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metoprolol 100 mg

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.

actavis pharma, inc.


4 years ago OVAL WHITE 676 metoprolol 100 mg

OVAL WHITE 676

4 years ago OVAL WHITE 676 metoprolol 100 mg

676 OVAL WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING

METOPROLOL SUCCINATE extended-release tablets, USP are supplied as follows: 25 mg – Each white to off-white, capsule shaped, film-coated tablet, debossed with on one side and A9 on the other side and scored on both sides contains 23.75 mg of

METOPROLOL SUCCINATE, USP equivalent to 25 mg of metoprolol tartrate, USP. Tablets are supplied in bottles of 100 (NDC 45963-709-11) and bottles of 1,000 (NDC 45963-709-96). 50 mg – Each white to off-white, capsule shaped, film-coated tablet, debossed with and 676 on one side and scored on the other side contains 47.5 mg of

METOPROLOL SUCCINATE, USP equivalent to 50 mg of metoprolol tartrate, USP. Tablets are supplied in bottles of 100 (NDC 45963-676-11) and bottles of 1,000 (NDC 45963-676-96). 100 mg – Each white to off-white, capsule shaped, film-coated tablet, debossed with and 677 on one side and scored on the other side contains 95 mg of

METOPROLOL SUCCINATE, USP equivalent to 100 mg of metoprolol tartrate, USP. Tablets are supplied in bottles of 100 (NDC 45963-677-11) and bottles of 1,000 (NDC 45963-677-96). 200 mg – Each white to off-white, capsule shaped, film-coated tablet, debossed with and 678 on one side and scored on the other side contains 190 mg of

METOPROLOL SUCCINATE, USP equivalent to 200 mg of metoprolol tartrate, USP. Tablets are supplied in bottles of 100 (NDC 45963-678-11). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. 1 1 1 1


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