Enalapril maleate oral solution 1 mg/mL

Enalapril maleate · SOLUTION · Bionpharma Inc.

No Recall History

Plain English

Enalapril maleate oral solution is a solution containing enalapril maleate at 1 mg/mL, taken oral. Manufactured by Bionpharma Inc..

Key Facts

Brand Name: Enalapril maleate oral solution
Generic Name: Enalapril maleate
NDC Code (Product): 69452-237
Manufacturer: Bionpharma Inc.
Strength: 1 mg/mL
Dosage Form: SOLUTION
Route: ORAL
Marketing Status
Application #: ANDA212408
Marketing Start: 08/11/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea985 reports

nausea982 reports

dyspnoea947 reports

fatigue838 reports

dizziness804 reports

drug interaction783 reports

drug ineffective720 reports

vomiting710 reports

asthenia656 reports

pain644 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Enalapril maleate is an angiotensin-converting enzyme inhibitor indicated for: • treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • 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 ) 1.1 Hypertension Enalapril maleate oral solution is indicated for the treatment of hypertension, to lower blood pressure in adults and children older than one month [see Pediatric Use ( 8.4 ) and Clinical Studies ( 14 )]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diab…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Hypertension • Adult: recommended initial dose is 5 mg once daily. Maximum dose is 40 mg daily. ( 2.1 ) • Pediatrics: recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily. ( 2.1 ) 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. 2.1 Hypertension Adults: The recommended initial dose in adults is 5 mg taken orally once a day. Titrate upward to maximum of 40 mg daily as needed to help achieve blood pressure goals. The dose may be divided and administered twice daily if the antihypertensive effect diminishes at the end of the dosing interval. Use with diuretics: If additional blood pressure reduction is needed, enalapril maleate oral solution may be administered with a low dose of diuretic. The recommended initial dose in patients taking diuretics is 2.5 mg daily. Dosage Adjustment for Renal Impairment: See table below. The dosage may be titrated upward as needed to a maximum of 40 mg daily. Renal…

Contraindications

4 CONTRAINDICATIONS Enalapril maleate oral solution is contraindicated in patients with: • a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme (ACE) inhibitor. [see Warnings and Precautions ( 5.2 )] • hereditary or idiopathic angioedema. [see Warnings and Precautions ( 5.2 )] Do not co-administer aliskiren with enalapril maleate oral solution in patients with diabetes [see Drug Interactions ( 7.2 )]. Enalapril maleate oral solution is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril maleate oral solution within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions ( 5.2 )]. • 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 )

Drug Interactions

7 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 ) 7.1 Non-Steroidal Anti-Inflammatory Agents (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including enalapril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving enalapril and NSAID therapy. In a clinical pharmacology study, indomethacin or sulindac was administered to hypertensiv…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere: • Angioedema [see Warnings and Precautions ( 5.2 )] • Hypotension [see Warnings and Precautions ( 5.3 )] • Hepatic failure [see Warnings and Precautions ( 5.4 )] • Renal impairment [see Warnings and Precautions ( 5.5 )] • Hyperkalemia [see Warnings and Precautions ( 5.6 )] • The most common adverse reaction for patients treated for hypertension (≥3%) was fatigue. ( 6.1 ) • The most common adverse reactions for patients treated for heart failure (>6%) were hypotension and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Enalapril has been evaluated for safety in more than 10,000 patients, including over 1,000 patients treated for one year or more. In clinical trials, discontinuation of therapy for clinical advers…

Frequently Asked Questions

What is Enalapril maleate oral solution used for?

Enalapril maleate oral solution contains Enalapril maleate. It is a solution taken oral. Consult your doctor for specific uses.

Is Enalapril maleate oral solution a controlled substance?

Enalapril maleate oral solution is not classified as a controlled substance by the DEA.

What is the generic name for Enalapril maleate oral solution?

The generic name for Enalapril maleate oral solution is Enalapril maleate. There are 12 other brand versions of Enalapril maleate.

What is the NDC code for Enalapril maleate oral solution 1 mg/mL?

The NDC (National Drug Code) for Enalapril maleate oral solution 1 mg/mL is 69452-237, listed by Bionpharma Inc..

Product NDC

69452-237

Package NDC

69452-237-46

Other Enalapril Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)