Olmesartan/amlodipine

Olmesartan/amlodipine
Combination of
Olmesartan Angiotensin II antagonist
Amlodipine Calcium channel blocker
Clinical data
Trade names Azor
AHFS/Drugs.com entry
  • US: D (Evidence of risk)
Oral
Identifiers
C09DB02

The combination drug olmesartan/amlodipine (trade name Azor in the US) is an oral antihypertensive medication which combines two antihypertensive agents in a film-coated tablet. It contains amlodipine, a calcium channel blocker, and olmesartan medoxomil (trade name: Benicar), an angiotensin-2 receptor antagonist (ARB or A2A). The patent is held by Daiichi Sankyo Pharmaceuticals. Daiichi Sankyo filed a supplemental New Drug Application (sNDA) for Azor with the United States Food and Drug Administration on September 17, 2008.[1] Azor has been studied in clinical trials; one test showed it reduced blood pressure during a 24-hour period and was well tolerated.[2] Azor is available in different dose preparations: 5 mg/20 mg, 10 mg/20 mg,5 mg/40 mg and 10/40 mg's of amlodipine and olmesartan respectively.[3] One investigation (which included doctors employed by Daiichi Sankyo) concluded that "From a pharmacokinetic perspective, the 2 drugs (amlodipine and olmesartan) are well suited to coadministration in a fixed-dose combination."[4]

References

  1. PR Newswire (Sep 17, 2008). "Daiichi Sankyo, Inc. Files Supplemental New Drug Application for AZOR(R) as Initial...". Reuters. Retrieved 2009-10-06.
  2. Joel M Neutel, MD and Henry Punzi, MD (June 2009 34(6)). "The AZTEC Trial: Amlodipine Besylate/Olmesartan Medoxomil (Azor)". P T (Pharmacy & Therapeutics) 34 (6): 318–21. PMC 2697919. PMID 19572050. Check date values in: |date= (help)
  3. Daiichi Sankyo, Inc (2009-10-06). "Information about Azor from the manufacturer". Daiichi Sankyo, Inc. Archived from the original on 29 September 2009. Retrieved 2009-10-06.
  4. Shashank Rohatagi, PhD, James Lee, PhD, Magdy Shenouda, MD, Stephen Haworth, MD, Mohinder Singh Bathala, PhD, Mark Allison, MD, Igor Rubets, PhD, Reinilde Heyrman, MD, Robert Noveck, MD and Daniel E. Salazar, PhD, FCP (2009-10-06). "PHARMACOKINETICS -- Pharmacokinetics of Amlodipine and Olmesartan After Administration of Amlodipine Besylate and Olmesartan Medoxomil in Separate Dosage Forms and as a Fixed-Dose Combination". The Journal of Clinical Pharmacology. Retrieved 2009-10-06.