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{{Short description|Chemical compound}} |
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{{Unreferenced stub|auto=yes|date=December 2009}} |
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{{Use dmy dates|date=September 2024}} |
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{{Drugbox |
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{{cs1 config |name-list-style=vanc |display-authors=6}} |
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| verifiedrevid = 395518285 |
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{{Infobox drug |
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| IUPAC_name = 3-(2-hydroxy-2,2-diphenylacetoxy)spirooctane-8,1'-pyrrolidin]-1'-ium |
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| verifiedrevid = 402706794 |
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| image = Trospium.svg |
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| class = ] (]) |
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| CASNo_Ref = {{cascite|correct|CAS}} |
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| image = Trospium chloride.svg |
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| ChemSpiderID = 10482307 |
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| alt = <!--Clinical data --> |
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| UNII_Ref = {{fdacite|correct|FDA}} |
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| pronounce = {{IPAc-en|ˈ|t|r|oʊ|s|p|i|ə|m}}<br />{{respell|TROHS|pee|əm}} |
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| UNII = 1E6682427E |
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| tradename = Regurin, Sanctura, others<ref name=brands/> |
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| InChI = 1/C25H30NO3/c27-24(25(28,19-9-3-1-4-10-19)20-11-5-2-6-12-20)29-23-17-21-13-14-22(18-23)26(21)15-7-8-16-26/h1-6,9-12,21-23,28H,7-8,13-18H2/q+1/t21-,22+,23+ |
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| Drugs.com = {{drugs.com|monograph|trospium_chloride}} |
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| InChIKey = OYYDSUSKLWTMMQ-JKHIJQBDBG |
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| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
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| smiles = OC(c1ccccc1)(c2ccccc2)C(=O)O3C5CC(C3)45CCCC4 |
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| pregnancy_category = |
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| StdInChI = 1S/C25H30NO3/c27-24(25(28,19-9-3-1-4-10-19)20-11-5-2-6-12-20)29-23-17-21-13-14-22(18-23)26(21)15-7-8-16-26/h1-6,9-12,21-23,28H,7-8,13-18H2/q+1/t21-,22+,23+ |
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| routes_of_administration = ] |
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| StdInChIKey = OYYDSUSKLWTMMQ-JKHIJQBDSA-N |
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| CAS_number = 10405-02-4 |
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| ATC_prefix = G04 |
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| ATC_prefix = G04 |
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| ATC_suffix = BD09 |
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| ATC_suffix = BD09 |
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| ATC_supplemental = |
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| ATC_supplemental = |
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| PubChem = 107979 |
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| DrugBank = APRD00393 |
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| C=25 | H=30 | N=1 | O=3 |
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| molecular_weight = 392.511 g/mol |
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| bioavailability = |
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| protein_bound = 50-85% |
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| metabolism = |
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| elimination_half-life = 20 hours |
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| excretion = |
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| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
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| pregnancy_US = <!-- A / B / C / D / X --> |
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| pregnancy_category = |
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| legal_AU = <!-- Unscheduled / S2 / S4 / S8 --> |
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| legal_AU = <!-- Unscheduled / S2 / S4 / S8 --> |
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| legal_UK = <!-- GSL / P / POM / CD --> |
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| legal_UK = <!-- GSL / P / POM / CD --> |
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| legal_US = <!-- OTC / Rx-only --> |
