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Prinivil

Generic Name: Lisinopril
Drug Category: ACE Inhibitor
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 6 years old for a maximum duration of 5 years.

Approved Uses

Indicated for:

Hypertension:

• Treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure.

PRINIVIL may be administered alone or with other antihypertensive agents.

Heart Failure:

• To reduce signs and symptoms of heart failure in patients who are not responding adequately to diuretics and digitalis.

Acute Myocardial Infarction:

• For the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta blockers.

If blood pressure is not controlled with PRINIVIL alone, a low dose of a diuretic may be added (e.g., hydrochlorothiazide 12.5 mg). The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day.

PRINIVIL is not recommended in pediatric patients <6 years or in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m 2

Avoid use of PRINIVIL in patients who are hemodynamically unstable after acute MI.

No dose adjustment of PRINIVIL is required in patients with creatinine clearance >30 mL/min. In patients with creatinine clearance 10-30 mL/min, reduce the initial dose of PRINIVIL to half of the usual recommended dose (i.e., hypertension, 5 mg; heart failure or acute MI, 2.5 mg). For patients on hemodialysis or creatinine clearance <10 mL/min, the recommended initial dose is 2.5 mg once daily

PRINIVIL 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.

Symptomatic hypotension is also possible in patients with severe aortic stenosis or hypertrophic cardiomyopathy.

Monitor serum potassium periodically in patients receiving PRINIVIL. 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.

Avoid use of aliskiren with PRINIVIL in patients with renal impairment (GFR <60 ml/min).

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.

Monitor renal function periodically in patients treated with PRINIVIL. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system.

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 PRINIVIL, 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. PRINIVIL 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. ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients.

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 C1 esterase levels were normal.

ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and sometimes death.

PRINIVIL 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

PRINIVIL is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer PRINIVIL within 36 hours of switching to or from sacubitril/valsartan, a product containing a neprilysin inhibitor.

Do not co-administer aliskiren with PRINIVIL in patients with diabetes.

In general, avoid combined use of RAS inhibitors.

Patients receiving co-administration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema.

Initiation of PRINIVIL in patients on diuretics may result in excessive reduction of blood pressure. The possibility of hypotensive effects with PRINIVIL can be minimized by either decreasing or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with PRINIVIL.

Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or other drugs that may increase serum potassium can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, monitor the patient’s serum potassium frequently.

Concomitant administration of PRINIVIL and antidiabetic medicines (insulins, oral hypoglycemic agents) may cause an increased blood-glucose-lowering effect with risk of hypoglycemia.

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.

Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs, which cause elimination of sodium, including ACE inhibitors.

PRINIVIL can cause fetal harm when administered to a pregnant woman. 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 PRINIVIL as soon as possible.

Because of the potential for serious adverse reactions in nursing infants from ACE inhibitors, discontinue nursing or discontinue PRINIVIL.

GoToSource

Off-label Uses

• Dosage greater than 80 mg per day for adult patients. GoToSource

• Use in patients under the age of 6 years. GoToSource

• Scleroderma renal crisis. GoToSource

• Diabetic nephropathy. GoToSource

• Idiopathic oligospermia and infertility in normotensive male patients. GoToSource

Adverse Events

Genital swelling. GoToSource 

Angioneurotic edema of the upper airways and swelling of the small intestine. GoToSource 

Upper airway obstruction in children. GoToSource

Hypotension, hyperkalemia (high potassium levels), kidney failure and bone marrow suppression. GoToSource

Pancreatitis (inflammation of the pancreas). GoToSource

Liver injury. GoToSource

Angioedema ( swelling in deep layers of skin). GoToSource

Birth defects. GoToSource

Litigation

Lawsuits filed for angioedema, liver failure and birth defects. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024