Safety and Side Effects

In patients with high blood pressure and angina, the most common side effects of TOPROL-XL were tiredness, dizziness, depression, diarrhea, rash, shortness of breath, and bradycardia.1

TOPROL-XL may not be right for everyone. TOPROL-XL is contraindicated for patients with the following:1:

  • Severe bradycardia
  • Heart block of second or third degree
  • Cardiogenic shock
  • Decompensated cardiac failure
  • Sick sinus syndrome (unless permanent pacemaker is in place)
  • Hypersensitivity to any component of TOPROL-XL
3035818 Last Updated 11/14

Important Safety Information for TOPROL-XL®

INDICATIONS AND USAGE

TOPROL-XL® (metoprolol succinate) is a beta-adrenergic blocker indicated for the treatment of:

  • Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Angina Pectoris
  • Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure
IMPORTANT SAFETY INFORMATION

Contraindications

  • Known hypersensitivity to product components.
  • Severe bradycardia: Greater than first degree heart block, or sick sinus syndrome without a pacemaker.
  • Cardiogenic shock or decompensated heart failure.

Warnings and Precautions

  • Abrupt cessation may exacerbate angina pectoris or myocardial ischemia. Reduce dosage gradually over a period of 1 to 2 weeks and monitor the patient. Warn patients not to discontinue without their physician's advice.
  • Heart Failure: Worsening cardiac failure may occur during up-titration.
  • Bronchospastic Disease: Avoid beta blockers.
  • Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of TOPROL-XL. Patients with first-degree atrioventricular block, sinus node dysfunction, conduction disorders (including Wolff- Parkinson-White) or on concomitant drugs that cause bradycardia (digitalis glycosides, clonidine, and diltiazem and verapamil) may be at increased risk. Monitor heart rate.
  • Pheochromocytoma: Initiate therapy with an alpha blocker.
  • Major Surgery: Avoid initiation of high-dose extended-release metoprolol in patients undergoing noncardiac surgery. Do not routinely withdraw chronic beta blocker therapy prior to surgery.
  • Diabetes and Hypoglycemia: May mask tachycardia occurring with hypoglycemia.
  • Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm.
  • Peripheral Vascular Disease: Can precipitate or aggravate symptoms of arterial insufficiency.
  • Patients may be unresponsive to the usual doses of epinephrine used to treat an allergic reaction.

Adverse Reactions

Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash.

Drug Interactions

  • Catecholamine-depleting drugs may have an additive effect when given with beta-blocking agents.
  • CYP2D6 Inhibitors are likely to increase metoprolol concentration.
  • Beta-blockers including metoprolol, may exacerbate the rebound hypertension that can follow the withdrawal of clonidine.

Use in Specific Populations

Hepatic Impairment: Consider initiating TOPROL-XL therapy at low doses and gradually increase dosage to optimize therapy, while monitoring closely for adverse events.

 

Click here for full Prescribing InformationAdobe Reader PDF document for TOPROL-XL.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.


References
  1. Prescribing Information for TOPROL-XL, Aralez Pharmaceuticals US, Inc., Princeton, NJ.