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Bystolic Generic Name & Formulations
Legal Class
Rx
General Description
Nebivolol (as HCl) 2.5mg, 5mg, 10mg, 20mg; tabs.
Pharmacological Class
Cardioselective beta-blocker.
How Supplied
Tabs—30, 100
Manufacturer
Generic Availability
NO
Mechanism of Action
The antihypertensive response of nebivolol, a β-adrenergic receptor blocker, is thought to include: decreased heart rate, decreased myocardial contractility, diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers, suppression of renin activity, and vasodilation and decreased peripheral vascular resistance.
Bystolic Indications
Indications
Hypertension.
Bystolic Dosage and Administration
Adult
≥18yrs: initially 5mg once daily. Individualize; may increase at 2-week intervals; max 40mg/day. Severe renal or moderate hepatic impairment: initially 2.5mg once daily.
Children
<18yrs: not recommended.
Bystolic Contraindications
Contraindications
Severe hepatic impairment (Child-Pugh >B). Severe bradycardia. 2nd- or 3rd-degree AV block. Cardiogenic shock. Overt heart failure. Sick sinus syndrome (unless paced).
Bystolic Boxed Warnings
Not Applicable
Bystolic Warnings/Precautions
Warnings/Precautions
CHF. Angina. Recent MI. Bronchospastic disease. Increased risk for hypoglycemia esp. in diabetics or those who are fasting (eg, surgery, not eating regularly, or vomiting). Hyperthyroidism. Severe renal impairment. Moderate hepatic impairment. Avoid abrupt cessation (taper over 1–2 weeks). Surgery. Peripheral vascular disease. Pheochromocytoma. Neonates (monitor). Pregnancy (esp. during 3rd trimester). Nursing mothers: not recommended.
Bystolic Pharmacokinetics
Absorption
Mean peak plasma concentrations occur ~1.5–4 hours post-dosing.
Distribution
Plasma protein bound: ~98%.
Elimination
Renal (38%), fecal (44%). Half-life: ~12 hours.
Bystolic Interactions
Interactions
Caution with phenylalkylamine and benzothiazepine calcium channel blockers (eg, verapamil, diltiazem), antiarrhythmics (eg, disopyramide), digoxin, reserpine, guanethidine; monitor. May be potentiated by CYP2D6 inhibitors (eg, quinidine, propafenone, paroxetine, fluoxetine); may need to reduce dose. If on both nebivolol and clonidine, discontinue nebivolol before tapering clonidine. May block epinephrine.
Bystolic Adverse Reactions
Adverse Reactions
Headache, fatigue, dizziness, GI upset.
Bystolic Clinical Trials
See Literature
Bystolic Note
Not Applicable
Bystolic Patient Counseling
See Literature
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