Aliskiren/amlodipine/hydrochlorothiazide: Difference between revisions
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{{Short description|Pharmaceutical drug}} |
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{{Drugbox |
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{{Use dmy dates|date=November 2019}} |
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{{Infobox drug |
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| type = combo |
| type = combo |
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| component1 = Aliskiren |
| component1 = Aliskiren |
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| class1 = [[Renin inhibitor]] |
| class1 = [[Renin inhibitor]] |
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| class3 = [[Diuretic]] |
| class3 = [[Diuretic]] |
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<!--Clinical data--> |
<!-- Clinical data --> |
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| tradename = |
| tradename = Amturnide |
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| Drugs.com = {{drugs.com| |
| Drugs.com = {{drugs.com|cons|aliskiren-amlodipine-and-hydrochlorothiazide}} |
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| MedlinePlus = |
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| licence_EU = <!-- EMEA requires brand name --> |
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| DailyMedID = Amturnide |
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| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
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| pregnancy_AU_comment = |
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| pregnancy_US = D |
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| pregnancy_category= |
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| ATC_prefix = C09 |
| ATC_prefix = C09 |
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| ATC_suffix = XA54 |
| ATC_suffix = XA54 |
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| ATC_supplemental = |
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<!-- |
<!-- Legal status --> |
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| legal_AU_comment = |
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| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F --> |
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| legal_BR_comment = |
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| legal_CA_comment = |
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| legal_DE = <!-- Anlage I, II, III or Unscheduled --> |
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| legal_DE_comment = |
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| legal_NZ_comment = |
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| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C --> |
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| legal_UK_comment = |
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| legal_US_comment = <ref name="Amturnide FDA label">{{cite web | title=Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 2010 | website=DailyMed | date=10 November 2016 | url=https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=237747 | access-date=6 February 2022}}</ref> |
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| legal_EU = |
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| legal_EU_comment = |
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| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV --> |
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| legal_UN_comment = |
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| legal_status = <!-- For countries not listed above --> |
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| CAS_number = |
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| CAS_supplemental = |
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| PubChem = 56841821 |
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| IUPHAR_ligand = |
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| DrugBank = |
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| ChemSpiderID = |
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| UNII = |
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| KEGG = D10291 |
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| ChEBI = |
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| ChEMBL = |
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| NIAID_ChemDB = |
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| PDB_ligand = |
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| synonyms = |
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<!-- Chemical and physical data --> |
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| IUPAC_name = |
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| C=57 | H=86 | Cl=2 | N=8 | O=15 | S=2 |
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| SMILES = CCOC(=O)C1=C(NC(=C(C1C2=CC=CC=C2Cl)C(=O)OC)C)COCCN.CC(C)C(CC1=CC(=C(C=C1)OC)OCCCOC)CC(C(CC(C(C)C)C(=O)NCC(C)(C)C(=O)N)O)N.C1NC2=CC(=C(C=C2S(=O)(=O)N1)S(=O)(=O)N)Cl |
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| StdInChI = 1S/C30H53N3O6.C20H25ClN2O5.C7H8ClN3O4S2/c1-19(2)22(14-21-10-11-26(38-8)27(15-21)39-13-9-12-37-7)16-24(31)25(34)17-23(20(3)4)28(35)33-18-30(5,6)29(32)36;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;8-4-1-5-7(2-6(4)16(9,12)13)17(14,15)11-3-10-5/h10-11,15,19-20,22-25,34H,9,12-14,16-18,31H2,1-8H3,(H2,32,36)(H,33,35);5-8,17,23H,4,9-11,22H2,1-3H3;1-2,10-11H,3H2,(H2,9,12,13)/t22-,23+,24-,25-;;/m0../s1 |
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| StdInChI_comment = |
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| StdInChIKey = YJDDFLDXUPNQTO-WMEHTASQSA-N |
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| density = |
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| density_notes = |
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| melting_point = |
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| melting_high = |
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| melting_notes = |
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| boiling_point = |
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| boiling_notes = |
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| solubility = |
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| sol_units = |
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| specific_rotation = |
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}} |
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'''Aliskiren/amlodipine/hydrochlorothiazide''', sold under the brand name '''Amturnide''', is a [[fixed-dose combination]] medication that is used to treat high blood pressure.<ref name="Amturnide FDA label" /><ref name="Neutel_2013">{{cite journal | vauthors = Neutel JM, Smith DH | title = Hypertension management: rationale for triple therapy based on mechanisms of action | journal = Cardiovascular Therapeutics | volume = 31 | issue = 5 | pages = 251–8 | date = October 2013 | pmid = 23121769 | doi = 10.1111/1755-5922.12015 }}</ref> It contains [[aliskiren]], a [[renin inhibitor]]; [[amlodipine]], as the [[besylate]], a [[calcium channel blocker]]; and [[hydrochlorothiazide]], a [[thiazide diuretic]].<ref name="Amturnide FDA label" /> It is taken [[Oral administration|by mouth]].<ref name="Amturnide FDA label" /> |
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The [[pharmaceutical drug|drug]] combination '''[[aliskiren]]/[[amlodipine]]/[[hydrochlorothiazide]]''' ([[International Nonproprietary Name|INNs]], trade name '''Amturnide''') is an [[antihypertensive]] approved by the [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) on December 21, 2010.<ref>[http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200045s000ltr.pdf Amturnide approval letter]. [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA).</ref> |
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It was approved for medical use in the United States in December 2010.<ref name="Amturnide FDA label" /><ref>{{cite web | title=Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 2010 | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=237747 | access-date=5 July 2024}}</ref><ref>{{cite web | title=Drug Approval Package: Amturnide(amlodipine/aliskiren/hydrochlorothiazide) NDA #200045 | website=U.S. [[Food and Drug Administration]] (FDA) | date=15 August 2011 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200045s000_amturnide_toc.cfm | access-date=27 August 2020}} |
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*{{lay source |template=cite web |title=Center for Drug Evaluation and Research: Application Number: 200045Orig1s000: Summary review |url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200045Orig1s000SumR.pdf |website=Food and Drug Administration}}</ref> Amturnide was withdrawn by Novartis from the US market in 2017.<ref>{{cite web | title=Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications | website=Federal Register | date=21 June 2017 | url=https://www.federalregister.gov/documents/2017/06/21/2017-12908/wyeth-pharmaceuticals-inc-et-al-withdrawal-of-approval-of-121-new-drug-applications-and-161 | access-date=6 February 2022}}</ref> |
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== References == |
== References == |
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==External links== |
==External links== |
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* {{cite web | title=FDA Drug Safety Communication: New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna) | website=U.S. [[Food and Drug Administration]] (FDA) | date=29 June 2021 | url=https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-new-warning-and-contraindication-blood-pressure-medicines-containing }} |
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* [http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200045s000lbl.pdf Amturnide full prescribing information] |
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{{Agents acting on the renin-angiotensin system}} |
{{Agents acting on the renin-angiotensin system}} |
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{{Calcium channel blockers}} |
{{Calcium channel blockers}} |
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{{Diuretics}} |
{{Diuretics}} |
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{{Portal bar | Medicine}} |
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{{DEFAULTSORT:Aliskiren Amlodipine Hydrochlorothiazide}} |
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[[Category:Drugs developed by Novartis]] |
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[[Category:Withdrawn drugs]] |
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{{cardiovascular-drug-stub}} |
{{cardiovascular-drug-stub}} |