Benazepril precautions
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-632-7753
List of precautions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Fetal/Neonatal Morbidity and Mortality
Nursing Mothers
Geriatric Use
Pediatric Use
General
Impaired Renal Function
As a consequence of inhibiting the renin-angiotensin-aldosterone system, 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-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme inhibitors, including Benazepril hydrochloride tablets, may be associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. In a small study of hypertensive patients with renal artery stenosis in a solitary kidney or bilateral renal artery stenosis, treatment with Benazepril hydrochloride tablets was associated with increases in blood urea nitrogen and serum creatinine; these increases were reversible upon discontinuation of Benazepril hydrochloride tablets or diuretic therapy, or both. When such patients are treated with ACE inhibitors, 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 Benazepril hydrochloride tablets have been given concomitantly with a diuretic. This is more likely to occur in patients with preexisting renal impairment. Dosage reduction of Benazepril hydrochloride tablets and/or discontinuation of the diuretic may be required. Evaluation of the hypertensive patient should always include assessment of renal function.
Hyperkalemia
In clinical trials, hyperkalemia (serum potassium at least 0.5 mEq/L greater than the upper limit of normal) occurred in approximately 1% of hypertensive patients receiving Benazepril hydrochloride tablets. In most cases, these were isolated values which resolved despite continued therapy. 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 Benazepril hydrochloride tablets.
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
In patients with hepatic dysfunction due to cirrhosis, levels of Benazeprilat are essentially unaltered.
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.
Information for Patients
Pregnancy
Female patients of childbearing age should be told about the consequences 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 intrauterine 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.
Angioedema
Angioedema, including laryngeal edema, can occur at any time with treatment with ACE inhibitors. Patients should be so advised and told to report immediately any signs or symptoms suggesting angioedema (swelling of face, eyes, lips, or tongue, or difficulty in breathing) and to take no more drug until they have consulted with the prescribing physician.
Symptomatic Hypotension
Patients should be cautioned that lightheadedness can occur, especially during the first days of therapy, and it should be reported to the prescribing physician. Patients should be told that if syncope occurs, Benazepril hydrochloride tablets should be discontinued until the prescribing physician has been consulted.
All patients should be cautioned that inadequate fluid intake or excessive perspiration, 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 prescribing 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.
Drug Interactions
Diuretics
Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with Benazepril hydrochloride tablets. The possibility of hypotensive effects with Benazepril hydrochloride tablets can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with Benazepril hydrochloride tablets. If this is not possible, the starting dose should be reduced.
Potassium Supplements and Potassium-Sparing Diuretics
Benazepril hydrochloride tablets can attenuate potassium loss caused by thiazide diuretics. Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, they should be given with caution, and the patient's serum potassium should be monitored frequently.
Oral Anticoagulants
Interaction studies with warfarin and acenocoumarol failed to identify any clinically important effects on the serum concentrations or clinical effects of these anticoagulants.
Lithium
Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. These drugs should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity may be increased.
Other
No clinically important pharmacokinetic interactions occurred when Benazepril hydrochloride tablets were administered concomitantly with hydrochlorothiazide, chlorthalidone, furosemide, digoxin, propranolol, atenolol, naproxen, or cimetidine.
Benazepril hydrochloride tablets have been used concomitantly with beta-adrenergic-blocking agents, calcium-channel-blocking agents, diuretics, digoxin, and hydralazine, without evidence of clinically important adverse interactions.
Benazepril, like other ACE inhibitors, has had less than additive effects with beta-adrenergic blockers, presumably because both drugs lower blood pressure by inhibiting parts of the renin-angiotensin system.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of carcinogenicity was found when Benazepril was administered to rats and mice for up to two years at doses of up to 150 mg/kg/day. When compared on the basis of body weights, this dose is 110 times the maximum recommended human dose. When compared on the basis of body surface areas, this dose is 18 and 9 times (rats and mice, respectively) the maximum recommended human dose (calculations assume a patient weight of 60 kg). No mutagenic activity was detected in the Ames test in bacteria (with or without metabolic activation), in an in vitro test for forward mutations in cultured mammalian cells, or in a nucleus anomaly test. In doses of 50-500 mg/kg/day (6-60 times the maximum recommended human dose based on mg/m2 comparison and 37-375 times the maximum recommended human dose based on a mg/kg comparison), Benazepril hydrochloride had no adverse effect on the reproductive performance of male and female rats.
Pregnancy Categories C (first trimester) and D (second and third trimesters)
Fetal/Neonatal Morbidity and Mortality
Nursing Mothers
Minimal amounts of unchanged Benazepril and of Benazeprilat are excreted into the breast milk of lactating women treated with Benazepril. A newborn child ingesting entirely breast milk would receive less than 0.1% of the mg/kg maternal dose of Benazepril and Benazeprilat.
Geriatric Use
Of the total number of patients who received Benazepril in U.S. clinical studies of Benazepril hydrochloride tablets, 18% were 65 or older while 2% were 75 or older. No overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Benazepril and Benazeprilat are substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Pediatric Use
The antihypertensive effects of Benazepril hydrochloride tablets have been evaluated in a double-blind study in pediatric patients 7 to 16 years of age. The pharmacokinetics of Benazepril hydrochloride tablets have been evaluated in pediatric patients 6 to 16 years of age. Benazepril hydrochloride tablets were generally well tolerated and adverse effects were similar to those described in adults.
Treatment with Benazepril hydrochloride tablets is not recommended in pediatric patients less than 6 years of age, and in children with glomerular filtration rate <30 mL/min as there are insufficient data available to support a dosing recommendation in these groups.
The content of this page is taken from the FDA package insert for this drug and should not be edited.
Acknowledgement and Attribution Regarding Sources of Content
Some of the initial content on this page may be incorporated in part from copyleft sources in the public domain including wikis such as Wikipedia and AskDrWiki. Drug information for patients came from the The National Library of Medicine. Infectious disease information may have come from the Centers for Disease Control (CDC). Differential Diagnoses are drawn from clinicians as well as an amalgamation of 3 sources: 1.The Disease Database; 2. Kahan, Scott, Smith, Ellen G. In A Page: Signs and Symptoms. Malden, Massachusetts: Blackwell Publishing, 2004:3; 3. Sailer, Christian, Wasner, Susanne. Differential Diagnosis Pocket. Hermosa Beach, CA: Borm Bruckmeir Publishing LLC, 2002:7 .
