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Azor

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Azor

AZOR
(amlodipine and olmesartan medoxomil) Tablets

Azor

WARNING

FETAL TOXICITY

  • When pregnancy is detected, discontinue Azor as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

DRUG DESCRIPTION

Azor provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil.

The amlodipine besylate component of Azor is chemically described as 3-ethyl-5methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5•C6H6O3S.

Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.

The olmesartan medoxomil component of Azor is chemically described as 2,3dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6.

The structural formula for amlodipine besylate is:

Amlodipine Besylate - Structural Formula Illustration

The structural formula for olmesartan medoxomil is:

Olmesartan medoxomil - Structural Formula Illustration

Azor contains amlodipine besylate, a white to off-white crystalline powder, and olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol.

Each tablet of Azor also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg tablets).

What are the possible side effects of amlodipine and olmesartan (Azor)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, amlodipine and olmesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have any other serious side effects, such as:

  • feeling like you...

Read All Potential Side Effects and See Pictures of Azor »

What are the precautions when taking amlodipine and olmesartan medoxomil tablets (Azor)?

Before taking this product, tell your doctor or pharmacist if you are allergic to either amlodipine or olmesartan; or to other calcium channel blockers (e.g., nifedipine); or to other angiotensin receptor blockers (e.g., losartan); or to ACE inhibitors (e.g., lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (e.g., renal artery stenosis), liver disease, heart/blood vessel disease (e.g., heart attack, heart failure, aortic stenosis), high levels of potassium in the blood (hyperkalemia), severe loss of body water and minerals such...

Read All Potential Precautions of Azor »

Last reviewed on RxList: 6/27/2014
This monograph has been modified to include the generic and brand name in many instances.

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Azor - User Reviews

Azor User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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