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Tekturna HCT

Drug Description
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Tekturna HCT®
(aliskiren and hydrochlorothiazide) Tablets

WARNING: AVOID USE IN PREGNANCY

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

DRUG DESCRIPTION

Tekturna HCT is a fixed combination of aliskiren, an orally active, nonpeptide, potent direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic.

Aliskiren

Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-Carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is

Tekturna HCT® (aliskiren and hydrochlorothiazide)  Structural Formula Illustration

Molecular formula: C30H53N3O6•0.5 C4H4O4

Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-Octanol, and highly soluble in water.

Hydrochlorothiazide

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

Tekturna HCT® (aliskiren and hydrochlorothiazide)  Structural Formula Illustration

Tekturna HCT tablets are formulated for oral administration to contain aliskiren and hydrochlorothiazide, USP 150/12.5 mg, 150/25 mg, 300/12.5 mg and 300/25 mg.The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide colorants, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide, and wheat starch.

Brand Name: Tekturna HCT
Generic Name: Aliskren and Hydrochlorothiazide Tablets

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