Amlodipine/valsartan

Amlodipine/valsartan
Combination of
AmlodipineCalcium channel blocker
ValsartanAngiotensin II receptor antagonist
Clinical data
Trade namesExforge, Copalia, Dafiro
AHFS/Drugs.comProfessional Drug Facts
License data
Pregnancy
category
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
ChemSpider
KEGG
CompTox Dashboard (EPA)
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Amlodipine/valsartan, sold under the brand name Exforge among others, is a blood pressure lowering combination drug. It contains amlodipine, as the besilate, a dihydropyridine-type calcium channel blocker, and valsartan, an angiotensin II receptor antagonist.[6] This combination is usually well tolerated and effective for the reduction of blood pressure.[7]

The combination was approved for medical use in the European Union in January 2007,[3] and in the United States in June 2007.[8]

The combination is also available with hydrochlorothiazide.[9][10] It was approved for medical use in the United States in April 2009,[11] and in the European Union in November 2009.[12][13][14]

  1. ^ "Amlodipine / valsartan (Exforge) Use During Pregnancy". Drugs.com. 11 July 2019. Retrieved 13 February 2020.
  2. ^ "Exforge- amlodipine besylate and valsartan tablet, film coated". DailyMed. 12 June 2019. Retrieved 12 February 2020.
  3. ^ a b "Exforge EPAR". European Medicines Agency (EMA). 17 January 2007. Retrieved 26 August 2024.
  4. ^ "Copalia EPAR". European Medicines Agency (EMA). 16 January 2007. Retrieved 26 August 2024.
  5. ^ "Dafiro EPAR". European Medicines Agency (EMA). 16 January 2007. Retrieved 26 August 2024.
  6. ^ "Valsartan Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Retrieved 3 March 2019.
  7. ^ Eckert S, Freytag SB, Müller A, Klebs SH (September 2013). "Meta-analysis of three observational studies of amlodipine/valsartan in hypertensive patients with additional risk factors". Blood Pressure. 22 (sup1): 11–21. doi:10.3109/08037051.2013.793891. PMID 23713686. S2CID 25814898.
  8. ^ "Drug Approval Package: Exforge (amlodipine and valsartan) NDA #021990". U.S. Food and Drug Administration (FDA). 3 October 2008. Retrieved 19 September 2021.
  9. ^ "Exforge HCT- amlodipine valsartan and hydrochlorothiazide tablet, film coated". DailyMed. Retrieved 12 February 2020.
  10. ^ "Amlodipine, Valsartan, and Hydrochlorothiazide". Drugs.com.
  11. ^ "Drug Approval Package: Exforge HCT (Amlodipine, Valsartan, Hydrochlorothiazide) Tablets NDA #022314". U.S. Food and Drug Administration (FDA). 2 September 2009. Retrieved 19 September 2021.
  12. ^ "Exforge HCT EPAR". European Medicines Agency (EMA). 16 October 2009. Retrieved 26 August 2024.
  13. ^ "Copalia HCT EPAR". European Medicines Agency (EMA). 4 November 2009. Retrieved 26 August 2024.
  14. ^ "Dafiro HCT EPAR". European Medicines Agency (EMA). 4 November 2009. Retrieved 26 August 2024.