Nebivolol-Valsartan

Nebivolol-Valsartan is a combination medication used for treatment of  hypertension (high blood pressure).

• Nebivolol-Valsartan is available under the following different brand names: Byvalson.

Common side effects of Nebivolol-Valsartan include:

• slow heartbeats

Serious side effects of Nebivolol-Valsartan include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• stomach pain,
• vomiting,
• lightheadedness,
• very slow heartbeats,
• chest pain or pressure,
• pain spreading to your jaw or shoulder,
• nausea,
• sweating,
• shortness of breath,
• swelling or numbness in the legs or feet,
• rapid weight gain,
• slow or unusual heart rate,
• weakness, and
• loss of movement

Rare side effects of Nebivolol-Valsartan include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 5 mg/80 mg

Hypertension

Adult dosage

• May be used as initial therapy (if not controlled on valsartan 80 mg or less than 10 mg nebivolol) or be substituted for its components in patients already receiving nebivolol 5 mg and valsartan 80 mg
• 1 tablet (i.e., 5 mg/80 mg) orally every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Nebivolol-Valsartan has severe interactions with the following drugs:
  • aliskiren
  • sparsentan
• Nebivolol-Valsartan has serious interactions with at least 44 other drugs.
• Nebivolol-Valsartan has moderate interactions with at least 293 other drugs.
• Nebivolol-Valsartan has minor interactions with at least 36 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

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 more than 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 the renin-angiotensin system increases the risk of hypotension, hyperkalemia, and renal impairment

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nebivolol-Valsartan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nebivolol-Valsartan?”

Cautions

• 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
• While taking beta-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge; these patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions
• In patients with known or suspected pheochromocytoma, initiate an alpha-blocker prior to the use of any beta-blocker
• ARBs associated with increased serum potassium levels; monitor closely
• Drug interaction overview
  • Nebivolol
    • Nebivolol is a CYP2D6 substrate; avoid coadministration with CYP2D6 inhibitors (e.g., quinidine, propafenone, fluoxetine, paroxetine)
    • Do not use with other beta-blockers
    • Monitor closely if coadministered with catecholamine-depleting drugs (e.g., reserpine, guanethidine); the added beta-blocking action of nebivolol may produce excessive reduction of sympathetic activity
    • If coadministered with clonidine, discontinue nebivolol for several days before the gradual tapering of clonidine
    • Digitalis glycosides: Coadministration increases risk of bradycardia; monitor
    • Nebivolol can exacerbate effects of myocardial depressants or inhibitors of atrioventricular conduction (eg, certain calcium channel blockers, especially the phenylalkylamine class [eg, verapamil] and benzothiazepine class [eg, diltiazem])
  • Valsartan
    • Concomitant use with other agents that block the renin-angiotensin system, potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium, or other agents that may increase potassium levels (eg, heparin) may result in hyperkalemia
    • Coadministration with NSAIDs or COX-2 inhibitors may result in renal function deterioration, especially in elderly patients, volume-depleted (including diuretics) patients, or those with renal impairment
    • Use of ARBs with ACE inhibitors or with aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function
    • Coadministration with aliskiren in patients with diabetes is contraindicated
    • Coadministration with lithium increase serum lithium levels and toxicity

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
• In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus
• In patients taking an ARB during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment
• Fetal testing may be appropriate, based on the week of gestation
• Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury
• Lactation
  • 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