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Monopril-HCT (Fosinopril Sodium / Hydrochlorothiazide) - Summary

 
 



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, MONOPRIL-HCT should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

 

MONOPRIL-HCT SUMMARY

Fosinopril is converted to fosinoprilat by hepatic cleavage of the ester group. Fosinoprilat, the active metabolite of fosinopril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Hydrochlorothiazide is a diuretic.

MONOPRIL-HCT (fosinopril sodium-hydrochlorothiazide tablets) is indicated for the treatment of hypertension.

These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION.)

In using MONOPRIL-HCT, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis).

ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).


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NEWS HIGHLIGHTS

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Page last updated: 2014-10-17

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