The First FDA-Approved Enalapril Maleate Oral Solution
From Azurity Pharmaceuticals, providing safe, high-quality treatments for patients requiring customized formulations for their care. See Important Safety Information below.
WARNING: FETAL TOXICITY
The First FDA-Approved Enalapril Maleate Oral Solution
From Azurity Pharmaceuticals, providing safe, high-quality treatments for patients requiring customized formulations for their care. See Important Safety Information below.
IMPORTANT SAFETY INFORMATION
EPANED® (enalapril maleate) Oral Solution, 1 mg/mL
WARNING: FETAL TOXICITY
See Full Prescribing Information for complete boxed warning.
- When pregnancy is detected, discontinue EPANED 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
EPANED is an angiotensin-converting enzyme (ACE) inhibitor indicated for:
- Treatment of hypertension in adults and children older than 1 month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
- Treatment of symptomatic heart failure.
- Treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure.
IMPORTANT SAFETY INFORMATION
EPANED® (enalapril maleate) Oral Solution, 1 mg/mL
WARNING: FETAL TOXICITY
See Full Prescribing Information for complete boxed warning.
- When pregnancy is detected, discontinue EPANED 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
EPANED is an angiotensin-converting enzyme (ACE) inhibitor indicated for:
- Treatment of hypertension in adults and children older than 1 month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
- Treatment of symptomatic heart failure.
- Treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure.
Epaned is not recommended in neonates (i.e., infants 1 month of age or less), preterm infants who have not reached a corrected post-conceptual age of 44 weeks, and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2.
Control of high blood pressure should be part of a complete cardiovascular risk management program. This program may also include lipid (cholesterol) control, diabetes management, antithrombotic (antistroke) therapy, exercise, quitting smoking, and limiting salt in the diet. Many patients will require more than one drug to achieve blood pressure goals.
Epaned is FDA Approved
EPANED is a prescription medicine for the:
- Treatment of high blood pressure in adults and children older than 1 month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events such as strokes and myocardial infarctions (heart attacks).
- Treatment of symptomatic heart failure.
- Treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure.
It’s the first FDA-approved liquid form of a medicine called enalapril maleate. Enalapril maleate belongs to a class of drugs called angiotensin-converting enzyme (ACE) inhibitors. Because it’s FDA approved, you can be sure it’s a high-quality product.
Epaned is not recommended in neonates (i.e., infants 1 month of age or less), preterm infants who have not reached a corrected post-conceptual age of 44 weeks, and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2.
EPANED DOSING INFORMATION
Taking Epaned
Your doctor will tell you how much Epaned you or the patient should take. Do not change the dose of Epaned unless your doctor tells you to.
- Epaned should be taken at the same time every day.
- Always carefully measure the prescribed dose of Epaned before you or the patient takes it.
- Make sure that you or the patient swallows the entire dose of Epaned.
- If you have questions about Epaned, ask your doctor or your pharmacist.
- Consult your doctor before making any changes to the medication.
Storing Epaned
- 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.
- No shaking necessary prior to administration.
- Keep Epaned and all medications out of reach of children.
Missed a dose of Epaned?
If you or the patient misses a dose of Epaned, the next dose should be taken at the regular time. Use the normal amount. Do not use more medicine than your doctor has prescribed.
ADDITIONAL IMPORTANT SAFETY INFORMATION
Epaned® (enalapril maleate) Oral Solution should not be used during pregnancy. Taking Epaned during pregnancy can harm the unborn child. Stop taking Epaned as soon as possible if pregnancy is detected.
Before you or your patient takes Epaned, tell the doctor if you or your patient has kidney, liver or heart disease, or diabetes or is on dialysis.
If you or your patient has diabetes or kidney disease, Epaned should not be taken with aliskiren (Amturnide®, Tekamlo®, Tekturna®, Valturna®).
Do not take Epaned in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer EPANED within 36 hours of switching to or from sacubitril/valsartan.
You or your patient should not use this medication if you or your patient is allergic to enalapril or similar medicines such as: benazepril (Lotensin®), captopril (Capoten®, Capozide® ), fosinoprll (Monopril®), lisinopril (Prinivil®, Prinzide®, Zestoretic®, Zestril®), moexipril (Univasc®, Uniretic®), perindopril (Aceon®), quinapril (Accupril®), ramipril (Altace®), trandolapril (Mavik®, Tarka®), and others.
Do not take or give your patient Epaned if there is a history of swelling of the face, lips, tongue, throat, hands, or feet (angioedema). Angioedema may occur at any time during treatment with angiotensin-converting enzyme inhibitors, including Epaned. If this occurs, discontinue Epaned and call the doctor.
If you or your patient has any of the following serious side effects at any time during treatment, call the doctor right away:
- swelling of face, lips, tongue, throat, hands or feet;
- difficulty swallowing or breathing; or
- yellowing of the skin or eyes
Do not take or give your patient Epaned if there is a known allergy to enalapril or any of the ingredients in Epaned.
If you or your patient is dehydrated or is taking a diuretic medicine, or has compromised kidney function, talk to the doctor before taking Epaned.
If you or your patient has diabetes or renal impairment, Epaned should not be taken with aliskiren (Amturnide®, Tekamlo®, Tekturna®, Valturna®).
Epaned may cause side effects:
Call your doctor if you or your patient shows any of these symptoms: tiredness, weakness, upset stomach, cough, or skin rash.
If you or your patient faints or feels lightheaded, especially during the first few days of treatment, discontinue taking or giving Epaned until you have talked with the doctor.
Epaned can cause symptomatic low blood pressure (hypotension). Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). If you or your patient has a prolonged illness that causes diarrhea or vomiting, tell the doctor.
If you or your patient needs surgery, tell the surgeon ahead of time that you or your patient is taking Epaned. The surgeon may recommend that Epaned be discontinued for a short time.
Tell the doctor about all other medicines you or your patient uses, including potassium supplements and/or potassium-containing salt substitutes, all prescription drugs, over-the-counter medicines, vitamins and supplements.
If you or your patient is currently taking a non-steroidal anti-inflammatory drug (NSAID), such as aspirin, ibuprofen or naproxen, talk to the doctor before taking or giving Epaned.
If you or your patient is currently taking a Lithium talk to your doctor before taking Epaned.
If you or your patient is currently taking injectable gold (sodium aurothiomalate) talk to your doctor before taking Epaned.
If you or your patient is currently taking a mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) talk to your doctor before taking Epaned.
Changes in kidney (renal) function, including acute renal failure, can be caused by Epaned. Your kidney function or your patient’s kidney function should be monitored by the doctor.
Epaned is not recommended in neonates (i.e., infants 1 month of age or less), preterm infants who have not reached a corrected post-conception age of 44 weeks, and in pediatric patients with a glomerular filtration rate less than 30 mL/min/1.73 m2.
Women should not breastfeed during treatment with Epaned.
These are not all the possible side effects of Epaned. Your doctor or your patient’s doctor is the best source of advice about side effects. Call the doctor immediately if you or your patient has any side effects that concern you or do not go away.
Your blood pressure or your patient’s blood pressure will need to be checked often. In addition, serum potassium levels and renal function will need to be monitored.
Make sure you or your patient visits the doctor regularly.
This Important Safety Information does not include all the information needed to use EPANED safely and effectively. Visit EPANED.com for Full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.