EPANED
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EPANED (EPANED).
Epaned contains enalapril maleate, an angiotensin-converting enzyme (ACE) inhibitor. Enalapril is a prodrug that is hydrolyzed to enalaprilat, which inhibits ACE, thereby reducing angiotensin II formation, decreasing vasoconstriction, aldosterone secretion, and sodium reabsorption.
| Metabolism | Enalapril is extensively metabolized in the liver by ester hydrolysis to its active form, enalaprilat. No significant CYP450 metabolism. |
| Excretion | Renal excretion of unchanged drug accounts for approximately 30-40% of elimination; biliary/fecal excretion accounts for 50-60% as metabolites and unchanged drug. |
| Half-life | Terminal elimination half-life is 4-6 hours in adults with normal renal function; prolonged to 10-12 hours in moderate renal impairment (CrCl 30-50 mL/min) and 15-20 hours in severe impairment (CrCl <30 mL/min). |
| Protein binding | Approximately 85-90% bound to serum albumin. |
| Volume of Distribution | 0.5-0.7 L/kg, indicating distribution primarily into extracellular fluid. |
| Bioavailability | Oral: 70-80% due to first-pass metabolism; Intravenous: 100%. |
| Onset of Action | Intravenous: 5-10 minutes; Oral: 30-60 minutes. |
| Duration of Action | Intravenous: 4-6 hours; Oral: 6-8 hours. Duration may be extended in renal impairment due to reduced clearance. |
0.2 mg/kg intravenously over 5 minutes every 2 hours; typical adult dose 10-20 mg IV.
| Dosage form | SOLUTION |
| Renal impairment | No adjustment required for renal impairment; drug is hepatically cleared. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: use with caution, consider dose reduction by 75%. |
| Pediatric use | 0.2 mg/kg intravenously over 5 minutes every 2 hours; maximum single dose 20 mg. |
| Geriatric use | Start at lower end of dosing range (0.1 mg/kg) due to potential for decreased hepatic function and increased sensitivity; monitor for QT prolongation. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for EPANED (EPANED).
| Breastfeeding | Not known if excreted in human milk. Caution advised. M/P ratio unknown. |
| Teratogenic Risk | Pregnancy category C. No adequate studies in pregnant women. In animal studies, no evidence of teratogenicity at clinically relevant doses. Risk of fetal harm cannot be ruled out. Use only if potential benefit justifies risk. |
| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and signs of hypersensitivity. Fetal monitoring not specifically required but consider if maternal condition warrants. |
■ FDA Black Box Warning
FDA Warning: When pregnancy is detected, discontinue Epaned as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
| Serious Effects |
["Hypersensitivity to enalapril or any ACE inhibitor","History of angioedema related to previous ACE inhibitor therapy","Hereditary or idiopathic angioedema","Pregnancy (especially second and third trimesters)","Concomitant use with aliskiren in patients with diabetes"]
| Precautions | ["Angioedema (including laryngeal edema) risk; discontinue immediately and treat appropriately.","Hypotension in volume-depleted patients (e.g., those on diuretics or with heart failure).","Monitor renal function; risk of acute renal failure, especially in bilateral renal artery stenosis.","Hyperkalemia risk, especially in renal impairment, diabetes, or concomitant K+-sparing diuretics/supplements.","Cough (nonproductive, persistent) may occur.","Hepatic failure; rare but reported. Discontinue if jaundice or significant liver enzyme elevation occurs."] |
Loading safety data…
| Fertility Effects | No known adverse effects on fertility in animal studies. |