Nebilet Special Precautions



A. Menarini


Full Prescribing Info
Special Precautions
Anesthesia: Continuation of β-blockade reduces the risk of arrhythmias during induction and intubation. If β-blockade is interrupted in preparation for surgery, the β-adrenergic antagonist should be discontinued at least 24 hrs beforehand. Caution should be observed with certain anesthetics that cause myocardial depression. The patient can be protected against vagal reactions by IV administration of atropine.
Cardiovascular: In general, β-adrenergic antagonists should not be used in patients with untreated congestive heart failure, unless their condition has been stabilized.
In patients with ischemic heart disease, treatment with a β-adrenergic antagonist should be discontinued gradually, ie, 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; 1st-degree heart block, because of the negative effect of β-blockers on conduction time; Prinzmetal's angina due to unopposed α-receptor mediated coronary artery vasoconstriction (β-adrenergic antagonists may increase the number and duration of anginal attacks).
Combination of nebivolol with calcium channel antagonist of the verapamil and diltiazem type, with class I antiarrhythmic drugs, and with centrally-acting antihypertensive drugs is generally not recommended.
Metabolic/Endocrinological: Nebilet 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, β-adrenergic antagonists should be used with caution as airway constriction may be aggravated.
Other: Patients with a history of psoriasis should take β-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 treatment with nebivolol necessitates regular monitoring. Treatment discontinuation should not be done abruptly unless clearly indicated.
Nebilet contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Nebilet.
Renal Insufficiency: There is no experience in patients with severe renal insufficiency (serum creatinine ≥250 micromol/L). Therefore, the use of nebivolol in these patients is not recommended.
Effects on the Ability to Drive or Operate Machinery: No studies on the effects on the ability to drive and use machines have been performed. Pharmacodynamic studies have shown that Nebilet 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.
Use in pregnancy: Nebivolol has pharmacological effects that may cause harmful effects on pregnancy and/or the fetus/newborn. In general, β-adrenoceptor blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion or early labor. Adverse reactions (eg, hypoglycemia and bradycardia) may occur in the fetus and newborn infant. If treatment with β-adrenoceptor blockers is necessary, β1-selective adrenoceptor blockers are preferable.
Nebivolol should not be used during pregnancy unless clearly necessary. If treatment with nebivolol is considered necessary, the uteroplacental blood flow and the fetal growth should be monitored. In case of harmful effects on pregnancy or the fetus alternative treatment should be considered. The newborn infant must be closely monitored. Symptoms of hypoglycemia and bradycardia are generally to be expected within the first 3 days.
Use in lactation: Animal studies have shown that nebivolol is excreted in breast milk. It is not known whether this drug is excreted in human milk. Most β-blockers, particularly lipophilic compounds like nebivolol and its active metabolites, pass into breast milk although to a variable extent. Therefore, breastfeeding is not recommended during administration of nebivolol.
Use in children: No studies have been conducted in children and adolescents. Therefore, use in children and adolescents is not recommended.
Use in the elderly: In view of the limited experience in patients >75 years, caution must be exercised and these patients monitored closely.
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