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VASOTEC
CHF and arrhythmias
Hypertension
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Drug Name:

VASOTEC Rx

Generic Name and Formulations:
Enalapril maleate 2.5mg, 5mg, 10mg, 20mg; scored tabs.

Company:
Valeant Pharmaceuticals, Inc

Therapeutic Use:

Indications for VASOTEC:

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

Adult:

Initially 2.5mg 1–2 times daily. May increase to 5–20mg daily in 1–2 divided doses; max 40mg/day. Reduce diuretic dosage before 1st dose, if possible; observe patient for at least 2 hrs after 1st dose, until BP has stabilized for at least 1 hr. CHF with hyponatremia or renal dysfunction: see literature. Left ventricular dysfunction: Initially 2.5mg twice daily; max 20mg daily in divided doses.

Children:

Not established.

Contraindications:

History of ACEI-associated or other angioedema. Concomitant neprilysin inhibitors (eg, sacubitril); do not administer lisinopril within 36hrs of switching to or from sacubitril/valsartan. Concomitant aliskiren in patients with diabetes.

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Renal impairment. Salt/volume depletion. CHF. Ischemic disease. Cerebrovascular disease. Dialysis (esp. high-flux membrane). Renal artery stenosis. Surgery. Diabetes. Monitor WBCs in renal or collagen vascular disease. Discontinue if neutropenia, angioedema, laryngeal edema, jaundice or marked elevations of hepatic enzymes develop. Monitor BP, electrolytes and renal function. Black patients may have higher rate of angioedema than non-Black patients. Neonates. Pregnancy, nursing mothers: not recommended.

Interactions:

See Contraindications. 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). Potentiated by, and hypotension with, diuretics. Hyperkalemia with K+-sparing diuretics, K+ supplements, or K+-containing salt substitutes. May increase lithium levels. May be antagonized by, and renal toxicity potentiated by NSAIDs, including COX-2 inhibitors (monitor renal function periodically in elderly and/or volume-depleted). Increased risk of angioedema with concomitant mTOR inhibitors (eg, temsirolimus, sirolimus, everolimus) or neprilysin inhibitors. Nitritoid reactions with concomitant injectable gold (eg, sodium aurothiomalate); rare.

Pharmacological Class:

ACE inhibitor.

Adverse Reactions:

Cough, headache, dizziness, fatigue, diarrhea, rash, orthostatic hypotension, asthenia, hyperkalemia, renal impairment, nausea; rare: hepatic failure.

Metabolism:

Hepatic.

Elimination:

Renal (primarily), fecal.

Generic Availability:

YES

How Supplied:

Tabs 2.5mg, 5mg—30, 90; 10mg, 20mg—30, 90, 1000

Indications for VASOTEC:

Hypertension.

Adult:

If on diuretics or CrCl <30mL/min: suspend diuretic for 2–3 days, if possible: initially 2.5mg daily; max 40mg. Monitor closely for first 2 wks. Others: initially 5mg daily. Usual range: 10–40mg daily in 1–2 divided doses.

Children:

Neonates or CrCl <30mL/min: not established. Initially 0.08mg/kg (up to 5mg) once daily; max 0.58mg/kg (or 40mg) daily. Suspension form may be prepared if unable to swallow tabs: see full labeling.

Contraindications:

History of ACEI-associated or other angioedema. Concomitant neprilysin inhibitors (eg, sacubitril); do not administer lisinopril within 36hrs of switching to or from sacubitril/valsartan. Concomitant aliskiren in patients with diabetes.

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Renal impairment. Salt/volume depletion. CHF. Ischemic disease. Cerebrovascular disease. Dialysis (esp. high-flux membrane). Renal artery stenosis. Surgery. Diabetes. Monitor WBCs in renal or collagen vascular disease. Discontinue if neutropenia, angioedema, laryngeal edema, jaundice or marked elevations of hepatic enzymes develop. Monitor BP, electrolytes and renal function. Black patients may have higher rate of angioedema than non-Black patients. Neonates. Pregnancy, nursing mothers: not recommended.

Interactions:

See Contraindications. 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). Potentiated by, and hypotension with, diuretics. Hyperkalemia with K+-sparing diuretics, K+ supplements, or K+-containing salt substitutes. May increase lithium levels. May be antagonized by, and renal toxicity potentiated by NSAIDs, including COX-2 inhibitors (monitor renal function periodically in elderly and/or volume-depleted). Increased risk of angioedema with concomitant mTOR inhibitors (eg, temsirolimus, sirolimus, everolimus) or neprilysin inhibitors. Nitritoid reactions with concomitant injectable gold (eg, sodium aurothiomalate); rare.

Pharmacological Class:

ACE inhibitor.

Adverse Reactions:

Cough, headache, dizziness, fatigue, diarrhea, rash, orthostatic hypotension, asthenia, hyperkalemia, renal impairment, nausea; rare: hepatic failure.

Metabolism:

Hepatic.

Elimination:

Renal (primarily), fecal.

Generic Availability:

YES

How Supplied:

Tabs 2.5mg, 5mg—30, 90; 10mg, 20mg—30, 90, 1000

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