Tamsulosin: Difference between revisions

{{Short description|Uroselective alpha 1 blockerMedication}}

| image = Tamsulosin Structure.svg

| legal_UK_comment = <ref>{{cite web | title=Flomaxtra XL, 400 micrograms, film-coated prolonged release tablet -– Summary of Product Characteristics (SmPC) | website=(emc) | date=12 November 2019 | url=https://www.medicines.org.uk/emc/product/97/smpc | access-date=2 December 2021}}</ref><ref>{{cite web | title=Faramsil 400 microgram Prolonged-release Tablets -– Summary of Product Characteristics (SmPC) | website=(emc) | date=4 November 2020 | url=https://www.medicines.org.uk/emc/product/4948/smpc | access-date=2 December 2021}}</ref>

| legal_US_comment = <ref>{{cite web | title=Flomax-Flomax– tamsulosin hydrochloride capsule | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8 | access-date=2 December 2021}}</ref>

[[File:Tamsulosin - ARISTO Pharma - 0,4 mg Retardtabletten - Urologikum.jpg|thumb|Tamsulosin -– ARISTO Pharma -– 0.4 mg prolonged-release tablets – Urologikum]]

'''Tamsulosin''', sold under the brand name '''Flomax''' among others, is a [[medication]] used to treat symptomatic [[benign prostatic hyperplasia]] (BPH) and [[Chronic prostatitis/chronic pelvic pain syndrome|chronic prostatitis]] and to help with the passage of [[kidney stones]].<ref name=AHFS2018>{{cite web |title=Tamsulosin Hydrochloride Monograph for Professionals |url=https://www.drugs.com/monograph/tamsulosin-hydrochloride.html |website=Drugs.com |publisher=AHFS |access-date=24 December 2018 |language=en}}</ref><ref>{{cite web |title=Prostatitis |url=https://www.nhs.uk/conditions/prostatitis |website=NHS |access-date=24 December 2018 |language=en |date=19 October 2017}}</ref><ref name=Wang2016>{{cite journal | vauthors = Wang RC, Smith-Bindman R, Whitaker E, Neilson J, Allen IE, Stoller ML, Fahimi J | title = Effect of Tamsulosin on Stone Passage for Ureteral Stones: A Systematic Review and Meta-analysis | journal = Annals of Emergency Medicine | volume = 69 | issue = 3 | pages = 353–361.e3 | date = March 2017 | pmid = 27616037 | doi = 10.1016/j.annemergmed.2016.06.044 | doi-access = free }}</ref> The evidence for benefit with a kidney stone is better when the stone is larger.<ref name=Wang2016/> ItTamsulosin is taken by mouth.<ref name=AHFS2018/>

Common side effects include dizziness, headache, sleeplessness, nausea, [[blurry vision]], and sexual problems.<ref name=BNF76/><ref name=AHFS2018/> Other side effects may include [[feeling lightheaded with standing]] due to changes in blood pressure, and [[angioedema]].<ref name=BNF76/> Tamsulosin is an [[alpha blocker]] and works by relaxing muscles in the prostate.<ref>{{cite book | vauthors = Hutchison LC, Sleeper RB |title=Fundamentals of Geriatric Pharmacotherapy: An Evidence-Based Approach |date=2010 |publisher=ASHP |isbn=9781585283057 |page=209 |url=https://books.google.com/books?id=fUtOugU_KeIC&pg=PA209 |language=en}}</ref> Specifically it is an [[alpha-1 adrenergic receptor|α₁ adrenergic receptor]] blocker.<ref name=AHFS2018/>

Tamsulosin was approved for medical use in the United States in 1997.<ref name=AHFS2018/> It is available as a [[generic medication]].<ref name=BNF76>{{cite book|title=British national formulary : BNF 76|date=2018|publisher=Pharmaceutical Press|isbn=9780857113382|pages=767|edition=76}}</ref> In 20202022, it was the 24th-twentieth most commonly prescribed medication in the United States, with more than 2425{{nbsp}}million prescriptions.<ref>{{cite web | title=The Top 300 of 20202022 | url=https://clincalc.com/DrugStats/Top300Drugs.aspx | website=ClinCalc | access-date=730 OctoberAugust 2024 | archive-date=30 August 2024 | archive-url=https://web.archive.org/web/20240830202410/https://clincalc.com/DrugStats/Top300Drugs.aspx | url-status=live 2022}}</ref><ref>{{cite web | title =Tamsulosin -Tamsulosin Drug Usage Statistics, United States, 2013 - 2022 | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/Tamsulosin | access-date =7 October30 August 2024 2022}}</ref>

Tamsulosin is primarily used for [[benign prostatic hyperplasia]] (BPH) and to help with the passage of [[kidney stone]]s.<ref>{{cite web | url = http://www.renalandurologynews.com/tamsulosin-aids-stone-expulsion/article/193855/ | title = Tamsulosin Aids Stone Expulsion | publisher = Renal and Urology News | date = 7 January 2011 | access-date = 4 October 2012 | archive-date = 14 May 2012 | archive-url = https://web.archive.org/web/20120514032753/http://www.renalandurologynews.com/tamsulosin-aids-stone-expulsion/article/193855/ | url-status = dead }}</ref><ref>{{cite web | url = http://www.prnewswire.com/news-releases/study-shows-use-of-tamsulosin-or-nifedipine-helps-patients-to-clear-ureteral-stone-fragments-faster-and-reduces-rate-of-recurrence-54518887.html | title = Study Shows Use of Tamsulosin or Nifedipine Helps Patients to Clear Ureteral Stone Fragments Faster and Reduces Rate of Recurrence }}</ref> Tamsulosin, however, appears to be effective only for stones over 4&nbsp;mm and less than 10&nbsp;mm in size.<ref name=Wang2016/>

