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Generic Name
Lisinopril
Brand Names
Qbrelis, Zestoretic, Zestril
FDA approval date: July 01, 2002
Classification: Angiotensin Converting Enzyme Inhibitor
Form: Tablet, Solution
What is Qbrelis (Lisinopril)?
QBRELIS is an angiotensin converting enzyme inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older.
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Brand Information
Qbrelis (lisinopril)
WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue QBRELIS as soon as possible
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus
1DOSAGE FORMS AND STRENGTHS
QBRELIS oral solution is available in a 150 mL bottle containing 1 mg/mL of lisinopril solution. QBRELIS oral solution is a clear to slightly opalescent liquid.
2CONTRAINDICATIONS
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
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
3OVERDOSAGE
Following a single oral dose of 20 g/kg no lethality occurred in rats, and death occurred in one of 20 mice receiving the same dose. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution.
Lisinopril can be removed by hemodialysis
4DESCRIPTION
Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril is a synthetic peptide derivative that is manufactured as a dihydrate and is chemically described as 1-[
Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52 (for dihydrate). It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol.
QBRELIS (lisinopril), 1 mg/mL, is a ready-to-use aqueous formulation. Each 1 mL of the oral solution contains 1.09 mg of lisinopril dihydrate, which is equivalent to 1 mg of lisinopril as the active ingredient and the following inactive ingredients: purified water, xylitol, sodium citrate, citric acid, sodium benzoate, and either hydrochloric acid or sodium hydroxide which may be added for pH adjustment. The solution is clear to slightly opalescent. The pH of the solution ranges from 4.3 to 5.1. QBRELIS is supplied as 150 mL of the solution packaged in a 150-mL round, white, opaque, high-density polyethylene (HDPE) bottle with a white, polypropylene, child-resistant closure with a heat induction layered inner seal.
5HOW SUPPLIED/STORAGE AND HANDLING
QBRELIS (lisinopril), 1 mg/mL, is supplied as 150 mL of a clear to slightly opalescent, colorless aqueous oral solution with a sweet taste in a 150-mL high-density polyethylene (HDPE) bottle with a child-resistant cap (NDC 52652-3001-1).
Store at controlled room temperature 20°C-25°C (68°F-77°F) [see USP] in a tightly closed container. Protect from freezing and excessive heat.
6PATIENT COUNSELING INFORMATION
Pregnancy: Tell female patients of childbearing age about the consequences of exposure to QBRELIS during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible.
Angioedema: Angioedema, including laryngeal edema may occur at any time during treatment with angiotensin converting enzyme inhibitors, including QBRELIS. Tell patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician.
Symptomatic Hypotension: Tell patients to report light-headedness especially during the first few days of therapy. If actual syncope occurs, tell the patient to discontinue the drug until they have consulted with the prescribing physician.
Tell patients that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; advise patients accordingly.
Hyperkalemia: Tell patients to consult their physician prior to using salt substitutes containing potassium.
Hypoglycemia: Tell diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor to monitor for hypoglycemia closely, especially during the first month of combined use
Leukopenia/Neutropenia: Tell patients to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of leukopenia/neutropenia.
7PRINCIPAL DISPLAY PANEL - Bottle Label
NDC 52652-3001-1
Qbrelis
Oral Solution
READY TO USE
150 mL
Each 1 mL contains
Usual Dose: See prescribing information.
Store at room temperature
KEEP THIS AND ALL
P/N 141146
Manufactured for:
Lot: