24 HR metoprolol succinate 200 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Metoprolol succinate extended-release tablets are a beta-adrenergic blocker indicated for the treatment of: • Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Angina Pectoris. ( 1.2 ) • Heart Failure, to reduce the risk of cardiovascular mortality and Heart Failure hospitalizations in patients with Heart Failure. ( 1.3 ) 1.1 Hypertension Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, Heart Failure, or diabetic kidney disease). These considerations may guide selection of therapy. Metoprolol succinate extended-release tablets may be administered with other antihypertensive agents. 1.2 Angina Pectoris Metoprolol succinate extended-release tablets are indicated in the long-term treatment of Angina Pectoris, to reduce angina attacks and to improve exercise tolerance. 1.3 Heart Failure Metoprolol succinate extended-release tablets are indicated to reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with Heart Failure.
Mylan Pharmaceuticals Inc.
OVAL WHITE M MT4
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16 HOW SUPPLIED/STORAGE AND HANDLING
METOPROLOL SUCCINATE Extended-Release Tablets, USP are available containing 23.75 mg, 47.5 mg, 95 mg or 190 mg of
METOPROLOL SUCCINATE, USP equivalent to 25 mg, 50 mg, 100 mg or 200 mg of metoprolol tartrate, USP, respectively. The 25 mg tablets are white to off-white, film-coated, round, scored tablets debossed with M above the break line on one side of the tablet and MT1 on the other side. They are available as follows: NDC 0378-4595-77 bottles of 90 tablets NDC 0378-4595-10 bottles of 1000 tablets The 50 mg tablets are white to off-white, film-coated, oval, scored tablets debossed with M on one side of the break line on one side of the tablet and MT2 on the other side. They are available as follows: NDC 0378-4596-77 bottles of 90 tablets NDC 0378-4596-10 bottles of 1000 tablets The 100 mg tablets are white to off-white, film-coated, oval, scored tablets debossed with M on one side of the break line on one side of the tablet and MT3 on the other side. They are available as follows: NDC 0378-4597-77 bottles of 90 tablets NDC 0378-4597-10 bottles of 1000 tablets The 200 mg tablets are white to off-white, film-coated, oval, scored tablets debossed with M on one side of the break line on one side of the tablet and MT4 on the other side. They are available as follows: NDC 0378-4598-77 bottles of 90 tablets NDC 0378-4598-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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