Monopril

[Fosinopril]

Experience with another angiotensin-converting enzyme inhibitor suggests that these increases are usually reversible upon discontinuation of ACE inhibitor and/ or diuretic therapy. In such patients, renal function should be monitored during the first few weeks of therapy. Some 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 MONOPRIL has been given concomitantly with a diuretic. This is more likely to occur in patients with preexisting renal impairment. Dosage reduction of MONOPRIL and/ or discontinuation of the diuretic may be required. Evaluation of patients with hypertension or heart failure should always include assessment of renal function (see DOSAGE AND ADMINISTRATION).

Impaired renal function decreases total clearance of fosinoprilat and approximate-ly doubles AUC. In general, no adjustment of dosing is needed. However, patients with heart failure and severely reduced renal function may be more sensitive to the hemodynamic effects (e. g., hypotension) of ACE inhibition (see CLINICAL PHARMACOLOGY).

Hyperkalemia:

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In clinical trials, hyperkalemia (serum potassium greater than 10% above the upper limit of normal) has occurred in approximately 2.6% of hypertensive patients receiving MONOPRIL. In most cases, these were isolated values which resolved despite continued therapy. In clinical trials, 0.1% of patients (two patients) were discontinued from therapy due to an elevated serum potassium. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements, and/ or potassium-containing salt substitutes, which should be used cautiously, if at all, with MONOPRIL (see PRECAUTIONS: Drug Interactions).

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.

Impaired Liver Function:

Since fosinopril is primarily metabolized by hepatic and gut wall esterases to its active moiety, fosinoprilat, patients with impaired liver function could develop elevated plasma levels of unchanged fosinopril. In a study in patients with alcoholic or biliary cirrhosis, the extent of hydrolysis was unaffected, although the rate was slowed. In these patients, the apparent total body clearance of fosinoprilat was decreased and the plasma AUC approximately doubled.

Surgery/ Anesthesia:

In patients undergoing surgery or during anesthesia with agents that produce hypotension, fosinopril 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.

Hemodialysis

Recent clinical observations have shown an association of hypersensitivity-like (ana-phylactoid) reactions during hemodialysis with high-flux dialysis membranes (e. g., AN69) in patients receiving ACE inhibitors as medication. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of medication. (See WARNINGS: Anaphylactoid reactions during membrane exposure.)

Information for Patients

Angioedema:

Angioedema, including laryngeal edema, can occur with treatment with ACE inhibitors, especially following the first dose. Patients should be advised to immediately report to their physician any signs or symptoms suggesting angioedema (e. g., swelling of face, eyes, lips, tongue, larynx, mucous membranes, and extremities; difficulty in swallowing or breathing; hoarseness) and to discontinue therapy. (See WARNINGS: Head and Neck Angioedema, Intestinal Angioedema and ADVERSE REACTIONS.)

Symptomatic Hypotension:

Patients should be cautioned that lightheadedness can occur, especially during the first days of therapy, and it should be reported to a physi-cian. Patients should be told that if syncope occurs, MONOPRIL should be discon-tinued until the physician has been consulted.

All patients should be cautioned that inadequate fluid intake or excessive perspi-ration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

Hyperkalemia:

Patients should be told not to use potassium supplements or salt substitutes containing potassium without consulting the physician.

Neutropenia:

Patients should be told to promptly report any indication of infection (e. g., sore throat, fever), which could be a sign of neutropenia.

Pregnancy:

Female patients of childbearing age should be told about the conse-quences of second-and third-trimester exposure to ACE inhibitors, and they should also be told that these consequences do not appear to have resulted from intrauter-ine ACE-inhibitor exposure that has been limited to the first trimester. These patients should be asked to report pregnancies to their physicians as soon as possible.

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