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Revision as of 10:42, 12 November 2010 editBeetstra (talk | contribs)Edit filter managers, Administrators172,044 edits Script assisted update of identifiers from ChemSpider, CommonChemistry and FDA for the Chem/Drugbox validation project - Updated: StdInChI StdInChIKey.  Latest revision as of 21:45, 26 August 2024 edit Whywhenwhohow (talk | contribs)Autopatrolled, Extended confirmed users, Pending changes reviewers49,206 edits update infobox, refs 
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{{Short description|Antihypertensive medication}}
{{Drugbox
{{Use dmy dates|date=September 2021}}
⚫ | type = combo
{{cs1 config |name-list-style=vanc |display-authors=6}}
⚫ | image = Amlodipine.png
{{Infobox drug
| image2 = Lipitor.png
| verifiedrevid = 396294114
⚫ | component1 = Amlodipine
⚫ | type = combo
⚫ | class1 = ]
⚫ | image = Amlodipine.svg
⚫ | component2 = Atorvastatin
| width =
| class2 = ]
| alt =
⚫ | ChemSpiderID = 7987512
| image2 = Valsartan skeletal.svg
| InChI = 1/C33H35FN2O5.C20H25ClN2O5/c1-21(2)31-30(33(41)35-25-11-7-4-8-12-25)29(22-9-5-3-6-10-22)32(23-13-15-24(34)16-14-23)36(31)18-17-26(37)19-27(38)20-28(39)40;1-4-28-20(25)18-15(11-27-10-9-22)23-12(2)16(19(24)26-3)17(18)13-7-5-6-8-14(13)21/h3-16,21,26-27,37-38H,17-20H2,1-2H3,(H,35,41)(H,39,40);5-8,17,23H,4,9-11,22H2,1-3H3/t26-,27-;/m1./s1
| width2 =
| smiles = Clc1ccccc1C2C(\C(=O)OC)=C(/N\C(=C2\C(=O)OCC)COCCN)C.O=C(O)C(O)C(O)CCn2c(c(c(c2c1ccc(F)cc1)c3ccccc3)C(=O)Nc4ccccc4)C(C)C
| alt2 =
| InChIKey = PEAJXAZCGDWDGS-CNZCJKERBU

| StdInChI = 1S/C33H35FN2O5.C20H25ClN2O5/c1-21(2)31-30(33(41)35-25-11-7-4-8-12-25)29(22-9-5-3-6-10-22)32(23-13-15-24(34)16-14-23)36(31)18-17-26(37)19-27(38)20-28(39)40;1-4-28-20(25)18-15(11-27-10-9-22)23-12(2)16(19(24)26-3)17(18)13-7-5-6-8-14(13)21/h3-16,21,26-27,37-38H,17-20H2,1-2H3,(H,35,41)(H,39,40);5-8,17,23H,4,9-11,22H2,1-3H3/t26-,27-;/m1./s1
<!-- Combo data -->
| StdInChIKey = PEAJXAZCGDWDGS-CNZCJKERSA-N
⚫ | component1 = Amlodipine
⚫ | CAS_number =
⚫ | class1 = ]
⚫ | ATC_prefix = C10
⚫ | component2 = Valsartan
⚫ | ATC_suffix = BX03
| class2 = ]
⚫ | PubChem = 9811759

⚫ | DrugBank =
<!-- Clinical data -->
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| tradename = Exforge, Copalia, Dafiro
| pregnancy_US = X
| Drugs.com = {{drugs.com|ppa|amlodipine-and-valsartan}}
⚫ | pregnancy_category=
⚫ | MedlinePlus =
⚫ | legal_AU = <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 -->
| DailyMedID = Amlodipine and valsartan
⚫ | legal_CA = <!-- / Schedule I, II, III, IV, V, VI, VII, VIII -->
| pregnancy_AU = D
⚫ | legal_UK = <!-- GSL / P / POM / CD / Class A, B, C -->
| pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{cite web | title=Amlodipine / valsartan (Exforge) Use During Pregnancy | website=Drugs.com | date=11 July 2019 | url=https://www.drugs.com/pregnancy/amlodipine-valsartan.html | access-date=13 February 2020}}</ref>
⚫ | legal_US = Rx-only
⚫ | pregnancy_category =
⚫ | legal_status =
| routes_of_administration = Oral | routes_of_administration = ]
⚫ | ATC_prefix = C09
⚫ | ATC_suffix = DB01

