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Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)
Date:8/19/2007

In clinical trials of patients with hypertension and angina pectoris, the most common adverse events reported with immediate release metoprolol tartrate are tiredness (10%), dizziness (10%), depression (5%), diarrhea (5%), pruritus or rash (5%), shortness of breath (3%), and bradycardia (3%).

In patients with heart failure, serious adverse events and adverse events leading up to discontinuation of study medication in MERIT-HF at an incidence greater then or equal to 1% in the group receiving metoprolol succinate extended release 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%).

Patients taking metoprolol succinate extended release should avoid abrupt cessation of therapy. Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, is some cases, myocardial infarction have occurred. The dosage should be reduced gradually over a one-to-two-week period, and the patient should be carefully monitored. For full prescribing information for metoprolol succinate extended release tablets, including boxed WARNING regarding abrupt cessation of therapy, call 1-800-828-9393 or visit http://www.parpharm.com.

Metoprolol succinate extended release should be used with caution in patients who have bronchospastic disease, diabetes, thyrotoxicosis, or peripheral vascular disease; who are undergoing major surgery, or who take calcium channel blockers of the verapamil and diltiazem type.

There is a risk of worsening cardiac failure during up-titration of the dose of metoprolol succinate extended release. Patients need to consult their physicians if the experience signs or symptoms of worsening heart failure such as weight gain or increased shortness of breath.

Patients should be advised to (1) avoid operating automobiles and machinery or engaging in othe
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SOURCE Par Pharmaceutical Companies, Inc.

Copyright©2007 PR Newswire.

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