Indications and Important Safety Information
TOPROL-XL is indicated for the treatment of hypertension, the long-term treatment of angina pectoris, and the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. Heart failure patients were already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis.
TOPROL-XL is contraindicated in severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product.
Patients taking TOPROL-XL should avoid abrupt cessation of therapy. Following abrupt cessation of therapy with certain ß-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. The dosage should be reduced gradually over a 1- to 2-week period, and the patient should be carefully monitored.
TOPROL-XL should be used with caution in patients who have bronchospastic disease, diabetes, thyrotoxicosis, peripheral vascular disease, who are undergoing major surgery, or who take calcium channel blockers of the verapamil and diltiazem type. See WARNINGS section in full Prescribing Information.
Inform patients to avoid activities that require alertness until their response to therapy has been determined.
The most common adverse events reported with immediate-release metoprolol tartrate in patients with hypertension and angina are tiredness (10%), dizziness (10%), depression (5%), diarrhea (5%), pruritus or rash (5%), shortness of breath (3%), and bradycardia (3%).
Serious adverse events and adverse events leading to discontinuation of study medication in
MERIT-HF at an incidence >1% in the group receiving TOPROL-XL and greater than placebo by more than 0.5% were dizziness/vertigo (1.8% vs 1.0%), bradycardia (1.5% vs 0.4%), and accident and/or injury (1.4% vs 0.8%).
Please see full Prescribing Information, including boxed WARNING regarding abrupt cessation of therapy.
TOPROL-XL is a registered trademark of the AstraZeneca group of companies.
238857 11/06 ©2006 AstraZeneca LP. All rights reserved.
 This Web site is intended for US health care professionals only.
|
