Irbesartan Explained

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

Common side effects include dizziness, diarrhea, feeling tired, muscle pain, and heartburn. Serious side effects may include kidney problems, low blood pressure, and angioedema. Use in pregnancy may harm the baby and use when breastfeeding is not recommended.[2] It is an angiotensin II receptor antagonist and works by blocking the effects of angiotensin II.[3]

Irbesartan was patented in 1990, and approved for medical use in 1997.[4] It is available as a generic medication.[5] In 2021, it was the 172nd most commonly prescribed medication in the United States, with more than 3million prescriptions.[6] [7]

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,[8] hypertension and microalbuminuria (>30 mg/24 h) or proteinuria (>900 mg/24 h).[9]

Combination with diuretic

Irbesartan is also available in a fixed-dose combination formulation with hydrochlorothiazide, a thiazide diuretic, to achieve an additive antihypertensive effect.[10] [11] [12] [13]

Society and culture

Brand names

It 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.

Recalls

In 2018, the US Food and Drug Administration reported that some versions of the angiotensin II receptor blocker medicines (including valsartan, losartan, irbesartan and other "-sartan" drugs) contain nitrosamine impurities.[14] Health Canada also reported nitrosamine impurities.[15]

Notes and References

  1. Web site: Avalide- irbesartan and hydrochlorothiazide tablet, film coated . DailyMed . 31 July 2018 . 19 March 2020 . 15 February 2018 . https://web.archive.org/web/20180215070748/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e . live .
  2. Web site: Irbesartan Pregnancy and Breastfeeding Warnings . Drugs.com . 3 March 2019 . 2 May 2019 . https://web.archive.org/web/20190502051508/https://www.drugs.com/pregnancy/irbesartan.html . live .
  3. Web site: Irbesartan Monograph for Professionals . Drugs.com . American Society of Health-System Pharmacists . 3 March 2019 . 30 November 2019 . https://web.archive.org/web/20191130140820/https://www.drugs.com/monograph/irbesartan.html . live .
  4. Book: Fischer J, Ganellin CR . Analogue-based Drug Discovery . 2006 . John Wiley & Sons . 9783527607495 . 470 .
  5. Book: British national formulary : BNF 76. 2018. Pharmaceutical Press. 9780857113382. 175. 76.
  6. Web site: The Top 300 of 2021 . ClinCalc . 14 January 2024 . 15 January 2024 . https://web.archive.org/web/20240115223848/https://clincalc.com/DrugStats/Top300Drugs.aspx . live .
  7. Web site: Irbesartan - Drug Usage Statistics . ClinCalc . 14 January 2024 . 11 April 2020 . https://web.archive.org/web/20200411195705/https://clincalc.com/DrugStats/Drugs/Irbesartan . live .
  8. Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, Ritz E, Atkins RC, Rohde R, Raz I . 6 . 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 . 11565517 . 10.1056/NEJMoa011303 . free . free . 2445/122787 .
  9. Book: Rossi S . . 2006 . Adelaide . Australian Medicines Handbook . 0-9757919-2-3.
  10. Web site: Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017 . Therapeutic Goods Administration (TGA) . 21 June 2022 . 30 March 2024 . 6 July 2023 . https://web.archive.org/web/20230706023149/https://www.tga.gov.au/resources/publication/publications/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines-2017 . live .
  11. Web site: Irbesartan and Hydrochlorothiazide (Professional Patient Advice) . Drugs.com . 5 June 2019 . 19 March 2020 . 20 March 2020 . https://web.archive.org/web/20200320030227/https://www.drugs.com/ppa/irbesartan-and-hydrochlorothiazide.html . live .
  12. Web site: European Medicines Agency . CoAprovel EPAR . 15 October 1998 . 13 June 2024 . 13 June 2024 . https://web.archive.org/web/20240613031725/https://www.ema.europa.eu/en/medicines/human/EPAR/coaprovel . live .
  13. Web site: Irbesartan and hydrochlorothiazide Advanced Patient Information . Drugs.com . 24 December 2019 . 19 March 2020 . 20 March 2020 . https://web.archive.org/web/20200320030225/https://www.drugs.com/cons/irbesartan-and-hydrochlorothiazide.html . live .
  14. Web site: 10 May 2021 . Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan . U.S. Food and Drug Administration (FDA) . 30 January 2023 . 13 October 2023 . https://web.archive.org/web/20231013055149/https://www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and-irbesartan . live .
  15. Web site: Nitrosamine impurities in medications: Guidance . . 4 April 2022 . 24 April 2023 . 1 June 2024 . https://web.archive.org/web/20240601045159/https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/medications-guidance.html . live .

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