VASOTEC I.V. SUMMARY
VASOTEC I.V. (Enalaprilat) is a sterile aqueous solution for intravenous administration. Enalaprilat is an angiotensin converting enzyme inhibitor.
VASOTEC I.V. is indicated for the treatment of hypertension when oral therapy is not practical.
VASOTEC I.V. has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension.
In using VASOTEC I.V., 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 VASOTEC I.V. does not have a similar risk. (See WARNINGS.)
In considering use of VASOTEC I.V., 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, Angioedema.)
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NEWS HIGHLIGHTSMedia Articles Related to Vasotec I.V. (Enalaprilat)
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Published Studies Related to Vasotec I.V. (Enalaprilat)
Myocardial protection with enalaprilat in patients unresponsive to ischemic preconditioning during percutaneous coronary intervention. [2008.12] Cardioprotection due to angiotensin enzyme inhibitors is attributed, at least in part, to the inhibition of bradykinin breakdown and the preconditioning effect of the elevated endogenous bradykinin level. We have previously shown that in patients undergoing percutaneous coronary intervention, one 120-second balloon inflation is insufficient to precondition the heart...
Pretreatment with intracoronary enalaprilat protects human myocardium during percutaneous coronary angioplasty. [2007.04.17] OBJECTIVES: We tested the hypothesis that enalaprilat induces preconditioning (PC)-mimetic actions in patients with stable coronary artery disease. BACKGROUND: Angiotensin-converting enzyme (ACE) inhibitors increase the bioavailability of bradykinin, which induces cardiac PC... CONCLUSIONS: Pretreatment with enalaprilat attenuates the manifestations of myocardial ischemia during angioplasty. This is the first in vivo evidence showing that an ACE inhibitor protects human myocardium, possibly via PC-mimetics actions, a novel property that might explain the cardioprotective actions of these drugs.
Effects of enalaprilat infusion on hemodynamics and renal function in patients undergoing cardiac surgery. [2004.12] OBJECTIVE: This study was undertaken to evaluate the effect of enalaprilat infusion on hemodynamics and renal function during cardiopulmonary bypass (CPB)... CONCLUSION: Our results demonstrate that enalaprilat infusion during CPB improves renal function and CO measurements in the early postoperative period.
Effects of enalaprilat on venoconstriction to norepinephrine: role of prostaglandins. [2003.07.01] OBJECTIVE: Most patients with cardiovascular disease continue to receive both aspirin and an angiotensin-converting enzyme (ACE) inhibitor. This is despite the fact that ACE inhibition also inhibits the enzyme kininase II and leads to accumulation of bradykinin which increases prostaglandins. We hypothesized that in normal veins, vasodilator prostaglandins contribute significantly to ACE inhibitor dilation of norepinephrine-induced venoconstriction, and this would be blocked by cyclooxygenase inhibition... CONCLUSIONS: The results suggest that vasodilator prostaglandins contribute significantly to the attenuation of sympathetic venoconstriction by enalaprilat. This may have clinical relevance in patients receiving aspirin and ACE inhibitors in the setting of increased sympathetic activity.
Effect of enalaprilat on postoperative hypertension after surgical repair of coarctation of the aorta. [2003.07] OBJECTIVE: Hypertension in pediatric patients after surgical repair of coarctation of the aorta can be difficult to control and may lead to morbidity. The renin-angiotensin system mediates at least part of this hypertension. Enalaprilat, the only intravenous angiotensin-converting enzyme inhibitor, is used to treat hypertension in pediatric patients in other settings. However, its effect on postoperative hypertension during the early postoperative period in patients undergoing surgical repair of coarctation of the aorta is unknown... CONCLUSIONS: Conclusions are limited by a small cohort. Angiotensin-converting enzyme inhibitor therapy resulted in improved blood pressure control after coarctation repair. Further improvement of blood pressure control may be achievable by use of a larger dose of enalaprilat or a 4-hr enalaprilat-dosing interval.
Clinical Trials Related to Vasotec I.V. (Enalaprilat)
Relative Bioavailability Study With Enalapril in Healthy Volunteers [Active, not recruiting]
Phase I study in healthy adult male and female volunteers to compare the bioavailability of
enalapril administered in orodispersible Minitablets with or without water in comparison to
the standard galenic tablet formulation of enalapril. The standard pharmacokinetic
parameters will be calculated from the bioanalytical results for enalapril and enalaprilat
and compared in a descriptive statistical analysis.
Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Enalapril maleate may help protect heart cells from the side effects of
chemotherapy. It is not yet known whether giving enalapril maleate before or after
doxorubicin hydrochloride is more effective in treating women with breast cancer.
PURPOSE: This randomized clinical trial is studying giving enalapril maleate together with
doxorubicin hydrochloride to see how well it works in treating women with breast cancer.
A Fixed Dose Combination Amlodipine + Enalapril Bioavailability Study [Completed]
The study is designed to estimate the bioavailability of amlodipine and enalapril maleate
fixed dose combination (FDC) relative to co-administration of amlodipine and enalapril
maleate tablets. The rational for this study is to provide a more convenient dosing regimen
for patients. This is an open-label, randomized, single dose, two-way crossover study, in
which 16 healthy adult male and female subjects will be enrolled and dosed under fasting
conditions. Each subject will participate in two treatment periods of 7 days each. There
will be at least 14 days of wash out period between the two dosing periods and a follow-up
period of up to 21 days after treatment period 2. The total duration of study will be
approximately 35 days from the start of the first treatment.
Comparison of the Antihypertensive Efficacy of Valsartan and Enalapril After Missing One Dose [Completed]
This study was designed in order to evaluate the blood pressure lowering effect of valsartan
compared to enalapril over 24 hours after skipping one daily dose. Both drugs act on the
renin-angiotensin-aldosterone system (RAAS) and are widely use for the treatment of
hypertension. Previous studies had a significant limitation: the effect of a missing dose
was not evaluated after the whole 24 hours post missing dose period (48 hours after last
taken dose), and as a result, it does not imitate the real life situation of a missing dose.
China Stroke Primary Prevention Trial [Completed]
The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is
more effective in preventing stroke among the patients with primary hypertension when
compared to enalapril maleate.
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