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| legal_US = Rx-only |
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| legal_US_comment = <ref name="FDAlabel">FDA {{cite web | url = http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021595s007lbl.pdf | title = Trospium chloride label | publisher = U.S. Food and Drug Administration | date = January 2011 }}</ref> |
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| legal_status = |
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| legal_status = Rx-only |
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| routes_of_administration = |
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<!--Pharmacokinetic data -->| bioavailability = |
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| protein_bound = 50–85% |
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| metabolism = |
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| elimination_half-life = 20 hours |
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| excretion = <!--Identifiers --> |
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| CAS_number = 10405-02-4 |
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| PubChem = 107979 |
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| DrugBank = DB00209 |
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| ChEBI = 32270 |
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| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}} |
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| ChemSpiderID = 10482307 |
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| UNII_Ref = {{fdacite|correct|FDA}} |
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| UNII = 1E6682427E |
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| ChEMBL = 1201344 |
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<!--Chemical data -->| IUPAC_name = 3‑(2‑Hydroxy-2,2‑diphenylacetoxy)spirooctane-8,1'‑pyrrolidin]-1'‑ium chloride |
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| C = 25 |
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| H = 30 |
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| Cl = 1 |
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| N = 1 |
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| O = 3 |
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| SMILES = OC(c1ccccc1)(c2ccccc2)C(=O)O3C5CC(C3)45CCCC4 |
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| StdInChI_Ref = {{stdinchicite|correct|chemspider}} |
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| StdInChI = 1S/C25H30NO3/c27-24(25(28,19-9-3-1-4-10-19)20-11-5-2-6-12-20)29-23-17-21-13-14-22(18-23)26(21)15-7-8-16-26/h1-6,9-12,21-23,28H,7-8,13-18H2/q+1/t21-,22+,23+ |
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| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}} |
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| StdInChIKey = OYYDSUSKLWTMMQ-JKHIJQBDSA-N |
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}} |
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}} |
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'''Trospium chloride''' is a ] used to treat ].<ref name=emcXLlabel>{{cite web | work = UK eMC | url = https://www.medicines.org.uk/emc/medicine/22236 | title = Regurin XL 60mg | date = 3 July 2015 }}</ref> It has side effects typical of this class of drugs, namely dry mouth, stomach upset, and constipation; these side effects cause problems with people taking their medicine as directed. However it doesn't cause central nervous system side effects like some other muscarinic antagonists.<ref name="2009rev">{{cite journal |vauthors=Biastre K, Burnakis T | title = Trospium chloride treatment of overactive bladder | journal = Ann Pharmacother | volume = 43 | issue = 2 | pages = 283–95 |date=February 2009 | pmid = 19193592 | doi = 10.1345/aph.1L160 | s2cid = 20102756 }}</ref> |
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'''Trospium''' is a ] ]. It is sold under the brand name '''Sanctura''' in the US, '''Trosec''' in Canada, '''Regurin''' in the United Kingdom and '''Spasmex''' in Croatia and Israel. |
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Chemically it is a ] which causes it to stay in periphery rather than crossing the ].<ref name=Quat2003>{{cite journal |vauthors=Pak RW, Petrou SP, Staskin DR | title = Trospium chloride : a quaternary amine with unique pharmacologic properties | journal = Curr Urol Rep | volume = 4 | issue = 6 | pages = 436–40 |date=December 2003 | pmid = 14622495 | doi = 10.1007/s11934-003-0023-1 | s2cid = 4512769 }}</ref> It works by causing the ] in the bladder to relax.<ref name=emcXLlabel/> |
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It is available in Egypt under the brand name '''Trospikan''' by Hikma pharma. |
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<!-- Society and culture --> |
