Each tablet contains Nebivolol 5mg + Hydrochlorothiazide 12.5mg.
For the treatment of essential hypertension.
Nebivolol-The mechanism of action of the antihypertensive response of nebivolol has not been definitively established. Possible factors that may be involved include: decreased heart rate, decreased myocardial contractility, diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centres, suppression of renin activity and vasodilation and decreased peripheral vascular resistance. Hydrochlorothiazide-Hydrochlorothiazide acts by inhibiting the reabsorption of sodium and chloride ions in the distal tubule, the diuretic action of hydrochlorothiazide reduces plasma volume.
One tablet, once daily in the morning.
Severe bradycardia, heart block greater than first degree, patients with cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), patients with severe hepatic impairment, anuria and known hypersensitivity to any of the constituents of the product.
Do not abruptly discontinue nebivolol therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with β-blockers. Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angleclosure glaucoma. Hence, use in caution with patients with untreated-angle closure glaucoma. Patients should be observed for signs of fluid or electrolyte disturbances, i.e., hyponatremia, hypochloremic alkalosis, and hypokalemia and hypomagnesemia. Should be used with caution in patients with impaired renal & hepatic function and parathyroid disease.
There are no well controlled and adequate studies regarding use of this product in pregnant women. Should be used only if the potential benefit outweighs the risk in pregnancy. Not recommended for use during lactation. Safety and efficacy in paediatric patients is not established.
Nebivolol: Use with caution when co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) as these drugs may increase plasma levels of nebivolol. Concomitant use with digitalis glycosides and β-blockers can increase the risk of bradycardia. Reserpine or clonidine may produce excessive reduction of sympathetic activity. Hydrochlorothiazide: Lithium: The renal clearance of lithium is reduced by thiazides and consequently the risk of lithium toxicity may be increased, dosage adjustment of the antidiabetic drug may be required, if used concomitantly. NSAIDs may reduce the diuretic, natriuretic, and antihypertensive effects of Hydrochlorothiazide.
Headache, fatigue, weakness, diarrhoea, vomiting and electrolyte disturbance.
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Nurses
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