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The following warnings and precautions apply to beta-adrenergic antagonists in general.
Anaesthesia: Continuation of beta-blockade reduces the risk of arrhythmias during induction and intubation. If beta-blockade is interrupted in preparation for surgery, the beta-adrenergic antagonist should be discontinued at least 24 hours beforehand. Caution should be observed with certain anaesthetics that cause myocardial depression. The patient can be protected against vagal reactions by intravenous administration of atropine.
Cardiovascular: In general beta-adrenergic antagonists should not be used in patients with untreated congestive heart failure (CHF), unless their condition has been stabilized.
In patients with ischaemic heart disease, treatment with a beta-adrenergic antagonist should be discontinued gradually, i.e. over 1-2 weeks. If necessary replacement therapy should be initiated at the same time to prevent exacerbation of angina pectoris.
Beta-adrenergic antagonists may induce bradycardia: if the pulse rate drops below 50-55 bpm at rest and/or the patient experiences symptoms that are suggestive of bradycardia, the dosage should be reduced.
Beta-adrenergic antagonists should be used with caution: In patients with peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication), as aggravation of these disorders may occur; In patients with first degree heart block, because of negative effect of beta-blockers on conduction time; In patients with Prinzmetal's angina due to unopposed alpha-receptor mediated coronary artery vasoconstriction: beta-adrenergic antagonists may increase the number and duration of angina attacks.
Combination of nebivolol with calcium channel antagonists of the verapamil and diltiazem type, with Class I antiarrhythmic drugs, and with centrally acting antihypertensive drugs is generally not recommended.
Metabolic/Endocrinological: Nebivolol does not affect glucose levels in diabetic patients. Care should be taken in diabetic patients however, as nebivolol may mask certain symptoms of hypoglycemia (tachycardia, palpitations).
Beta-adrenergic blocking agents may mask tachycardic symptoms in hyperthyroidism. Abrupt withdrawal may intensify symptoms.
Respiratory: In patients with chronic obstructive pulmonary disorders, beta-adrenergic antagonists should be used with caution as airway constriction maybe aggravated.
Other: Patients with history of psoriasis should take beta-adrenergic antagonists only after careful consideration.
Beta-adrenergic antagonists may increase the sensitivity to allergens and the severity of anaphylactic reactions.
The initiation of Chronic Heart Failure with nebivolol necessitates regular monitoring. Treatment discontinuation should not be done abruptly unless clearly indicated.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed. Pharmacodynamic studies have shown that Nebivolol 5 mg does not affect psychomotor function. When driving vehicles or operating machines it should be taken into account that dizziness and fatigue may occasionally occur.