Tamsulosin does not decrease the overall size of the prostate in men with BPH, and is not recommended for prevention of [[prostate cancer]].<ref name=":0">{{Cite book|title=Medical-surgical nursing : assessment and management of clinical problems| vauthors = Lewis SM, Dirksen SR, Heitkemper MM, Bucher LH |dateyear=5 December 2013|isbn=978-0-323-10089-2|edition=Ninth9th|location=St. Louis, Missouri|oclc=228373703}}</ref>

The results of the CombAT (combination of [[dutasteride]] (Avodart) and tamsulosin, under the brand name Duodart) trial in 2008 demonstrated that treatment with the combination of dutasteride and tamsulosin provides greater symptom benefits compared to monotherapy with either agent alone for treatment of benign prostatic hyperplasia.<ref name="Roehrborn2008">{{cite journal | vauthors = Roehrborn CG, Siami P, Barkin J, Damião R, Major-Walker K, Morrill B, Montorsi F | title = The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study | journal = The Journal of Urology | volume = 179 | issue = 2 | pages = 616–21616–621; discussion 621 | date = February 2008 | pmid = 18082216 | doi = 10.1016/j.juro.2007.09.084 }}</ref>

When alpha 1 receptors in the bladder neck, prostate, ureter, and urethra are blocked, a relaxation in smooth muscle tissue results.<ref name=":0" /> This mechanism decreases resistance to urinary flow, reduces discomfort associated with BPH, and facilitates passage of [[kidney stone disease|kidney stones]].<ref name=":0" /> Selective action of tamsulosin in alpha 1A/D receptors is controversial and over three-quarters of tamsulosin registered human studies are unpublished.<ref name="BirdDelaney2013" />

Tamsulosin was first marketed in 1996 under the [[trade name]] Flomax. The U.S. patent expired in October 2009.<ref>{{cite web|title=Flomax – Big Patent Expirations of 2010 | url=http://www.fiercepharma.com/special-reports/flomax-big-patent-expirations-2010|date=10 February 2010|access-date=14 January 2012|archive-date=22 April 2012|archive-url=https://web.archive.org/web/20120422163615/http://www.fiercepharma.com/special-reports/flomax-big-patent-expirations-2010|url-status=dead}}</ref> The [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) approved generics in March 2010.<ref>{{cite press release| url = https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202728.htm| title = FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland| date = 2 March 2010| publisher=[[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA)}}</ref> In 2010, tamsulosin was available as OTC medication in UK.<ref>{{cite journal | vauthors = | title = OTC tamsulosin for benign prostatic hyperplasia | journal = Drug and Therapeutics Bulletin | volume = 48 | issue = 10 | pages = 113–116 | date = October 2010 | pmid = 20926447 | doi = 10.1136/dtb.2010.10.0052 | s2cid = 32141889 }}</ref>

It is marketed by various companies under licence, including [[Boehringer Ingelheim]] and [[CSL Limited|CSL]]. Tamsulosin hydrochloride extended-release capsules are marketed under the trade names Urimax 0.4 (India),Tamlocept 0.4 (India), Flomax, Flomaxtra, Contiflo XL, bestflo, Mecir LP (France), Urimax, Pamsvax, and Pradif,<ref>{{cite web|title=Pradif 0,4 Mg Capsule Rigide A Rilascio Prolungato |url=http://www.torrinomedica.it/farmaci/schedetecniche/PRADIF.asp |work=Torrinomedica.it|access-date=15 November 2012 | vauthors = Magnanelli S, Vetere AM }}</ref> although generic, unmodified-release capsules are still approved and marketed in many countries (such as [[Canada]]). Generic extended-release tablets are marketed in most countries of the [[European Economic Area|EEA]].<ref>{{cite web|title=Tamsulosina Mylan 0,4 mg cápsulas duras de liberación modificada EFG|url=http://cima.aemps.es/cima/pdfs/es/p/67279/67279_p.pdf|work=cima.aemps.es|access-date=29 October 2018 }}</ref> In [[Mexico]], it is marketed as Secotex and as Harnal D in [[Japan]] and [[Indonesia]] and as Harnal OCAS (oral controlled absorption system) in Thailand.<ref>{{cite web | title = Drugs.com Database | url= https://www.drugs.com/international/harnal-d.html}}</ref> In [[Egypt]],<ref>{{cite news |title= Novartis hits Astellas with transplant drug generic|url=https://www.reuters.com/article/americasRegulatoryNews/idUST34424920090811 |publisher= Reuters|date= 11 August 2009|access-date=11 August 2009}}</ref> [[Italy]], [[Russia]] and [[Iceland]], it is marketed under the trade name Omnic by Astellas Pharma Europe. The largest manufacturer of tamsulosin, drug substance, is Synthon BV (the Netherlands).{{Cn|date=September 2023}} Tamsulosin hydrochloride is marketed in Bangladesh under the trade names Uromax, Prostanil MR, Tamisol MR, and Tamsin.{{citation needed|date=August 2017}}