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, PRINIVIL should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
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PRINIVIL SUMMARY
PRINIVIL (Lisinopril), a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor.
PRINIVIL is indicated for the following:
Hypertension
PRINIVIL is indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents. Heart Failure
PRINIVIL is indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Acute Myocardial Infarction
PRINIVIL is indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers.
In using PRINIVIL, 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, and that available data are insufficient to show that PRINIVIL does not have a similar risk. (See WARNINGS.)
In considering use of PRINIVIL, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks (see WARNINGS, Anaphylactoid and Possibly Related Reactions, Angioedema).
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NEWS HIGHLIGHTS
Published Studies Related to Prinivil (Lisinopril)
Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial. [2011.06.15] BACKGROUND: High blood pressure during acute stroke is associated with poorer stroke outcome. Previous trials have failed to show benefit from lowering blood pressure but treatment may have been commenced too late to be effective... The results will inform the design of a definitive RCT to evaluate the effects of very early blood pressure lowering in acute stroke.
Potential pharmacodynamic drug-drug interaction between concomitantly administered lisinopril and diclofenac sodium: a call for appropriate management in hypertensive osteoarthritic patients. [2011] Abstract Background: The present study was designed as an open label, multiple-dose, randomized, parallel trial to evaluate the pharmacodynamic drug-drug interaction of lisinopril and concomitantly administered diclofenac sodium in non-diabetic and diabetic, mild to moderate hypertensive, osteoarthritic patients...
Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study
protocol for a pilot randomised controlled trial. [2011] BACKGROUND: High blood pressure during acute stroke is associated with poorer
stroke outcome. Previous trials have failed to show benefit from lowering blood
pressure but treatment may have been commenced too late to be effective... The results will inform the design of a definitive RCT
to evaluate the effects of very early blood pressure lowering in acute stroke.
Carotid artery hemodynamics: observing patient-specific changes with amlodipine and lisinopril by using MR imaging computation fluid dynamics. [2010.12] PURPOSE: To assess whether using magnetic resonance (MR) imaging combined with computational fluid dynamics (CFD) could reveal changes in common carotid artery (CCA) flow and wall shear stress (WSS) that might contribute to differences in CCA remodeling between amlodipine, a calcium channel blocker, and lisinopril, an angiotensin-converting enzyme inhibitor, despite similar reductions in blood pressure (BP)... CONCLUSION: Amlodipine causes increased blood flow and increased time-averaged WSS in the CCA compared with lisinopril, despite similar reductions in BP. Differences in the subacute hemodynamic effects of amlodipine and lisinopril could contribute to the differences in CCA remodeling seen in long-term studies. SUPPLEMENTAL MATERIAL: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100788/-/DC1. (c) RSNA, 2010
Comparison of the influence of angiotensin-converting enzyme inhibitor lisinopril and angiotensin II receptor antagonist losartan in patients with idiopathic membranous nephropathy and nephrotic syndrome. [2010.09] CONCLUSION: Treatment with lisinopril and losartan in nephrotic patients with idiopathic membranous nephropathy results in similar (and significant) effects on renal function, hypoalbuminaemia, proteinuria and blood pressure.
Clinical Trials Related to Prinivil (Lisinopril)
Bioequivalence Study of Two Formulations of 10 mg Lisinopril Tablet Under Fasting Condition [Completed]
The present study was conducted to find out whether the bioavailability of 10 mg lisinopril
tablets produced by PT Dexa Medica was equivalent to the tablets produced by the innovator
(ZestrilŪ 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, under license from Astra
Zeneca UK Ltd.)
Modulation of Heme Oxygenase 1 by Nizatidine and Lisinopril in Healthy Subjects [Completed]
To assess if oral nizatidine or lisinopril alone and in combination will increase heme
oxygenase 1 (HO-1) protein concentration and activity compared to placebo in healthy
subjects.
The Vascular Effects of Carvedilol Controlled Release (CR) in Abdominally Obese Hypertensive Patients [Completed]
The purpose of this study is to compare the effects of two different combination therapies
for high blood pressure on vascular health.
Research Study To Test Carvedilol CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure [Completed]
Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2
essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline.
Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril +
placebo. Subjects will be uptitrated over a 6 week period until target blood pressure
(<140/90mmHg) is met. The primary objective of the study is to compare the proportion of
subjects who achieve target blood pressure after 6 weeks of treatment.
Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant [Completed]
The drug lisinopril is approved by the U. S. Food and Drug Administration for the treatment
of high blood pressure, heart failure, and acute heart attacks in adult patients. In
children over 6 years of age, lisinopril is approved for the treatment of high blood
pressure. Lisinopril is in a group of medications called angiotensin-converting enzyme
inhibitors (ACE). ACE inhibitors such as lisinopril work by decreasing certain chemicals
that tighten the blood vessels so blood flows more smoothly and the heart can pump blood
more efficiently.
There is some information available about how children with high blood pressure absorb,
distribute, metabolize, and eliminate lisinopril (this information about medication
processing by the body is called pharmacokinetic data). However, there is no information
about how children with high blood pressure who have received a kidney transplant process
lisinopril. In addition to decreasing blood pressure, investigators believe that lisinopril
may help kidney transplants work longer by reducing the activity of chemicals made by cells
in kidney transplants that can lead to inflammation and injury. Such benefits have not been
found with another group of blood pressure medications called calcium channel blockers,
which are the most commonly used medication group to control high blood pressure in children
after a kidney transplant. A clinical trial will be conducted in the future to compare which
medication group helps kidney transplants in children last longer. To guide the selection of
the best dose to test in future studies, investigators in this study will try to determine
the safety profile, dose tolerability, and pharmacokinetics of lisinopril in children and
adolescents (2-17 years of age) who have received a kidney transplant and have high blood
pressure.
Reports of Suspected Prinivil (Lisinopril) Side Effects
Completed Suicide (24),
Overdose (21),
Cough (12),
Dizziness (11),
Renal Failure Acute (11),
Hypotension (10),
Nausea (8),
Drug Ineffective (7),
Back Pain (7),
Hypertension (7), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 30 ratings/reviews, Prinivil has an overall score of 5.27. The effectiveness score is 7.13 and the side effect score is 6.60. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| Prinivil review by 65 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Highly Effective |
Side effects: | | No Side Effects | | Treatment Info |
Condition / reason: | | HBP |
Dosage & duration: | | 10-20mg taken once a day for the period of 27 years |
Other conditions: | | none |
Other drugs taken: | | Maxide, Atenolol | | Reported Results |
Benefits: | | After starting on a diuretic and a beta blocker without significant results, adding the ACE inhibitor worked wonders, and has continued to do so for 27 years. The next step, if one becomes necessary will be to add a sartan. Based on my previous response. I expect it to be a happy experience. |
Side effects: | | For no apparent reason the dosage needs to be adjusted, up or down from time to time. Fortunately hypertension is not asymptomatic in this patient: have a headache, it's up, raise the dose; feel wiped out, it's down, lower the dose. All this has been confirmed by home, office, and pharmacy readings. |
Comments: | | I never expected to live this long, let alone feel as healthy as I do. My mother died at age 53, and the last years of her life were marred by pain, discomfort and significant disability due to cardiovascular disease.
My experience is one more validation of the benefits of early and aggressive intervention in the case of mild hypertension. |
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| Prinivil review by 45 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Marginally Effective |
Side effects: | | Moderate Side Effects | | Treatment Info |
Condition / reason: | | diabetes |
Dosage & duration: | | 2.5 MG taken one tablet/day for the period of two months |
Other conditions: | | none |
Other drugs taken: | | insulin: Lantis and humolog | | Reported Results |
Benefits: | | Apparently, this ace inhibitor has positive effects against retinal and renal pathologies associated with diabetes and other cardio-vascular diseases. |
Side effects: | | Excessive prolonged coughing spells, especially at night, occasional diarrhea, isolated, patchy skin rashes on torso and extremities and itchy scalp all noticed within a week of starting this drug and has been persistent since. |
Comments: | | My doctor prescribed this medication as a prophylactic measure, since I have had Type I diabetes for the last 33 years. Recent tests have shown traces of protien in my urine possibly indicating early signs of renal failure. |
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| Prinivil review by 73 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Considerably Effective |
Side effects: | | Severe Side Effects | | Treatment Info |
Condition / reason: | | high blood pressure |
Dosage & duration: | | 2.5mg daily taken daily for the period of 6 months |
Other conditions: | | high cholesterol |
Other drugs taken: | | cholesterol med | | Reported Results |
Benefits: | | blood pressure under control |
Side effects: | | Head itching, mouth and throat itchy swollen, cough, ringing in ears, bloating, extreme fatigue and depression. |
Comments: | | I have been off this medication for 2 weeks. No more itching/swelling, ringing. I still have some fatigue, but not constantly and hope that I will continue to improve.
While many people seem to take this drug without significant side effects, for some it is pure poison. Beware! |
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Page last updated: 2013-02-10
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