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QBRELIS
CHF and arrhythmias
Hypertension
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Drug Name:

QBRELIS Rx

Generic Name and Formulations:
Lisinopril 1mg/mL; oral soln.

Company:
Silvergate Pharmaceuticals

Therapeutic Use:

Indications for QBRELIS:

To reduce signs/symptoms of systolic heart failure. Adjunct to other therapies within 24hrs post-MI in hemodynamically stable patients, to reduce mortality.

Adult:

HF with diuretic +/or digitalis: initially 5mg once daily; max 40mg once daily as tolerated; if hyponatremia: initially 2.5mg once daily; monitor closely. May need to adjust the diuretic dose to minimize hypovolemia. Post-MI (initiation): 5mg within 24hrs of onset of symptoms, then 5mg after 24hrs, then 10mg once daily for up to 6 weeks; if low systolic BP (≤120mmHg and >100mmHg) during the 1st 3 days after the infarct, start with 2.5mg once daily, then titrate up as tolerated; (maintenance): usually 10mg once daily; if low systolic BP (≤100mmHg) occurs, start with 5mg daily, then reduce to 2.5mg daily as needed; discontinue if prolonged hypotension (systolic BP ≤90mmHg for >1hr) occurs. Both: CrCl ≤30mL/min or hemodialysis: initially 2.5mg once daily; max 40mg daily as tolerated.

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 36 hours of switching to or from sacubitril/valsartan.

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Dialysis (esp. high-flux membrane). Renal impairment; consider withholding or discontinuing therapy if significant renal dysfunction occurs. Renal artery stenosis. Chronic kidney disease. Severe CHF. Post-MI. Heart failure with SBP <100mmHg. Ischemic heart disease. Cerebrovascular disease. Hyponatremia. Salt/volume depletion. Severe aortic stenosis. Hypertrophic cardiomyopathy. Surgery. Monitor BP, electrolytes, renal and liver function. Monitor serum potassium 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: avoid. Nursing mothers: not recommended.

Interactions:

See Contraindications. Increased risk of angioedema with concomitant neprilysin inhibitor or mTOR inhibitor (eg, temsirolimus, sirolimus, everolimus). May cause hypotension with concomitant diuretics. 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. Increased risk of hypoglycemia with concomitant antidiabetics. 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:

Headache, dizziness, cough, hypotension, chest pain; acute renal or hepatic failure, blood dyscrasias (rare).

Generic Availability:

NO

How Supplied:

Oral soln—150mL

Indications for QBRELIS:

Hypertension.

Adult:

Initially and if not on diuretics: 10mg once daily. Usual range: 20–40mg once daily. Doses up to 80mg/day have been used. If BP not controlled by lisinopril alone, may add low-dose diuretic. After adding diuretic, may need to reduce lisinopril dose. If on diuretics: initially 5mg once daily. CrCl ≥10–≤30mL/min: initially 5mg once daily; max 40mg daily as tolerated. CrCl <10mL/min or hemodialysis: initially 2.5mg once daily.

Children:

<6yrs or GFR <30mL/min/1.73m2: not recommended. ≥6yrs and GFR ≥30mL/min/1.732: initially 0.07mg/kg (max 5mg) once daily; usual max 0.61mg/kg (40mg) once daily.

Contraindications:

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

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Dialysis (esp. high-flux membrane). Renal impairment; consider withholding or discontinuing therapy if significant renal dysfunction occurs. Renal artery stenosis. Chronic kidney disease. Severe CHF. Post-MI. Heart failure with SBP <100mmHg. Ischemic heart disease. Cerebrovascular disease. Hyponatremia. Salt/volume depletion. Severe aortic stenosis. Hypertrophic cardiomyopathy. Surgery. Monitor BP, electrolytes, renal and liver function. Monitor serum potassium 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: avoid. Nursing mothers: not recommended.

Interactions:

See Contraindications. Increased risk of angioedema with concomitant neprilysin inhibitor or mTOR inhibitor (eg, temsirolimus, sirolimus, everolimus). May cause hypotension with concomitant diuretics. 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. Increased risk of hypoglycemia with concomitant antidiabetics. 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:

Headache, dizziness, cough, hypotension, chest pain; acute renal or hepatic failure, blood dyscrasias (rare).

Generic Availability:

NO

How Supplied:

Oral soln—150mL

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