Indications for: BYVALSON


Adult Dosage:

Initial therapy or if inadequately controlled on valsartan 80mg or nebivolol doses ≤10mg: 1 tab once daily.

Children Dosage:

Not established.

BYVALSON Contraindications:

Severe bradycardia. Heart block >1st-degree. Cardiogenic shock. Decompensated cardiac failure. Sick sinus syndrome (unless paced). Severe hepatic impairment (Child-Pugh >B). Concomitant aliskiren in patients with diabetes.

Boxed Warning:

Drugs that act directly on renin-angiotensin system can cause injury and death to the developing fetus. Discontinue if pregnancy detected.

BYVALSON Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Hypotension: correct salt/volume depletion prior to initiation. Coronary artery disease, angina, post-MI, arrhythmias: avoid abrupt cessation (taper over 1–2 weeks). Worsening HF or fluid retention; consider diuretics and treat appropriately. Bronchospastic disease. Surgery. Diabetes. Hyperthyroidism. Peripheral vascular disease. Monitor renal function in renal artery stenosis, chronic kidney disease, severe CHF, or volume depletion. Risk of hyperkalemia; discontinue if necessary. Risk of anaphylactic reactions. Pheochromocytoma. Severe renal or moderate hepatic impairment: initial therapy not recommended. Severe hepatic impairment: not recommended. Neonates. Nursing mothers: not recommended.

BYVALSON Classification:

Beta-blocker + angiotensin II receptor blocker (ARB).

BYVALSON Interactions:

See Contraindications. Avoid concomitant CYP2D6 inhibitors (eg, quinidine, propafenone, fluoxetine, paroxetine), other beta-blockers. If concomitant with clonidine, discontinue nebivolol for several days before tapering clonidine. Increased risk of bradycardia with concomitant digitalis glycosides; monitor. Concomitant anesthetics (eg, ether, cyclopropane, trichloroethylene), reserpine, guanethidine; monitor closely. β-blockers may mask hypoglycemia; caution with concomitant insulin or antihyperglycemics. Concomitant verapamil or diltiazem (monitor HR, BP), disopyramide (monitor HR, cardiac conduction). Concomitant K+ supplements, K+ sparing diuretics, K+-containing salt substitutes may cause hyperkalemia; monitor. May be antagonized by, and renal toxicity potentiated by, NSAIDs, including selective COX-2 inhibitors (monitor renal function periodically in elderly and/or volume depleted). Dual inhibition of the renin-angiotensin system with ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely, in general, avoid combined use of RAS inhibitors. Concomitant aliskiren in renal impairment (GFR <60mL/min): not recommended. May increase lithium levels; monitor. May be potentiated by inhibitors of OATP1B1 (eg, rifampin, cyclosporine) or MRP2 (eg, ritonavir).

Adverse Reactions:

Hypotension, hyperkalemia, others; see full labeling.

Generic Drug Availability:


How Supplied:

Tabs—30, 90