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Fosinopril (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, fosinopril sodium tablets should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

 

FOSINOPRIL SUMMARY

FOSINOPRIL SODIUM TABLETS
Rx only

Fosinopril sodium 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.

Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.

Fosinopril sodium tablets are 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 fosinopril sodium 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 sodium does not have a similar risk (see WARNINGS).

In considering use of fosinopril sodium, 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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NEWS HIGHLIGHTS

Media Articles Related to Fosinopril

fosinopril sodium, Monopril
Source: MedicineNet Kidney Failure Specialty [2009.10.12]
Title: fosinopril sodium, Monopril
Category: Medications
Created: 12/31/1997
Last Editorial Review: 10/12/2009

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Published Studies Related to Fosinopril

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...

Long-term effects of pravastatin and fosinopril on peripheral endothelial function in albuminuric subjects. [2006.11.30]
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 40mg 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.

Effect of fosinopril in children with steroid-resistant idiopathic nephrotic syndrome. [2006.07]
We aimed to test if fosinopril reduces urinary protein excretion and alleviates renal tubular damage in normotensive children with steroid-resistant idiopathic nephrotic syndrome (SRINS). We also aimed to evaluate whether there are changes in steady-state blood pressure and serum concentrations of serum angiotensin-converting enzyme (ACE) and plasma renin activity or angiotensin II (AT-II) in children under this treatment...

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Clinical Trials Related to Fosinopril

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.

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

ACE Inhibition and Novel Cardiovascular Risk Factors [Completed]

Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension [Completed]
Plasma renin values determine whether volume or vasoconstrictor (renin) factors predominate in elevating blood pressure and are useful in selecting effective antihypertensive therapy. 2,3

The researchers hypothesize that:

1. Plasma renin-guided therapeutics will improve systolic and diastolic blood pressure control in patients with untreated hypertension as well as in patients with treatment refractory or resistant hypertension that are managed by Clinical Hypertension Specialists.

2. Renin-guided therapeutics will reduce the number of medications required to maintain blood pressure control to <140/90 mmHg in hypertensive patients receiving 3 or more medications, while under the care of a Clinical Hypertension Specialist.

3. Renin-guided therapeutics selection will reduce the total cost of antihypertensive care provided by Clinical Hypertension Specialists.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Fosinopril has an overall score of 4. The effectiveness score is 8 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
 

Fosinopril review by 62 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   High Blood Pressure
Dosage & duration:   20 mg taken daily for the period of 1 year
Other conditions:   hypothryroid, osteopena
Other drugs taken:   Synthroid, Fosamax
  
Reported Results
Benefits:   Blood pressure was controlled with the same dose as the former drug I used, MiCARDIS. My insurance would not cover it and I started using fosinopril. I didnt think I had adverse effects from it until someone pointed out my dry constant cough.
Side effects:   I developed a dry cough and it seemed to get persistently worse as months went by. I didnt realize the cough could be a side effect from the drug, but as soon as I replaced it with Benicar, the symptons disappeared.
Comments:   I took the drug once daily in the morning and outwardly I felt no discomfort at all. Blood pressure was controlled. I took this drug approximately one year before starting Benicar and losing the symptom of coughing.

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Page last updated: 2009-10-12

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