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EPANED
CHF and arrhythmias
Hypertension
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Drug Name:

EPANED Rx

Generic Name and Formulations:
Enalapril maleate 150mg/150mL; pwd for oral soln; and 1mg/mL; ready-to-use oral soln w. mixed-berry flavor.

Company:
Silvergate Pharmaceuticals

Therapeutic Use:

Indications for EPANED:

Symptomatic heart failure usually with digitalis and diuretics. Asymptomatic left ventricular dysfunction (ejection fraction ≤35%).

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.

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.

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.

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.

Pharmacological Class:

ACE inhibitor.

Adverse Reactions:

Fatigue, orthostatic hypotension, dizziness, rash, cough, asthenia; angioedema, hyperkalemia; rare: hepatic failure.

Generic Availability:

NO

How Supplied:

Kit—1 (pwd + diluent); Soln (ready-to-use)—150mL

Indications for EPANED:

Hypertension.

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.

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.

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.

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.

Pharmacological Class:

ACE inhibitor.

Adverse Reactions:

Fatigue, orthostatic hypotension, dizziness, rash, cough, asthenia; angioedema, hyperkalemia; rare: hepatic failure.

Generic Availability:

NO

How Supplied:

Kit—1 (pwd + diluent); Soln (ready-to-use)—150mL

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