Introduction
Qbrelis (lisinopril) is an oral solution formulation of the angiotensin-converting enzyme (ACE) inhibitor lisinopril. It is specifically designed for patients who have difficulty swallowing tablets, particularly pediatric populations and elderly patients with dysphagia. Qbrelis provides the same therapeutic benefits as tablet formulations but in a liquid form that allows for precise dosing adjustments.
Mechanism of Action
Qbrelis works by competitively inhibiting angiotensin-converting enzyme (ACE). This inhibition prevents the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. By reducing angiotensin II levels, Qbrelis decreases vasoconstriction and aldosterone secretion, resulting in decreased peripheral arterial resistance and blood pressure. Additionally, it reduces degradation of bradykinin, which may contribute to its vasodilatory effects.
Indications
- Hypertension in adults and children ≥6 years
- Adjunctive therapy for heart failure in patients not responding adequately to diuretics and digitalis
- Treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction to improve survival
- Diabetic nephropathy in hypertensive patients with type 1 diabetes
Dosage and Administration
Hypertension (Adults): Initial dose: 5-10 mg once daily; Maintenance: 20-40 mg daily Hypertension (Pediatric ≥6 years): Initial dose: 0.07 mg/kg once daily (up to 5 mg); Maximum dose: 0.61 mg/kg or 40 mg Heart Failure: Initial dose: 2.5-5 mg once daily; Target dose: 20-40 mg daily Acute MI: 5 mg within 24 hours, then 5 mg after 24 hours, 10 mg after 48 hours, then 10 mg daily Administration: Oral solution - use calibrated measuring device. May be taken without regard to meals. Shake bottle well before each use. Special Populations:- Renal impairment: Adjust dose based on creatinine clearance
- Hepatic impairment: No adjustment typically needed
- Geriatric: Consider lower starting doses
- Pediatric: Use weight-based dosing
Pharmacokinetics
Absorption: Approximately 25% bioavailable, with peak concentrations reached within 7 hours Distribution: Volume of distribution: 0.5 L/kg; Minimal protein binding Metabolism: Not metabolized by cytochrome P450 system; excreted unchanged Elimination: Primarily renal excretion; half-life: 12 hours Special Considerations: Food does not significantly affect absorptionContraindications
- History of angioedema related to previous ACE inhibitor treatment
- Hereditary or idiopathic angioedema
- Concomitant use with aliskiren in patients with diabetes
- Hypersensitivity to any component of Qbrelis
- Pregnancy (second and third trimesters)
Warnings and Precautions
Black Box Warning:- Fetal toxicity: Can cause injury and death to developing fetus when used during second and third trimesters
- Discontinue when pregnancy is detected
- Angioedema: May occur at any time during treatment
- Hypotension: Risk in volume-depleted patients
- Impaired renal function: Monitor renal function periodically
- Hyperkalemia: May occur, particularly in patients with renal impairment or diabetes
- Cough: Characteristic dry, persistent cough may develop
- Neutropenia/agranulocytosis: Rare but serious
Drug Interactions
Major Interactions:- Diuretics: Enhanced hypotensive effect
- NSAIDs: May reduce antihypertensive effect and increase renal impairment risk
- Lithium: Increased lithium levels and toxicity
- Potassium-sparing diuretics/potassium supplements: Increased hyperkalemia risk
- Aliskiren: Contraindicated in diabetic patients
- Gold injections: Nitritoid reactions reported
- Antidiabetic agents: Enhanced hypoglycemic effects
- Sympathomimetics: May reduce antihypertensive effect
Adverse Effects
Common (>10%):- Headache
- Dizziness
- Cough
- Fatigue
- Orthostatic hypotension
- Gastrointestinal disturbances
- Rash
- Impotence
- Angioedema
- Acute renal failure
- Severe hypotension
- Hyperkalemia
- Neutropenia/agranulocytosis
- Hepatic failure
Monitoring Parameters
- Blood pressure (standing and supine)
- Renal function (serum creatinine, BUN)
- Serum electrolytes (particularly potassium)
- Complete blood count (if clinical signs suggest neutropenia)
- Signs/symptoms of angioedema
- Pregnancy testing in women of childbearing potential
- Growth parameters in pediatric patients
Patient Education
- Take medication exactly as prescribed at the same time each day
- Use provided measuring device for accurate dosing
- Report any signs of allergic reaction (swelling of face, lips, tongue, or throat)
- Notify provider if persistent dry cough develops
- Rise slowly from sitting/lying position to prevent dizziness
- Maintain adequate fluid intake unless otherwise directed
- Avoid potassium supplements or salt substitutes without medical advice
- Inform all healthcare providers about Qbrelis use
- Use effective contraception; discontinue immediately if pregnancy is suspected
- Store at room temperature; discard after 60 days of opening
References
1. FDA Prescribing Information: Qbrelis (lisinopril) oral solution 2. Whelton PK, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. J Am Coll Cardiol. 2018 3. National Heart, Lung, and Blood Institute. Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents. Pediatrics. 2004 4. Lewis EJ, et al. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N Engl J Med. 1993 5. GISSI-3: Effects of lisinopril and transdermal glyceryl trinitrate singly and together on 6-week mortality and ventricular function after acute myocardial infarction. Lancet. 1994 6. Micromedex Solutions. Lisinopril Drug Information. Truven Health Analytics