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{{Urologicals}} |
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It was patented in 1966 and approved for medical use in 1974.<ref>{{cite book | vauthors = Fischer J, Ganellin CR |title=Analogue-based Drug Discovery |date=2006 |publisher=John Wiley & Sons |isbn=9783527607495 |page=446 |url=https://books.google.com/books?id=FjKfqkaKkAAC&pg=PA446 }}</ref> It was first approved in the US in 2004, and an extended release version was brought to market in 2007. It became generic in the EU in 2009, and the first extended-release generic was approved in the US in 2012. |
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== Medical uses == |
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] |
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Trospium chloride is used for the treatment of ] with symptoms of ] and ].<ref name=emcXLlabel/><ref name=2009rev/><ref name=FDAlabel/> |
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It should not be used with people who ], who have severe ], ], narrow-angle ], or ].<ref name=emcXLlabel/> |
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It should be used with caution in people who have problems with their ] (]) or who have ], or in whom fast heart rates are undesirable, such as people with hyperthyroidism, coronary artery disease and congestive heart failure.<ref name=emcXLlabel/> |
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{{Medicine-stub}} |
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There are no adequate and well-controlled studies of trospium chloride in pregnant women and there are signs of harm to the fetus in animal studies. The drug was excreted somewhat in the milk of nursing mothers.<ref name=emcXLlabel/> The drug was studied in children.<ref name=emcXLlabel/> |
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] |
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] |
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== Side effects == |
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Side effects are typical of gastrointestinal effects of ] drugs, and include dry mouth, indigestion, and constipation. These side effects lead to problems with adherence, especially for older people.<ref name=2009rev/> |
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The only CNS side effect is headache, which was very rare. Tachycardia is a rare side effect.<ref name=emcXLlabel/> |
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== Pharmacology == |
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=== Mechanism of action === |
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{| class="wikitable floatright" style="font-size:small;" |
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|+ Trospium binding affinities<ref name="BindingDB">{{cite journal | last=Liu | first=Tiqing | title=BindingDB BDBM50540489 Flotros::IP-631::IP631::Regurin::Regurin xl::Sanctura::Sanctura xr::Spasmo-lyt::Trospium chloride::Uraplex | journal=Journal of Medicinal Chemistry | date=2020 | volume=63 | issue=11 | pages=5763–5782 | doi=10.1021/acs.jmedchem.9b02100 | pmid=32374602 | pmc=8007111 | url=https://www.bindingdb.org/rwd/bind/chemsearch/marvin/MolStructure.jsp?monomerid=50540489 | access-date=28 October 2024}}</ref><ref name="DelBelloBonifaziGiorgioni2020">{{cite journal | vauthors = Del Bello F, Bonifazi A, Giorgioni G, Piergentili A, Sabbieti MG, Agas D, Dell'Aera M, Matucci R, Górecki M, Pescitelli G, Vistoli G, Quaglia W | title = Novel Potent Muscarinic Receptor Antagonists: Investigation on the Nature of Lipophilic Substituents in the 5- and/or 6-Positions of the 1,4-Dioxane Nucleus | journal = J Med Chem | volume = 63 | issue = 11 | pages = 5763–5782 | date = June 2020 | pmid = 32374602 | pmc = 8007111 | doi = 10.1021/acs.jmedchem.9b02100 | url = }}</ref> |
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! Target !! Affinity (K<sub>i</sub>, nM) !! Species |
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| ] || 3.5 || Human |
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| ] || 1.1 || Human |
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| ] || 1.0 || Human |
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| ] || 1.4 || Human |
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| ] || 6.0 || Human |
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|- class="sortbottom" |
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| colspan="3" style="width: 1px; background-color:#eaecf0; text-align: center;" | '''Notes:''' Values are K<sub>i</sub>, unless otherwise specified. The smaller the value, the more strongly the drug binds to the site. |
