Prinivil

[lisinopril]

By whole body autoradiography, radioactivity was found in the placenta following administration of labelled lisinopril to pregnant rats, but none was found in the fetuses.

PRECAUTIONS

Renal Impairment

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As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function have been seen in susceptible individuals. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, such as patients with bilateral renal artery stenosis, unilateral renal artery stenosis to a solitary kidney, or severe congestive heart failure, treatment with agents that inhibit this system has been associated with oliguria, progressive azotemia, and rarely, acute renal failure and/ or death. In susceptible patients, concomitant diuretic use may further increase risk.

In acute myocardial infarction, treatment with lisinopril should not be initiated in patients with evidence of renal dysfunction, defined as serum creatinine concentration exceeding 177 µmol/ L and/ or proteinuria exceeding 500 mg/ 24 hour. If renal dysfunction develops during treatment with PRINIVIL ® (lisinopril tablets, Merck Frosst Std.) (serum creatinine concentration exceeding 265 µmol/ L or a doubling from the pre-treatment value), then the physician should consider withdrawal of PRINIVIL ® .
Use of PRINIVIL ® should include appropriate assessment of renal function.

Hypotension Following Acute Myocardial Infarction

Lisinopril treatment following acute myocardial infarction must not be initiated in patients at risk of further serious hemodynamic deterioration after vasodilator treatment. These include patients with systolic blood pressure of 100 mmHg or lower or those in cardiogenic shock.

During the first three days following the infarction, dosage reduction should occur if systolic blood pressure is between 100 and 120 mmHg (see DOSAGE AND ADMINISTRATION, Treatment Following Acute Myocardial Infarction). Patients with myocardial infarction in the GISSI-3 study treated with PRINIVIL ® had a higher (9.0% vs 3.7%) incidence of persistent hypotension (systolic blood pressure less than 90 mmHg for more than 1 hour) than patients treated with placebo.

Hyperkalemia

In clinical trials hyperkalemia (serum potassium >5.7 mEq/ L) occurred in approximately 2.2% of hyper-tensive patients and 4.0% of patients with congestive heart failure. In most cases these were isolated values which resolved despite continued therapy. Hyperkalemia was a cause of discontinuation of therapy in approximately 0.1% of hypertensive patients. Risk factors for the development of hyperkalemia may include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements and/ or potassium-containing salt substitutes (see DRUG INTERACTIONS).

Valvular Stenosis, Hypertrophic Cardiomyopathy

There is concern on theoretical grounds that patients with aortic stenosis or hypertrophic cardiomyopathy might be at particular risk of decreased coronary perfusion when treated with vasodilators. PRINIVIL ® should be given with caution to these patients.

Surgery/ Anesthesia

In patients undergoing major surgery or during anesthesia with agents that produce hypotension, lisinopril blocks angiotensin II formation, secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.

Patients with Impaired Liver Function

Hepatitis, jaundice (hepatocellular and/ or cholestatic), elevations of liver enzymes and/ or serum bilirubin have occurred during therapy with lisinopril in patients with or without pre-existing liver abnormalities (see ADVERSE REACTIONS). In most cases the changes were reversed on discontinuation of the drug.

Should the patient receiving PRINIVIL ® experience any unexplained symptoms (see INFORMATION FOR PATIENTS), particularly during the first weeks or months of treatment, it is recommended that a full set of liver function tests and any other necessary investigation be carried out. Discontinuation of PRINIVIL ® should be considered when appropriate.

There are no adequate studies in patients with cirrhosis and/ or liver dysfunction. PRINIVIL ® should be used with particular caution in patients with pre-existing liver abnormalities. In such patients, baseline liver function tests should be obtained before administration of the drug and close monitoring of response and metabolic effects should apply.

Cough

A dry, persistent cough, which usually disappears only after withdrawal or lowering of the dose of PRINIVIL ® has been reported. Such a possibility should be considered as part of the differential diagnosis of the cough.

Use in Nursing Mothers

Exercise caution when giving PRINIVIL ® to lactating women. Milk of lactating rats contains radioactivity following administration of 14 C lisinopril. It is not known whether PRINIVIL ® is secreted in human breast milk.

Use in the Elderly

In general, blood pressure response and adverse experiences were similar in younger and older patients given similar doses of PRINIVIL ® . Pharmacokinetic studies, however, indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients so that dosage adjustments should be made with particular caution (see DOSAGE AND ADMINISTRATION).

Pediatric Use

Safety and effectiveness in children have not been established.

Anaphylactoid Reactions during Membrane Exposure

Anaphylactoid reactions have been reported in patients dialysed with high-flux membranes (e. g., polyacrylonitrile [PAN]) and treated concomitantly with an ACE inhibitor. Dialysis should be stopped immediately if symptoms such as nausea, abdominal cramps, burning, angioedema, shortness of breath and severe hypotension occur. Symptoms are not relieved by antihistamines. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
Anaphylactoid Reactions during LDL Apheresis Rarely, patients receiving ACE inhibitors during low-density lipoprotein (LDL) apheresis with dextran sulfate have experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE inhibitor therapy prior to each apheresis.

Anaphylactoid Reactions during Hymenoptera Desensitization

There have been isolated reports of patients experiencing sustained life-threatening anaphylactoid reactions while receiving ACE inhibitors during desensitizing treatment with hymenoptera (bees, wasp) venom. In the same patients, these reactions have been avoided when ACE inhibitors were temporarily withheld for at least 24 hours, but they have reappeared upon inadvertent rechallenge.

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