References

  1. Prescribing Information for TOPROL-XL. Aralez Pharmaceuticals US Inc., Princeton, NJ.
  2. Sandberg A, Ragnarsson G, Jonsson UE, Sjögren J. Design of a new multiple-unit controlled-release formulation of metoprolol—metoprolol CR. Eur J Clin Pharmacol. 1988;33(Suppl):S3-S7.
  3. Darmansjah I, Wong E, Setiawati A, et al. Pharmacokinetic and pharmacodynamics properties of controlled release (CR/ZOK) metoprolol in healthy Oriental subjects: A comparison with conventional formulations of metoprolol and atenolol. J Clin Pharmacol. 1990;30(2suppl):S39-S45.
  4. Papademetriou V, Hainer JW, Sugg J, Munzer D, for the ATTACH Study Group. Factorial antihypertensive study of an extended-release metoprolol and hydrochlorothiazaide combination. Am J Hypertens. 2006;10(12):1217-1225.
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.

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