11. The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22 H 25 F 2 NO 4 •HCl) with the following structural formula: SRRR - or d-nebivolol hydrochloride RSSS - or l-nebiv...

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1. BYSTOLIC 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 Hypertension BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure . BYSTOLIC may be used alone or in combination with other antihypertensive agents . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovasc...

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2. Can be taken with and without food. Individualize to the needs of the patient and monitor during up-titration. Hypertension: Most patients start at 5 mg once daily. Dose can be increased at 2-week intervals up to 40 mg. 2.1 Hypertension The dose of BYSTOLIC must be individualized to the needs of the patient. For most patients, the recommended starting dose is 5 mg once daily, with or without food, as monotherapy or in combination with other agents. For patients requiring further reduction in blood p...

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4. BYSTOLIC is 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 Heart block greater than first degree Patients with cardiogenic shock Decompensated cardiac failure Sick sinus syndrome...

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10. In clinical trials and worldwide postmarketing experience there were reports of BYSTOLIC overdose. The most common signs and symptoms associated with BYSTOLIC overdosage are bradycardia and hypotension. Other important adverse reactions reported with BYSTOLIC overdose include cardiac failure, dizziness, hypoglycemia, fatigue and vomiting. Other adverse reactions associated with β-blocker overdose include bronchospasm and heart block. The largest known ingestion of BYSTOLIC worldwide involved a pa...

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5. Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. Diabetes: Monitor glucose as β-blockers may mask symptoms of hypoglycemia. 5.1 Abrupt Cessation of Therapy Do not abruptly discontinue BYSTOLIC 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. ...

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7. CYP2D6 enzyme inhibitors may increase nebivolol levels. Reserpine or clonidine may produce excessive reduction of sympathetic activity. Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Verapamil- or diltiazem-type calcium channel blockers may cause excessive reductions in heart rate, blood pressure, and cardiac contractility. 7.1 CYP2D6 Inhibitors Use caution when BYSTOLIC is co-administered with...

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Available data regarding use of BYSTOLIC 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 . Oral administration of nebivolol to pregnant rats during organog...

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