Prinivil

[lisinopril]

Laboratory Test Findings

Serum Electrolytes

Hyperkalemia and hyponatremia have occurred (see PRECAUTIONS).

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Creatinine, Blood Urea Nitrogen:

Increases in blood urea nitrogen and serum creatinine, usually reversible upon discontinuation of therapy, were observed in 1.1% and 1.6% of patients, respectively, with essential hypertension treated with PRINIVIL ® alone. Increases were more common in patients receiving concomitant diuretics and in patients with renal artery stenosis (see PRECAUTIONS). Reversible increases in blood urea nitrogen (14.5%) and serum creatinine (11.2%) were observed in approximately 12.0% of patients with congestive heart failure on concomitant diuretic therapy. Frequently, these abnormalities resolved when the dosage of the diuretic was decreased.

Hematology

Decreases in hemoglobin and hematocrit (mean decreases of approximately 0.9 g percent and 0.6 vol percent, respectively) occurred frequently in patients treated with PRINIVIL ® but were rarely of clinical importance in patients without some other cause of anemia.
Rarely hemolytic anemia has been reported Agranulocytosis and bone marrow depression, manifested as anemia, thrombocytopenia or leucopenia, have been caused by angiotensin-converting enzyme inhibitors, including lisinopril. Several cases of agranulocytosis and neutropenia have been reported in which a causal relationship to lisinopril cannot be excluded (see WARNINGS, Neutropenia/ Agranulocytosis).

Hepatic

Elevations of liver enzymes and/ or serum bilirubin have occurred (see PRECAUTIONS).

Discontinuations

Overall, 1.0% of patients discontinued therapy due to laboratory adverse experiences, principally elevations in blood urea nitrogen (0.8%), serum creatinine (0.1%) and serum potassium (0.1%).

Drug Interactions

Hypotension

Patients on Diuretic Therapy Patients on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with lisinopril. The possibility of symptomatic hypotension with lisinopril can be minimized by discontinuing the diuretic prior to initiation of treatment with lisinopril and/ or lowering the initial dose of lisinopril (see WARNINGS, Hypotension and DOSAGE AND ADMINISTRATION).

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