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Vasotec

Generic Name: Enalapril Maleate
Drug Category: ACE Inhibitor
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 1 month old for a maximum duration of 3 years.

Approved Uses

Indicated for the treatment of:

Hypertension:

• VASOTEC is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of VASOTEC and thiazides are approximately additive.

Heart Failure:

• VASOTEC is indicated for the treatment of symptomatic congestive heart failure, usually in combination
with diuretics and digitalis. In these patients VASOTEC improves symptoms, increases survival, and decreases the frequency of hospitalization.

Asymptomatic Left Ventricular Dysfunction:

• In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), VASOTEC decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure.

Do not co-administer aliskiren with VASOTEC in patients with diabetes.

Avoid use of aliskiren with enalapril maleate in patients with renal impairment (GFR < 60 mL/min).

VASOTEC is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer VASOTEC within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor.

VASOTEC is not recommended in neonates and in pediatric patients with glomerular filtration rate <30
mL/min/1.73 m2, as no data are available.

In considering use of enalapril maleate tablets USP, 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.

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx as well as intestinal angioedema has been reported in patients treated with angiotensin converting enzyme inhibitors, including enalapril maleate. Intestinal angioedema has been reported in patients treated with ACE inhibitors. 

As with all vasodilators, enalapril should be given with caution to patients with obstruction in the outflow tract of the left ventricle.

In using VASOTEC 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 does not have a similar risk.

Another angiotensin converting enzyme inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in uncomplicated patients but more frequently in patients with renal impairment, especially if they also have a collagen vascular disease. Available data from clinical trials of enalapril are insufficient to show that enalapril does not cause agranulocytosis at similar rates. Marketing experience has revealed cases of neutropenia or agranulocytosis in which a causal relationship to enalapril cannot be excluded. Periodic monitoring of white blood cell counts in patients with collagen vascular disease and renal disease should be considered.

Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis, and (sometimes) death.

Increases in blood urea nitrogen and serum creatinine were observed in 20 percent of hypertensive patients with unilateral or bilateral renal artery stenosis.

Patients should be told not to use salt substitutes containing potassium without consulting their physician.

Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough.

In patients undergoing major surgery or during anesthesia with agents that produce hypotension, enalapril may block angiotensin II formation secondary to compensatory renin release.

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.

All patients should be cautioned that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Patients on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with enalapril.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including enalapril, may result in deterioration of renal function, including possible acute renal failure.

NSAIDs may diminish the antihypertensive effect of ACE inhibitors.

Enalapril maleate attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. Potassium sparing agents should generally not be used in patients with heart failure receiving enalapril maleate.

Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs which cause elimination of sodium, including ACE inhibitors.

Patients receiving co-administration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema.

Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge.

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. When pregnancy is detected, discontinue VASOTEC as soon as possible.

Enalapril and enalaprilat have been detected in human breast milk. Because of the potential for serious
adverse reactions in nursing infants from enalapril, a decision should be made whether to discontinue nursing or to discontinue VASOTEC, taking into account the importance of the drug to the mother.

GoToSource

Off-label Uses

• Slow cognitive decline in patients with mild to moderate alzheimer’s disease. GoToSource

• Chronic gastritis. GoToSource

• Diminish albuminuria (and potentially slow the progression of renal insufficiency) in patients with cystinosis. GoToSource

• Hypertrophic scars. GoToSource

• Use in patients under the age of 1 month. GoToSource

Adverse Events

Angioedema (swelling in deep layers of skin). GoToSource

Birth defects. GoToSource 

Deterioration of kidney function and kidney failure. GoToSource

Pemphigus vegetans (blistering and sores of the skin and mucous membranes). GoToSource 

Hyponatremia (low sodium levels), hypokalemia (low potassium levels), metabolic alkalosis (body’s pH level is elevated), elevated liver enzymes, hyperkalemia (high potassium levels), hyperglycemia (high blood sugar), edema (excess fluid in body tissues) and cough. GoToSource  

Psoriatic erythroderma (inflammatory type of psoriasis). GoToSource  

Dysgeusia (taste distortion). GoToSource 

Pancreatitis (inflammation of the pancreas). GoToSource 

Eosinophilic gastroenteritis (rare digestive disease). GoToSource

Acute liver failure. GoToSource 

Oral ulcerations. GoToSource 

Fatal intestinal necrosis. GoToSource

Litigation

Lawsuits filed for birth defects, angioedema, kidney failure, hypotension and hyperkalemia. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 28, 2024