Nebivolol/Valsartan

DEA Class;  Rx

Common Brand Names; Byvalson

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Long-term beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and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