Enalapril Maleate 20 mg/1
Enalapril Maleate · TABLET · Solco Healthcare US, LLC
Enalapril is a prescription medication taken by mouth that helps lower blood pressure and is used to treat heart failure and kidney disease related to diabetes. It works by relaxing blood vessels to improve blood flow and reduce the workload on your heart.
Key Facts
- Brand Name
- Enalapril Maleate
- Generic Name
- Enalapril Maleate
- NDC Code (Product)
43547-548- Manufacturer
- Solco Healthcare US, LLC
- Strength
- 20 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA213273
- Marketing Start
- 07/31/2022
Recall History
MAJOR PHARMACEUTICALS
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Apotex Inc.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Valeant Pharmaceuticals North America LLC
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Golden State Medical Supply Inc.
CGMP Deviations
Apace KY LLC
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Wockhardt Limited
Failed Impurities/Degradation Specifications
AMERICAN HEALTH PACKAGING
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Golden State Medical Supply Inc.
CGMP Deviations
Aidarex Pharmaceuticals LLC
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Wockhardt Limited
Failed Impurities/Degradation Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Hypertension Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. Heart Failure Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). Asymptomatic Left Ventricular Dysfunction In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). In using enalapril maleate consideration should be given to the fact that another an…
Dosage & Administration
DOSAGE AND ADMINISTRATION Hypertension In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of enalapril maleate. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with enalapril maleate to reduce the likelihood of hypotension (see WARNINGS, Hypotension ). If the patient's blood pressure is not controlled with enalapril maleate alone, diuretic therapy may be resumed. If the diuretic cannot be discontinued an initial dose of 2.5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS, Hypotension and PRECAUTIONS, Drug Interactions ). The recommended initial dose in patients not on diuretics is 5 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 10 mg to 40 mg per day administered in a single dose or two divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration shoul…
Warnings
WARNINGS Anaphylactoid and Possibly Related Reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including enalapril maleate) may be subject to a variety of adverse reactions, some of them serious. Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin-converting enzyme inhibitors, including enalapril maleate. This may occur at any time during treatment. In such cases enalapril maleate should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred. In instances where swelling has been confined to the face and lips the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema associated with laryngeal edema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine solution 1:100…
Contraindications
CONTRAINDICATIONS Enalapril maleate is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. Do not coadminister aliskiren with enalapril maleate in patients with diabetes (see PRECAUTIONS, Drug Interactions ). Enalapril maleate is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril maleate within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS, Head and Neck Angioedema ).
Drug Interactions
Drug Interactions Neprilysin Inhibitors Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema (see WARNINGS ). Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function, and electrolytes in patients on enalapril maleate and other agents that affect the RAS. Do not coadminister aliskiren with enalapril maleate in patients with diabetes. Avoid use of aliskiren with enalapril maleate in patients with renal impairment (GFR <60 mL/min). Hypotension — Patients on Diuretic Therapy Patients on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with enalapril. The possibility of hyp…
Adverse Reactions
ADVERSE REACTIONS Enalapril maleate has been evaluated for safety in more than 10,000 patients, including over 1000 patients treated for one year or more. Enalapril maleate has been found to be generally well tolerated in controlled clinical trials involving 2987 patients. For the most part, adverse experiences were mild and transient in nature. In clinical trials, discontinuation of therapy due to clinical adverse experiences was required in 3.3 percent of patients with hypertension and in 5.7 percent of patients with heart failure. The frequency of adverse experiences was not related to total daily dosage within the usual dosage ranges. In patients with hypertension the overall percentage of patients treated with enalapril maleate reporting adverse experiences was comparable to placebo. Hypertension Adverse experiences occurring in greater than one percent of patients with hypertension treated with enalapril maleate in controlled clinical trials are shown below. In patients treated with enalapril maleate, the maximum duration of therapy was three years; in placebo-treated patients the maximum duration of therapy was 12 weeks. Enalapril Maleate (n = 2314) Incidence (discontinuatio…
Frequently Asked Questions
What is Enalapril Maleate used for?
Enalapril is a prescription medication taken by mouth that helps lower blood pressure and is used to treat heart failure and kidney disease related to diabetes. It works by relaxing blood vessels to improve blood flow and reduce the workload on your heart.
Is Enalapril Maleate a controlled substance?
Enalapril Maleate is not classified as a controlled substance by the DEA.
What is the generic name for Enalapril Maleate?
The generic name for Enalapril Maleate is Enalapril Maleate. There are 3 other brand versions of Enalapril Maleate.
What is the NDC code for Enalapril Maleate 20 mg/1?
The NDC (National Drug Code) for Enalapril Maleate 20 mg/1 is 43547-548, listed by Solco Healthcare US, LLC.