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These highlights do not include all the information needed to use metoprolol succinate extended-release tablets safely and effectively. See full prescribing information for metoprolol succinate extended-release tablets. Metoprolol Succinate Extended-Relea | METOPROLOL SUCCINATE

13:39 EDT 19th June 2013 | BioPortfolio
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WARNING: 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 metoprolol succinate extended-release tablets, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 - 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, metoprolol succinate extended-release tablets administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Warn patients 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 metoprolol succinate extended-release tablets therapy abruptly even in patients treated only for hypertension (5.1).


Metoprolol succinate extended-release tablets
n=1990% of patients
Placebo
n=2001% of patients
Dizziness/vertigo
1.8
1.0
Bradycardia
1.5
0.4
Accident and/or injury
1.4
0.8
IMAGE Meoprolol ER Tablets_structur.jpgIMAGE Meoprolol ER Tablets_Figure.jpg
Clinical Endpoints in the MERIT-HF Study
Clinical Endpoint Number of Patients Relative Risk (95% Cl) Risk Reduction With Metoprolol Succinate Extended-Release Tablets Nominal P-value
Placebo n=2001 Metoprolol Succinate Extended-Release Tablets n=1990
All-cause mortality plus all-caused hospitalizationTime to first event 767 641 0.81(0.73- 0.90) 19% 0.00012
All-cause mortality 217 145 0.66(0.53- 0.81) 34% 0.00009
All-cause mortality plus heart failure hospitalization 439 311 0.69(0.60- 0.80) 31% 0.0000008
Cardiovascular mortality 203 128 0.62(0.50- 0.78) 38% 0.000022
Sudden death 132 79 0.59(0.45- 0.78) 41% 0.0002
Death due to worsening heart failure 58 30 0.51(0.33- 0.79) 49% 0.0023
Hospitalizations due to worsening heart failureComparison of treatment groups examines the number of hospitalizations (Wilcoxon test); relative risk and risk reduction are not applicable. 451 317 N/A N/A 0.0000076
Cardiovascular hospitalization 773 649 N/A N/A 0.00028
Tablet
Shape
Debossed
Bottle of 30 NDC 64679-
Bottle of 100 NDC 64679-
Bottle of 500 NDC 64679-
Unit Dose Packages of 100 NDC 64679-
25 mg*
Oval
W and 34
734-01
734-02
734-03 734-05
50 mg
Circular, beveled edge
W
735
735-01
735-02
735-03 735-05
100 mg
Circular, beveled edge W
736
736-01
736-02
736-03 736-05
200 mg
Oval, beveled edge W
737
737-01
737-02
737-03 737-05
IMAGE Metoprolol ER Tablets Container Label 25 mg.jpgIMAGE Metoprolol ER Tablets Container Label 100 mg.jpg

Manufacturer

WOCKHARDT LIMITED

Active Ingredients

Source

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