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Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) 1.1 Hypertension Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ( 14.1 )]. Nebivolol tablets may be used alone or in combination with other antihypertensive agents [see Drug Interactions ( 7 )]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nebivolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous …

Nebivolol tablets are contraindicated in the following conditions: • Severe bradycardia • Heart block greater than first degree • Patients with cardiogenic shock • Decompensated cardiac failure • Sick sinus syndrome (unless a permanent pacemaker is in place) • Patients with severe hepatic impairment (Child-Pugh >B) • Patients who are hypersensitive to any component of this product. • Severe bradycardia ( 4 ) • Heart block greater than first degree ( 4 ) • Patients with cardiogenic shock ( 4 ) • Decompensated cardiac failure ( 4 ) • Sick sinus syndrome (unless a permanent pacemaker is in place) ( 4 ) • Patients with severe hepatic impairment (Child-Pugh >B) ( 4 ) • Hypersensitive to any component of this product ( 4 )

• Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. ( 5.1 ) • Diabetes: May mask symptoms of hypoglycemia and alter glucose levels; monitor ( 5.5 ) 5.1 Abrupt Cessation of Therapy Do not abruptly discontinue nebivolol tablets therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with β-blockers. Myocardial infarction and ventricular arrhythmias may occur with or without preceding exacerbation of the angina pectoris. Caution patients without overt coronary artery disease against interruption or abrupt discontinuation of therapy. As with other β-blockers, when discontinuation of nebivolol tablets is planned, carefully observe and advise patients to minimize physical activity. Taper nebivolol tablets over 1 to 2 weeks when possible. If the angina worsens or acute coronary insufficiency develops, re-start nebivolol tablets promptly, at least temporarily. 5.2 Angina and Acute Myocardial Infarction Nebivolol tablets were not studied in patients with angina pectoris or who had a recent MI. 5.3 Bronchospastic Diseases In general, patients with bronchospastic diseases should not receive β-blockers. 5.4 Anesthesia and Major Surgery Because beta-blocker withdrawal has been associated with an increased risk of MI and chest pain, patients already on …

8.1 Pregnancy Risk Summary Available data regarding use of nebivolol tablets in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. The use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in the neonate [see Clinical Considerations]. Oral administration of nebivolol to pregnant rats during organogenesis resulted in embryofetal and perinatal lethality at doses approximately equivalent to the maximum recommended human dose …