Randomised placebo-controlled trial of lisinopril in normotensive patients with insulin-dependent diabetes and normoalbuminuria or microalbuminuria.
5 mg PO within 24 hours of onset of symptoms of acute MI, THEN 5 mg after 24 hours, 10 mg after 48 hours, and 10 mg qDay for 6 weeksIf patient has low systolic blood pressure (ie, ≤120 mm Hg) when treatment initiated or during the first 3 days, administer a lower dose of 2.5 mgIf hypotension occurs (systolic BP ≤100 mm Hg), a daily maintenance dose of 5 mg may be given, with temporary reductions to 2.5 mg if neededNot taking diuretic: 10 mg PO qDay initially; usual range is 20-40 mg/day as single daily doseAdjunctive therapy with diuretics and (usually) digitalis5 mg PO qDay initially; increase by ≤10 mg no more frequent than 2 week intervals to 20-40 mg PO qDayPatients with hypnatremia (<130 mEq/L serum sodium): 2.5 mg PO qDay initially; increase by ≤10 mg no more frequent than 2 week intervals to 20-40 mg PO qDayUsual effective dosage range: 5-40 mg PO qDay (Zestril); 5-20 mg PO qDay (Prinivil)May gradually increase dose according to blood pressure response; dosage range is 20-40 mg/dayIndicated for hypertension in pediatric patients aged ≥6 yr to lower blood pressureAge <6 years or GFR <30 mL/min/1.73m²: Safety and efficacy not established≥6 years and GFR ≥30 mL/min/1.73m²: 0.07 mg/kg PO qDay initially, not to exceed 5 mg/day; may slowly titrate upward and adjusted according to blood pressure; not to exceed 0.61 mg/kg/day or >40 mg/day Oral solution: Orphan designation for treatment of primary hypertension with complications and secondary hypertension in pediatric patients (ages 0 through 16 years of age)Consider lower initial dose of 2.5-5 mg and titrate to response in the elderlyAdjust dose to blood pressure response; doses up to 80 mg have been used but do not appear to have a greater effectTaking diuretic: Discontinue diuretic for 2-3 days before initiating lisinopril to reduce chance of hypotension; may resume diuretic if blood pressure is not controlled; if diuretic cannot be discontinued, initial dose of lisinopril 2.5 mg should be used under supervision for at least 2 hours and until blood pressure has stabilized for at least 1 hourDiscontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury and/or deathHypersensitivity to lisinopril/other ACE inhibitorsHistory of ACE inhibitor-induced angioedema, hereditary or idiopathic angioedemaCoadministration of neprilysin inhibitors (eg, sacubitril)Coadministration with aliskiren in patients with diabetes mellitus or with renal impairment (ie, GFR <60 mL/min/1.73m²Anaphylactoid reactions reported in some patients dialyzed with high-flux membranesHematologic effects including agranulocytosis and neutropenia/agranulocytosis reported especially in patients with renal impairment and collagen vascular disease; monitor CBC periodically with differentialExcessive hypotension with concomitant diuretics, hypovolemia, hyponatremia may occurNeprilysin inhibitors (eg, sacubitril) with ACE inhibitors may increase angioedema risk; do not administer ACE inhibitors within 36 hr of switching to or from sacubitril/valsartanRisk of hyperkalemia, especially in patients with renal impairment or DM or in patients taking concomitant K+-elevating drugsACE inhibition also causes an increase in bradykinin levels, which putatively mediates angioedema; in comparison with other patients, a higher incidence of angioedema caused by ACE inhibitors has been observed in black patientsA dry hacking cough may occur within a few months of initiating drug therapy with ACE inhibitors; exclude other causes of cough before discontinuing therapyCholestatic jaundice associated with ACE inhibitors; discontinue if marked elevation of hepatic transaminases or jaundice occursCoadministration with mTOR inhibitors (eg, temsirolimus, everolimus) may increased risk for angioedemaUse caution in patients with renal impairment; renal deterioration reported in patients with low renal blood flowUse caution in patients with severe aortic stenosis, cardiovascular disease, collagen vascular disease, hypertrophic cardiomyopathyDual blockade of the renin-angiotensin-aldosterone system (ie, ARB plus an ACE inhibitor) in patients with established atherosclerotic disease or heart failure or with diabetes with end organ damage is associated with a higher frequency of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure), as compared with use of a single renin-angiotensin-aldosterone system agent; limit dual blockade to individually defined cases, with close monitoring of renal functionNeonates with history of in utero exposure: If oliguria or hypotension occurs, support of blood pressure and renal perfusion; exchange transfusions or dialysis may be requiredAngioedema of the face, extremities, lips, tongue, glottis and/or larynx, including some fatal reactions, at any time during treatment; patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially patients with history of airway surgery; promptly discontinue and provide appropriate therapy and monitoring until complete and sustained resolution of signs and symptoms of angioedema has occurredIntestinal angioedema reported; patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal; symptoms resolved after stopping the ACE inhibitorHypotension may occur sometimes complicated by oliguria, progressive azotemia, acute renal failure or death; patients at risk of excessive hypotension include 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; in such patients initiate therapy under medical supervision and follow such patients for the first two weeks of treatment and whenever dose of lisinopril and/or diuretic is increased; avoid use in patients who are hemodynamically unstable after acute MI; symptomatic hypotension also possible in patients with severe aortic stenosis or hypertrophic cardiomyopathyPatients undergoing major surgery or during anesthesia with agents that produce hypotension, lisinopril may block angiotensin II formation secondary to compensatory renin release; if hypotension occurs and considered to be due to this mechanism, it can be corrected by volume expansionMonitor renal function periodically; changes in renal function including acute renal failure can be caused by drugs that inhibit renin-angiotensin system; patients whose renal function may depend in part on activity of the renin-angiotensin system (eg, patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, post-myocardial infarction or volume depletion) may be at particular risk of developing acute renal failure; consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal functionDiscontinue as soon as pregnancy detected; during the second and third trimesters of pregnancy, drugs that act directly on the renin-angiotensin system have been associated with fetal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible and irreversible renal failure, and deathLactation: Not known if excreted into breast milk; not recommendedA: Generally acceptable.