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Trospium chloride is a ]. Trospium chloride blocks the effect of ] on ] receptors organs that are responsive to the compounds, including the ].<ref name=emcXLlabel/> Its ] action relaxes the smooth muscle in the bladder.<ref name=2009rev/> Receptor assays showed that trospium chloride has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses.<ref name=emcXLlabel/> The drug has high and similar ] for all five of the muscarinic acetylcholine receptor subtypes, including the ], ], ], ], and ]s.<ref name="PerettoPetrilloImbimbo2009">{{cite journal | vauthors = Peretto I, Petrillo P, Imbimbo BP | title = Medicinal chemistry and therapeutic potential of muscarinic M3 antagonists | journal = Med Res Rev | volume = 29 | issue = 6 | pages = 867–902 | date = November 2009 | pmid = 19399831 | doi = 10.1002/med.20158 | url = }}</ref><ref name="PakPetrouStaskin2003">{{cite journal | vauthors = Pak RW, Petrou SP, Staskin DR | title = Trospium chloride: a quaternary amine with unique pharmacologic properties | journal = Curr Urol Rep | volume = 4 | issue = 6 | pages = 436–440 | date = December 2003 | pmid = 14622495 | doi = 10.1007/s11934-003-0023-1 | url = }}</ref><ref name="RosaBaucknehtScala2013">{{cite journal | vauthors = Rosa GM, Bauckneht M, Scala C, Tafi E, Leone Roberti Maggiore U, Ferrero S, Brunelli C | title = Cardiovascular effects of antimuscarinic agents in overactive bladder | journal = Expert Opin Drug Saf | volume = 12 | issue = 6 | pages = 815–827 | date = November 2013 | pmid = 23800037 | doi = 10.1517/14740338.2013.813016 | url = }}</ref> |
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=== Pharmacokinetics === |
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After oral administration, less than 10% of the dose is absorbed. Mean absolute ] of a 20 mg dose is 9.6% (range: 4.0 to 16.1%). Peak plasma concentrations (C<sub>max</sub>) occur between 5 and 6 hours post-dose. Mean ] increases greater than dose-proportionally; a 3-fold and 4-fold increase in C<sub>max</sub> was observed for dose increases from 20 mg to 40 mg and from 20 mg to 60 mg, respectively. ] exhibits dose linearity for single doses up to 60 mg. Trospium chloride exhibits diurnal variability in exposure with a decrease in C<sub>max</sub> and AUC of up to 59% and 33%, respectively, for evening relative to morning doses.<ref name=PK>{{cite journal |vauthors=Doroshyenko O, Jetter A, Odenthal KP, Fuhr U | title = Clinical pharmacokinetics of trospium chloride | journal = Clin Pharmacokinet | volume = 44 | issue = 7 | pages = 701–20 | year = 2005 | pmid = 15966754 | doi = 10.2165/00003088-200544070-00003| s2cid = 10968270 }}</ref> |
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Administration with a high fat meal resulted in reduced absorption, with AUC and C<sub>max</sub> values 70 to 80% lower than those obtained when trospium chloride was administered while fasting. Therefore, it is recommended that trospium chloride should be taken at least one hour prior to meals or on an empty stomach.<ref name=PK/> |
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Protein binding ranged from 50 to 85% when concentration levels of trospium chloride (0.5 to 50 ng/mL) were incubated with human serum in vitro. The <sup>3</sup>H-trospium chloride ratio of plasma to whole blood was 1.6:1. This ratio indicates that the majority of <sup>3</sup>H-trospium chloride is distributed in plasma. The apparent volume of distribution for a 20 mg oral dose is 395 (± 140) liters.<ref name=PK/> |
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The metabolic pathway of trospium in humans has not been fully defined. Of the 10% of the dose absorbed, metabolites account for approximately 40% of the excreted dose following oral administration. The major metabolic pathway is hypothesized as ] ] with subsequent ] of benzylic acid to form azoniaspironortropanol with ]. ] is not expected to contribute significantly to the elimination of trospium. Data taken from in vitro human liver ]s investigating the inhibitory effect of trospium on seven cytochrome P450 isoenzyme substrates (CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4) suggest a lack of inhibition at clinically relevant concentrations.<ref name=PK/> |
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The plasma half-life for trospium chloride following oral administration is approximately 20 hours. After oral administration of an immediate-release formulation of <sup>14</sup>C-trospium chloride, the majority of the dose (85.2%) was recovered in feces and a smaller amount (5.8% of the dose) was recovered in urine; 60% of the radioactivity excreted in urine was unchanged trospium. The mean renal clearance for trospium (29 L/hour) is 4-fold higher than average glomerular filtration rate, indicating that active tubular secretion is a major route of elimination for trospium. There may be competition for elimination with other compounds that are also renally eliminated.<ref name=PK/> |
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==Chemistry== |
