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).
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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.
Clinical Trials Related to Monopril (Fosinopril)
Eplerenone, ACE Inhibition and Albuminuria [Recruiting]
The purpose of this study is to determine whether eplerenone is more effective than doubling
the dose of ACE inhibitor in reducing urinary protein (albumin) loss in diabetes mellitus
Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery [Not yet recruiting]
Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and
including the morning of an intermediate risk surgery will experience more intraoperative
hypotension than those who hold their chronic ACEI perioperatively.
Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and
including the morning of an intermediate risk surgery will experience better postoperative
control of hypertension than those who hold their chronic ACEI perioperatively.
Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and
including the morning of an intermediate risk surgery will experience less acute renal
failure than those who hold their chronic ACEI perioperatively.
Secondary research hypothesis #3: Patients with a preoperative systolic blood pressure less
than 110 mmHg who are continued on their chronicACEI therapy perioperatively will have a
significant decrease in blood pressure during anesthesia compared to those who have a
preoperative systolic blood pressure greater than 110 who are continued on their chronic
Secondary research hypothesis #4: Patients above the age of 64 who are continued on their
chronic ACEI therapy perioperatively will have a significant decrease in blood pressure
during anesthesia compared to those aged 64 or younger who are continued on their chronic
Angiotensin-converting Enzyme (ACE)-Inhibition and Mechanisms of Skeletal Muscle Weakness in Chronic Obstructive Pulmonary Disease (COPD) [Recruiting]
A double blind randomised placebo controlled parallel trial of the effect of fosinopril, an
angiotensin converting enzyme inhibitor, on the quadriceps muscle in 80 COPD patients who
have quadriceps weakness. Patients will have a baseline assessment including measures of
quadriceps strength and endurance and a quadriceps biopsy. Patients with weakness will be
randomised to ACE inhibitor or placebo and re-assessed after three months of treatment.
The investigators aim to show that ACE-inhibition will alter the IGF-1/AKT/FoXO/atrogene
pathways involved in muscle wasting in COPD.
Is There an Adverse Drug Reaction Between Renin-Angiotensin System Blockade and Inhaled Anesthetics [Recruiting]
It is controversial whether or not patients whose Renin Angiotensin System is blocked for
the treatment of hypertension suffer increased risk when undergoing surgery and anaesthesia.
The investigators wish to test the hypothesis: Blockade of the Renin Angiotensin System
causes altered dose response under general anaesthesia in a dose dependant manner. The
investigators wish to look for altered responses across the usual anaesthetic dosing range
as measured by blood pressure and heart responses.
Reports of Suspected Monopril (Fosinopril) Side Effects
Road Traffic Accident (5),
Renal Impairment (5),
Neuropathy Peripheral (4),
Blood Cholesterol Increased (4),
Back Disorder (4),
Mental Impairment (4),
Feeling Abnormal (3),
Hypersensitivity (2), more >>