#AZOR GENERIC 2016 FULL#

See Full Prescribing Information for other Adverse Reactions (6).Ĭommon adverse reactions where rate on lisinopril exceeds the rate on placebo by at least 2% by use are:

If jaundice or marked elevations of hepatic enzymes develop, discontinue the ACE inhibitor and receive appropriate medical treatment. Hepatic Failure: ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death. 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. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Hyperkalemia: Serum potassium should be monitored in patients receiving QBRELIS. If hypotension occurs and it is considered to be due to this mechanism, it can be corrected by volume expansion. 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. Avoid the use of QBRELIS in hemodynamically unstable patients after acute MI. QBRELIS should be started under close medical supervision and followed closely for the first 2 weeks of treatment and whenever the dose of QBRELIS and/or a diuretic is increased. Hypotension: QBRELIS can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia, acute renal failure, or death. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on QBRELIS. Patients whose renal function may depend in part on the activity of the RAS (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, post-MI or volume depletion) may be at particular risk of developing acute renal failure on QBRELIS. Changes in renal function, including acute renal failure, can be caused by drugs that inhibit the renin-angiotensin system (RAS). Impaired Renal Function: Monitor renal function in patients treated with QBRELIS. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption and in patients undergoing desensitizing treatment with hymenoptera venom.

In these patients, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent. Symptoms have not been relieved by antihistamines in these situations. In such patients, dialysis must be stopped immediately, and aggressive therapy for anaphylactoid reactions must be initiated. Discontinue QBRELIS and obtain appropriate therapy.Īnaphylactoid Reactions: Sudden and potentially life-threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes treated concomitantly with an ACE inhibitor. Intestinal angioedema has been reported with ACE inhibitors. ACE inhibitors have been associated with a higher rate of angioedema in Black than non-Black patients. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor. 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 ACE inhibitors, including QBRELIS, at any time during treatment. Do not administer QBRELIS within 36 hours of switching to or from sacubitril/valsartan. QBRELIS is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). QBRELIS is contraindicated in patients with hereditary or idiopathic angioedema.ĭo not co-administer aliskiren with Qbrelis in patients with diabetes. QBRELIS is contraindicated in patients who are hypersensitive to lisinopril or any component of QBRELIS, or in patients with a history of hypersensitivity related to previous ACE inhibitor treatment. ADDITIONAL IMPORTANT SAFETY INFORMATION: Contraindications:

Azor generic 2016