Chemistry:Irbesartan

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Irbesartan, sold under the brand name Aprovel among others, is a medication used to treat hypertension (high blood pressure), heart failure, and diabetic kidney disease.[1] It is a reasonable initial treatment for high blood pressure.[1] It is taken by mouth.[1] Versions are available as the combination irbesartan/hydrochlorothiazide.[1][2][3][4]

Medical uses

Irbesartan is used for the treatment of hypertension. It may also delay progression of diabetic nephropathy and is also indicated for the reduction of renal disease progression in patients with type 2 diabetes,[5] hypertension and microalbuminuria (>30 mg/24 h) or proteinuria (>900 mg/24 h).[6]

Combination with diuretic

Irbesartan is also available in a fixed-dose combination formulation with hydrochlorothiazide, a thiazide diuretic, to achieve an additive antihypertensive effect.[7][8][3][9]

Side effects

Common side effects include dizziness, diarrhea, feeling tired, muscle pain, and heartburn.[1][10] Serious side effects may include kidney problems, low blood pressure, and angioedema.[1] Use in pregnancy may harm the baby and use when breastfeeding is not recommended.[11]

Mechanism of action

Irbesartan is an angiotensin II receptor antagonist and works by blocking the effects of angiotensin II.[1]

History

Irbesartan was developed by Sanofi Research (part of Sanofi-Aventis). It is jointly marketed by Sanofi-Aventis and Bristol-Myers Squibb under the brand names Aprovel, Karvea, and Avapro.[12][11]

It was patented in 1990, and approved for medical use in 1997.[13] It is available as a generic medication.[10] In 2023, it was the 134th most commonly prescribed medication in the United States, with more than 4 million prescriptions.[14][15]

Society and culture

Recalls

In 2018, the US Food and Drug Administration (FDA) reported that some versions of the angiotensin II receptor blocker medicines (including valsartan, losartan, irbesartan and other "-sartan" drugs) contain nitrosamine impurities.[16] Health Canada also reported nitrosamine impurities.[17]

The FDA issued revised guidelines about nitrosamine impurities in September 2024.[18]

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 "Irbesartan Monograph for Professionals". American Society of Health-System Pharmacists. https://www.drugs.com/monograph/irbesartan.html. 
  2. ↑ "Avalide- irbesartan and hydrochlorothiazide tablet, film coated". 31 July 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e. 
  3. ↑ 3.0 3.1 "CoAprovel EPAR". 15 October 1998. https://www.ema.europa.eu/en/medicines/human/EPAR/coaprovel. 
  4. ↑ "Karvezide EPAR". 16 October 1998. https://www.ema.europa.eu/en/medicines/human/EPAR/karvezide. 
  5. ↑ "Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes". The New England Journal of Medicine 345 (12): 851–860. September 2001. doi:10.1056/NEJMoa011303. PMID 11565517. 
  6. ↑ Australian Medicines Handbook. Adelaide: Australian Medicines Handbook. 2006. ISBN 0-9757919-2-3. 
  7. ↑ "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". 21 June 2022. https://www.tga.gov.au/resources/publication/publications/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines-2017. 
  8. ↑ "Irbesartan and Hydrochlorothiazide (Professional Patient Advice)". 5 June 2019. https://www.drugs.com/ppa/irbesartan-and-hydrochlorothiazide.html. 
  9. ↑ "Irbesartan and hydrochlorothiazide Advanced Patient Information". 24 December 2019. https://www.drugs.com/cons/irbesartan-and-hydrochlorothiazide.html. 
  10. ↑ 10.0 10.1 British national formulary : BNF 76 (76 ed.). Pharmaceutical Press. 2018. pp. 175. ISBN 9780857113382. 
  11. ↑ 11.0 11.1 Cite error: Invalid <ref> tag; no text was provided for refs named Drugs.com pregnancy
  12. ↑ Cite error: Invalid <ref> tag; no text was provided for refs named Avapro FDA label
  13. ↑ Analogue-based Drug Discovery. John Wiley & Sons. 2006. p. 470. ISBN 9783527607495. https://books.google.com/books?id=FjKfqkaKkAAC&pg=PA470. 
  14. ↑ "Top 300 of 2023". https://clincalc.com/DrugStats/Top300Drugs.aspx. 
  15. ↑ "Irbesartan Drug Usage Statistics, United States, 2013 - 2023". https://clincalc.com/DrugStats/Drugs/Irbesartan. 
  16. ↑ "Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan". U.S. Food and Drug Administration (FDA). 10 May 2021. https://www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and-irbesartan. 
  17. ↑ "Nitrosamine impurities in medications: Guidance". 4 April 2022. https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/medications-guidance.html. 
  18. ↑ "Control of Nitrosamine Impurities in Human Drugs". 24 February 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/control-nitrosamine-impurities-human-drugs. 



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