Covemarin warnings
General:
Impaired Renal Function: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
Hypertensive Patients with Congestive Heart Failure: In patients with severe congestive heart failure, where renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors, including Covemarin tablets, may be associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death.
Hypertensive Patients with Renal Artery Stenosis: In hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine may occur. Experience with ACE inhibitors suggests that these increases are usually reversible upon discontinuation of the drug. In such patients, renal function should be monitored during the first few weeks of therapy.
Some hypertensive patients without apparent pre-existing renal vascular disease have developed increases in blood urea nitrogen and serum creatinine, usually minor and transient. These increases are more likely to occur in patients treated concomitantly with a diuretic and in patients with pre-existing renal impairment. Reduction of dosages of Covemarin tablets, the diuretic or both may be required. In some cases, discontinuation of either or both drugs may be necessary.
Evaluation of hypertensive patients should always include an assessment of renal function.
Hyperkalemia: Elevations of serum potassium have been observed in some patients treated with ACE inhibitors, including Covemarin tablets. In U.S. controlled clinical trials, 1.4% of the patients receiving Covemarin tablets and 2.3% of patients receiving placebo showed increased serum potassium levels to greater than 5.7 mEq/L. Most cases were isolated single values that did not appear clinically relevant and were rarely a cause for withdrawal. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus and the concomitant use of agents such as potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes. Drugs associated with increases in serum potassium should be used cautiously, if at all, with Covemarin 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. In controlled trials with Perindopril, cough was present in 12% of Perindopril patients and 4.5% of patients given placebo.
Surgery/Anesthesia: In patients undergoing surgery or during anesthesia with agents that produce hypotension, Covemarin tablets may block angiotensin II formation that would otherwise occur secondary to compensatory renin release. Hypotension attributable to this mechanism can be corrected by volume expansion.
Information for Patients:
Angioedema: Angioedema, including laryngeal edema, can occur with ACE inhibitor therapy, especially following the first dose. Patients should be told to report immediately signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, hoarseness or difficulty in swallowing or breathing) and to take no more drug before consulting a physician.
Symptomatic Hypotension: As with any antihypertensive therapy, patients should be cautioned that lightheadedness can occur, especially during the first few days of therapy and that it should be reported promptly. Patients should be told that if fainting occurs, Covemarin tablets should be discontinued and a physician 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 in association with ACE inhibitor therapy.
Hyperkalemia: Patients should be advised not to use potassium supplements or salt substitutes containing potassium without a physician
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Information checked by Dr. Sachin Kumar, MD Pharmacology
