epaned
Pharmaranks rates Epaned 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Epaned (Enalapril Maleate) is an angiotensin converting enzyme inhibitor used to treat Rheumatoid Arthritis, Bartter Syndrome, Diabetic Nephropathies, Edema.
Enalapril Maleate · by Azurity
Available as a generic: Enalapril Maleate
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Enalapril Maleate
- Drug class
- Angiotensin Converting Enzyme Inhibitor
- Form
- Solution
- Strength
- Enalapril Maleate 1MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Azurity
- What the pharmacy pays
- ~$0.07 per ml — not your price
- FDA application
- NDA208686
- FDA boxed warning
- Yes — see the boxed warning
What is Epaned?
From the FDA label: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 20 H 28 N 2 O 5 •C 4 H 4 O 4 , and its structural formula is: 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. Enalapril maleate 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. Enalapril maleate oral solution is clear and colorless. Structural Formula
How to use
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 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 Status Creatinine-Clearance mL/min Initial Dose mg/day Normal or Mild Impairment of Renal Function >30 mL/min 5 mg Moderate to Severe Impairment ≤30 mL/min 2.5 mg Dialysis Patients [See Warnings and Precautions ( 5.2)] . Should be taken after…
Side effects
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 Wilshire Pharmaceuticals, Inc. at 1-877-495-6856 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 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%)…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
FETAL TOXICITY • When pregnancy is detected, discontinue ENALAPRIL MALEATE as soon as possible. [See Warnings and Precautions ( 5.1 )] • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. [See Warnings and Precautions ( 5.1 )] WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue ENALAPRIL MALEATE 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 ).
Warnings
Important safety information
Angioedema and Anaphylactoid Reactions ( 5.2 ). Impaired Renal Function: Assess renal function ( 5.5 ). Hyperkalemia ( 5.6 ). 5.1 Fetal Toxicity Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue enalapril maleate as soon as possible [see Use in Specific Populations ( 8.1 )] . 5.2 Angioedema and Anaphylactoid Reactions Angioedema Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis and/or larynx, including some fatal reactions, have occurred in patients treated with angiotensin converting enzyme inhibitors, including enalapril maleate, at any time during treatment. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery. Enalapril maleate should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms of angioedema has occurred. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor [see Contraindications ( 4 )] . ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients. Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema [see Drug Interactions ( 7.6 , 7.7 )]. Intestinal Angioedema Intestinal angioedema has occurred in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. In some cases, the angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Anaphylactoid Reactions Anaphylactoid Reactions during Desensitization Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. Anaphylactoid Reactions during Dialysis Sudden and potentially life-threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. In such patients, dialysis must be stopped immediately, and aggressive therapy for anaphylactoid reactions must be initiated. Symptoms have not been relieved by antihistamines in these situations. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption. 5.3 Hypotension Enalapril maleate can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia, acute renal failure or death. Patients at risk of excessive hypotension include those with the following conditions or characteristics: heart failure with systolic blood pressure below 100 mmHg, ischemic heart disease, cerebrovascular disease, hyponatremia, high dose diuretic therapy, renal dialysis, or severe volume and/or salt depletion of any etiology. In these patients, enalapril maleate should be started under very close medical supervision and such patients should be followed closely for the first two weeks of treatment and whenever the dose of enalapril maleate and/or diuretic is increased. Symptomatic hypotension is also possible in patients with severe aortic stenosis or hypertrophic cardiomyopathy. Surgery/Anesthesia In patients undergoing major surgery or during anesthesia with agents that produce hypotension, enalapril maleate may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be through this mechanism, it can be corrected by volume expansion. 5.4 Hepatic Failure Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis, and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up. 5.5 Impaired Renal Function Monitor renal function in patients treated with enalapril maleate. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, post-myocardial infarction or volume depletion) may be at particular risk of developing acute renal failure on enalapril maleate. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on enalapril maleate [see Adverse Reactions (6.2) and Drug Interactions (7.2, 7.3)]. 5.6 Hyperkalemia Serum potassium should be monitored in patients receiving enalapril maleate. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes [see Drug Interactions ( 7.3 )].
Who should not take Epaned
Enalapril maleate 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 in patients with diabetes [see Drug Interactions ( 7.2 )] . 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 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 ).
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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 hypertensive patients receiving enalapril maleate. In this study, there was no evidence of a blunting of the antihypertensive action of enalapril maleate. However, reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. 7.2 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. In most patients no benefit has been associated with using two RAS inhibitors concomitantly. 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 co-administer aliskiren with enalapril maleate in patients with diabetes. Avoid use of aliskiren with enalapril maleate in patients with renal impairment (GFR <60 mL/min). 7.3 Agents Increasing Serum Potassium Enalapril maleate attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. 7.4 Lithium Lithium toxicity has been reported in patients receiving enalapril and lithium concomitantly which was generally reversible. It is recommended that serum lithium levels be monitored frequently if enalapril is administered concomitantly with lithium. 7.5 Gold Nitritoid reactions (symptoms include facial flushing, nausea, vomiting, and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including enalapril. 7.6 mTOR Inhibitors Patients taking concomitant mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema [ see Warnings and Precautions (5.2) ]. 7.7 Neprilysin Inhibitor Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema [see Warnings and Precautions ( 5.2 )] .
Foods & drinks to be careful with
Well-established interactions for this medicine’s drug class, summarized from public health authorities. General information, not medical advice — always confirm with your pharmacist or the label.
Potassium-rich foods & salt substitutes
Watch out for: salt substitutes containing potassium, and large amounts of potassium-rich foods or supplements.
These medicines can raise blood potassium. Adding a lot of extra potassium can push it too high (hyperkalemia), which can affect the heart.
What to do: Don't use potassium-based salt substitutes unless your clinician approves, and ask before taking potassium supplements. Your clinician may check your potassium level with blood tests.
Source: Lisinopril (an ACE inhibitor) — MedlinePlus (U.S. National Library of Medicine) · Spironolactone (a potassium-sparing diuretic) — MedlinePlus (U.S. National Library of Medicine)
Drug class
May treat (source: NIH RxClass)
See how Epaned ranks — best-rated angiotensin converting enzyme inhibitor for:
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Epaned treat?
- Epaned (Enalapril Maleate) may be used to treat rheumatoid arthritis, bartter syndrome, diabetic nephropathies, edema, heart failure, malignant hypertension, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Epaned rated?
- pharmaranks gives Epaned a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Epaned cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.07 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Epaned?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Epaned. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Epaned?
- Epaned is marketed by Azurity. You can see Azurity's full profile, rating, and other products on pharmaranks.
- Is Epaned a brand-name or generic drug?
- Epaned is a brand-name product with the active ingredient Enalapril Maleate. Lower-cost generic equivalents containing Enalapril Maleate are available — ask your pharmacist.
- Is Epaned available over the counter?
- No. Epaned is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Epaned come in?
- Epaned is currently marketed as solution, per the FDA's National Drug Code Directory.
- What class of drug is Epaned?
- Epaned is classified as angiotensin converting enzyme inhibitor, per the FDA's Established Pharmacologic Class.
- Is Epaned FDA-registered?
- Epaned is on record with the U.S. FDA under application number NDA208686. You can verify this on its official FDA label.
- Has Epaned been recalled by the FDA?
- Epaned has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Epaned safe?
- There's no single safe-or-not verdict. pharmaranks gives Epaned a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Epaned?
- Epaned's side effects are taken directly from its FDA label. From the label: 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… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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epaned
70/100