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EDARBYCLOR
(azilsartan medoxomil and chlorthalidone) Tablets

WARNING

FETAL TOXICITY

  • When pregnancy is detected, discontinue Edarbyclor 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

Edarbyclor is a combination of azilsartan medoxomil (ARB; as its potassium salt) and chlorthalidone (thiazide-like diuretic).

Azilsartan medoxomil, a prodrug, is hydrolyzed to azilsartan in the gastrointestinal tract during absorption. Azilsartan is a selective AT1 subtype angiotensin II receptor antagonist. Chlorthalidone is a monosulfamyl thiazide-like diuretic that differs chemically from thiazide diuretics by the lack of a benzothiadiazine structure.

The potassium salt of azilsartan medoxomil, azilsartan kamedoxomil, 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.

Chlorthalidone is chemically described as 2-chloro-5(1-hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide. Its empirical formula is C14H11ClN2O4S.

The structural formula for azilsartan medoxomil is

Azilsartan medoxomil Structural Formula Illustration

This structural formula for chlorthalidone is

chlorthalidone 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.

Chlorthalidone is a white to yellowish white powder with a molecular weight of 338.76. Chlorthalidone is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol.

Edarbyclor is available for oral use as tablets. The tablets have a characteristic odor. Each Edarbyclor tablet contains 42.68 mg of azilsartan kamedoxomil, which is equivalent to containing azilsartan medoxomil 40 mg plus 12.5 or 25 mg of chlorthalidone. Each tablet of Edarbyclor also contains the following inactive ingredients: mannitol, microcrystalline cellulose, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, crospovidone, magnesium stearate, hypromellose 2910, talc, titanium dioxide, ferric oxide red, polyethylene glycol 8000, and printing ink gray F1.

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