weaker than with other SSRIs, with the exception of gastrointestinal side-effects.<ref name="Vezmar-2009">Template:Cite journal</ref>

Fluvoxamine appears to be more tolerable than other SSRIs, particularly with respect to cardiovascular complications.<ref name = "Westenberg_2006">Template:Cite journal</ref> Compared to escitalopram and sertraline, fluvoxamine's gastrointestinal profile may be less intense,<ref name="Oliva Lippi Paci Del Fabro 2021 p. 110266">Template:Cite journal</ref> often being limited to nausea.<ref name="pmid18568110">Template:Cite journal</ref> Mosapride has demonstrated efficacy in treating fluvoxamine-induced nausea.<ref name="Ueda Yoshimura Shinkai Terao 2001 pp. 259–264">Template:Cite journal</ref> It is also advised practice to divide total daily doses of fluvoxamine greater than 100 milligrams, with the higher fraction being taken in the evening (e.g., 50 mg at the beginning of the waking day and 200 mg at bedtime). In any case, high starting daily doses of fluvoxamine rather than the recommended gradual titration (starting at 50 milligrams and gradually titrating, up to 300 if necessary) may increase the likelihood of nausea.<ref name="Ware 1997 pp. 15–23">Template:Cite journal</ref>

It is on the World Health Organization's List of Essential Medicines.<ref name="WHO23rd">Template:Cite book</ref>

Medical usesEdit

In many countries (e.g., Australia,<ref name = AMH/><ref name="NPS-MedicineWise-2018">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> the United Kingdom,<ref name = BNF/> and Russia<ref name="Drug Registry of Russia (RLS) Drug Compendium">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>) it is commonly used for major depressive disorder. Fluvoxamine is also approved in the United States for obsessive–compulsive disorder (OCD),<ref name = DailyMed/><ref name="pmid20140100" /> and social anxiety disorder.<ref name="Luvox CR approved for OCD and SAD">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> In Japan, it is also approved to treat OCD, social anxiety disorder and major depressive disorder.<ref name="Astellas-Pharma-2018">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref name="www.medscape.com-2018">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> Fluvoxamine is indicated for children and adolescents with OCD.<ref name="Jazz Pharmaceuticals, Inc.-2005">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> The NICE guidelines in the United Kingdom have, as of 2005, authorized its use for obsessive-compulsive disorder in adults and adolescents of any age and children over the age of 7.Template:Medical citation needed

There is evidence that fluvoxamine is effective for generalised social anxiety in adults, although, as with other SSRIs, some of the results may be compromised by having been funded by pharmaceutical companies.<ref name="pmid29048739">Template:Cite journal</ref><ref name="pmid29995828">Template:Cite journal</ref> Of the SSRIs, however, fluvoxamine, paroxetine and sertraline do appear consistent as viable treatments for generalised social anxiety.<ref name="Williams-2020">Williams, T., McCaul, M., Schwarzer, G., Cipriani, A., Stein, D. J., & Ipser, J. (2020). Pharmacological treatments for social anxiety disorder in adults: a systematic review and network meta-analysis. Acta neuropsychiatrica, 32(4), 169–176. https://doi.org/10.1017/neu.2020.6 Template:Webarchive</ref><ref name="Davidson-2003">Davidson J. R. (2003). Pharmacotherapy of social phobia. Acta psychiatrica Scandinavica. Supplementum, (417), 65–71. https://doi.org/10.1034/j.1600-0447.108.s417.7.x Template:Webarchive</ref>

Fluvoxamine is also effective for treating a range of anxiety disorders in children and adolescents, including generalized anxiety disorder, social anxiety disorder, panic disorder and separation anxiety disorder.<ref name="NIHR-Evidence-2022">Template:Cite journal</ref><ref name="pmid32982805">Template:Cite journal</ref><ref name="pmid34002501">Template:Cite journal</ref>

The drug works long-term, and retains its therapeutic efficacy for at least one year.<ref name="pmid7507038">Template:Cite journal</ref>

The average therapeutic dose for fluvoxamine is 100 to 300 mg/day, with 300 mg being the upper daily limit normally recommended. Obsessive-compulsive disorder, however, often requires higher doses; doses of up to 450 mg/day may be prescribed in this case.<ref name="Seibell-2015">Seibell PJ, Hamblin RJ, Hollander E.

