Nebivolol

Visa No.: 893110179524

Product: Nebivolol STADA 5 mg

API: Nebivolol

Product Category: Cardiovascular & Metabolism

Version approved leaflet: 31356e/QLD - ĐK_05/09/20 25

INDICATIONS

Hypertension
Treatment of essential hypertension.
Chronic heart failure (CHF)
Used in combination with standard therapy for the treatment of stable mild to moderate chronic heart failure in elderly patients (≥ 70 years of age).
 

DOSAGE AND ADMINISTRATION

Dosage:
Hypertension
Adults
Take 1 tablet daily (5 mg), preferably at the same time each day.
The antihypertensive effect becomes clearly evident after 1–2 weeks of treatment. In some cases, the maximum effect is achieved only after 4 weeks.
Combination with other antihypertensive agents:
Beta-blockers may be used alone or in combination with other antihypertensive agents. To date, an enhanced antihypertensive effect has been observed when nebivolol 5 mg is combined with hydrochlorothiazide 12.5–25 mg.
Patients with renal impairment
In patients with renal impairment, the recommended initial dose is 2.5 mg/day. If necessary, the dose may be increased to 5 mg/day.
Patients with hepatic impairment
Data in patients with hepatic dysfunction or hepatic impairment are limited. Therefore, nebivolol is contraindicated in these patients.
Elderly
In patients over 65 years of age, the recommended initial dose is 2.5 mg/day. If necessary, the dose may be increased to 5 mg/day. However, there is limited experience in patients over 75 years of age; caution and close monitoring are required in this population.
Children
No data are available on the safety and efficacy of nebivolol in children and adolescents under 18 years of age. Therefore, use in children and adolescents is not recommended.

Chronic heart failure
For the treatment of stable chronic heart failure, the dose should be titrated gradually until the optimal dose for the inpidual patient is reached.
Patients with stable chronic heart failure are those who have not experienced acute heart failure episodes within the previous 6 weeks. Treatment should be initiated by a physician experienced in the management of chronic heart failure.
In patients receiving cardiovascular medications, including diuretics and/or digoxin and/or ACE inhibitors and/or angiotensin II receptor antagonists, the doses of these agents should be kept stable for 2 weeks before starting treatment with nebivolol.

Dose up-titration should be performed stepwise, with an interval of 1–2 weeks between dose increases, depending on patient response:
1.25 mg nebivolol, increased to 2.5 mg nebivolol once daily, then 5 mg once daily, followed by 10 mg once daily.
The maximum dose is 10 mg once daily.
At initiation of treatment and at each dose increase, patients should be closely monitored for at least 2 hours by a physician experienced in the management of chronic heart failure, to ensure that clinical status remains stable (in particular blood pressure, heart rate, conduction disturbances, and signs of worsening heart failure).
The occurrence of undesirable effects may prevent some patients from being treated with the maximum dose. If necessary, the maximum dose may be reduced stepwise as appropriate. During dose titration, if heart failure worsens or the patient does not tolerate the medicinal product, the dose of nebivolol should first be reduced or treatment should be discontinued immediately if required (in cases of severe hypotension, worsening heart failure with acute pulmonary edema, cardiogenic shock, symptomatic bradycardia, or atrioventricular block).
Treatment of stable chronic heart failure with nebivolol is generally long-term treatment.
Nebivolol must not be discontinued abruptly, as this may lead to worsening of heart failure. If discontinuation is necessary, the dose should be gradually reduced by half each week.
Patients with renal impairment
No dose adjustment is required in patients with mild to moderate renal impairment, as up-titration to the maximum dose is inpidualized. There is no experience in patients with severe renal impairment (serum creatinine ≥ 250 µmol/L). Therefore, nebivolol is not recommended in these patients.
Patients with hepatic impairment: Data in patients with hepatic impairment are limited. Therefore, nebivolol is contraindicated in these patients. 
Elderly: No dose adjustment is required, as the maximum tolerated dose is inpidualized for each patient.
Children: 
No data are available on the safety and efficacy of nebivolol in children and adolescents under 18 years of age. Therefore, use in children and adolescents is not recommended.
Method of administration: For oral use.
The medicinal product may be taken with food. 

CONTRAINDICATIONS

• Hypersensitivity to the active substance or to any of the excipients listed in the Composition section.
• Hepatic impairment or hepatic dysfunction.
• Acute heart failure, cardiogenic shock, or episodes of decompensated heart failure requiring intravenous inotropic therapy.

In addition, as with other beta-blockers, nebivolol is contraindicated in the following conditions:

• Sick sinus syndrome, including sinoatrial block.
• Second-degree and third-degree atrioventricular block (without a pacemaker).
• History of bronchospasm or bronchial asthma.
• Untreated pheochromocytoma.
• Metabolic acidosis.
• Bradycardia (heart rate < 60 beats per minute prior to initiation of treatment).
• Hypotension (systolic blood pressure < 90 mmHg).
• Severe peripheral vascular disease.
   

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children