Label Changes for:

Bystolic (nebivolol) Tablets

December 2011

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2010 and December 2011

 

December 2011 

 

PATIENT COUNSELING INFORMATION

What is high blood pressure (hypertension)?

  • Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too great.
  • High blood pressure makes the heart work harder to pump blood through the body and causes damage to the blood vessels. BYSTOLIC tablets can help your blood vessels relax so your blood pressure is lower.
  • Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.

 

February 2010

 

WARNING & PRECAUTIONS

Anesthesia and Major Surgery
  • Because beta-blocker withdrawal has been associated with an increased risk of MI and chest pain, patients already on beta-blockers should generally continue treatment throughout the perioperative period.
Non-dihydropyridine Calcium Channel Blockers (reworded)
  • Because of significant negative inotropic and chronotropic effects in patients treated with β-blockers and calcium channel blockers of the verapamil and diltiazem type, monitor the ECG and blood pressure in patients treated concomitantly with these agents.
Impaired Renal Function (first paragraph reworded)
  • Renal clearance of nebivolol is decreased in patients with severe renal impairment. Bystolic has not been studied in patients receiving dialysis.
Impaired Hepatic Function (first paragraph reworded)
  • Metabolism of nebivolol is impaired in patients with moderate hepatic impairment. Bystolic has not been studied in patients with severe hepatic impairment.
Risk of Anaphylactic Reactions (first paragraph reworded)
  • While taking β-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. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
Pheochromocytoma
  • In patients with known or suspected pheochromocytoma, initiate an α-blocker prior to the use of any β-blocker.

DRUG INTERACTIONS

Calcium Channel Blockers (reworded)
  • Bystolic can exacerbate the effects of myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide.

USE IN SPECIFIC POPULATIONS

Heart Failure
  • In a placebo-controlled trial of 1067 patients over 70 years of age with chronic heart failure receiving a maximum dose of 10 mg per day for a median of 20 months, no worsening of heart failure was reported with nebivolol compared to placebo. However, if heart failure worsens, consider discontinuation of Bystolic.

 

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