Obsessive-compulsive disorder: Overview and standard treatment strategies. Psychiatric Annals. 2015 Jun 1;45(6):297-302.</ref><ref name="Rivas-1997">Rivas-Vazquez, R.A. and Blais, M.A., 1997. Selective serotonin reuptake inhibitors and atypical antidepressants: A review and update for psychologists. Professional Psychology: Research and Practice, 28(6), p.526.</ref><ref name="Middleton-2019">Middleton, R., Wheaton, M.G., Kayser, R. and Simpson, H.B., 2019. Treatment resistance in obsessive-compulsive disorder. Treatment resistance in psychiatry: risk factors, biology, and management, pp.165-177.</ref> The (off-label) upper daily limits for other serotonin-reuptake inhibitors used in the treatment of obsessive-compulsive disorder, by analogy, are 400 mg for sertraline,<ref name="pmid16426083">Ninan PT, Koran LM, Kiev A, Davidson JR, Rasmussen SA, Zajecka JM, Robinson DG, Crits-Christoph P, Mandel FS, Austin C. High-dose sertraline strategy for nonresponders to acute treatment for obsessive-compulsive disorder: a multicenter double-blind trial. J Clin Psychiatry. 2006 Jan;67(1):15-22. doi: 10.4088/jcp.v67n0103. PMID 16426083.</ref> 100 mg for paroxetine, 120 mg for both fluoxetine and citalopram, 60 mg for escitalopram and 300 mg for clomipramine.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref name="pmid17849776">Koran LM, Hanna GL, Hollander E, Nestadt G, Simpson HB; American Psychiatric Association. Practice guideline for the treatment of patients with obsessive-compulsive disorder. Am J Psychiatry. 2007 Jul;164(7 Suppl):5-53. PMID 17849776.</ref>

In any case with fluvoxamine, treatment is generally begun at 50 mg and increased in 50 mg increments every 4 to 7 days until a therapeutic optimum is reached.<ref name="Figgitt-2000">Figgitt, D.P. and McClellan, K.J., 2000. Fluvoxamine: an updated review of its use in the management of adults with anxiety disorders. Drugs, 60, pp.925-954.</ref>

Adverse effectsEdit

Fluvoxamine's side-effect profile is very similar to other SSRIs. Gastrointestinal side effects are characteristic of those receiving treatment with fluvoxamine.<ref name=LUVOX>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref name=DailyMed>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref name="AMH">Template:Cite book</ref><ref name="BNF">Template:Cite book</ref><ref name="Maudsley">Template:Cite book</ref><ref name="electronic Medicines Compendium-2013">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

In comparison to other SSRIs, fluvoxamine has the second highest rate of causing Discontinuation syndrome, as a result of the low half life of fluvoxamine<ref>Template:Cite journal</ref>

CommonEdit

Common side effects occurring with 1–10% incidence:

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UncommonEdit

Uncommon side effects occurring with 0.1–1% incidence:

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  • Arthralgia
  • Confusional state
  • Cutaneous hypersensitivity reactions (e.g. oedema [buildup of fluid in the tissues], rash, pruritus)
  • Extrapyramidal side effects (e.g. dystonia, parkinsonism, tremor, etc.)
  • Hallucination
  • Orthostatic hypotension

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RareEdit

Rare side effects occurring with 0.01–0.1% incidence:

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  • Abnormal hepatic (liver) function
  • Galactorrhoea (expulsion of breast milk unrelated to pregnancy or breastfeeding)
  • Mania
  • Photosensitivity (being abnormally sensitive to light)
  • Seizures

