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Nebivolol/Valsartan

    Brands

    DEA Class;  Rx

    Common Brand Names; Byvalson

    • ARBs; 
    • Beta-Blockers, Beta-1 Selective

    Oral beta-blocker and angiotensin II receptor blocker (ARB)
    Used for the treatment of hypertension
    Can be used in patients not adequately controlled on valsartan 80 mg or nebivolol up to and including 10 mg or in patients already receiving 5 mg nebivolol and 80 mg valsartan

    Indicated for the treatment of hypertension.

    Severe bradycardia

    Heart block greater than first degree (if no pacemaker)

    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 coadminister aliskiren with an angiotensin receptor blocker (ARB) (eg, valsartan) in patients with diabetes; dual blockade of renin-angiotensin system increases risk of hypotension, hyperkalemia, and renal impairment

    Increased serum potassium by >20% (4.4%)

    Symptomatic hypotension

    Nebivolol

    • Cardiac: Atrioventricular block (both second and third degree), myocardial infarction
    • Central nervous system: Somnolence, syncope, vertigo
    • Circulatory: Raynaud phenomenon, peripheral ischemia/claudication, thrombocytopenia
    • Dermatologic: Pruritus, psoriasis, various rashes and skin disorders
    • Digestive: Vomiting Hepatic: Abnormal hepatic function (including increased AST, ALT and bilirubin)
    • Hypersensitivity: Hypersensitivity (including urticaria, allergic vasculitis, and rare reports of angioedema)
    • Renal: Acute renal failure
    • Respiratory: Acute pulmonary edema, bronchospasm
    • Sexual dysfunction: Erectile dysfunction

    Valsartan

    • Hypersensitivity: Angioedema
    • Digestive: Elevated liver enzymes, hepatitis
    • Renal: Impaired renal function, renal failure
    • Clinical laboratory tests: Hyperkalemia
    • Dermatologic: Alopecia, bullous dermatitis
    • Blood and lymphatic: Thrombocytopenia
    • Vascular: Vasculitis

    Fetal toxicity: ARB (eg, valsartan) use during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Black Box Warnings, Pregnancy)

    Increased risk of symptomatic hypotension in patients with activated renin-angiotensin-aldosterone system (eg, volume/ and/or salt-depleted)

    Do not abruptly discontinue nebivolol in patients with coronary artery disease; severe exacerbation of angina, myocardial infarction, and ventricular arrhythmias reported

    Worsening heart failure or fluid retention may occur during nebivolol therapy because of its beta-blocking effects

    Generally, patients with bronchospastic diseases should not receive beta-blockers

    Long-term beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures

    Beta-blockers may mask manifestations of hypoglycemia, particularly tachycardia

    Beta-blockers may mask clinical signs of hyperthyroidism (eg, tachycardia)

    Do not abruptly discontinue beta-blockers

    Nebivolol: Neonates of women with hypertension who are treated with beta-blockers during pregnancy may be at increased risk for hypotension, bradycardia, hypoglycemia, and respiratory depression

    Valsartan

    Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, and skeletal deformations, including skull hypoplasia, hypotension, and death

     

    Unknown if distributed in human breast milk

    Because of the potential for beta-blockers to produce serious adverse reactions in nursing infants, especially bradycardia, and the potential for valsartan to affect postnatal renal development in nursing infants, advise females not to breastfeed during treatment

    Adults

    Nebivolol 5 mg and valsartan 80 mg PO once daily.

    Geriatric

    Nebivolol 5 mg and valsartan 80 mg PO once daily.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Not indicated.

    Neonates

    Not indicated.

    Nebivolol/valsartan

    tablet

    • 5mg/80mg