Diovan HCT
Diovan HCT®
(valsartan and hydrochlorothiazide, USP) 80 mg/12.5 mg, 160 mg/12.5 mg, 160
mg/25 mg, 320 mg/12.5 mg, 320 mg/25 mg Combination Tablets
USE IN PREGNANCY
When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus<. When pregnancy is detected, Diovan HCT should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.
DRUG DESCRIPTION
Diovan HCT® (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.
Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N- [[2´-(1H-tetrazol-5-yl)[1,1´-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is
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Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water.
Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4- benzothiadiazine-7- sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is
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Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.
Generic Name: Valsartan and Hydrochlorothiazide
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