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Unknown frequencyEdit

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InteractionsEdit

File:Luvox.jpg
Luvox (fluvoxamine) 100 mg film-coated scored tablets

Fluvoxamine inhibits the following cytochrome P450 enzymes:<ref name=Pharm>Template:Cite book</ref><ref name="GG">Template:Cite book</ref><ref name="pmid8968657">Template:Cite journal</ref><ref name="pmid9184622">Template:Cite journal</ref><ref name="pmid9809216">Template:Cite journal</ref><ref name="pmid17278909">Template:Cite journal</ref><ref name="pmid17823102">Template:Cite journal</ref><ref name="Waknine-2007">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref name="Mayo-Clinic-2018">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>Template:Excessive citations inline

By so doing, fluvoxamine can increase serum concentration of the substrates of these enzymes.<ref name = Pharm/>

Fluvoxamine may also elevate plasma levels of olanzapine by approximately two times.<ref name="pmid17214606">Template:Cite journal</ref> Combined olanzapine and fluvoxamine, which may cause increased sedation,<ref name="pmid11063782">Template:Cite journal</ref> should be used cautiously and controlled clinically and by therapeutic drug monitoring to avoid olanzapine induced adverse effects and/or intoxication.<ref name="pmid12352274">Template:Cite journal</ref><ref name="NPS MedicineWise-2020">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

The plasma levels of oxidatively metabolized benzodiazepines (e.g., triazolam, midazolam, alprazolam and diazepam) are likely to be increased when co-administered with fluvoxamine. However, the clearance of benzodiazepines metabolized by glucuronidation (e.g., lorazepam; oxazepam, which is coincidentally a metabolite of diazepam;<ref name="pmid28903606">Template:Cite journal</ref> temazepam)<ref name="Raouf-2016">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref name="pmid8700792">Template:Cite journal</ref> are not affected by fluvoxamine and may be safely taken alongside fluvoxamine should concurrent treatment with a benzodiazepine be necessary.<ref name="fluvoxamine maleate-2016">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> Additionally, it appears that benzodiazepines metabolized by nitro-reduction (clonazepam, nitrazepam) may also, in a somewhat similar vein, be unlikely to be affected by fluvoxamine.<ref name="Medsafe, New Zealand-2017">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref name="NPS MedicineWise-2022">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

Using fluvoxamine and alprazolam together can increase alprazolam plasma concentrations.<ref name="pmid12698310">Template:Cite journal</ref> If alprazolam is coadministered with fluvoxamine, the initial alprazolam dose should be reduced to the lowest effective dose.<ref name="Gerlach-2014">Template:Cite book</ref><ref name="pmid8005185">Template:Cite journal</ref>

As with all SSRI medications, using fluvoxamine with NSAIDs like ibuprofen may increase the risk of bleeding, particularly in the GI tract.<ref>Template:Cite journal</ref>

Fluvoxamine is contraindicated with other medications that increase serotonin (Dextromethorphan, ondansetron, ampetamine, sumatriptan, Tramadol, Hypericum perforatum, etc.).<ref>Template:Cite journal</ref> Combining these medications may rarely lead to a life-threatening complication known as Serotonin syndrome.

Fluvoxamine and ramelteon coadministration is not indicated.<ref name="pmid20478852">Template:Cite journal</ref><ref name="pmid23861638">Template:Cite journal</ref>

Fluvoxamine has been observed to increase serum concentrations of mirtazapine, which is mainly metabolized by CYP1A2, CYP2D6, and CYP3A4, by three- to four-fold in humans.<ref name="AnttilaRasanen2001">Template:Cite journal</ref> Caution and adjustment of dosage as necessary are warranted when combining fluvoxamine and mirtazapine.<ref name="AnttilaRasanen2001" />

Fluvoxamine seriously affects the pharmacokinetics of tizanidine and increases the intensity and duration of its effects. Because of the potentially hazardous consequences, the concomitant use of tizanidine with fluvoxamine, or other potent inhibitors of CYP1A2, should be avoided.<ref name="pmid15060511">Template:Cite journal</ref>

