QBRELIS

Adult Patients : QBRELIS is bioequivalent to lisinopril tablets under fasted and fed conditions. Following oral administration of lisinopril tablets, peak serum concentrations of lisinopril occur within about 7 hours, although there was a trend to a small delay in time taken to reach peak serum concentrations in acute myocardial infarction patients. Food does not alter the bioavailability of lisinopril tablets. Declining serum concentrations exhibit a prolonged terminal phase, which does not con...

14.1 Hypertension Two dose-response studies utilizing a once-daily regimen were conducted in 438 mild to moderate hypertensive patients not on a diuretic. Blood pressure was measured 24 hours after dosing. An antihypertensive effect of lisinopril was seen with 5 mg of lisinopril in some patients. However, in both studies blood pressure reduction occurred sooner and was greater in patients treated with 10, 20 or 80 mg of lisinopril than patients treated with 5 mg of lisinopril. In controlled clinical studies of patients with mild to moderate hypertension, patients were treated with lisinopril 2...

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 ...

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 ...

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-a...

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...