Enalapril

FDA label

Read the full label on DailyMed ↗

Titration Heart failure / LV dysfunction: titrate upward as tolerated over a few days to weeks

Renal CrCl >30: usual dose; CrCl ≤30 (SCr ≥3 mg/dL): start 2.5 mg QD; dialysis: 2.5 mg on dialysis days

Hepatic Undefined

Instructions

• If on a diuretic, discontinue 2-3 days before starting if possible, or use an initial 2.5 mg dose under supervision; observe for hypotension.
• Observe heart failure/LV dysfunction patients ≥2 h after initial dose until blood pressure stable.
• Extemporaneous 1 mg/mL oral suspension may be prepared from tablets per label.

Contraindications

• History of angioedema related to previous ACE inhibitor therapy, or hereditary/idiopathic angioedema
• Concomitant aliskiren in patients with diabetes
• Combination with a neprilysin inhibitor (e.g., sacubitril); do not use within 36 h of switching to/from sacubitril/valsartan

Cautions

• Fetal toxicity (boxed) - second/third-trimester use reduces fetal renal function and increases fetal/neonatal morbidity and death (oligohydramnios, lung hypoplasia, skull hypoplasia, anuria, renal failure); discontinue as soon as pregnancy is detected
• Head and neck angioedema (face, lips, tongue, glottis, larynx) - may occur at any time; laryngeal edema may be fatal; discontinue promptly and treat (e.g., SC epinephrine); increased risk with concomitant mTOR inhibitors or a neprilysin inhibitor
• Intestinal angioedema - consider in patients on ACE inhibitors presenting with abdominal pain
• Anaphylactoid reactions during hymenoptera-venom desensitization, high-flux membrane dialysis, or LDL apheresis with dextran sulfate
• Excessive hypotension, sometimes with oliguria/azotemia and rarely acute renal failure/death, in volume- or salt-depleted patients (heart failure, hyponatremia, high-dose or recent diuretics, dialysis) - start under close supervision; follow closely for first 2 weeks and after dose increases
• Neutropenia/agranulocytosis - cannot be excluded; consider periodic WBC monitoring in patients with renal disease and collagen vascular disease
• Hepatic failure - rare syndrome starting with cholestatic jaundice progressing to fulminant hepatic necrosis; discontinue if jaundice or marked hepatic-enzyme elevations develop
• Impaired renal function - BUN/creatinine rises in renal-artery stenosis (20%) and in severe heart failure (oliguria, azotemia, rarely acute renal failure); monitor renal function
• Hyperkalemia (risk factors: renal insufficiency, diabetes, potassium-sparing diuretics, potassium supplements, salt substitutes) - use such agents cautiously if at all
• Persistent nonproductive cough (resolves on discontinuation)
• Caution in aortic stenosis/hypertrophic cardiomyopathy (as with all vasodilators)
• Hypotension during major surgery/anesthesia with hypotension-producing agents - correct with volume expansion

Adverse reactions

• Fatigue
• Orthostatic effects
• Asthenia
• Diarrhea
• Nausea
• Headache
• Dizziness
• Cough
• Rash

Pregnancy Fetal toxicity (boxed); discontinue as soon as pregnancy is detected.

Lactation Enalapril and enalaprilat detected in human milk; decide whether to discontinue nursing or the drug.