Enalapril

Class
Antihypertensives
Subclass
Angiotensin-converting enzyme inhibitors
Substance name
Enalapril maleate
Brand names
Vasotec®
Common formulations
Tablet
Dosage and administration
Adults patients
Congestive HF
•
Start at: 2.5 mg PO BID
•
Maintenance: 2.5-20 mg PO BID
•
Maximum: 40 mg per day
Administered in combination with diuretics.
Hypertension
•
Start at: 5 mg PO daily
•
Maintenance: 10-40 mg PO daily, in 1-2 divided doses
•
Maximum: 40 mg per day
Alternative
•
Start at: 2.5 mg PO daily
•
Maintenance: 10-40 mg PO daily, in 1-2 divided doses
•
Maximum: 40 mg per day
Administered in combination with diuretics.
LV dysfunction • Ejection fraction ≤ 35%, asymptomatic
•
Start at: 2.5 mg PO BID
•
Maintenance: 2.5-10 mg PO BID
•
Maximum: 20 mg per day
Chemotherapy-induced cardiomyopathy • Off-label
•
Start at: 2.5 mg PO daily
•
Maintenance: 20 mg PO daily
CKD in patients without diabetes mellitus • Off-label
•
Start at: 5 mg PO daily
•
Maintenance: 5-20 mg PO daily
•
Maximum: 20 mg per day
Alternative
•
5-40 mg PO daily, in 1-2 divided doses
Diabetic nephropathy • Off-label
•
Maintenance: 5-10 mg PO q12-24h
•
Maximum: 20 mg per day
Myocardial infarction • Off-label
•
Start at: 2.5 mg PO daily
•
Maintenance: 20 mg PO daily
Other off-label uses
•
Treatment of HF
•
Prevention of migraine attacks
Indications for use
Labeled indications
Adults
•
Treatment of congestive HF
•
Treatment of hypertension
•
Treatment of LV dysfunction (ejection fraction ≤ 35%, asymptomatic)
Children
•
Treatment of hypertension
Off-label indications
Adults
•
Treatment of chemotherapy-induced cardiomyopathy
•
Treatment of CKD in patients without diabetes mellitus
•
Treatment of diabetic nephropathy
•
Treatment of myocardial infarction
•
Prevention of migraine attacks
Children
•
Treatment of HF
Safety risks
Boxed warnings
Fetal toxicity
•
Do not use in pregnant patients. Discontinue enalapril as soon as possible when pregnancy is detected.
Contraindications
Hypersensitivity to enalapril or its components
History of ACEi-induced angioedema, hereditary angioedema, or idiopathic angioedema
Concomitant use of aliskiren in patients with diabetes
Warnings and precautions
ACE inhibitor-induced angioedema
•
Use caution in patients taking mTOR inhibitors.
Anaphylactoid reactions
•
Use caution in patients on hemodialysis with high-flux membranes, desensitizing treatment with hymenoptera venom, or low density lipoprotein apheresis with dextran sulfate absorption.
Cholestatic jaundice, ALF
•
Maintain a high level of suspicion, as ACEis have been rarely associated with cholestatic jaundice and fulminant hepatic necrosis. Discontinue enalapril in patients developing jaundice or marked elevations of hepatic enzymes.
Hypotension
•
Use caution in patients with HF, ischemic heart disease, cerebrovascular disease, hyponatremia, renal dialysis, severe volume and/or salt depletion of any etiology, taking high-dose diuretic therapy, or undergoing major surgery or anesthesia with agents producing hypotension.
Increased BUN, increased serum creatinine
•
Use caution in patients with unilateral or bilateral renal artery stenosis.
Increased serum potassium
•
Use caution in patients with renal insufficiency, diabetes mellitus or taking potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes.
Neutropenia, agranulocytosis
•
Use caution in patients with connective tissue diseases (such as SLE or systemic sclerosis) or impaired renal function.
Renal failure
•
Use caution in patients with renal artery stenosis, CKD, severe congestive HF, post-myocardial infarction, or volume depletion.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 30 mL/min
•
Start at dose of 2.5 mg once daily. Maximal dose of 40 mg per day. Monitor serum creatinine.
Renal replacement therapy
Any modality
•
Start at a dose of 2.5 mg. Maximal dose of 10 mg. Titrate to response. Administer 2.5 mg on dialysis days. Adjust dose on non-dialysis day depending on blood pressure response.
Hepatic impairment
Any severity
•
Use acceptable. No dose adjustment required.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Do not use. Evidence of fetal harm in humans. Advise adequate methods of contraception. Discontinue enalapril as soon as possible when pregnancy is detected.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown drug levels in breastfed infants.
No overt adverse effects reported in breastfed infants.
No overt adverse effects on lactation reported.
Adverse reactions
Common 1-10%
•
Hypertension, ↑ serum potassium, myocardial infarction, orthostatic hypotension, abdominal pain, asthenia, chest pain, constipation, cough, diarrhea, dizziness, dyspnea, fatigue, headache, nausea, skin rash, syncope, vertigo, vomiting
Unknown frequency
•
AF, acute liver failure, AT, agranulocytosis, anemia, angioedema, ataxia, bradycardia, bronchospasm, cholestasis, conjunctivitis, ↓ blood neutrophil count, ↓ platelet count, ↓ serum sodium, diaphoresis, erythema multiforme, exfoliative dermatitis, gynecomastia, ↑ BUN, ↑ WBC count, ↑ blood eosinophil count, ↑ liver enzymes, ↑ serum TBIL, jaundice, liver necrosis, pemphigus vulgaris, peripheral neuropathy, photosensitivity of skin, pulmonary edema, renal failure, anosmia, arthralgia, blurred vision, confusion, depression, drowsiness, dry mouth, dysesthesia, dysgeusia, dyspepsia, flank pain, hair loss, hoarseness, impotence, insomnia, loss of appetite, low urine output, melena, muscle cramps, myalgia, nightmares, palpitations, paresthesia, pruritus, rhinorrhea, skin flushing, tinnitus, Stevens-Johnson syndrome, stomatitis, toxic epidermal necrolysis, urticaria, vasculitis, xerophthalmia
Interactions
Drug(s)
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