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] drugs used to treat overactive bladder were all ] as of 2003. ] in general are more ] than other amines and don't cross membranes well, so they tend to be poorly absorbed from the digestive system, and to not cross the ]. ], ], ], and ] are tertiary amines while trospium chloride and ] are quaternary amines.<ref name=Quat2003/> |
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==History== |
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The synthesis of trospium was described by scientists from Dr. Robert Pfleger Chemische Fabrik GmbH, Heinz Bertholdt, Robert Pfleger, and Wolfram Schulz, in US. Pat. No. 3,480,626 (the US equivalent to DE119442), and its activity was first published in the literature in 1967.<ref>{{cite patent | url = https://docs.google.com/viewer?url=patentimages.storage.googleapis.com/pdfs/US6974820.pdf | country = US | number = 6974820 }} which cites {{cite patent | url = https://docs.google.com/viewer?url=patentimages.storage.googleapis.com/pdfs/US3480626.pdf | country = US | number = 3480626 }} and {{cite journal | pmid = 5632538 | volume=17 | issue=6 | title= | year=1967 | vauthors = Bertholdt H, Pfleger R, Schulz W | journal=Arzneimittelforschung | pages=719–26 }}</ref><ref name = "DE1194422">{{ cite patent | country = DE | number = 1194422 | status = patent | title = (A process for preparing azonia-spirono-tropane derivatives) | gdate = 10 June 1965 | inventor = Bertholdt H, Pfleger R, Schulz W | assign1 = Dr. Robert Pfleger Chemische Fabrik GmbH }}</ref> |
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The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets.<ref name=MHRA>{{cite web | work = Medicines and Healthcare products Regulatory Agency | date = 7 April 2011 | url = http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con120241.pdf | title = Trospium Chloride 20mg Film-Coated Tablets, Public Assessment Report }}</ref>{{rp|13}} Madaus is considered the originator for regulatory filings worldwide.<ref name=AdisInsight>{{cite web | work = AdisInsight | publisher = Springer Nature Switzerland AG | url = http://adisinsight.springer.com/drugs/800014035 | title = Trospium chloride }}</ref> The German filing was recognized throughout Europe under the ].<ref name=MHRA/>{{rp|13}} |
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Madaus licensed the US rights to trospium chloride to Interneuron in 1999 and Interneuron ran clinical trials in the US to win FDA approval.<ref>{{cite web | vauthors = Miller J | work = Boston Business Journal | date = 23 September 2002 | url = http://www.bizjournals.com/boston/blog/mass-high-tech/2002/09/indevus-to-apply-for-new-drug-status.html | title = Indevus to apply for new drug status for incontinence drug }}</ref><ref>{{cite web | vauthors = Herper M | work = Forbes | date = 25 September 2002 | url = https://www.forbes.com/2002/09/25/0925indevus.html | title = A Biotech Phoenix Could Be Rising }}</ref> Interneuron changed its name to Indevus in 2002<ref>{{cite web | url = https://www.sec.gov/Archives/edgar/data/854222/000092701602001953/dex991.txt | title = Indevus Pharmaceuticals, Inc., Formerly Interneuron, to Begin Trading on Nasdaq | work = Indevus Press Release | date = 2 April 2002 }}</ref> Indevus entered into a partnership with Odyssey Pharmaceuticals, a subsidiary of ], to market the drug in April 2004,<ref>{{cite web | work = Indevus Press Release | date = 7 April 2004 | url = http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=50060 | title = Indevus and PLIVA Sign Co-Promotion and Licensing Agreement for SANCTURA -Trospium Chloride | access-date = 14 May 2016 | archive-date = 27 August 2021 | archive-url = https://web.archive.org/web/20210827165135/https://www.evaluate.com/ | url-status = dead }}</ref> and won FDA approval for the drug, which it branded as Sanctura, in May 2004.<ref>{{cite web | work = CenterWatch | url = http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/862/sanctura-trospium-chloride | title = Sanctura (trospium chloride) | access-date = 13 May 2016 }}</ref><ref>{{cite web | work = Indevus Press Release | date = 28 May 2004 | url = https://www.sec.gov/Archives/edgar/data/854222/000119312504101689/dex991.htm | title = Indevus Announces FDA Approval Of Sanctura }}</ref> The approval earned Indevus a milestone payment of $120M from Pliva, which had already paid Indevus $30 million at signing; the market for overactive bladder therapies was estimated to be worth $1.1 billion in 2004.