|
Lotensin HCT
T2006-84
Lotensin HCT ®
benazepril hydrochloride and hydrochlorothiazide USP
Combination Tablets
5 mg/6.25 mg 10 mg/12.5 mg 20 mg/12.5 mg 20 mg/25 mg
Rx only
Prescribing Information
DESCRIPTION
Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H -1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is
Its empirical formula is C24H28N2O5·HCl, and its molecular weight is 460.96.
Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group.
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’s chemical name is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is
Its empirical formula is C7 H8 ClN3 O4 S2, and its molecular weight is 297.73. Hydrochloro-thiazide is a thiazide diuretic.
Lotensin HCT is a combination of benazepril hydrochloride and hydrochlorothiazide USP. The tablets are formulated for oral administration with a combination of 5, 10, or 20 mg of benazepril hydrochloride and 6.25, 12.5, or 25 mg of hydrochlorothiazide USP. The inactive ingredients of the tablets are cellulose compounds, crospovidone, hydrogenated castor oil, iron oxides (10/12.5-mg, 20/12.5-mg, and 20/25-mg tablets), lactose, polyethylene glycol, talc, and titanium dioxide.
|