Classes
DEA Class; Rx
Common Brand Names; Byvalson
- ARBs;
- Beta-Blockers, Beta-1 Selective
Description
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
Indications
Indicated for the treatment of hypertension.
Contraindications
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
Adverse Effects
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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
Nebivolol 5 mg and valsartan 80 mg PO once daily.
Nebivolol 5 mg and valsartan 80 mg PO once daily.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
Not indicated.
How supplied
Nebivolol/valsartan
tablet
- 5mg/80mg