When a beta-blocker is required, atenolol,<ref name="pmid7988100">Template:Cite journal</ref> pindolol<ref name="pmid11543734">Template:Cite journal</ref><ref name="Sluzewska-1996">Template:Cite journal</ref><ref name="pmid9817627">Template:Cite journal</ref> and, possibly, metoprolol<ref name="pmid9681670">Template:Cite journal</ref><ref name="pmid8904628">Template:Cite journal</ref><ref name="pmid11876575"/><ref name="Belpaire-1997">Template:Cite journal</ref> may be safer choices than propranolol, as the latter's metabolism is seriously, potentially dangerously, inhibited by fluvoxamine.<ref name="pmid8846617">Template:Cite journal</ref> Indeed, fluvoxamine may increase propranolol blood-levels by five-fold.<ref name="pmid22311403">Template:Cite journal</ref>

Clomipramine increases fluvoxamine levels and, conversely-likewise, fluvoxamine increases clomipramine levels (thereby its serotoninergic potential) and inhibits its metabolism to its strongly-noradrenergic metabolite, norclomipramine.<ref name="pmid8666564">Template:Cite journal</ref><ref name="pmid34777510">Template:Cite journal</ref>

PharmacologyEdit

PharmacodynamicsEdit

Receptor affinity profile<ref name="pmid17662961">Template:Cite journal</ref><ref name="Schatzberg-2009">Template:Cite book</ref><ref name="pmid28501470">Template:Cite journal</ref>
Site Ki (nM)
Template:Abbrlink 2.5
Template:Abbrlink 1,427
5-HT2C 5,786
α1-adrenergic 1,288
σ1 36

Fluvoxamine is a potent selective serotonin reuptake inhibitor with around 100-fold affinity for the serotonin transporter over the norepinephrine transporter.<ref name = GG/> It has negligible affinity for the dopamine transporter or any other site, with the sole exception of the σ1 receptor.<ref name = sig>Template:Cite journal</ref><ref name = "Westenberg_2006" /> It behaves as a potent agonist at this receptor and has the highest affinity (36 nM) of any SSRI for doing so.<ref name = sig/> This may contribute to its antidepressant and anxiolytic effects and may also afford it some efficacy in treating the cognitive symptoms of depression.<ref name = cog>Template:Cite journal</ref> It increases concentrations of the neurosteroid allopregnanolone, which may also contribute to its anxiolytic effects.<ref name="pmid9501247">Template:Cite journal</ref> Unlike some other SSRIs, fluvoxamine's metabolites are pharmacologically neutral.<ref name="pmid1931931">Template:Cite journal</ref>

PharmacokineticsEdit

Literature reviews have stated that fluvoxamine is metabolized primarily by CYP2D6 and to a minor extent by CYP1A2.<ref name="AltamuraCaldiroliBuoli2015">Template:Cite journal</ref><ref name="Wyska2019">Template:Cite journal</ref> However, CYP2D6 poor metabolizers do not have considerably higher fluvoxamine levels than extensive metabolizers.<ref name="AltamuraCaldiroliBuoli2015" /> Fluvoxamine inhibits oxidative drug metabolising enzymes (particularly CYP1A2, and less potently CYP3A4 and CYP2D6)<ref>Template:Cite journal</ref> The mean plasma half-life of fluvoxamine after multiple oral doses of 100 mg/day in healthy, young volunteers was 13.6-15.6 hours. In the elderly, however the half life ranged from 17.4 to 25.9.<ref name=":0">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> Steady-state plasma fluvoxamine concentrations were 2-3 fold higher in children than in adolescents.

