Indications

This is a combination product containing beta adrenergic blocker and an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Composition

Pharmacology

Nebivolol is a cardiovascular drug belonging to the group of selective beta-blocking agents (i.e. with a selective action on the cardiovascular system). It prevents increased heart rate and controls heart pumping strength. It also widens blood vessels which helps to lower blood pressure. Valsartan blocks the action of angiotensin II receptor by acting on AT1 subtype, dilates blood vessels and reduces blood pressure without affecting pulse rate.

Dosage & Administration

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.

Contraindications

This is contraindicated in the following conditions: 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 (Child-Pugh >B) Patients who are hypersensitive to any component of this product Do not co-administer aliskiren with 5/80 in patients with diabetes

Side Effects

Hypotension Hyperkalemia

Pregnancy & Lactation

This can cause fetal harm when administered to a pregnant woman. Not recommended during pregnancy. Advise not to breastfeed.

Precautions & Warnings

Acute exacerbation of coronary artery disease upon cessation of therapy : Do not abruptly discontinue. Diabetes : Monitor glucose as -blockers may mask symptoms of hypoglycemia. In susceptible patients : Need to monitor renal function and potassium level.

Therapeutic Class

Combined antihypertensive preparations

Storage Conditions

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