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Edarbi

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Edarbi

Edarbi
(azilsartan medoxomil)

Edarbi

WARNING

FETAL TOXICITY

  • When pregnancy is detected, discontinue Edarbi as soon as possible [see WARNINGS AND PRECAUTIONS ].
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

Edarbi (azilsartan medoxomil), a prodrug, is hydrolyzed to azilsartan in the gastrointestinal tract during absorption. Azilsartan is a selective AT1 subtype angiotensin II receptor antagonist.

The drug substance used in the drug product formulation is the potassium salt of azilsartan medoxomil, also known by the US accepted name of azilsartan kamedoxomil and is chemically described as (5Methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4yl]methyl}-1H-benzimidazole-7-carboxylate monopotassium salt.

Its empirical formula is C30H23KN4O8 and its structural formula is:

Edarbi (azilsartan medoxomil) Structural Formula Illustration

Azilsartan kamedoxomil is a white to nearly white powder with a molecular weight of 606.62. It is practically insoluble in water and freely soluble in methanol.

Edarbi is available for oral use as tablets. The tablets have a characteristic odor. Each Edarbi tablet contains 42.68 or 85.36 mg of azilsartan kamedoxomil, which is equivalent to containing 40 mg or 80 mg respectively, of azilsartan medoxomil and the following inactive ingredients: mannitol, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.

What are the possible side effects of azilsartan (Edarbi)?

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.

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, vomiting; or
  • swelling, weight gain, feeling short of breath.

Less serious side effects may include:

  • diarrhea, mild nausea;
  • cough;
  • muscle...

Read All Potential Side Effects and See Pictures of Edarbi »

What are the precautions when taking azilsartan medoxomil (Edarbi)?

Before taking azilsartan, tell your doctor or pharmacist if you are allergic to it; 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: severe loss of body water and minerals (volume depletion, dehydration).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or...

Read All Potential Precautions of Edarbi »

Last reviewed on RxList: 10/16/2012
This monograph has been modified to include the generic and brand name in many instances.

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Edarbi - User Reviews

Edarbi User Reviews

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Here is a collection of user reviews for the medication Edarbi sorted by most helpful. Patient Discussions FAQs

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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