WARNING: FETAL TOXICITY
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When pregnancy is detected, discontinue
fosinopril
sodium tablets as soon as possible.
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Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS, Fetal Toxicity.
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FOSINOPRIL SUMMARY
Fosinopril sodium tablets are 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. They 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 tablets, 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 tablets do not have a similar risk (see
WARNINGS).
In considering use of fosinopril sodium tablets, 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,
Anaphylactoid
and Possible Related Reactions,
Head and Neck Angioedema
and
Intestinal Angioedema
).
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NEWS HIGHLIGHTS
Published Studies Related to 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...
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.
Clinical Trials Related to 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.
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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: 2011-12-09
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