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Nebivolol & S-Amlodipine Tablet is indicated for the treatment of essential hypertension and the treatment of chronic stable angina.
Hypertension and Chronic Stable Angina
Adults: The usual dosage is one Nebivolol & S-Amlodipine tablet 5mg/5mg, with or without food, once a day. The maximum daily dose should not exceed 5mg/10mg once daily.
Elderly: In patients over 65 years of age, the recommended starting dose is one 2.5mg/5mg tablet daily. The dose may be upward titrated to 5mg/10mg if needed or as prescribed by the physician.
Patients with renal Impairment: No dosage adjustment is required in patients with mild to moderate renal impairment. In patients with severe renal impairment (ClCr < 30 mL/min) the recommended starting dose is 2.5mg/5mg once daily. If needed, upward titration should be performed cautiously.
Patients with hepatic disease: In patients with moderate hepatic impairment (Child-Pugh B), the recommended starting dose is 2.5mg/5mg once daily. If needed, the dosage should be upward titrated cautiously. Nebivolol and Amlodipine have not been studied in patients with severe hepatic impairment and therefore the fixed dose combination of Nebivolol plus Amlodipine is not recommended in patients with this condition.
Children and Adolescents: No studies have been conducted in children and adolescents. Therefore, use in children and adolescents is not recommended.
CYP2D6 Polymorphism: Dose adjustments are not necessary for patients who are CYP2D6 poor metabolizers. The clinical effect and safety profile observed in poor metabolizers were similar to those of extensive metabolizers.
dyspnoea, headache, dizziness, paraesthesia, constipation, nausea, diarrhoea.
Nebivolol:
Anaesthesia: Continuation of beta-blockade reduces the risk of arrhythmias during induction and intubation. Caution should be observed with certain anaesthetics that cause myocardial depression.
Cardiovascular: In general, beta-adrenergic antagonists should not be used in patients with untreated congestive heart failure (CHF). In patients with ischaemic heart disease, treatment with a beta-adrenergic antagonist should be discontinued gradually. Combination of nebivolol with calcium channel antagonists of the verapamil and diltiazem type is generally not recommended.
Metabolic/Endocrinological: Nebivolol does not affect glucose levels in diabetic patients.
Respiratory: In patients with chronic obstructive pulmonary disorders, beta-adrenergic antagonists should be used with caution as airway constriction may be aggravated.
Amlodipine:
The safety and efficacy of amlodipine in hypertensive crisis has not been established.
Patients with cardiac failure: Patients with heart failure should be treated with caution. Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure.
Patients with hepatic impairment: The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established.
Elderly patients: In the elderly increase of the dosage should take place with.
Patients with renal impairment: Amlodipine may be used in such patients at normal doses. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment.
Store below 30°C. Protect from light and moisture.
Keep out of reach of children.
3 x 10 Alu/Alu blister pack
Nebivolol 5 mg & S-Amlodipine 5 mg Tablets – BEVOS is available in an Alu/Alu blister of 10 tablets. Such 03 blisters in a unit carton with package insert.
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