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Prinzide

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PRINZIDE®
(lisinopril-hydrochlorothiazide) Tablets

USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, PRINZIDE should be discontinued as soon as possible. See WARNINGS, Pregnancy, Lisinopril, Fetal/Neonatal Morbidity and Mortality.

DRUG DESCRIPTION

PRINZIDE* (Lisinopril-Hydrochlorothiazide) combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide.

Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5· 2H2O and its structural formula is:

Prinzide (Lisinopril-Hydrochlorothiazide)

Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol.

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:

Prinzide (Lisinopril-Hydrochlorothiazide)

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

PRINZIDE is available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: PRINZIDE 10-12.5, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide, PRINZIDE 20-12.5, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide and PRINZIDE 20-25, containing 20 mg lisinopril and 25 mg hydrochlorothiazide.

Inactive ingredients are calcium phosphate, magnesium stearate, mannitol, and starch. PRINZIDE 10-12.5 also contains FD&C Blue #2 aluminum lake. PRINZIDE 20-12.5 and PRINZIDE 20-25 also contain iron oxide.

* Registered trademark of MERCK & CO., Inc. COPYRIGHT © 1989, 1992, 2005 MERCK & CO., Inc. All rights reserved

Brand Name: Prinzide
Generic Name: Lisinopril-Hydrochlorothiazide

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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