BYVALSON Dosage & Rx Info | Uses, Side Effects

Byvalson Generic Name & Formulations

Legal Class

General Description

Nebivolol 5mg, valsartan 80mg; tabs.

Pharmacological Class

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

How Supplied

Tabs—30, 90

Manufacturer

AbbVie

Generic Availability

Byvalson Indications

Indications

Hypertension.

Byvalson Dosage and Administration

Adult

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

Children

Not established.

Administration

Byvalson Contraindications

Contraindications

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

Byvalson Boxed Warnings

Boxed Warning

Fetal toxicity.

Byvalson Warnings/Precautions

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. Increased risk for hypoglycemia esp. in diabetics or those who are fasting (eg, surgery, not eating regularly, or vomiting). 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 (monitor). Pregnancy (esp. during 2^nd & 3^rd trimesters). Nursing mothers: not recommended.

Byvalson Pharmacokinetics

Absorption

Peak plasma concentrations are reached post-dose: ~1 to 6 hours (nebivolol); ~2 to 4 hours (valsartan).

Distribution

Plasma protein bound: ~98% (nebivolol); 95% (valsartan).

Steady state volume of distribution of valsartan: 17 L.

Metabolism

Nebivolol is predominantly metabolized via direct glucuronidation and to a lesser extent via N-dealkylation and oxidation via CYP2D6.

Valsartan is primarily metabolized via CYP2C9.

Elimination

Half-life: ~12 hours (nebivolol); ~6 hours (valsartan).

Nebivolol: fecal (44%), renal (38%). Valsartan: fecal (83%), renal (13%).

Byvalson Interactions

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).

Byvalson Adverse Reactions

Adverse Reactions

Hypotension, hyperkalemia, others; see full labeling.

Byvalson Clinical Trials

See Literature

Byvalson Note

Not Applicable

Byvalson Patient Counseling