qbrelis
Pharmaranks rates Qbrelis 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Qbrelis (Lisinopril) is an angiotensin converting enzyme inhibitor used to treat Diabetic Nephropathies, Heart Failure, Hypertension, Myocardial Infarction.
Lisinopril · by Azurity
Available as a generic: Lisinopril
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Lisinopril
- Drug class
- Angiotensin Converting Enzyme Inhibitor
- Form
- Solution
- Strength
- Lisinopril 1MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- diabetic nephropathies, heart failure, hypertension
- Manufacturer
- Azurity
- Half-life
- about 12 hours (the effective half-life, in adults with normal kidney function) (how long it stays in your system)
- What the pharmacy pays
- ~$0.77 for 30 — not your price
- FDA application
- NDA208401
- FDA boxed warning
- Yes — see the boxed warning
What is Qbrelis?
From the FDA label: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-[ N 2 -[( S )-1-Carboxy-3-phenylpropyl]-L-lysyl]-L-proline dihydrate. Its molecular formula is C 21 H 31 N 3 O 5 ·2H 2 O and its structural formula is: 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. Structural Formula
How to use
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 in adults If blood pressure is not controlled with QBRELIS alone, a low dose of a diuretic may be added (e.g., hydrochlorothiazide, 12.5 mg). After the addition of a diuretic, it may be possible to reduce the dose of QBRELIS.…
Side effects
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 patients with heart failure, therapy was discontinued in 8.1% of patients treated with lisinopril for 12 weeks, compared to 7.7% of patients treated with placebo for 12 weeks. The following adverse reactions (events 2% greater…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
When pregnancy is detected, discontinue QBRELIS as soon as possible [see Warnings and Precautions ( 5.1 )] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 )] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue QBRELIS as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 ).
Warnings
Important safety information
Angioedema: Discontinue QBRELIS; provide appropriate therapy and monitor until resolved ( 5.2 ). Renal impairment: Monitor renal function periodically ( 5.3 ). Hypotension: Patients with other heart or renal diseases have increased risk, monitor blood pressure after initiation ( 5.4 ). Hyperkalemia: Monitor serum potassium periodically ( 5.5 ). Cholestatic jaundice and hepatic failure: Monitor for jaundice or signs of liver failure ( 5.6 ). 5.1 Fetal Toxicity Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue QBRELIS as soon as possible [see Use in Specific Populations ( 8.1 )]. 5.2 Angioedema and Anaphylactoid Reactions Angioedema Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis and/or larynx, including some fatal reactions, have occurred in patients treated with angiotensin converting enzyme inhibitors, including lisinopril, at any time during treatment. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery. QBRELIS should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms of angioedema has occurred. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor [see Contraindications ( 4 )] . ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients. Patients receiving coadministration of an ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema [see Drug Interactions ( 7.7 , 7.8 )] . Intestinal Angioedema Intestinal angioedema has occurred in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. In some cases, the angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Anaphylactoid Reactions Anaphylactoid Reactions During Desensitization Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. Anaphylactoid Reactions During Dialysis Sudden and potentially life threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. In such patients, dialysis must be stopped immediately, and aggressive therapy for anaphylactoid reactions must be initiated. Symptoms have not been relieved by antihistamines in these situations. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption. 5.3 Impaired Renal Function Monitor renal function periodically in patients treated with QBRELIS. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, post-myocardial infarction or volume depletion) may be at particular risk of developing acute renal failure on QBRELIS. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on QBRELIS [see Adverse Reactions ( 6.1 ) and Drug Interactions ( 7.4 )] . 5.4 Hypotension QBRELIS can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia, acute renal failure or death. Patients at risk of excessive hypotension include those with the following conditions or characteristics: heart failure with systolic blood pressure below 100 mmHg, ischemic heart disease, cerebrovascular disease, hyponatremia, high dose diuretic therapy, renal dialysis, or severe volume and/or salt depletion of any etiology. In these patients, QBRELIS should be started under very close medical supervision and such patients should be followed closely for the first two weeks of treatment and whenever the dose of QBRELIS and/or diuretic is increased. Avoid use of QBRELIS in patients who are hemodynamically unstable after acute MI. Symptomatic hypotension is also possible in patients with severe aortic stenosis or hypertrophic cardiomyopathy. Surgery/Anesthesia In patients undergoing major surgery or during anesthesia with agents that produce hypotension, QBRELIS may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion. 5.5 Hyperkalemia Serum potassium should be monitored periodically in patients receiving QBRELIS. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes [see Drug Interactions ( 7.1 )] . 5.6 Hepatic Failure ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and sometimes death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical treatment.
