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Monopril (Fosinopril Sodium) - 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 should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

 

MONOPRIL SUMMARY

MONOPRIL® (fosinopril sodium tablets) is the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme.

MONOPRIL (fosinopril sodium tablets) is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.

MONOPRIL is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).

In using MONOPRIL, 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 MONOPRIL does not have a similar risk (see WARNINGS).

In considering use of MONOPRIL, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, 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).


See all Monopril indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Monopril (Fosinopril)

Yoga Improves Quality of Life in Pulmonary Hypertension
Source: Medscape Critical Care Headlines [2016.04.29]
Adults with pulmonary arterial hypertension could derive some relief from yoga, results from a preliminary study suggest. The 12-week program eased anxiety and depression, among other measures.
Medscape Medical News

RA: Hypertension, High LDL Often Missed or Undertreated
Source: Medscape Rheumatology Headlines [2016.04.25]
Patients with rheumatoid arthritis are likely to need more intensive monitoring and treatment of cardiovascular risk factors, but often receive less.
Medscape Medical News

Healthy diet could lower hypertension risk for women with gestational diabetes
Source: Diabetes News From Medical News Today [2016.04.19]
Researchers have found that the long-term risk of high blood pressure that is caused by pregnancy-related diabetes could be reduced by following a healthy diet.

Pulmonary Hypertension
Source: MedicineNet Fainting Specialty [2016.03.30]
Title: Pulmonary Hypertension
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 3/30/2016 12:00:00 AM

High Blood Pressure (Hypertension) Quiz: Test Your Medical IQ
Source: MedicineNet Nosebleed Specialty [2016.01.05]
Title: High Blood Pressure (Hypertension) Quiz: Test Your Medical IQ
Category: MedicineNet Quiz
Created: 2/9/2011 12:56:00 PM
Last Editorial Review: 1/5/2016 2:12:26 PM

more news >>

Published Studies Related to Monopril (Fosinopril)

Long-term effects of fosinopril and pravastatin on cardiovascular events in subjects with microalbuminuria:Ten years of follow-up of Prevention of Renal and Vascular End-stage Disease Intervention Trial (PREVEND IT). [2011.06]
BACKGROUND: The PREVEND IT investigated whether treatment targeted at lowering urinary albumin excretion (UAE) would reduce adverse cardiovascular events. We obtained extended follow-up data to approximately 10 years to investigate the long-term effects of fosinopril 20 mg and pravastatin 40 mg on cardiovascular outcomes in subjects with UAE >15 mg per 24 hours... CONCLUSIONS: Elevated UAE is associated with increased cardiovascular mortality and morbidity after 9.5 years of follow-up, with a doubling of the risk if the UAE is >50 mg per 24 hours. In this group, the benefits of 4-year treatment with fosinopril were sustained during posttrial follow-up for cardiovascular mortality and morbidity. We propose that UAE be used to estimate risk in the general population and that large clinical trials be designed to confirm the hypothesis that angiotensin-converting enzyme-inhibitor treatment may be beneficial in patients with mildly elevated UAE despite the absence of other comorbidities. Copyright (c) 2011 Mosby, Inc. All rights reserved.

Effects of combination therapy with amlodipine and fosinopril administered at different times on blood pressure and circadian blood pressure pattern in patients with essential hypertension. [2010.06]
OBJECTIVE: The objective of our study was to compare the effects of a combination therapy with amlodipine and fosinopril administered concomitantly or at different times on blood pressure and circadian blood pressure pattern in subjects with essential hypertension... CONCLUSION: Compared to concomitant administration of amlodipine and fosinopril in the morning, administration of the drugs at different times significantly decreased nocturnal blood pressure, increased the diurnal/nocturnal blood pressure ratio, and normalized the circadian blood pressure pattern. These findings indicate that chronotherapy may be an important strategy for optimizing blood pressure control and restoring the circadian blood pressure pattern.

Long-term effects of pravastatin and fosinopril on peripheral endothelial function in albuminuric subjects. [2008.01]
The purpose of this double-blind, randomized, placebo-controlled trial was to determine the long-term effects of pravastatin and fosinopril treatment on peripheral endothelial function in subjects with albuminuria. Subjects (mean age 51 years, 63% male) were randomized to pravastatin 40 mg or matching placebo and to fosinopril 20mg or matching placebo...

Prevention of cardiovascular events in end-stage renal disease: results of a randomized trial of fosinopril and implications for future studies. [2006.10]
Cardiovascular events (CVEs) are the leading cause of death in chronic hemodialysis patients. Results of trials in non-end-stage renal disease (ESRD) patients cannot be extrapolated to patients with ESRD... These trends may have become statistically significant had the sample size been larger, and these findings warrant further study.

Racial differences are seen in blood pressure response to fosinopril in hypertensive children. [2006.08]
BACKGROUND: Few antihypertensive therapies have been systematically studied in children and dosages for many agents are either extrapolated from adult studies or obtained from small homogenous pediatric populations. It is well established that adult patients of different races show disparate response to angiotensin-converting enzyme (ACE) inhibitors, however no such studies have been performed in children... CONCLUSIONS: Fosinopril was effective in treating hypertension, but black children required a higher dose per body weight in order to achieve adequate control. This suggests that black children treated with fosinopril for hypertension on average require higher doses to achieve adequate systolic blood pressure control that non-black children.

more studies >>

Clinical Trials Related to Monopril (Fosinopril)

Bioequivalence Study of Fosinopril 40mg Tablets Under Fed Conditions [Completed]
The objective of this study is to compare the relative bioavailability of fosinopril sodium 40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in healthy adult subjects under non-fasting conditions.

Bioequivalence Study of Fosinopril 40mg Tablets Under Fasting Conditions [Completed]
The objective of this study is to compare the relative bioavailability of fosinopril sodium 40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in healthy adult subjects under fasting conditions.

Bioequivalence Study of Fosinopril Sodium/ Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fasting Conditions [Completed]
The objective of this study was to compare the relative bioavailability of Fosinopril sodium and hydrochlorothiazide 20-12. 5 mg tablets by Ranbaxy Laboratories Limited with that of Monopril ®.-HCT 20-12. 5 mg tablets by Bristol-Meyers Squibb following a single oral dose (1 x 20-12. 5 mg tablet) in healthy adult subjects under fasting conditions

Effectiveness Study on Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3 [Active, not recruiting]
The purpose of this study is to determine whether fosinopril and losartan are effective in the treatment of patients with Chronic Kidney Disease(CKD) stage 3.

Bioequivalence Study of Fosinopril Sodium / Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fed Conditions [Completed]
The objective of this study is to compare the relative bioavailability of Fosinopril sodium and hydrochlorothiazide 20-12. 5 mg tablets of Ranbaxy laboratories Limited with that of

Monopril ® - HCT 20-12. 5 mg tablets by Bristol Meyers Squibb following a single oral dose (1

x 20/12. 5 mg tablet) in healthy adult subjects under non-fasting conditions.

more trials >>

Reports of Suspected Monopril (Fosinopril) Side Effects

Road Traffic Accident (5)Renal Impairment (5)Neuropathy Peripheral (4)Fibromyalgia (4)Blood Cholesterol Increased (4)Back Disorder (4)Mental Impairment (4)Neuralgia (4)Feeling Abnormal (3)Hypersensitivity (2)more >>


Page last updated: 2016-04-29

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