HistoryEdit

Fluvoxamine was developed by Kali-Duphar,<ref name="Sittig"/> part of Solvay Pharmaceuticals, Belgium, now Abbott Laboratories, and introduced as Floxyfral in Switzerland in 1983.<ref name=Sittig>Template:Cite book</ref> It was approved by the U.S. Food and Drug Administration (FDA) in 1994, and introduced as Luvox in the US.<ref name="pmid15995053">Template:Cite journal</ref> In India, it is available, among several other brands, as Uvox by Abbott.<ref name=India>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> It was one of the first SSRI antidepressants to be launched, and is prescribed in many countries to patients with major depression.<ref name="Cochrane 2010/2013">Template:Cite journal</ref> It was the first SSRI, a non-TCA drug, approved by the U.S. FDA specifically for the treatment of OCD.<ref name="OCD Medication">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> At the end of 1995, more than ten million patients worldwide had been treated with fluvoxamine.<ref name="Fluvoxamine Product Monograph-1999">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>Template:Failed verification Fluvoxamine was the first SSRI to be registered for the treatment of obsessive compulsive disorder in children by the FDA in 1997.<ref name="Luvox Approved For Obsessive Compulsive Disorder in Children and Teens-2009">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> In Japan, fluvoxamine was the first SSRI to be approved for the treatment of depression in 1999<ref name="pmid19300537">Template:Cite journal</ref><ref name="Wishart">Template:Cite HMDB</ref> and was later in 2005 the first drug to be approved for the treatment of social anxiety disorder.<ref name="Solvay-2018">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> Fluvoxamine was the first SSRI approved for clinical use in the United Kingdom.<ref name="Churchill Livingstone Elsevier-2007">Template:Cite book</ref> Manufacturers include BayPharma, Synthon, and Teva, among others.<ref name="www.drugbank.ca-2019">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

Research directionsEdit

A 2022 review concluded that according to low-certainty evidence, fluvoxamine may slightly decrease all-cause mortality by day 28 and potentially reduce the risk of hospitalization or death in outpatients with mild COVID-19.<ref name="pmid36103313">Template:Cite journal</ref> While early studies have suggested potential benefits for fluvoxamine as an anti-inflammatory agent and a possible impact on reducing cytokine storms, further studies did not confirm this expected benefit on COVID-19 patients.<ref name="pmid35383578">Template:Cite journal</ref><ref name="pmid36532776">Template:Cite journal</ref> A cytokine storm refers to an excessive immune response characterized by a release of large amounts of pro-inflammatory cytokines.<ref name="pmid32592501">Template:Cite journal</ref>

In May 2022, based on a review of available scientific evidence, the U.S. Food and Drug Administration (FDA) chose not to issue an emergency use authorization covering the use of fluvoxamine to treat COVID-19, saying that, at the time, the data was not sufficient to conclude that fluvoxamine may be effective in treating non-hospitalized people with COVID-19 to prevent serious illness or hospitalization. The agency stated that study results suggest that further clinical trials may be warranted.<ref name="Reuters-2022">Template:Cite news</ref><ref name="Food and Drug Administration-2022">Template:Cite tech report Template:PD-notice</ref>

Reviews published in 2024 indicate that clinical trials have shown fluvoxamine to be more effective than a placebo in reducing clinical deterioration and hospitalization in COVID-19 patients, particularly those taking 200 mg or more daily.<ref name="pmid38148036">Template:Cite journal</ref><ref name="pmid38862591">Template:Cite journal</ref><ref name="pmid38753761">Template:Cite journal</ref>

EnvironmentEdit

Fluvoxamine is a common finding in waters near human settlement.<ref name="Runoff" /> Christensen et al. 2007 finds it is "very toxic to aquatic organisms" by European Union standards.<ref name="Runoff"> 

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ReferencesEdit

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 | group2 = Template:Abbrlink Template:Abbrlink
 |  list2 = 

 | group3 = Hypnotics
 | list3 =



 | group4 = Gabapentinoids
([[Voltage-dependent calcium channel#.CE.B12.CE.B4_Subunit|Template:Abbr Template:Abbr]] blockers)
 |  list4 =

 | group5 = Antidepressants
 | list5 = 

 | group6 = Antipsychotics
 | list6 =



 | group7 = Sympatholytics
(Antiadrenergics)
 |  list7 =

 | group8 = Others
 |  list8 =

| list9 = Template:PharmNavFootnote



}} Template:OCD pharmacotherapies Template:Monoamine reuptake inhibitors Template:Sigma receptor modulators Template:Portal bar

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