Uses
Hypertension
Management of hypertension (alone or in combination with other classes of antihypertensive agents). May use enalaprilat when oral therapy is not practical.
One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, high coronary disease risk, diabetes mellitus, chronic renal failure, and/or cerebrovascular disease.
Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.
Enalaprilat has been used effectively to control BP in adults with severe hypertension or hypertensive emergencies†.
Enalaprilat has been used for rapid reduction of BP in pediatric patients 1–17 years of age† with hypertensive urgencies or emergencies.
CHF
Management of symptomatic CHF, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.
Asymptomatic Left Ventricular Dysfunction
Treatment of clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35%) to improve survival and to reduce the incidence of overt heart failure and subsequent hospitalizations for CHF.
Diabetic Nephropathy
A first-line agent in the treatment of diabetic nephropathy† in hypertensive patients with type 2 diabetes mellitus.
Dosage and Administration
General
Hypertension
Administration
Administer enalapril orally once or twice daily; administer enalaprilat every 6 hours by slow IV infusion. Do not administer enalaprilat by other parenteral routes.
Oral Administration
Administer enalapril orally without regard to meals. Administer as extemporaneously prepared oral suspension in patients unable to swallow tablets.
Administer enalapril/felodipine fixed combination (Lexxel®) either without food or with a light meal (administration with substantial meal increases peak plasma felodipine concentrations). Swallow tablets whole; do not crush, chew, or divide.
Reconstitution
Preparation of extemporaneous suspension containing enalapril maleate 1 mg/mL: Add 50 mL of sodium citrate dihydrate (Bicitra®) to a polyethylene terephthalate (PET) bottle containing ten 20-mg tablets of enalapril maleate; shake contents for ≥2 minutes. Allow concentrated suspension to stand for 60 minutes following reconstitution, then shake for an additional minute. Dilute concentrated suspension with 150 mL of syrup (Ora-Sweet SF®); shake container to disperse ingredients. Shake suspension before dispensing each dose.
IV Administration
Administer enalaprilat by slow IV infusion as undiluted or diluted solution.
Dilution
Can dilute enalaprilat injection with up to 50 mL of compatible IV infusion solution.
For solution and drug compatibility information, see Compatibility under Stability.
Rate of Administration
Infuse dose over ≥5 minutes. In patients at risk of excessive hypotension, infusion of dose over up to 1 hour is preferred.
Dosage
Available as enalapril maleate (oral tablets); dosage expressed in terms of the salt. Also available as enalaprilat (IV injection); dosage expressed in terms of the base.
Dosage of enalapril and enalaprilat are not identical; caution when converting from oral to IV therapy or vice versa.
Pediatric Patients
Hypertension
Oral
Children 1 month to 16 years of age: Enalapril 0.08 mg/kg (up to 5 mg) once daily.
Adjust dosage until the desired BP goal is achieved (up to maximum dosage of 0.58 mg/kg or 40 mg).
Hypertensive Urgencies or Emergencies
Rapid Reduction of BP
IV
Children and adolescents 1–17 years of age: 0.05–0.1 mg/kg per dose (up to 1.25 mg per dose) given by direct IV injection†.†
Adults
Hypertension
Oral
Initially, enalapril 2.5–5 mg daily as monotherapy. Adjust dosage at 2- to 4-week intervals to achieve BP control.
In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating enalapril. May cautiously resume diuretic therapy if BP not controlled adequately with enalapril alone. If diuretic cannot be discontinued, give initial enalapril dose of 2.5 mg under close medical supervision (observe patient for ≥2 hours and until BP has stabilized for at least an additional hour).
When switching from IV enalaprilat to oral enalapril, initiate enalapril at 5 mg once daily as monotherapy. If used with a diuretic, 2.5 mg once daily (in patients who responded to enalaprilat 0.625 mg every 6 hours). Adjust dosage as necessary.
Usual dosage: Enalapril 10–40 mg daily, given in 1 dose or 2 divided doses.
If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering drug in 2 divided doses.
IV
Initially, enalaprilat 1.25 mg every 6 hours in patients not receiving a diuretic or in those converting from enalapril monotherapy.
In patients receiving a diuretic, enalaprilat 0.625 mg initially. If BP response after 1 hour is inadequate, administer another dose of 0.625 mg. May administer additional doses of 1.25 mg at 6-hour intervals.
In patients at risk of marked hypotension (see Hypotension under Cautions), ≤0.625 mg of enalaprilat initially, given by slow IV infusion (over ≥5 minutes, preferably up to 1 hour) under very close medical supervision.
Enalapril/Hydrochlorothiazide Combination Therapy
Oral
If BP is not adequately controlled by monotherapy with either enalapril or hydrochlorothiazide, or if stable dosages of these drugs have been achieved, can switch to the fixed-combination preparation containing enalapril 5 mg and hydrochlorothiazide 12.5 mg or, alternatively, enalapril 10 mg and hydrochlorothiazide 25 mg.
Adjust dosage of either or both drugs according to patient’s response.
