Drug Detail:Enalapril (Enalapril (oral/injection) [ e-nal-a-pril ])
Drug Class: Angiotensin Converting Enzyme Inhibitors
Usual Adult Dose for Hypertension
Initial dose (oral tablets or solution): 5 mg orally once a day
Maintenance dose (oral tablets or solution): 10 to 40 mg orally per day as a single dose or in 2 divided doses
Maximum dose: 40 mg orally daily as a single dose or in 2 divided doses
In combination with diuretics:
Initial dose: 2.5 mg orally once a day
If feasible, the diuretic should be discontinued 2 to 3 days prior to initiation of therapy with enalapril. If required, diuretic therapy may be gradually resumed.
Parenteral: 1.25 to 5 mg IV over a 5 minute period every 6 hours
Comments:
- Clinical response is usually seen within 15 minutes after IV administration.
- If required, diuretic therapy may be gradually resumed.
Usual Adult Dose for Congestive Heart Failure
Initial dose: 2.5 mg orally once a day
Maintenance dose: 2.5 to 20 mg daily in 2 divided doses
Maximum dose: 40 mg orally per day in 2 divided doses
Comments:
- Treatment is usually combined with diuretics and digitalis.
- Doses should be titrated upward, as tolerated, over a period of a few days or weeks.
Usual Adult Dose for Left Ventricular Dysfunction
Initial dose: 2.5 mg orally twice a day
Maintenance dose: 20 mg orally per day in 2 divided doses
Comments:
- After the initial dose, the patient should be observed for at least 2 hours and until blood pressure has stabilized for at least an additional hour.
- If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension.
Usual Pediatric Dose for Hypertension
Oral tablets or solution:
Children 1 month to 17 years:
Initial dose: 0.08 mg/kg/day (up to 5 mg) in 1 to 2 divided doses. Adjust dosage based on patient response.
Maximum dose: Doses greater than 0.58 mg/kg (40 mg) have not been evaluated in pediatric patients.
Comment:
- Not recommended in neonates and in pediatric patients with glomerular filtration rate less than 30 mL/min, as no data are available.
Renal Dose Adjustments
CrCl 30 mL/min or less:
- Oral tablet: 2.5 mg once a day titrated upward until blood pressure is controlled up to a maximum of 40 mg orally daily in single or 2 divided doses
- Oral solution: Use a lower initial dose
- Intravenous: 0.625 mg every 6 hours and increase dose based on response
There are no data on the safety and efficacy of enalapril in neonates and pediatric patients with CrCl of less than 30 mL/min.
Liver Dose Adjustments
Data not available
Dose Adjustments
- In some patients treated with once daily dosing, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered.
- If blood pressure is not adequately controlled with enalapril alone, a diuretic may be added.
- If enalapril is added to a diuretic, the dose of diuretic should be reduced before the initiation of enalapril.
- To reduce the likelihood of hypotension, the diuretic should be discontinued 2 to 3 days prior to beginning therapy with enalapril. If blood pressure is not controlled with enalapril alone, diuretic therapy should be resumed.
- If diuretic therapy cannot be discontinued, an initial dose of 2.5 mg (oral) or 0.625 mg (IV) should be used with careful medical supervision for several hours and until blood pressure has stabilized.
Precautions
US BOXED WARNING:
- FETAL TOXICITY: If pregnancy is detected, this drug should be discontinued as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
IV solution: Safety and efficacy have not been established in patients younger than 18 years.
Oral solution: This drug is not recommended for use in neonates (1 month or younger), preterm infants less than 44 weeks (corrected post-conceptual age), or pediatric patients with CrCl less than 30 mL/min. Safety and efficacy have not been established in pediatric patients with heart failure or asymptomatic left ventricular dysfunction.
Oral tablet: This drug is not recommended for use in neonates or pediatric patients with CrCl less than 30 mL/min.
Consult WARNINGS section for dosing related precautions.
Dialysis
Enalapril is removed by hemodialysis (20% to 50%)
Hemodialysis: 2.5 mg on dialysis days; oral solution: Use a lower initial dose.
The dosage on nondialysis days should be adjusted according to blood pressure response.
Other Comments
Administration Advice:
- May be taken without regard to meals.
- Generally, the use of IV enalapril is not recommended for more than 7 days.
General:
- In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of enalapril.
- Compared with Caucasian patients, Black patients have a reduced blood pressure response to monotherapy with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers; however, the reduced response is largely eliminated if combination therapy that includes an adequate dose of a diuretic is instituted.
- Following first time MI, all ACE inhibitors, at comparable appropriate dosages, appear to be equally effective for reducing mortality and recurrent MI rates.
Monitoring:
- Hepatic: Liver function tests should be monitored during enalapril therapy. It is recommended to discontinue enalapril and initiate appropriate treatment in patients who develop jaundice and/or experience a marked increase in hepatic enzymes.
Patient advice:
- Advise patients to immediately report any signs or symptoms suggestive of angioedema (swelling of face, eyes, lips, tongue, or extremities, or difficulty swallowing or breathing).