Olmesartan/amlodipine

Olmesartan/amlodipine
Combination of
Olmesartan Angiotensin II antagonist
Amlodipine Calcium channel blocker
Clinical data
Trade names Azor
AHFS/Drugs.com azor
Pregnancy
category
  • US: D (Evidence of risk)
Routes of
administration
Oral
ATC code C09DB02 (WHO)
Legal status
Legal status
Identifiers

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 & Henry Punzi, MD (June 2009 34(6)). "The AZTEC Trial: Amlodipine Besylate/Olmesartan Medoxomil (Azor)". P T. Pharmacy & Therapeutics. 34 (6): 318–21. PMC 2697919Freely accessible. 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, James Lee, Magdy Shenouda, MD, Stephen Haworth, MD, Mohinder Singh Bathala, Mark Allison, MD, Igor Rubets, Reinilde Heyrman, MD, Robert Noveck, MD and Daniel E. Salazar, 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.


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