Enalapril


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Hypertension Initial: 5 mg once daily. Maintenance: 10-20 mg once daily, up to 40 mg in 2 divided doses. Dose should be individualised according to patient profile and blood pressure response. Max: 40 mg/day. Heart failure; Asymptomatic left ventricular dysfunction Initial: 2.5 mg once daily, increased gradually up to 20 mg. Usual maintenance dose: 20 mg daily as a single dose or in 2 divided doses, titrated according to patient tolerance over 2-4 weeks. Max: 40 mg/day in 2 divided doses. IV Hypertension As enalaprilat: 1.25 mg 6 hourly via slow infusion over 5 minutes.
Dosage Details
Intravenous
Hypertension
Adult: As enalaprilat: 1.25 mg 6 hourly via slow infusion over 5 minutes.

Oral
Hypertension
Adult: Initially, 5 mg once daily. Maintenance: 10-20 mg once daily, up to 40 mg in severe cases, may be given in 2 divided doses if control is inadequate. Dose should be individualised according to patient profile and blood pressure response. Max: 40 mg daily.
Child: 20-<50 kg: Initially, 2.5 mg once daily, may increase to Max 20 mg once daily if necessary. ≥50 kg: Initially, 5 mg once daily, increase to Max 40 mg once daily if necessary.
Elderly: Initially, 2.5 mg once daily, adjust subsequent dose according to response.

Oral
Asymptomatic left ventricular dysfunction, Heart failure
Adult: Initially, 2.5 mg once daily, increased gradually up to 20 mg. Usual maintenance dose: 20 mg daily as a single dose or in 2 divided doses, titrated according to patient tolerance over 2-4 weeks. Max: 40 mg daily in 2 divided doses.
Elderly: Initially, 2.5 mg once daily, adjust subsequent dose according to response.
Special Patient Group
Hypertension
PO
Patients taking diuretic: Initially, 2.5 mg daily. Discontinue diuretic 2-3 days before enalapril administration.

IV
Patients taking diuretic: Half the initial dose.
Renal Impairment
Oral:
CrCl (mL/min) Dosage
≤30 or on dialysis Initially, 2.5 mg once daily, adjusted subsequently according to response.

