Generic Name
Enalapril
Brand Names
Epaned, Vaseretic, Vasotec
FDA approval date: December 24, 1985
Classification: Angiotensin Converting Enzyme Inhibitor
Form: Tablet, Solution
What is Epaned (Enalapril)?
EPANED 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.
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Brand Information
Epaned (enalapril maleate)
WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue EPANED
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
1DOSAGE FORMS AND STRENGTHS
EPANED is a ready-to-use oral solution that contains 1 mg/mL of enalapril maleate. It is a clear, colorless solution with a mixed berry flavor packaged in a 150 mL white, round, high-density polyethylene bottle with a white, polypropylene, child-resistant cap and tamper-evident seal. Each bottle contains 150 mL.
2CONTRAINDICATIONS
EPANED is contraindicated in patients with:
- a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme (ACE) inhibitor
- hereditary or idiopathic angioedema
Do not co-administer aliskiren with EPANED in patients with diabetes
EPANED is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer EPANED within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor
3ADVERSE REACTIONS
The following adverse reactions are described elsewhere:
- Angioedema
- Hypotension
- Hepatic failure
- Renal impairment
- Hyperkalemia
3.1Clinical 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 adverse experiences was required in 3.3% of patients with hypertension and in 5.7% of patients with heart failure.
Hypertension
Adverse reactions (where rate on enalapril exceeds the rate on placebo by at least 0.2%) occurring in greater than 1% of patients with hypertension treated with enalapril in controlled clinical trials are shown below. In patients treated with enalapril, the maximum duration of therapy was three years; in placebo treated patients, the maximum duration of therapy was 12 weeks.
Heart Failure
Adverse reactions seen in clinical trials of heart failure were similar to those seen in clinical trials for hypertension. In patients treated for heart failure, there was an increased incidence of hypotension 6.7 percent versus 0.6 percent in placebo and dizziness 7.9 percent versus 0.6 percent in placebo.
3.2Other Adverse Reactions from Clinical Studies or Postmarketing Experience
The following adverse reactions have been reported in clinical studies or postmarketing experience with enalapril. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Other serious clinical adverse experiences occurring since the drug was marketed or adverse experiences occurring in 0.5 to 1.0% of patients with hypertension or heart failure in clinical trials are listed below and, within each category, are in order of decreasing severity.
Cardiovascular:Cardiac arrest; myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients [see Warnings and Precautions ( ; pulmonary embolism and infarction; pulmonary edema; rhythm disturbances, including atrial tachycardia and bradycardia; atrial fibrillation; palpitation; Raynaud's phenomenon.
Digestive:Ileus, pancreatitis, melena, anorexia, dyspepsia, constipation, glossitis, stomatitis, dry mouth.
Hematologic:Rare cases of neutropenia, thrombocytopenia, and bone marrow depression.
Musculoskeletal:Muscle cramps.
Nervous/Psychiatric:Depression, confusion, ataxia, somnolence, insomnia, nervousness, peripheral neuropathy (e.g., paresthesia, dysesthesia), dream abnormality.
Respiratory:Bronchospasm, rhinorrhea, sore throat and hoarseness, asthma, upper respiratory infection, pulmonary infiltrates, eosinophilic pneumonitis.
Skin:Exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, pemphigus, herpes zoster, erythema multiforme, urticaria, pruritus, alopecia, flushing, diaphoresis, photosensitivity.
Special Senses:Blurred vision, taste alteration, anosmia, tinnitus, conjunctivitis, dry eyes, tearing.
Urogenital:Flank pain, gynecomastia, impotence.
Miscellaneous:A symptom complex has been reported which may include some or all of the following: a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia/myositis, fever, serositis, vasculitis, leukocytosis, eosinophilia, photosensitivity, dermatologic manifestations.
4OVERDOSAGE
Limited data are available in regard to overdosage in humans.
Single oral doses of enalapril above 1,000 mg/kg and ≥1,775 mg/kg were associated with lethality in mice and rats, respectively.
The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution.
Enalaprilat may be removed from general circulation by hemodialysis and has been removed from neonatal circulation by peritoneal dialysis
5DESCRIPTION
EPANED (enalapril maleate) Oral Solution is the maleate salt of enalapril, the ethyl ester prodrug of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C
Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.52. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol.
EPANED Oral Solution is a ready-to-use oral solution. Each 1 mL contains 1 mg of enalapril maleate, USP equivalent to 0.764 mg of enalapril. Inactive ingredients include citric acid, mixed berry flavor, purified water, sodium benzoate, sodium citrate, and sucralose. It may also contain hydrochloric acid or sodium hydroxide for pH adjustment. EPANED Oral Solution is clear and colorless.
6HOW SUPPLIED/STORAGE AND HANDLING
EPANED is a ready-to-use solution that contains 1 mg/mL of enalapril maleate. It is a clear, colorless oral solution with a mixed berry flavor, packaged in a 150-mL, white, round, high-density polyethylene bottle with a white, polypropylene, child-resistant cap and tamper-evident seal. Each bottle contains 150 mL.
NDC 52652-4001-1
Store refrigerated (2°C-8°C/36°F-46°F) in a tightly closed container. Patients may store EPANED either refrigerated (2°C-8°C/36°F-46°F) or at room temperature (20°C-25°C/68°F-77°F). If stored at room temperature, discard after 60 days. Avoid freezing and excessive heat.
7PATIENT COUNSELING INFORMATION
- Pregnancy
Tell female patients of childbearing age about the consequences of exposure to EPANED during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
- Angioedema
Angioedema, including laryngeal edema, may occur at any time during treatment with angiotensin-converting enzyme inhibitors, including enalapril. Advise patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, or tongue, or difficulty in swallowing or breathing) and to consult with the prescribing physician before taking more drug.
- Hypotension
Caution patients to report lightheadedness, especially during the first few days of therapy. If actual syncope occurs, tell patients to discontinue the drug until they have consulted with the prescribing physician.
Tell patients that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; advise patients to consult with their physician.
- Hyperkalemia
Tell patients to consult their physician prior to using salt substitutes containing potassium.
8PRINCIPAL DISPLAY PANEL - Bottle Label
NDC 52652-4001-1
Epaned
Oral Solution
For Oral Use Only
READY TO USE
150 mL
azurity™
Rx Only
Each 1 mL contains 1 mg
Usual Dose: See prescribing information.
Store refrigerated
Patients may store Epaned
KEEP THIS AND ALL
P/N 141145
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