Nebilet Dosage/Direction for Use



A. Menarini


Full Prescribing Info
Dosage/Direction for Use
Hypertension: Adults: One tablet (5 mg) daily, preferably at the same time of the day. Tablets may be taken with meals.
Combination with Other Antihypertensive Agents: Beta-blockers can be used alone or concomitantly with other antihypertensive agents. To date, an additional antihypertensive effect has been observed only when Nebilet 5 mg is combined with hydrochlorothiazide 12.5-25 mg.
Renal Insufficiency: Recommended Starting Dose: 2.5 mg daily. If needed, the daily dose may be increased to 5 mg. No dose adjustment is required in mild to moderate renal insufficiency since up-titration to the maximum tolerated dose is individually adjusted.
Elderly >65 years: Recommended Starting Dose: 2.5 mg daily. If needed, the daily dose may be increased to 5 mg.
Chronic Heart Failure: The treatment of stable chronic heart failure has to be initiated with a gradual up-titration of dosage until the optimal individual maintenance dose is reached.
Patients should have stable chronic heart failure without acute failure during the past 6 weeks. It is recommended that the treating physician should be experienced in the management of chronic heart failure.
For those patients receiving cardiovascular drug therapy including diuretics and/or digoxin and/or ACE inhibitors and/or angiotensin II antagonists, dosing of these drugs should be stabilized during the past 2 weeks prior to initiation of Nebilet treatment.
The initial up-titration should be done according to the following steps at 1-2 weekly intervals based on the patient's tolerability: Nebivolol 1.25 mg, to be increased to 2.5 mg once daily, then to 5 mg once daily and then to 10 mg once daily. The maximum recommended dose is nebivolol 10 mg once daily.
Initiation of therapy and every dose increase should be done under the supervision of an experienced physician over a period of at least 2 hrs to ensure that the clinical status (especially as regards blood pressure, heart rate, conduction disturbances, signs of worsening of heart failure) remains stable.
Occurrence of adverse events may prevent all patients being treated with the maximum recommended dose. If necessary, the dose reached can also be decreased step by step and reintroduced as appropriate.
During the titration phase, in case of worsening of the heart failure or intolerance, it is recommended first to reduce the dose of nebivolol, or to stop it immediately if necessary (in case of severe hypotension, worsening of heart failure with acute pulmonary edema, cardiogenic shock, symptomatic bradycardia or atrioventricular block).
Treatment of stable chronic heart failure with nebivolol is generally a long-term treatment. The treatment with nebivolol is not recommended to be stopped abruptly since this might lead to a transitory worsening of heart failure. If discontinuation is necessary, the dose should be gradually decreased divided into ½ weekly.
Administration: Tablets may be taken with meals.
If physician prescribed to take ¼ or ½ tablet daily, follow the given instructions on how to break Nebilet 5 mg cross-scored tablets: Place the tablets onto a flat, hard surface (eg, a table or worktop), with the cross score facing up; break the tablet by pushing it with the index fingers of both hands placed along 1 breakmark. Tablet quarters are obtained by breaking the halves in the same way.
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