Intravenous:
Hypertension
CrCl (mL/min) Dosage
<30 or on haemodialysis
As enalaprilat: Initially, 0.625 mg given over 5 minutes up to 1 hour, repeat dose after 1 hour if necessary. May give additional dose of 1.25 mg 6 hourly according to response.
Administration
May be taken with or without food.
Reconstitution
Inj: Dilute vial with up to 50 mL of a compatible diluent (e.g. dextrose 5%, NaCl 0.9%).
Incompatibility
Incompatible with phenytoin Na in NaCl 0.9%, and amphotericin B in dextrose 5% solution.
Contraindications
History of angioedema related to previous treatment with ACE inhibitor, idiopathic or hereditary angioedema. Concomitant use with aliskiren in patient with diabetes mellitus. Coadministration with or within 36 hours of switching to or from a neprilysin inhibitor (e.g. sacubitril). Pregnancy.
Special Precautions
Patient with diabetes mellitus, volume depletion, renal artery stenosis, severe aortic stenosis; ascites due to cirrhosis or refractory ascites; ischaemic heart disease or cerebrovascular disease; collagen vascular disease; hypertrophic cardiomyopathy and outflow tract obstruction; pre-existing renal insufficiency. Black race. Renal and hepatic impairment. Children and elderly. Lactation.
Adverse Reactions
Significant: Cough, haematologic effects (e.g. neutropenia, agranulocytosis, anaemia, thrombocytopenia), hyperkalaemia, hypersensitivity reactions (e.g. anaphylactic/anaphylactoid reactions), hypotension, syncope, renal function deterioration, increased serum creatinine. Rarely, cholestatic jaundice.
Cardiac disorders: Chest pain, rhythm disturbances, angina pectoris, orthostatic hypotension, dyspnoea, tachycardia.
Eye disorders: Blurred vision.
Gastrointestinal disorders: Abdominal pain, anorexia, constipation, diarrhoea, dysgeusia, nausea, vomiting, taste alteration.
General disorders and administration site conditions: Weakness, asthenia, fatigue.
Nervous system disorders: Dizziness, headache.
Psychiatric disorders: Depression.
Respiratory, thoracic and mediastinal disorders: Bronchitis.
Skin and subcutaneous tissue disorders: Rash.
Potentially Fatal: Angioedema. Rarely, fulminant hepatic necrosis.
Patient Counseling Information
This drug may cause occasional dizziness or weariness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor blood pressure, baseline serum creatinine and K; reassess serum creatinine and K within 1-2 weeks after initiation and periodically thereafter in patient treated for heart failure.
Overdosage
Symptoms: Marked hypotension, stupor, circulatory shock, electrolyte disturbance, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough. Management: Infuse normal saline solution and put patient in supine position in case of hypotension. May consider treatment with IV catecholamines. May induce emesis, perform gastric lavage or administer absorbents or sodium sulfate in recent ingestion.
Drug Interactions
May potentiate hypotensive action with diuretics, other antihypertensives, TCAs, vasodilating agents (e.g. nitrates) or anaesthetics. May increase lithium serum concentration and enhance risk of lithium toxicity. May increase risk of hypoglycaemia with oral antidiabetic agents or insulin. May increase risk of hyperkalaemia with K-sparing diuretics (e.g. spironolactone, triamterene, amiloride), K-containing supplements or salt substitutes. May increase risk of renal impairment with NSAIDs (e.g. aspirin, ibuprofen) including COX-2 inhibitors. Rarely, may cause nitritoid reactions with injectable gold (Na aurothiomalate).
Potentially Fatal: Increased risk of angioedema with neprilysin inhibitors (e.g. sacubitril, racecadotril), and mammalian target of rapamycin inhibitors (e.g. sirolimus, everolimus). May increase risk of side effects (e.g. hypotension, hyperkalaemia, acute renal failure) with aliskiren in patient with diabetes.
Food Interaction
Increased hypotensive effect with alcohol.
Action
Description: Enalapril is a prodrug of enalaprilat, which inhibits conversion of angiotensin I to angiotensin II (a potent vasoconstrictor) resulting in reduced angiotensin II-induced vasoconstriction, Na retention and aldosterone secretion.
Onset: Approx 1 hour.
Duration: 12-24 hours.
Pharmacokinetics:
Absorption: Rapidly absorbed in the gastrointestinal tract. Time to peak plasma concentration: Approx 0.5-1.5 hour (enalapril); 3-4.5 hours (enalaprilat).
Distribution: Plasma protein binding: Approx 50%.
Metabolism: Extensively hydrolysed in the liver into active metabolite enalaprilat.
Excretion: Via urine (61%; 18% as enalapril, 43% as enalaprilat); faeces (33%; 6% as enalapril, 27% as enalaprilat). Elimination half-life: 2 hours (enalapril); approx 35 hours (enalaprilat).
Chemical Structure

Chemical Structure Image
Enalapril

Source: National Center for Biotechnology Information. PubChem Database. Enalapril, CID=5388962, https://pubchem.ncbi.nlm.nih.gov/compound/Enalapril (accessed on Mar. 26, 2020)

Storage
Tab: Store below 25°C. Protect from moisture. Oral solution: Store between 2-8°C. May store between 20-25°C for up to 60 days. Do not freeze and avoid excessive heat. Inj: Store at 25°C.
ATC Classification
C09AA02 - enalapril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.
References
Anon. Enalapril. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 06/11/2019.

Anon. Enalapril. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/11/2019.

Buckingham R (ed). Enalapril. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/11/2019.

Enalapril Maleate Tablet (Sandoz, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 06/11/2019.

Enalaprilat Injection (West-Ward Pharmaceuticals Corp). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 06/11/2019.

Epaned Solution (Silvergate Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 06/11/2019.

Joint Formulary Committee. Enalapril Maleate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/11/2019.

Disclaimer: This information is independently developed by MIMS based on Enalapril from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • BQL
  • Enam
  • Vexopril
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in