Toprol XL - Warnings & Precautions

Metoprolol

WARNINGS

Ischemic Heart Disease

Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered TOPROL-XL, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1Ð 2 weeks and the patient should be carefully monitored.

If angina markedly worsens or acute coronary insufficiency develops, TOPROL-XL administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue TOPROL-XL therapy abruptly even in patients treated only for hypertension.



Bronchospastic Diseases

PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS. Because of its relative beta 1 -selectivity, however, TOPROL-XL may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Since beta 1 -selectivity is not absolute, a beta 2 -stimulating agent should be administered concomitantly, and the lowest possible dose of TOPROL-XL should be used (see DOSAGE AND ADMINISTRATION).

Favors Toprol-XL

Total Mortality

NYHA II

NYHA III

NYHA IV

EF: >0.25 (mean 0.32)

Ischemic etiology

Non-ischemic etiology

Male sex

Female sex

Caucasians

Blacks

Previous MI

No previous MI

Diabetes mellitus

No diabetes mellitus

HR: >76 (mean 88 bpm)

US = United States; NYHA = New York Heart Association; EF = ejection fraction; MI = myocardial infarction; HR = heart rate.

Previous hypertension

No previous hypertension

Total Mortality or All-Cause Hospitalization

(Time to First Event)

Total Mortality or Hospitalization

for Heart Failure (Time to First Event)

Favors Toprol-XL Favors Toprol-XL Favors Placebo


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