<!-- Legal status -->
⚫ | legal_AU = <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 -->
⚫ | legal_CA = <!-- / Schedule I, II, III, IV, V, VI, VII, VIII -->
⚫ | legal_UK = <!-- GSL / P / POM / CD / Class A, B, C -->
⚫ | legal_US = Rx-only
| legal_US_comment = <ref name="Exforge FDA label">{{cite web | title=Exforge- amlodipine besylate and valsartan tablet, film coated | website=DailyMed | date=12 June 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7 | access-date=12 February 2020}}</ref>
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Exforge EPAR">{{cite web | title=Exforge EPAR | website=European Medicines Agency (EMA) | date=17 January 2007 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/exforge | access-date=26 August 2024}}</ref><ref name="Copalia EPAR">{{cite web | title=Copalia EPAR | website=] (EMA) | date=16 January 2007 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/copalia | access-date=26 August 2024}}</ref><ref name="Dafiro EPAR">{{cite web | title=Dafiro EPAR | website=European Medicines Agency (EMA) | date=16 January 2007 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/dafiro | access-date=26 August 2024}}</ref>
⚫ | legal_status =

<!-- Identifiers -->
| index2_label = with HCTZ
| CAS_number =1190398-97-0
⚫ | PubChem = 11354874
⚫ | DrugBank =
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
⚫ | ChemSpiderID = 13092186
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D09745
| KEGG2_Ref = {{keggcite|correct|kegg}}
| KEGG2 = D10286

<!-- Chemical and physical data -->
}} }}
The drug combination '''atorvastatin/amlodipine''' (trade names '''Caduet''' in the ] and '''Envacar''' elsewhere) is a medication approved by the ] (FDA) for the treatment of ] and ]. It is a ] drug containing the ] ] and the ] ]. It is being marketed by the ] ].<ref>{{cite web|url=http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm202933.htm|format=PDF|title=CADUET (amlodipine besylate/atorvastatin calcium) Tablets|month=February | year=2010|work=NDA 21-540/S-009|publisher=]|accessdate=2010-09-25}}</ref>


'''Amlodipine/valsartan''', sold under the brand name '''Exforge''' among others, is a ] ]. It contains ], as the besilate, a ]-type ], and ], an ].<ref name=AHFS2019>{{cite web |title=Valsartan Monograph for Professionals |url=https://www.drugs.com/monograph/valsartan.html |website=Drugs.com |publisher=American Society of Health-System Pharmacists |access-date=3 March 2019}}</ref> This combination is usually well tolerated and effective for the reduction of blood pressure.<ref name="EckertFreytag2013">{{cite journal | vauthors = Eckert S, Freytag SB, Müller A, Klebs SH | title = Meta-analysis of three observational studies of amlodipine/valsartan in hypertensive patients with additional risk factors | journal = Blood Pressure | volume = 22 | issue = sup1 | pages = 11–21 | date = September 2013 | pmid = 23713686 | doi = 10.3109/08037051.2013.793891 | s2cid = 25814898 }}</ref>

The combination was approved for medical use in the European Union in January 2007,<ref name="Exforge EPAR" /> and in the United States in June 2007.<ref>{{cite web | title=Drug Approval Package: Exforge (amlodipine and valsartan) NDA #021990 | publisher=U.S. ] (FDA) | date=3 October 2008 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021990_exforge_toc.cfm | access-date=19 September 2021}}</ref>

The combination is also available with ].<ref>{{cite web | title=Exforge HCT- amlodipine valsartan and hydrochlorothiazide tablet, film coated | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de | access-date=12 February 2020}}</ref><ref>{{cite web | url=https://www.drugs.com/ppa/amlodipine-valsartan-and-hydrochlorothiazide.html | title=Amlodipine, Valsartan, and Hydrochlorothiazide | publisher=Drugs.com }}</ref> It was approved for medical use in the United States in April 2009,<ref>{{cite web | title=Drug Approval Package: Exforge HCT (Amlodipine, Valsartan, Hydrochlorothiazide) Tablets NDA #022314 | publisher=U.S. ] (FDA) | date=2 September 2009 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022314s000TOC.cfm | access-date=19 September 2021 }}</ref> and in the European Union in November 2009.<ref name="Exforge HCT EPAR">{{cite web | title=Exforge HCT EPAR | website=European Medicines Agency (EMA) | date=16 October 2009 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/exforge-hct | access-date=26 August 2024}}</ref><ref name="Copalia HCT EPAR">{{cite web | title=Copalia HCT EPAR | website=] (EMA) | date=4 November 2009 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/copalia-hct | access-date=26 August 2024}}</ref><ref name="Dafiro HCT EPAR">{{cite web | title=Dafiro HCT EPAR | website=European Medicines Agency (EMA) | date=4 November 2009 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/dafiro-hct | access-date=26 August 2024}}</ref>
== References == == References ==
{{reflist}} {{reflist}}


{{Angiotensin II receptor antagonists}}
== External links ==
{{Angiotensin receptor modulators}}
* (caduet.com)
{{Portal bar | Medicine}}
{{Authority control}}


{{DEFAULTSORT:Amlodipine Valsartan}}
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{{cardiovascular-drug-stub}} {{antihypertensive-stub}}