This combination contains a beta-adrenergic blocker and an angiotensin II receptor blocker (ARB), and is indicated for the treatment of hypertension to reduce elevated blood pressure. Lowering blood pressure helps decrease the risk of serious cardiovascular events such as stroke and myocardial infarction.

Nebivolol is a selective beta-1 adrenergic blocker that acts primarily on the cardiovascular system. It reduces heart rate, decreases cardiac contractility, and produces vasodilation, contributing to a reduction in blood pressure. Valsartan is an angiotensin II receptor blocker that selectively inhibits the AT1 receptor, leading to vasodilation and decreased blood pressure without significantly affecting heart rate.

As initial therapy and in patients not adequately controlled on valsartan 80 mg or nebivolol up to and including 10 mg, the recommended dose of 5 mg/80 mg (nebivolol/valsartan) is one tablet, taken orally once daily. Maximum antihypertensive effects are attained within 2 to 4 weeks. Increasing the dose of nebivolol/valsartan 5/80 does not result in any meaningful further blood pressure reduction. 5/80 may be substituted for its components in patients already receiving 5 mg nebivolol and 80 mg valsartan.

CYP2D6 enzyme inhibitors may increase nebivolol plasma levels. Reserpine or clonidine may cause excessive reduction of sympathetic activity.
Digitalis glycosides increase the risk of bradycardia. Verapamil or diltiazem-type calcium channel blockers may lead to excessive reduction in heart rate, blood pressure, and cardiac contractility.

Potassium-sparing diuretics, potassium supplements, or salt substitutes may increase serum potassium levels. NSAIDs may reduce antihypertensive effect and increase the risk of renal impairment.

Dual inhibition of the renin-angiotensin system may increase the risk of renal impairment, hypotension, and hyperkalemia.

This combination is contraindicated in the following conditions:

• Severe bradycardia
• Second or higher degree heart block
• Cardiogenic shock
• Decompensated heart failure
• Sick sinus syndrome (unless a permanent pacemaker is present)
• Severe hepatic impairment (Child-Pugh > B)
• Hypersensitivity to any component of the product
• Concomitant use with aliskiren in diabetic patients is contraindicated.

• Hypotension
• Hyperkalemia

This combination may cause fetal harm and is not recommended during pregnancy. Breastfeeding should be avoided during therapy.

• Do not abruptly discontinue therapy as it may worsen coronary artery disease.
• In diabetic patients, blood glucose should be monitored as beta-blockers may mask symptoms of hypoglycemia.
• Renal function and serum potassium should be regularly monitored in susceptible patients.

Pediatric Use: Safety and efficacy not established.

Geriatric Use: No major differences observed compared to younger patients.

Renal Impairment: Not recommended as initial therapy in severe renal impairment.

Hepatic Impairment: No specific studies available.

Nebivolol: If overdose occurs, provide general supportive and symptomatic treatment.

• Bradycardia: Treat with IV atropine.
• Hypotension: Administer IV fluids and vasopressors; IV glucagon may be helpful.
• Heart block (second or third degree): Monitor and manage with isoproterenol infusion. In some cases, transthoracic or transvenous pacemaker insertion may be required.
• Congestive heart failure: Treat with digitalis glycosides and diuretics. In selected cases, inotropic and vasodilating agents may be used.
• Bronchospasm: Manage with bronchodilators such as short-acting inhaled beta-2 agonists and/or aminophylline.
• Hypoglycemia: Administer IV glucose; repeated doses or glucagon may be required.
• Supportive care should continue until clinical stability is achieved. The half-life of low-dose nebivolol is 12–19 hours.

Valsartan: Limited data are available regarding overdose in humans. The most likely effects are hypotension and tachycardia; bradycardia may occur due to vagal stimulation. Valsartan is not removed by hemodialysis.

Combined antihypertensive preparations

Do not store above 30°C. Keep in a dry place. Protect from light. Keep out of reach of children.