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Epaned Generic Name & Formulations
Legal Class
Rx
General Description
Enalapril maleate 150mg/150mL; pwd for oral soln; and 1mg/mL; ready-to-use oral soln w. mixed-berry flavor.
Pharmacological Class
ACE inhibitor.
How Supplied
Kit—1 (pwd + diluent); Soln (ready-to-use)—150mL
Manufacturer
Generic Availability
NO
Epaned Indications
Indications
Symptomatic heart failure usually with digitalis and diuretics. Asymptomatic left ventricular dysfunction (ejection fraction ≤35%).
Epaned Dosage and Administration
Adult
HF: initially 2.5mg twice daily; may titrate up to max 20mg twice daily. Hyponatremia or serum creatinine >1.6mg/dL: initially 2.5mg once daily. Left ventricular dysfunction: initially 2.5mg twice daily; may titrate up to max 10mg twice daily.
Children
Not established.
Epaned Contraindications
Contraindications
History of ACEI-associated or other angioedema. Concomitant aliskiren in patients with diabetes. Concomitant neprilysin inhibitor (eg, sacubitril); do not give within 36hrs of switching to or from sacubitril/valsartan.
Epaned Boxed Warnings
Boxed Warning
Fetal toxicity.
Epaned Warnings/Precautions
Warnings/Precautions
Fetal toxicity may develop; discontinue if pregnancy is detected. Salt/volume depletion. Heart failure with SBP <100mmHg. Ischemic heart disease. Cerebrovascular disease. Hyponatremia. Dialysis (esp. high-flux membrane). Hypertrophic cardiomyopathy. Surgery. Renal artery stenosis. Chronic kidney disease. Severe CHF. Recent MI. Monitor BP, electrolytes, renal and liver function. Monitor for hyperkalemia in diabetes or renal insufficiency. Black patients may have higher rate of angioedema than non-black patients. Discontinue if angioedema, laryngeal edema, jaundice or marked elevations of liver enzymes occur. Elderly. Neonates. Pregnancy, nursing mothers: not recommended.
Epaned Pharmacokinetics
See Literature
Epaned Interactions
Interactions
See Contraindications. Increased risk of angioedema with concomitant neprilysin inhibitor or mTOR inhibitor (eg, temsirolimus, sirolimus, everolimus). May cause hyperkalemia with K+ sparing diuretics, K+ supplements, or K+-containing salt substitutes. May be antagonized by, and renal toxicity potentiated by NSAIDs, including COX-2 inhibitors; monitor renal function periodically in elderly and/or volume-depleted. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Avoid concomitant aliskiren in renal impairment (CrCl <60mL/min). May increase lithium levels; monitor frequently. Nitritoid reactions with concomitant injectable gold (eg, sodium aurothiomalate); rare.
Epaned Adverse Reactions
Adverse Reactions
Fatigue, orthostatic hypotension, dizziness, rash, cough, asthenia; angioedema, hyperkalemia; rare: hepatic failure.
Epaned Clinical Trials
See Literature
Epaned Note
Not Applicable
Epaned Patient Counseling
See Literature
Epaned Generic Name & Formulations
Legal Class
Rx
General Description
Enalapril maleate 150mg/150mL; pwd for oral soln; and 1mg/mL; ready-to-use oral soln w. mixed-berry flavor.
Pharmacological Class
ACE inhibitor.
How Supplied
Kit—1 (pwd + diluent); Soln (ready-to-use)—150mL
Manufacturer
Generic Availability
NO
Epaned Indications
Indications
Hypertension.
Epaned Dosage and Administration
Adult
Initially 5mg once daily; may titrate up to max 40mg daily in 1–2 divided doses. If on diuretics, CrCl ≤30mL/min or on dialysis (give after dialysis session): initially 2.5mg daily; max 40mg daily.
Children
Neonates (<1month), preterm infants (<44wks post-conceptual age) or CrCl <30mL/min: not recommended. >1month: Initially 0.08mg/kg (up to 5mg) once daily; max 0.58mg/kg (or 40mg) daily.
Epaned Contraindications
Contraindications
History of ACEI-associated or other angioedema. Concomitant aliskiren in patients with diabetes. Concomitant neprilysin inhibitor (eg, sacubitril); do not give within 36hrs of switching to or from sacubitril/valsartan.
Epaned Boxed Warnings
Boxed Warning
Fetal toxicity.
Epaned Warnings/Precautions
Warnings/Precautions
Fetal toxicity may develop; discontinue if pregnancy is detected. Salt/volume depletion. Heart failure with SBP <100mmHg. Ischemic heart disease. Cerebrovascular disease. Hyponatremia. Dialysis (esp. high-flux membrane). Hypertrophic cardiomyopathy. Surgery. Renal artery stenosis. Chronic kidney disease. Severe CHF. Recent MI. Monitor BP, electrolytes, renal and liver function. Monitor for hyperkalemia in diabetes or renal insufficiency. Black patients may have higher rate of angioedema than non-black patients. Discontinue if angioedema, laryngeal edema, jaundice or marked elevations of liver enzymes occur. Elderly. Neonates. Pregnancy, nursing mothers: not recommended.
Epaned Pharmacokinetics
See Literature
Epaned Interactions
Interactions
See Contraindications. Increased risk of angioedema with concomitant neprilysin inhibitor or mTOR inhibitor (eg, temsirolimus, sirolimus, everolimus). May cause hyperkalemia with K+ sparing diuretics, K+ supplements, or K+-containing salt substitutes. May be antagonized by, and renal toxicity potentiated by NSAIDs, including COX-2 inhibitors; monitor renal function periodically in elderly and/or volume-depleted. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Avoid concomitant aliskiren in renal impairment (CrCl <60mL/min). May increase lithium levels; monitor frequently. Nitritoid reactions with concomitant injectable gold (eg, sodium aurothiomalate); rare.
Epaned Adverse Reactions
Adverse Reactions
Fatigue, orthostatic hypotension, dizziness, rash, cough, asthenia; angioedema, hyperkalemia; rare: hepatic failure.
Epaned Clinical Trials
See Literature
Epaned Note
Not Applicable
Epaned Patient Counseling
See Literature
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