Clinical Information
Gen. Code and Des.
76637 enalapril maleate ORAL SOLUTION 1 MG/ML
GCN and Des.
42337 enalapril maleate ORAL SOLUTION 1 MG/ML
Strength
1MG-ML
Dose Form
SOLUTION, ORAL
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
24320400 ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
24084404 ANGIOTENSIN-CONVERT.ENZYME INHIB(HYPOTN)
Active Ingredients
657 enalapril maleate 76095164
Inactive Ingredients
2468 propylene glycol 57556
2599 sorbitol 50704
3203 paraben 99967
These highlights do not include all the information needed to use ENALAPRIL MALEATE ORAL SOLUTION safely and effectively. See full prescribing information for ENALAPRIL MALEATE ORAL SOLUTION.
ENALAPRIL MALEATE oral solution
Initial U.S. Approval: 1985
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue enalapril maleate oral solution as soon as possible. ( 5.1)
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1)
INDICATIONS AND USAGE
Enalapril is an angiotensin-converting enzyme inhibitor indicated for:
treatment of symptomatic heart failure. ( 1.2)
treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure. ( 1.3)
DOSAGE AND ADMINISTRATION
Heart Failure: Initiate at 2.5 mg twice daily. Titrate up to 20 mg twice daily as tolerated. ( 2.2)
Asymptomatic Left Ventricular Dysfunction: Initiate at 2.5 mg twice daily. Titrate up to 10 mg twice daily. ( 2.3)
Enalapril maleate oral solution is a ready-to-use solution intended for oral use only.
DOSAGE FORMS AND STRENGTHS
Enalapril maleate oral solution is a ready-to-use oral solution: 1 mg/mL enalapril maleate, USP. ( 3)
CONTRAINDICATIONS
Hypersensitivity related to previous treatment with an ACEI. ( 4)
Hereditary or idiopathic angioedema. ( 4)
Do not co-administer aliskiren in patients with diabetes. ( 4)
In combination with a neprilysin inhibitor. ( 4)
WARNINGS AND PRECAUTIONS
Angioedema and Anaphylactoid Reactions. ( 5.2)
Impaired Renal Function: Assess renal function. ( 5.5)
Hyperkalemia. ( 5.6)
ADVERSE REACTIONS
The most common adverse reactions for patients treated for heart failure (>6%) were hypotension and dizziness. ( 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
In patients who are elderly, volume-depleted (as on diuretic therapy), or with compromised renal function, use with NSAIDs, including selective COX-2 inhibitors, may result in deterioration of renal function, including renal failure. Monitor renal function periodically. ( 7.1)
Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia. ( 7.2)
Avoid potassium sparing agents in patients with heart failure. ( 7.3)
Monitor serum lithium levels frequently. ( 7.4)
USE IN SPECIFIC POPULATIONS
Enalapril is not recommended in neonates and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m 2. ( 8.4)
Lactation: Advise not to breastfeed. ( 8.2)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 6/2022
