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Enalapril maleate: Indications, Dosing, Side Effects and Interactions
Enalapril maleate clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 8 min read
Enalapril maleate: Indications, Dosing, Side Effects and Interactions
Enalapril maleate clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Hypertension**
- **Adult** (By Mouth): Initially 5 mg once daily, lower initial doses may be required when used in addition to diuretic or in renal impairment; maintenance 20 mg once daily; maximum 40 mg per day.
**Heart failure**
- **Adult** (By Mouth): (under close medical supervision) Initially 2.5 mg once daily, increased if tolerated to 10-20 mg twice daily, dose to be increased gradually over 2-4 weeks.
**Prevention of symptomatic heart failure in patients with asymptomatic left ventricular dysfunction**
- **Adult** (By Mouth): (under close medical supervision) Initially 2.5 mg once daily, increased if tolerated to 10-20 mg twice daily, dose to be increased gradually over 2-4 weeks.
**Hypertension for enalapril maleate**
- **Neonate (under expert supervision)** (By mouth using tablets, or by mouth using oral solution): Initially 10 micrograms/kg once daily, monitor blood pressure carefully for 1-2 hours, increased if necessary up to 500 micrograms/kg daily in 1-3 divided doses, limited information.
- **Child 1 month-11 years (under expert supervision)** (By mouth using tablets, or by mouth using oral solution): Initially 100 micrograms/kg once daily, monitor blood pressure carefully for 1-2 hours, then increased if necessary up to 1 mg/kg daily in 1-2 divided doses.
- **Child 12-17 years (under expert supervision) (body-weight up to 50 kg)** (By mouth using tablets, or by mouth using oral solution): Initially 2.5 mg once daily, monitor blood pressure carefully for 1-2 hours, maintenance 10-20 mg daily in 1-2 divided doses.
- **Child 12-17 years (under expert supervision) (body-weight 50 kg and above)** (By mouth using tablets, or by mouth using oral solution): Initially 2.5 mg once daily, monitor blood pressure carefully for 1-2 hours, maintenance 10-20 mg daily in 1-2 divided doses; maximum 40 mg per day.
**Heart failure for enalapril maleate**
- **Neonate (under expert supervision)** (By mouth using tablets, or by mouth using oral solution): Initially 10 micrograms/kg once daily, monitor blood pressure carefully for 1-2 hours, increased if necessary up to 500 micrograms/kg daily in 1-3 divided doses, limited information.
- **Child 1 month-11 years (under expert supervision)** (By mouth using tablets, or by mouth using oral solution): Initially 100 micrograms/kg once daily, monitor blood pressure carefully for 1-2 hours, then increased if necessary up to 1 mg/kg daily in 1-2 divided doses.
- **Child 12-17 years (under expert supervision) (body-weight up to 50 kg)** (By mouth using tablets, or by mouth using oral solution): Initially 2.5 mg once daily, monitor blood pressure carefully for 1-2 hours, maintenance 10-20 mg daily in 1-2 divided doses.
- **Child 12-17 years (under expert supervision) (body-weight 50 kg and above)** (By mouth using tablets, or by mouth using oral solution): Initially 2.5 mg once daily, monitor blood pressure carefully for 1-2 hours, maintenance 10-20 mg daily in 1-2 divided doses; maximum 40 mg per day.
**Proteinuria in nephritis (under expert supervision) for enalapril maleate**
- **Neonate** (By mouth using tablets, or by mouth using oral solution): Initially 10 micrograms/kg once daily, monitor blood pressure carefully for 1-2 hours, increased if necessary up to 500 micrograms/kg daily in 1-3 divided doses, limited information.
- **Child 1 month-11 years** (By mouth using tablets, or by mouth using oral solution): Initially 100 micrograms/kg once daily, monitor blood pressure carefully for 1-2 hours, then increased if necessary up to 1 mg/kg daily in 1-2 divided doses.
- **Child 12-17 years (body-weight up to 50 kg)** (By mouth using tablets, or by mouth using oral solution): Initially 2.5 mg once daily, monitor blood pressure carefully for 1-2 hours, maintenance 10-20 mg daily in 1-2 divided doses.
- **Child 12-17 years (body-weight 50 kg and above)** (By mouth using tablets, or by mouth using oral solution): Initially 2.5 mg once daily, monitor blood pressure carefully for 1-2 hours, maintenance 10-20 mg daily in 1-2 divided doses; maximum 40 mg per day.
**Diabetic nephropathy (under expert supervision) for enalapril maleate**
- **Child 12-17 years (body-weight up to 50 kg)** (By mouth using tablets, or by mouth using oral solution): Initially 2.5 mg once daily, monitor blood pressure carefully for 1-2 hours; maintenance 10-20 mg daily in 1-2 divided doses.
- **Child 12-17 years (body-weight 50 kg and above)** (By mouth using tablets, or by mouth using oral solution): Initially 2.5 mg once daily, monitor blood pressure carefully for 1-2 hours; maintenance 10-20 mg daily in 1-2 divided doses; maximum 40 mg per day.
**Heart failure (initiated by a specialist) for Aqumeldi**
- **Neonate** (By mouth using orodispersible tablet): Test dose 10-40 micrograms/kg for 1 dose, test dose at the lower end of the recommended range should be used, monitor blood pressure carefully for 1-2 hours, then maintenance 150-300 micrograms/kg daily in 1-2 divided doses, to be started 8 hours after test dose, adjusted according to response.
- **Child** (By mouth using orodispersible tablet): Test dose 10-40 micrograms/kg for 1 dose (max. per dose 2 mg), monitor blood pressure carefully for 1-2 hours, then maintenance 150-300 micrograms/kg daily in 1-2 divided doses, to be started 8 hours after test dose, adjusted according to response; maximum 20 mg per day.
Cautions
For all angiotensin-converting enzyme inhibitors Concomitant diuretics; diabetes (may lower blood glucose; increased risk of hyperkalaemia); first dose hypotension (especially in patients taking high doses of diuretics, on a low-sodium diet, on dialysis, dehydrated, or with cerebrovascular disease, ischaemic heart disease, or heart failure); patients of black African or African-Caribbean origin (may respond less well to ACE inhibitors); peripheral vascular disease or generalised atherosclerosis (risk of clinically silent renovascular disease); primary aldosteronism (patients may respond less well to ACE inhibitors); the risk of agranulocytosis is possibly increased in collagen vascular disease (blood counts recommended); use with care in patients with aortic or mitral valve stenosis (risk of hypotension); use with care in patients with hypertrophic cardiomyopathy Cautions, further information Anaphylactoid reactions To prevent anaphylactoid reactions, ACE inhibitors should be avoided during dialysis with high-flux membranes (e.g. polyacrylonitrile) and during low-density lipoprotein apheresis with dextran sulfate; they should also be withheld before desensitisation with wasp or bee venom. M Elderly Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information). Potentially inappropriate: with hyperkalaemia with persistent postural hypotension i.e. recurrent drop in systolic blood pressure 20 mmHg (risk of syncope and falls)
Contraindications
For all angiotensin-converting enzyme inhibitors Hereditary or idiopathic angioedema; history of angioedema associated with prior ACE inhibitor therapy; the combination of an ACE inhibitor with aliskiren is contra-indicated in patients with an eGFR less than 60 mL/minute/1.73 m 2 ; the combination of an ACE inhibitor with aliskiren is contra-indicated in patients with diabetes mellitus
Side effects
For all angiotensin-converting enzyme inhibitors Common or very common Alopecia; angina pectoris; angioedema (can be delayed; more common in black patients); arrhythmias; asthenia; chest pain; constipation; cough; depression; diarrhoea; dizziness; drowsiness; dry mouth; dyspnoea; electrolyte imbalance; gastrointestinal discomfort; headache; hypotension; myalgia; nausea; palpitations; paraesthesia; renal impairment; rhinitis; skin reactions; sleep disorder; syncope; taste altered; tinnitus; vertigo; vomiting Uncommon Arthralgia; confusion; eosinophilia; erectile dysfunction; fever; haemolytic anaemia; hyperhidrosis; myocardial infarction; pancreatitis; peripheral oedema; photosensitivity reaction; respiratory disorders; stroke Rare or very rare Agranulocytosis; hepatitis; leucopenia; neutropenia; pancytopenia; Stevens-Johnson syndrome; thrombocytopenia Side-effects, further information In light of reports of cholestatic jaundice, hepatitis, fulminant hepatic necrosis, and hepatic failure, ACE inhibitors should be discontinued if marked elevation of hepatic enzymes or jaundice occur. Side-effects For enalapril maleate Common or very common Hypersensitivity; vision blurred Uncommon Anaemia; appetite decreased; asthma; bone marrow disorders; flushing; gastrointestinal disorders; hoarseness; hypoglycaemia; malaise; muscle cramps; nervousness; proteinuria; rhinorrhoea; sleep disorders; throat pain Rare or very rare Alveolitis allergic; autoimmune disorder; gynaecomastia; hepatic disorders; lymphadenopathy; oral disorders; Raynaud's phenomenon; toxic epidermal necrolysis Frequency not known SIADH
Interactions
**Severe interactions:**
- Potassium sparing diuretics (e.g., spironolactone, eplerenone, triamterene or amiloride), potassium supplements, potassium-containing salt substitutes, or other medicinal products that may increase...
**Other interactions (16):**
- Blockade of the renin-angiotensin-aldosterone system (RAAS) Clinical study data have shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE...
- Potassium sparing diuretics, potassium supplements, or other medicinal products that may increase serum potassium ACE inhibitors attenuate diuretic induced potassium loss.
- Diuretics (thiazide or loop diuretics) Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with enalapril (see section 4.4).
- Antihypertensives Concomitant use of these medicinal products may increase the hypotensive effects of enalapril.
- Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
- Concomitant use of thiazide diuretics may further increase lithium levels and enhance the risk of lithium toxicity with ACE inhibitors.
Pregnancy
Important safety information For all angiotensin-converting enzyme inhibitors MHRA/CHM advice: ACE inhibitors and angiotensin II receptor antagonists: not for use in pregnancy (December 2014) See Conception and contraception and Pregnancy . MHRA/CHM advice: ACE inhibitors and angiotensin II receptor antagonists: recommendations on how to use for breastfeeding (December 2014) See Breast feeding .
Breast feeding
For all angiotensin-converting enzyme inhibitors Information on the use of ACE inhibitors in breast-feeding is limited. Breast feeding For enalapril maleate Avoid in first few weeks after delivery, particularly in preterm infants-risk of profound neonatal hypotension; can be used in mothers breast-feeding older infants if essential but monitor infant's blood pressure.
Hepatic impairment
Enalapril is a prodrug.
Renal impairment
For all angiotensin-converting enzyme inhibitors Caution (hyperkalaemia and other side-effects of ACE inhibitors are more common in those with impaired renal function). M Dose adjustments Start with low dose and adjust according to response. M Renal impairment For enalapril maleate Dose adjustments See Prescribing in renal impairment . Max. initial dose 2.5 mg daily if creatinine clearance less than 30 mL/minute. M
Medicinal forms
Solution,Tablet,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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