Qbrelis 1 mg/mL

lisinopril · SOLUTION · Azurity Pharmaceuticals, Inc.

No Recall History

Plain English

Qbrelis is a solution containing lisinopril at 1 mg/mL, taken oral. Manufactured by Azurity Pharmaceuticals, Inc..

Key Facts

Brand Name: Qbrelis
Generic Name: lisinopril
NDC Code (Product): 52652-3001
Manufacturer: Azurity Pharmaceuticals, Inc.
Strength: 1 mg/mL
Dosage Form: SOLUTION
Route: ORAL
Marketing Status
Application #: NDA208401
Marketing Start: 08/29/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue18,991 reports

nausea17,593 reports

drug ineffective16,880 reports

diarrhoea16,527 reports

dyspnoea13,281 reports

pain12,960 reports

dizziness12,826 reports

headache12,254 reports

asthenia10,401 reports

off label use10,380 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE QBRELIS is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1 ). Adjunct therapy for heart failure ( 1.2 ). Treatment of Acute Myocardial Infarction ( 1.3 ). 1.1 Hypertension QBRELIS is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, De…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Hypertension: Initial adult dose is 10 mg once daily. Titrate up to 40 mg daily based on blood pressure response. Initiate patients on diuretics at 5 mg once daily ( 2.1 ). Pediatric patients with glomerular filtration rate > 30 mL/min/1.73m 2 : Initial dose in patients 6 years of age and older is 0.07 mg per kg (up to 5 mg total) once daily ( 2.1 ). Heart Failure: Initiate with 5 mg once daily. Increase dose as tolerated to 40 mg daily ( 2.2 ). Acute Myocardial Infarction (MI): Give 5 mg within 24 hours of MI followed by 5 mg after 24 hours, then 10 mg once daily ( 2.3 ). Renal Impairment: For patients with creatinine clearance ≥ 10 mL/min and ≤ 30 mL/min, halve usual initial dose. For patients with creatinine clearance < 10 mL/min or on hemodialysis, the recommended initial dose is 2.5 mg ( 2.4 ). 2.1 Hypertension Adults Initial Therapy in adults: The recommended initial dose is 10 mg taken orally once a day. Adjust dosage as needed according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered in a single daily dose. Doses up to 80 mg per day have been used but do not appear to give greater effect. Use with diuretics …

Contraindications

4 CONTRAINDICATIONS QBRELIS is contraindicated in patients with: a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme inhibitor hereditary or idiopathic angioedema Do not co-administer aliskiren with QBRELIS in patients with diabetes [see Drug Interactions ( 7.4 )] . QBRELIS is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer QBRELIS within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions ( 5.2 )] . Angioedema or a history of hereditary or idiopathic angioedema ( 4 ). Hypersensitivity ( 4 ). Co-administration of aliskiren with QBRELIS in patients with diabetes ( 4 , 7.4 ). In combination with a neprilysin inhibitor ( 4 ).

Drug Interactions

7 DRUG INTERACTIONS Diuretics: Excessive drop in blood pressure ( 7.1 ). NSAIDS: Increased risk of renal impairment and loss of antihypertensive efficacy ( 7.3 ). Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia ( 7.4 ). Lithium: Symptoms of lithium toxicity ( 7.5 ). Gold: Nitritoid reactions have been reported ( 7.6 ). 7.1 Diuretics Initiation of QBRELIS in patients on diuretics may result in excessive reduction of blood pressure. The possibility of hypotensive effects with QBRELIS can be minimized by either decreasing or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with QBRELIS. If this is not possible, reduce the starting dose of QBRELIS [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.4 )] . QBRELIS attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, monitor the patient’s serum potassium frequently. 7.2 Antidiabetics Concomitant administration of QBRELIS and anti…

Adverse Reactions

6 ADVERSE REACTIONS Common adverse reactions (events 2% greater than placebo) by use: Hypertension: headache, dizziness and cough ( 6.1 ). Heart Failure: hypotension and chest pain ( 6.1 ). Acute Myocardial Infarction: hypotension ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc., at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Hypertension In clinical trials in patients with hypertension treated with lisinopril, 5.7% of patients on lisinopril discontinued with adverse reactions. The following adverse reactions (events 2% greater on lisinopril than on placebo) were observed with lisinopril alone: headache (by 3.8%), dizziness (by 3.5%), and cough (by 2.5%). Heart Failure In patients with systolic heart failure treated with lisinopril for up to four years, 11% discontinued therapy with adverse reactions. In controlled studies in patient…

Frequently Asked Questions

What is Qbrelis used for?

Qbrelis contains lisinopril. It is a solution taken oral. Consult your doctor for specific uses.

Is Qbrelis a controlled substance?

Qbrelis is not classified as a controlled substance by the DEA.

What is the generic name for Qbrelis?

The generic name for Qbrelis is lisinopril. There are 11 other brand versions of lisinopril.

What is the NDC code for Qbrelis 1 mg/mL?

The NDC (National Drug Code) for Qbrelis 1 mg/mL is 52652-3001, listed by Azurity Pharmaceuticals, Inc..

Product NDC

52652-3001

Package NDC

52652-3001-1

Other Lisinopril Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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