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Toprol XL

[Metoprolol]

Clinical Trials

In controlled clinical studies, an immediate release dosage form of metoprolol has been shown to be an effective antihypertensive agent when used alone or as concomitant therapy with thiazide-type diuretics at dosages of 100Ð 450 mg daily. TOPROL-XL, in dosages of 100 to 400 mg once daily, has been shown to possess comparable ß 1 -blockade as conventional metoprolol tablets administered two to four times daily. In addition, TOPROL-XL administered at a dose of 50 mg once daily has been shown to lower blood pressure 24-hours post-dosing in placebo-controlled studies.

In controlled, comparative, clinical studies, immediate release metoprolol appeared comparable as an antihypertensive agent to propranolol, methyldopa, and thiazide-type diuretics, and affected both supine and standing blood pressure. Because of variable plasma levels attained with a given dose and lack of a consistent relationship of antihy-pertensive activity to drug plasma concentration, selection of proper dosage requires individual titration.

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Angina Pectoris

By blocking catecholamine-induced increases in heart rate, in velocity and extent of myocardial contraction, and in blood pressure, metoprolol reduces the oxygen require-ments of the heart at any given level of effort, thus making it useful in the long-term management of angina pectoris.

Clinical Trials

In controlled clinical trials, an immediate release formulation of metoprolol has been shown to be an effective antianginal agent, reducing the number of angina attacks and increasing exercise tolerance. The dosage used in these studies ranged from 100 to 400 mg daily. TOPROL-XL, in dosages of 100 to 400 mg once daily, has been shown to possess beta-blockade similar to conventional metoprolol tablets administered two to four times daily.

Heart Failure

The precise mechanism for the beneficial effects of beta-blockers in heart failure has not been elucidated.

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