Drug Information for Bystolic (Physicians Total Care, Inc.): WARNINGS

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  • Abrupt Cessation of Therapy

    Patients with coronary artery disease treated with BYSTOLIC should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with ß-blockers. Myocardial infarction and ventricular arrhythmias may occur with or without preceding exacerbation of the angina pectoris. Even patients without overt coronary artery disease should be cautioned against interruption or abrupt discontinuation of therapy. As with other ß-blockers, when discontinuation of BYSTOLIC is planned, patients should be carefully observed and advised to minimize physical activity. BYSTOLIC should be tapered over 1 to 2 weeks when possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that BYSTOLIC be promptly reinstituted, at least temporarily.

    Cardiac Failure

    Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and ß-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In patients who have compensated congestive heart failure, BYSTOLIC should be administered cautiously. If heart failure worsens, discontinuation of BYSTOLIC should be considered.

    Angina and Acute Myocardial Infarction

    BYSTOLIC was not studied in patients with angina pectoris or who had a recent MI.

    Bronchospastic Diseases

    In general, patients with bronchospastic diseases should not receive ß-blockers.

    Anesthesia and Major Surgery

    If BYSTOLIC is to be continued perioperatively, patients should be closely monitored when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If ß-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

    The ß-blocking effects of BYSTOLIC can be reversed by ß-agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with ß-blockers.

    Diabetes and Hypoglycemia

    ß-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective ß-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be advised about these possibilities and nebivolol should be used with caution.

    Thyrotoxicosis

    ß-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of ß-blockers may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.

    Peripheral Vascular Disease

    ß-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in these patients.

    Non-dihydropyridine Calcium Channel Blockers

    Because of significant negative inotropic and chronotropic effects in patients treated with ß-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be used in patients treated concomitantly with these agents and ECG and blood pressure should be monitored.

  • Drug Information Provided by National Library of Medicine (NLM).
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