Indicated for:

Hypertension:

• For the treatment of hypertension, to lower blood pressure in adults and children older than one month.

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

Heart Failure:

• For the treatment of symptomatic heart failure, usually in combination with diuretics and digitalis. In these patients, EPANED 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), EPANED decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure.

Doses above 0.58 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients.

EPANED is not recommended in neonates (i.e., infants 1 month of age or less), preterm infants who have not reached a corrected post-conceptual age of 44 weeks, and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m².

Safety and effectiveness of enalapril have not been established in pediatric patients with heart failure or asymptomatic left ventricular dysfunction.

EPANED is contraindicated in patients with hereditary or idiopathic angioedema.

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx, including some fatal reactions, have occurred in patients treated with angiotensin converting enzyme inhibitors, including EPANED, at any time during treatment. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery.

Intestinal angioedema has occurred in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal.

Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions.

EPANED can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia, acute renal failure or death.

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

Monitor renal function in patients treated with EPANED. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system.

Sudden and potentially life-threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor.

Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema.

Serum potassium should be monitored in patients receiving EPANED. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes.

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

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

In general, avoid combined use of RAS inhibitors.

Lithium toxicity has been reported in patients receiving enalapril and lithium concomitantly which was generally reversible.

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting, and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including enalapril.

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. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue EPANED as soon as possible.

Enalapril and enalaprilat have been detected in human breast milk. Because of the potential for  severe adverse reactions in the breastfed infant, including hypotension, hyperkalemia and renal impairment, advise women not to breastfeed during treatment with EPANED.

GoToSource

• Use in patients under 1 month of age. GoToSource

• Use in pediatric patients with heart failure or asymptomatic left ventricular dysfunction. GoToSource

• Alport syndrome. GoToSource

• Scleroderma. GoToSource

Liver failure. GoToSource

Hypotension (low blood pressure). GoToSource

Hyperkalemia (elevated potassium levels), chronic cough and angioedema (swelling in the deep layers of the skin). GoToSource

No major injury lawsuits reported.