Cautions
Contraindications
Warnings/Precautions
Warnings
Hypotension
Possible symptomatic hypotension, sometimes associated with oliguria and/or progressive azotemia and, rarely, acute renal failure and/or death. Patients at particular risk include those with CHF with BP <100 mm Hg, intensive diuretic therapy or recent increase in diuretic dose, dialysis, or severe volume and/or salt depletion of any etiology. Risk of marked hypotension in patients with CHF.
Potential for excessive hypotension to result in MI or stroke in patients with AMI or ischemic cardiovascular or cerebrovascular disease. Do not use in patients with AMI at risk of further serious hemodynamic deterioration following treatment with a vasodilator (e.g., those with SBP ≤100 mm Hg) or in those with cardiogenic shock.
Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.
To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions. May minimize potential for hypotension by withholding diuretic therapy, reducing diuretic dosage, and/or increasing sodium intake prior to initiation of lisinopril. (See Dosage under Dosage and Administration.)
In patients at risk of excessive hypotension, initiate therapy under close medical supervision; monitor closely for first 2 weeks following initiation of lisinopril or any increase in lisinopril or diuretic dosage.
If excessive hypotension occurs, immediately place patient in a supine position and, if necessary, administer IV infusion of sodium chloride 0.9%. Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion). If symptomatic hypotension develops, dosage reduction or discontinuance of lisinopril or diuretic may be necessary.
Hematologic Effects
Neutropenia and agranulocytosis reported with captopril; risk appears to depend principally on presence of renal impairment and/or presence of collagen vascular disease. Data insufficient to rule out similar incidence of leukopenia, neutropenia, or agranulocytosis with lisinopril.
Consider monitoring leukocyte counts in patients with collagen vascular disease and renal disease.
Hepatic Effects
Clinical syndrome that usually is manifested initially by cholestatic jaundice and may progress to fulminant hepatic necrosis (occasionally fatal) reported rarely with ACE inhibitors.
If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.
Fetal/Neonatal Morbidity and Mortality
Possible fetal and neonatal morbidity and mortality when used during pregnancy. (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.
Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.
Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving. Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.
Sensitivity Reactions
Anaphylactoid reactions and/or head and neck angioedema possible; if associated with laryngeal edema, may be fatal. Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx. Antihistamines and corticosteroids may not provide sufficient relief; prolonged observation may be necessary. Use caution in patients with history of angioedema unrelated to ACE inhibitor therapy.
Intestinal angioedema possible; consider in differential diagnosis of patients who develop abdominal pain. Manifestations include abdominal pain (with or without nausea or vomiting). Consider intestinal angioedema in the differential diagnosis of patients receiving ACE inhibitors and presenting with abdominal pain.
Sudden and potentially life-threatening anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing dialysis with high-flux membranes (e.g., AN69®). If anaphylactoid reactions occur, immediately stop dialysis and initiate aggressive therapy (symptoms not relieved by antihistamines). Consider using a different type of dialysis membrane or a different class of antihypertensive agent.
Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption.
Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.
Not recommended in patients with a history of angioedema associated with or unrelated to ACE inhibitors.
General Precautions
Aortic Stenosis/Hypertrophic Cardiomyopathy
Use with caution in patients with obstruction in the outflow tract of the left ventricle (e.g., aortic stenosis, hypertrophic cardiomyopathy).
Renal Effects
Transient increases in BUN and Scr possible; more likely to occur in patients with preexisting renal impairment or those receiving concomitant diuretic therapy. Possible increases in BUN and Scr in patients with unilateral or bilateral renal artery stenosis; generally reversible following discontinuance of ACE inhibitor and/or diuretic.
Possible oliguria, progressive azotemia, and, rarely, acute renal failure and/or death in patients with severe CHF.
Closely monitor renal function for the first few weeks of therapy in hypertensive patients with unilateral or bilateral renal-artery stenosis. Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic.
In patients with AMI who develop renal impairment (Scr >3 mg/dL or a doubling of baseline Scr), consider discontinuing therapy.
Hyperkalemia
Possible hyperkalemia, especially in patients with renal impairment or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes). (See Specific Drugs under Interactions.)
Cough
Persistent and nonproductive cough; resolves after drug discontinuance.
Use of Fixed Combinations
When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.
Specific Populations
Pregnancy
Category C (1st trimester); Category D (2nd and 3rd trimesters). (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)
Lactation
Distributed into milk in rats; not known whether lisinopril is distributed into milk in humans. Discontinue nursing or the drug.
Pediatric Use
Safety and efficacy not established in children <6 years of age or in those with Clcr <30 mL/minute per 1.73 m2.
Geriatric Use
Response in patients ≥65 years of age does not appear to differ from that in younger adults; however, use with caution due to greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly. (See Geriatric Patients under Dosage and Administration and see Special Populations under Pharmacokinetics.)
Renal Impairment
Deterioration of renal function may occur in susceptible patients. (See Renal Effects under Cautions.)
Increased lisinopril concentrations, particularly in patients with GFR <30 mL/minute. Initial dosage adjustment recommended in patients with severe renal impairment. (See Renal Impairment under Dosage and Administration.)
Lisinopril/hydrochlorothiazide fixed combinations are not recommended in patients with severe renal impairment.
Blacks
BP reduction may be smaller in black patients compared with nonblack patients; however, no apparent population difference during combined therapy with ACE inhibitor and thiazide diuretic. Use in combination with a diuretic.
Higher incidence of angioedema reported with ACE inhibitors in blacks compared with other races.
Common Adverse Effects
Patients with hypertension: Headache, dizziness, cough, fatigue, diarrhea, upper respiratory tract infection, nausea. With fixed combination preparation, muscle cramps, asthenia, orthostatic effects, paresthesia.
Patients with CHF: Dizziness, hypotension, headache, diarrhea, chest pain, nausea, abdominal pain, rash, upper respiratory tract infection.
Patients with AMI: Hypotension, renal dysfunction.
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