Indication

Nebivolol is indicated in:
? mild to moderate essential hypertension,
? mild to moderate hypertension with coronary artery diseases(CAD),
? mild to moderate hypertension with hyperlipidemia,
? mild to moderate hypertension, in elderly, with diabetes mellitus,
? chronic heart failure (CHF).


Dosage & Administration

The dose of Nebivolol 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 pressure, the dose can be increased at 2-week intervals up to 40 mg.
Dosage guideline for nebivolol oral administration is as follows:
Essential hypertension:
Adult: 5 mg once daily
Elderly: Initially 2.5 mg once daily, then increased if necessary to 5 mg once daily
Hypertension in patient with renal impairment:
Adult: Initially 2.5 mg once daily, then increased if necessary to 5 mg once daily
Adjunct in stable mild to moderate heart failure:
Adult 70 years and over: Initially 1.25 mg once daily for 1-2 weeks, then increased if tolerated to 2.5 mg once daily for 1-2 weeks, then increased if tolerated to 5 mg once daily for 1-2 weeks, then increased if tolerated to 10 mg once daily


Precautions

Abrupt Cessation of Therapy:
Do not abruptly discontinue nebivolol 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 is planned, carefully observe and advise patients to minimize physical activity. Taper nebivolol over 1 to 2 weeks when possible. If the angina worsens or acute coronary insufficiency develops, re-start nebivolol promptly, at least temporarily.
Angina and Acute Myocardial Infarction:
Nebivolol 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 β-blockers.
Anesthesia and Major Surgery:
Because beta-blocker withdrawal has been associated with an increased risk of MI and chest pain, patients already on beta-blockers should generally continue treatment throughout the perioperative period.If nebivolol is to be continued perioperatively, monitor patients closely when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene are used. If β-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 β-blocking effects of nebivolol can be reversed by β-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 β-blockers.
Diabetes and Hypoglycemia:
β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects. Advise patients subject to spontaneous hypoglycemia and diabetic patients receiving insulin or oral hypoglycemic agents about these possibilities.
Thyrotoxicosis:
β-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockers may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.
Peripheral Vascular Disease:
β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.
Non-dihydropyridine Calcium Channel Blockers:
Because of significant negative inotropic and chronotropic effects in patients treated with β-blockers and calcium channel blockers of the verapamil and diltiazem type, monitor the ECG and blood pressure in patients treated concomitantly with these agents.
Use with CYP2D6 Inhibitors:
Nebivolol exposure increases with inhibition of CYP2D6 (see Drug Interactions). The dose of nebivolol may need to be reduced.
Impaired Renal Function:
Renal clearance of nebivolol is decreased in patients with severe renal impairment. Nebivolol has not been studied in patients receiving dialysis (see Dosage and Administration).
Impaired Hepatic Function:
Metabolism of nebivolol is decreased in patients with moderate hepatic impairment. Nebivolol has not been studied in patients with severe hepatic impairment (see Dosage and Administration).
Risk of Anaphylactic Reactions:
While taking β-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
Pheochromocytoma:
In patients with known or suspected pheochromocytoma, initiate an α-blocker prior to the use of any β-blocker.
Pregnancy:
US-FDA pregnancy category C.
Lactation:
Nebivolol is not recommended for nursing mother.


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