Amlodipine/benazepril precautions

List of precautions
Impaired Renal Function unilateral or bilateral renal artery stenosis Renal vascular disease Hyperkalemia Patients With Congestive Heart Failure Patients With Hepatic Failure Surgery/Anesthesia

Impaired Renal Function
Lotrel should be used with caution in patients with severe renal disease. When the renin-angiotensin-aldosterone system is inhibited by benazepril, changes in renal function may be anticipated in susceptible individuals. In patients with severe congestive heart failure, whose renal function may depend on the activity of the renin-angiotensinaldosterone system, treatment with ACE inhibitors (including benazepril) may be associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Return to top

unilateral or bilateral renal artery stenosis
In a small study of hypertensive patients with unilateral or bilateral renal artery stenosis, treatment with benazepril was associated with increases in blood urea nitrogen and serum creatinine; these increases were reversible upon discontinuation of benazepril therapy, concomitant diuretic therapy, or both. When such patients are treated with Lotrel, renal function should be monitored during the first few weeks of therapy. Return to top

Renal vascular disease
Some benazepril-treated hypertensive patients with no apparent preexisting renal vascular disease have developed increases in blood urea nitrogen and serum creatinine, usually minor and transient, especially when benazepril has been given concomitantly with a diuretic. Dosage reduction of Lotrel may be required. Evaluation of the hypertensive patient should always include assessment of renal function. Return to top

Hyperkalemia
In U.S. placebo-controlled trials of Lotrel, hyperkalemia (serum potassium at least 0.5 mEq/L greater than the upper limit of normal) not present at baseline occurred in approximately 1.5% of hypertensive patients receiving Lotrel. Increases in serum potassium were generally reversible. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassiumcontaining salt substitutes. Return to top

Patients With Congestive Heart Failure
Although hemodynamic studies and a controlled trial in patients with NYHA Class II-III heart failure have shown that amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction, and clinical symptomatology, studies have not been performed in patients with NYHA Class IV heart failure. In general, all calcium channel blockers should be used with caution in patients with heart failure. Return to top

Patients With Hepatic Failure
In patients with hepatic dysfunction due to cirrhosis, levels of benazeprilat are essentially unaltered. However, since amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with impaired hepatic function, caution should be exercised when administering Lotrel to patients with severe hepatic impairment (see also WARNINGS). Cough: Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough. Return to top

Surgery/Anesthesia
In patients undergoing surgery or during anesthesia with agents that produce hypotension, benazepril will block the angiotensin II formation that could otherwise occur secondary to compensatory renin release. Hypotension that occurs as a result of this mechanism can be corrected by volume expansion. Return to top