The FDA has approved Silvergate Pharmaceuticals, Inc’s, Epaned (enalapril maleate powder for oral solution) for the treatment of hypertension in patients 1 month and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, such as strokes and myocardial infarctions.1
Epaned provides enalapril, which is one of the most commonly prescribed antihypertensive agents in the United States, in an oral solution formulation to promote accurate dosing. The appealing taste may help to promote adherence in children. Patients who have difficulty swallowing enalapril tablets may also benefit from treatment with Epaned.2
Pharmacology and Pharmacokinetics
Epaned is an angiotensin-converting enzyme inhibitor (ACEI). It decreases plasma angiotensin II, which leads to decreased vasopressor activity and decreased aldosterone secretion, thus resulting in beneficial effects on hypertension and heart failure.
In adult patients, peak serum concentrations of enalapril tablets occur within about 1 hour after oral administration, with approximately 60% absorption. The excretion of Epaned is primarily renal. A study in pediatric patients demonstrated pharmacokinetic findings that were consistent with those in adults.1
Dosage and Administration
For adult patients with creatinine clearance over 30 mL/min, Epaned should be initiated as 5 mg orally once a day. The dose may be gradually increased to achieve optimal hypertension goals, with a maximum daily dose of 40 mg per day. Doses may be divided and administered twice daily if the antihypertensive effect diminishes toward the end of the dosing interval. Patients with creatinine clearance ≤30 mL/min should begin with 2.5 mg daily, and patients undergoing dialysis should begin with 2.5 mg on dialysis days.
For pediatric patients older than 1 month, Epaned should be initiated as 0.08 mg/kg (up to 5 mg) orally once a day. Doses over 0.58 mg/kg (or over 40 mg) have not been studied in children. Epaned should not be used in neonates and pediatric patients with a glomerular filtration rate of <30 mL/min.
After reconstitution, the resulting solution contains 1 mg/mL of enalapril.1
Contraindications, Warnings, and Precautions
Epaned carries a boxed warning that it should be discontinued immediately if pregnancy is detected, as medications that act directly on the renin-angiotensin system may result in injury or death of a developing fetus.
Epaned is contraindicated in patients with hypersensitivity to previous treatment with an ACEI or with hereditary or idiopathic angioedema. Epaned should not be given concurrently with aliskiren to diabetic patients.
Angioedema and anaphylactoid reactions have occurred in some patients using ACEIs. If either reaction occurs during use of Epaned, the medication should be discontinued immediately and the patient should be monitored until the reaction is completely resolved. Hypotension, impaired renal function, and hyperkalemia may also occur.
Concomitant use of nonsteroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors, may result in deterioration of renal function, especially in patients who are elderly, are volume depleted (receiving diuretic therapy), or have compromised renal function. Coadministration of Epaned with medications that also inhibit the renin-angiotensin system, such as ACEIs, angiotensin-receptor blockers, or aliskiren, is associated with an increased risk of renal impairment, hypotension, and hyperkalemia. Epaned attenuates potassium loss caused by thiazide-type diuretics. Significant increases in serum potassium may occur during concurrent treatment with potassium-sparing diuretics, potassium supplements, or salt substitutes that contain potassium. Potassium-sparing diuretics should be avoided in patients with heart failure. Concurrent administration of an ACEI and lithium may lead to lithium toxicity, so lithium levels should be monitored frequently in these patients.
Epaned is Pregnancy Category D. It should not be used in patients who are breast-feeding.1,2
Dr. Holmberg earned her PharmD from the University of Connecticut and completed an ambulatory care residency at the Phoenix VA Healthcare System. Her practice has also included pediatrics and inpatient mental health. She resides in Phoenix, Arizona.
Epaned [package insert]. www.epaned.com/wp-content/uploads/2013/08/Enalapril-Prescribing-Information.pdf. Accessed March 2014.
FDA approves Epaned, a powder for a liquid form of enalapril for children and adults. Silvergate Pharmaceuticals Inc website. www.silvergatepharma.com/fda-approves-epaned-a-liquid-form-of-enalapril-for-children-and-adults. Accessed March 2014.