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Nebivolol.

Structure

Nebivolol 2.5 tablets:
- 2.5 mg - Nebivolol hydrochloride;

Nebivolol 5 tablets:
- 5 mg - Nebivolol hydrochloride;

Without a Prescription

Hypertension
Stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients > 70 years

Dosage

Hypertension
The dose of Nebivolol should 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. A more frequent dosing regimen is unlikely to be beneficial.

Renal Impairment
In patients with severe renal impairment (ClCr <30 mL/min) the recommended initial dose is Nebivolol 2.5 once daily; upward titration should be performed cautiously if needed. Nebivolol has not been studied in patients receiving dialysis.

Hepatic Impairment
In patients with moderate hepatic impairment, the recommended initial dose is Nebivolol 2.5 once daily; upward titration should be performed cautiously if needed. Nebivolol has not been studied in patients with severe hepatic impairment and therefore Nebivolol is not recommended in that population.

Chronic heart failure in elderly
The treatment of stable chronic heart failure has to be initiated with a gradual uptitration of dosage until the optimal individual maintenance dose is reached.

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 halves weekly.
The maximum recommended dose is 10 mg Nebivolol once daily.
The initial uptitration should be done according to the following steps at 1-2 weekly intervals based on patient tolerability:
Tablets may be taken with meals.
Patients should have stable chronic heart failure without acute failure during the past six weeks. 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 stabilised during the past two weeks prior to initiation of Nebivolol treatment.
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.
Initiation of therapy and every dose increase should be done under the supervision of an experienced physician over a period of at least 2 hours to ensure that the clinical status (especially as regards blood pressure, heart rate, conduction disturbances, signs of worsening of heart failure) remains stable.
Half-tablet of Nebivolol 2.5 , to be increased to one tablet of Nebivolol 2.5 once daily, then to Nebivolol 5 once daily and then to 2 tablets of Nebivolol 5 once daily.
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 oedema, cardiogenic shock, symptomatic bradycardia or AV block).

Renal impairment
No dose adjustment is required in mild to moderate renal insufficiency since uptitration to the maximum tolerated dose is individually adjusted. There is no experience in patients with severe renal insufficiency (serum creatinine 250?mol/L). Therefore, the use of Nebivolol in these patients is not recommended.

Hepatic impairment
Data in patients with hepatic insufficiency are limited. Therefore the use of Nebivolol in these patients is contraindicated.

Contraindications


- Cardiogenic shock;
- Decompensated cardiac failure;
- Heart block greater than first degree;
- Heart failure patients with hepatic impairment;
- Heart failure patients with severe renal insufficiency (serum creatinine ? 250?mol/L);
- Hypersensitivity to any component of this product;
- Hypertensives with severe hepatic impairment (Child-Pugh >B);
- Severe bradycardia;
- Sick sinus syndrome (unless a permanent pacemaker is in place);

Form

Strip of 10 tablets.

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2004 - 2017