February 22, 2017
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Candesartan Cilexetil Hydrochlorothiazide Tablets

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS

WARNING

FETAL TOXICITY

  • When pregnancy is detected, discontinue candesartan cilexetil and hydrochlorothiazide tablets as soon as possible.
  • Drugs that act directly on the renin-angiotens in system can cause injury and death to the developing fetus. See WARNINGS : Fetal Toxicity

DRUG DESCRIPTION

Candesartan cilexetil and hydrochlorothiazide tablets, USP combines an angiotensin II receptor (type AT ) antagonist and a diuretic, hydrochlorothiazide.

Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o- 1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester).

Its empirical formula is C33H34N6O6, and its structural formula is

Candesartan cilexetil - Structural Formula Illustration

Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is

Hydrochlorothiazide - Structural Formula Illustration

Hydrochlorothiazide is a white, or practically white, odourless, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

Candesartan cilexetil and hydrochlorothiazide tablets, USP are available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide.

Candesartan cilexetil and hydrochlorothiazide tablets, USP, 16 mg/12.5 mg contain 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

Candesartan cilexetil and hydrochlorothiazide tablets, USP, 32 mg/12.5 mg contain 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

Candesartan cilexetil and hydrochlorothiazide tablets, USP, 32 mg/25 mg contain 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide. The inactive ingredients of the tablets are carboxymethyl cellulose calcium, corn starch, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and triacetin. Ferric oxide red is added only to the 16/12.5 mg and 32/25 mg tablets as colorant.

Last reviewed on RxList: 1/12/2017
This monograph has been modified to include the generic and brand name in many instances.

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