Who should not take Qbrelis
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 ).
Overdose — what happens if you take too much
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 [see Clinical Pharmacology ( 12.3 )] .
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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 antidiabetic medicines (insulins, oral hypoglycemic agents) may cause an increased blood-glucose-lowering effect with risk of hypoglycemia. 7.3 Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including lisinopril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving lisinopril and NSAID therapy. The antihypertensive effect of ACE inhibitors, including lisinopril, may be attenuated by NSAIDs. 7.4 Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. The VA NEPHRON trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 mL/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on QBRELIS and other agents that affect the RAS. Do not co-administer aliskiren with QBRELIS in patients with diabetes. Avoid use of aliskiren with QBRELIS in patients with renal impairment (GFR < 60 mL/min). 7.5 Lithium Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs, which cause elimination of sodium, including ACE inhibitors. Lithium toxicity was usually reversible upon discontinuation of lithium and the ACE inhibitor. Monitor serum lithium levels during concurrent use. 7.6 Gold Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including lisinopril. 7.7 mTOR Inhibitors Patients taking concomitant mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema [see Warnings and Precautions ( 5.2 )] . 7.8 Neprilysin Inhibitor Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema [see Warnings and Precautions ( 5.2 )].
Foods & drinks to be careful with
Well-established interactions for this medicine’s drug class, summarized from public health authorities. General information, not medical advice — always confirm with your pharmacist or the label.
Potassium-rich foods & salt substitutes
Watch out for: salt substitutes containing potassium, and large amounts of potassium-rich foods or supplements.
These medicines can raise blood potassium. Adding a lot of extra potassium can push it too high (hyperkalemia), which can affect the heart.
What to do: Don't use potassium-based salt substitutes unless your clinician approves, and ask before taking potassium supplements. Your clinician may check your potassium level with blood tests.
Source: Lisinopril (an ACE inhibitor) — MedlinePlus (U.S. National Library of Medicine) · Spironolactone (a potassium-sparing diuretic) — MedlinePlus (U.S. National Library of Medicine)
How long does Lisinopril stay in your body?
The elimination half-life of lisinopril is about 12 hours (the effective half-life, in adults with normal kidney function) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Lisinopril is not metabolized and is cleared unchanged by the kidneys, so its half-life is longer in people with reduced kidney function and in older adults; how much is absorbed also varies widely between individuals. The 12-hour figure is the label's "effective half-life of accumulation" (the clinically meaningful value), not a single-dose terminal half-life.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: LISINOPRIL tablet — DailyMed (FDA label), Clinical Pharmacology / Pharmacokinetics.
Drug class
May treat (source: NIH RxClass)
See how Qbrelis ranks — best-rated angiotensin converting enzyme inhibitor for:
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
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Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Qbrelis treat?
- Qbrelis (Lisinopril) may be used to treat diabetic nephropathies, heart failure, hypertension, myocardial infarction, left ventricular dysfunction, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Qbrelis rated?
- pharmaranks gives Qbrelis a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Qbrelis cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.77 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Qbrelis?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Qbrelis. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Qbrelis?
- Qbrelis is marketed by Azurity. You can see Azurity's full profile, rating, and other products on pharmaranks.
- Is Qbrelis a brand-name or generic drug?
- Qbrelis is a brand-name product with the active ingredient Lisinopril. Lower-cost generic equivalents containing Lisinopril are available — ask your pharmacist.
- Is Qbrelis available over the counter?
- No. Qbrelis is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Qbrelis come in?
- Qbrelis is currently marketed as solution, per the FDA's National Drug Code Directory.
- What class of drug is Qbrelis?
- Qbrelis is classified as angiotensin converting enzyme inhibitor, per the FDA's Established Pharmacologic Class.
- Is Qbrelis FDA-registered?
- Qbrelis is on record with the U.S. FDA under application number NDA208401. You can verify this on its official FDA label.
- Has Qbrelis been recalled by the FDA?
- Qbrelis has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Qbrelis safe?
- There's no single safe-or-not verdict. pharmaranks gives Qbrelis a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Qbrelis?
- Qbrelis's side effects are taken directly from its FDA label. From the label: 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.,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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qbrelis
70/100