Enalapril/Felodipine Combination Therapy
Oral
If BP is not adequately controlled by monotherapy with either enalapril (or another ACE inhibitor) or felodipine (or another dihydropyridine-derivative calcium-channel blocking agent), can switch to the fixed-combination preparation containing enalapril 5 mg and felodipine 5 mg daily. If BP is not adequately controlled after 1 or 2 weeks, increase dosage to enalapril 10 mg and felodipine 10 mg once daily. If necessary, may increase dosage to enalapril 20 mg and felodipine 10 mg once daily.
If control of BP is still inadequate, consider adding a thiazide diuretic.
CHF
Oral
Manufacturer recommends initial enalapril dosage of 2.5 mg twice daily. Usual maintenance dosage: 2.5–20 mg twice daily.
Some clinicians recommend initial enalapril dosage of 2.5 mg once or twice daily in patients with normal renal function and serum sodium concentration. Usual maintenance dosage: 2.5–20 mg daily, given in 2 divided doses.
Following initial dose, monitor closely for ≥2 hours and until BP has stabilized for at least an additional hour. To minimize risk of hypotension, reduce diuretic dosage, if possible, prior to initiating therapy. Adjust dosage gradually over several weeks to prespecified target (≥20 mg daily) or maximum tolerated dosage.
In patients with hyponatremia (serum sodium concentration <130 mEq/L), manufacturer recommends initial enalapril dosage of 2.5 mg daily under close monitoring. Increase dosage at intervals of ≥4 days, to 2.5 mg twice daily, then 5 mg twice daily, and then higher, provided excessive hypotension or deterioration of renal function is not present at the time of intended dosage adjustment; dosage should not exceed 40 mg daily.
Asymptomatic Left Ventricular Dysfunction
Oral
Initially, enalapril 2.5 mg twice daily. Titrate upward as tolerated to target dosage of 20 mg daily, given in divided doses. Following initial dose, monitor closely for ≥2 hours and until BP has stabilized for at least an additional hour. To minimize risk of hypotension, reduce diuretic dosage, if possible, prior to initiating therapy.
Prescribing Limits
Pediatric Patients
Hypertension
Oral
Maximum 0.58 mg/kg or 40 mg of enalapril daily.
Adults
Hypertension
Oral
Dosage of enalapril/hydrochlorothiazide fixed combination generally should not exceed enalapril 20 mg and hydrochlorothiazide 50 mg daily.
IV
Enalaprilat dosages up to 5 mg every 6 hours were well tolerated for up to 36 hours in controlled clinical studies. Insufficient experience with dosages >20 mg daily.
Usually not administered for >48 hours, but has been administered for as long as 7 days.
CHF
Oral
Maximum 40 mg of enalapril daily, given in 2 divided doses.
Special Populations
Dosage in Renal Impairment
Hypertension
Oral
Patients with Clcr >30 mL/minute: Manufacturer states that no dosage adjustment is required.
Adults with Clcr ≤30 mL/minute or Scr ≥3 mg/dL: Manufacturer recommends initial enalapril dosage of 2.5 mg once daily; titrate until BP is controlled or to maximum of 40 mg daily. When switching from IV enalaprilat, initiate oral therapy at 2.5 mg once daily; adjust dosage according to patient’s BP response. Manufacturer does not recommend use of enalapril in pediatric patients with Clcr <30 mL/minute per 1.73 m2.
Some clinicians recommend dosage of 75–100% of usual enalapril dosage in patients with Clcr of 10–50 mL/minute and dosage of 50% of usual enalapril dosage in those with Clcr <10 mL/minute.
Hemodialysis patients: Enalapril 2.5 mg on dialysis days; on days between dialysis, adjust dosage according to BP response.
IV
Adults with Clcr >30 mL/minute: No dosage adjustment required.
Adults with Clcr ≤30 mL/minute or Scr ≥3 mg/dL: Enalaprilat 0.625 mg initially. If BP response after 1 hour is inadequate, administer another dose of 0.625 mg. May administer additional doses of 1.25 mg at 6-hour intervals.
Hemodialysis patients: Enalaprilat 0.625 mg every 6 hours.
Enalapril/Hydrochlorothiazide Combination Therapy
Oral
Not recommended in patients with severe renal impairment.
Enalapril/Felodipine Combination Therapy
Oral
Adults with Clcr ≤30 mL/minute or Scr >3 mg/dL: Enalapril 2.5 mg daily recommended by manufacturer.
CHF
Oral
Patients with Scr >1.6 mg/dL: Enalapril 2.5 mg daily initially under close monitoring. Increase dosage at intervals of ≥4 days, to 2.5 mg twice daily, then 5 mg twice daily, and then higher, provided excessive hypotension or deterioration of renal function is not present at the time of intended dosage adjustment; do not exceed 40 mg daily.
Geriatric Patients
Hypertension
Initiate therapy with enalapril/hydrochlorothiazide fixed combination at lower end of usual range.
Initiate therapy with enalapril/felodipine fixed combination with initial enalapril dosage of 2.5 mg daily.
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