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.