<ref>{{cite web | vauthors = Osterweil N | work = for First Word Pharma | date = 28 May 2004 | url = http://www.firstwordpharma.com/node/217249#axzz48bRQM79j | title = FDA approves Indevus' Sanctura }}</ref> In 2005 Pliva exited the relationship, selling its rights to Esprit Pharma,<ref>{{cite web | work = Urology Times | date = 21 July 2005 | url = http://urologytimes.modernmedicine.com/urology-times/news/clinical/urology/novartis-pg-enter-agreement-oab-drug | title = Novartis, P&G enter agreement for OAB drug }}</ref> and in September 2007 ] acquired Esprit, and negotiated a new agreement with Indevus under which Allergan would completely take over the US manufacturing, regulatory approvals, and marketing.<ref name=AllerganDeal>{{cite web | work = Indevus Press Release | date = 19 September 2007 | url = https://www.sec.gov/Archives/edgar/data/854222/000119312507205446/dex991.htm | title = Indevus Announces Allergan as New Partner for Sanctura Brand }}</ref> A month before, Indevus had received FDA approval for an extended release formulation that allowed once a day dosing, Sanctura XR.<ref>{{cite web | work = The Pharma Letter | date = 13 August 2007 | url = http://www.thepharmaletter.com/article/indevus-sanctura-xr-approved-by-us-fda | title = Indevus' Sanctura XR approved by US FDA }}</ref> Indevus had developed intellectual property around the extended release formulation which it licensed to Madaus for most of the world.<ref name=AllerganDeal/> |
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In 2012 the FDA approved the first generic version of the extended release formulation, granting approval to the ANDA that ] had filed in 2009.<ref>{{cite web | work = U.S. Food and Drug Administration | url = http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091289Orig1s000ltr.pdf | title = ANDA 091289 approval letter | date = 12 October 2012 }}</ref> Annual sales in the US at that time were $67M.<ref>{{cite web | work = Watson Press Release | date = 12 October 2012 | url = http://www.prnewswire.com/news-releases/watsons-generic-sanctura-xr--receives-fda-approval-173939421.html | title = Watson's Generic Sanctura XR Receives FDA Approval }}</ref> European patents had expired in 2009.<ref name=lexology/> |
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As of 2016, the drug is available worldwide under many brand names and formulations, including oral, extended release, suppositories, and injections.<ref name=brands>{{cite web | url = https://www.drugs.com/international/trospium-chloride.html | work = Drugs.com | title = International brands of trospium | access-date = 13 May 2016 }}</ref> |
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==Society and culture== |
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Marketing rights to the drug became subject to ] litigation in Europe in the case of Speciality European Pharma Ltd v Doncaster Pharmaceuticals Group Ltd / Madaus GmbH (Case No. A3/2014/0205) which was resolved in March 2015. Madaus had exclusively licensed the right to use the Regurin trademark to Speciality European Pharma Ltd. In 2009, when European patents expired on the drug, Doncaster Pharmaceuticals Group, a well known parallel importer, which had been selling the drug in the UK under another label, Ceris, which was used in France, began to put stickers on their packaging with the Regurin name. Speciality and Madaus sued and initially won based on the argument that 90% of prescriptions were already generic, but Doncaster appealed and won the appeal based on the argument that it could not charge a premium with a generic label. The case has broad implications for trade in the EU.<ref name=lexology>{{cite web | work = Lexology | date = 6 March 2015 | url = http://www.lexology.com/library/detail.aspx?g=495a7b9a-baad-4e88-9acc-65863c86064e | title = Court takes a permissive approach to parallel importers within the EU }}</ref><ref>R.P.C. (2015) 132 (7): 521-540. |
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doi: 10.1093/rpc/rcv039</ref> |
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==Research== |
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In 2007 Indevus partnered with Alkermes to develop and test an inhaled form of trospium chloride as a treatment for ]; it was in Phase II trials at that time.<ref>{{cite web | work = UPI | date = 25 April 2007 | url = http://www.upi.com/Health_News/2007/04/25/Alkermes-Indevus-testing-COPD-drug/62691177536273/ | title = Alkermes, Indevus testing COPD drug }}</ref> |
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== References == |
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{{Reflist}} |
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== External links == |
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* {{MeSH name|Trospium chloride}} |
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{{Urologicals}} |
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{{Muscarinic acetylcholine receptor modulators}} |
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{{Portal bar | Medicine}} |
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{{Authority control}} |
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