1 INDICATIONS AND USAGE Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: â€¢ 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 ) â€¢ Angina Pectoris. ( 1.2 ) â€¢ Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute Myocardial Infarction in hemodynamically stable patients ( 1.3 ) 1.1 Hypertension Metoprolol tartrate tablets are indicated for the treatment of Hypertension in adult patients, 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 Programâ€™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 tartrate tablets may be administered with other antihypertensive agents. 1.2 Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of Angina Pectoris, to reduce angina attacks and to improve exercise tolerance. 1.3 Myocardial Infarction Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute Myocardial Infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol.
Mylan Pharmaceuticals Inc.
16 HOW SUPPLIED/STORAGE AND HANDLING
METOPROLOL TARTRATE Tablets, USP are available containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of
METOPROLOL TARTRATE, USP. The 25 mg tablets are white, film-coated, round, scored tablets debossed with M over 18 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0018-01 bottles of 100 tablets NDC 0378-0018-05 bottles of 500 tablets The 37.5 mg tablets are light blue, film-coated, round, scored tablets debossed with M above the score and MT below the score on one side of the tablet and 37.5 on the other side. They are available as follows: NDC 0378-4593-01 bottles of 100 tablets The 50 mg tablets are pink, film-coated, round, scored tablets debossed with M over 32 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0032-01 bottles of 100 tablets NDC 0378-0032-10 bottles of 1000 tablets The 75 mg tablets are white, film-coated, round, scored tablets debossed with M above the score and MT below the score on one side of the tablet and 75 on the other side. They are available as follows: NDC 0378-4594-01 bottles of 100 tablets The 100 mg tablets are light blue, film-coated, round, scored tablets debossed with M over 47 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0047-01 bottles of 100 tablets NDC 0378-0047-10 bottles of 1000 tablets Store at 20Â° to 25Â°C (68Â° to 77Â°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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