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lisinopril
Overview
What is Qbrelis?
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-[
-[()-1-Carboxy-3-phenylpropyl]-L-lysyl]-L-proline dihydrate. Its molecular formula is CHNO·2HO 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. 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.
What does Qbrelis look like?
What are the available doses of Qbrelis?
Oral solution: 1 mg/mL ()
What should I talk to my health care provider before I take Qbrelis?
How should I use Qbrelis?
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, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
QBRELIS may be administered alone or with other antihypertensive agents .
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.
The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day.
Pediatric Patients 6 years of age and older with hypertension
For pediatric patients with glomerular filtration rate > 30 mL/min/1.73m, the recommended starting dose is 0.07 mg per kg (up to 5 mg total) taken orally once daily. Dosage should be adjusted according to blood pressure response up to a maximum of 0.61 mg per kg (up to 40 mg) once daily. Doses above 0.61 mg per kg (or in excess of 40 mg) have not been studied in pediatric patients .
QBRELIS is not recommended in pediatric patients less than 6 years of age or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m
What interacts with Qbrelis?
Sorry No Records found
What are the warnings of Qbrelis?
Sorry No Records found
What are the precautions of Qbrelis?
Sorry No Records found
What are the side effects of Qbrelis?
Sorry No records found
What should I look out for while using Qbrelis?
QBRELIS is contraindicated in patients with:
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 .
What might happen if I take too much Qbrelis?
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 .
How should I store and handle Qbrelis?
Store the kit at 2°-8°C (36°-46°F). Protect the kit from light.This reagent kit is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State; store and dispose of technetium Tc99m tetrofosmin in accordance with these regulations.Store the kit at 2°-8°C (36°-46°F). Protect the kit from light.This reagent kit is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State; store and dispose of technetium Tc99m tetrofosmin in accordance with these regulations.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. 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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Lisinopril inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of lisinopril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium. In hypertensive patients with normal renal function treated with lisinopril alone for up to 24 weeks, the mean increase in serum potassium was approximately 0.1 mEq/L; however, approximately 15% of patients had increases greater than 0.5 mEq/L and approximately 6% had a decrease greater than 0.5 mEq/L. In the same study, patients treated with lisinopril and hydrochlorothiazide for up to 24 weeks had a mean decrease in serum potassium of 0.1 mEq/L; approximately 4% of patients had increases greater than 0.5 mEq/L and approximately 12% had a decrease greater than 0.5 mEq/L . Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity.
ACE is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of QBRELIS remains to be elucidated.
While the mechanism through which QBRELIS lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, QBRELIS is antihypertensive even in patients with low-renin hypertension. Although lisinopril was antihypertensive in all races studied, Black hypertensive patients (usually a low‑renin hypertensive population) had a smaller average response to monotherapy than non-Black patients.
Concomitant administration of lisinopril and hydrochlorothiazide further reduced blood pressure in Black and non-Black patients and any racial differences in blood pressure response were no longer evident.
Non-Clinical Toxicology
QBRELIS is contraindicated in patients with: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 .
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
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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