Drug Catalog - Product Detail
METOPROLOL TARTRATE TABS 25MG 1000CT
NDC | Mfr | Size | Str | Form |
---|---|---|---|---|
57237-0100-99 | RISING PHARMACEUTICALS | 1000 | 25MG | TABLET |
PACKAGE FILES
Generic Name
METOPROLOL TARTRATE
Substance Name
METOPROLOL TARTRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA077739
Description
11 DESCRIPTION Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1 -adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p -(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro -tartrate salt, and its structural formula is Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Metoprolol Tartrate Tablets, USP are available as follows: Tablets 25 mg are white round shaped, film coated tablets debossed with ‘C over 73’ on one side and deep break line on other side. Bottles of 100 NDC 57237-100-01 (Non Child Resistant Closure) Bottles of 1,000 NDC 57237-100-99 (Non Child Resistant Closure) Tablets 50 mg are pink round shaped, film coated tablets debossed with ‘C over 74’ on one side and deep break line on other side. Bottles of 100 NDC 57237-101-01 (Non Child Resistant Closure) Bottles of 1,000 NDC 57237-101-99 (Non Child Resistant Closure) Tablets 100 mg are light blue round shaped, film coated tablets debossed with ‘C over 75’ on one side and deep break line on other side. Bottles of 100 NDC 57237-102-01 (Non Child Resistant Closure) Bottles of 1,000 NDC 57237-102-99 (Non Child Resistant Closure) Store at 20° to 25 °C (68° to 77 °F); excursions permitted to 15 ° to 30 °C (59 ° to 86 °F) [see USP Controlled Room Temperature ]. Protect from moisture and heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Indications & Usage
1 INDICATIONS AND USAGE Metoprolol tartrate 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 ) 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 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 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.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Administer once daily with food or after a meal. Titrate at weekly or longer intervals as needed and tolerated. ( 2 ) Hypertension: Recommended starting dosage is 100 mg daily, in single or divided doses. ( 2.1 ) Angina Pectoris: Recommended starting dosage is 100 mg daily, given as two divided doses. ( 2.2 ) Myocardial Infarction: The starting dosage depends upon tolerance of intravenous metoprolol, see full prescribing information. ( 2.3 ) 2.1 Hypertension Individualize the dosage of metoprolol tartrate tablets. Metoprolol tartrate tablets should be taken with or immediately following meals. The usual initial dosage is 100 mg daily in single or divided doses. Adjust dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy. The effective dosage range of metoprolol tartrate tablets is 100 mg to 450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period. Larger or more frequent daily doses may be required. Measure blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. 2.2 Angina Pectoris The dosage of metoprolol tartrate tablets should be individualized. Metoprolol tartrate tablets should be taken with or immediately following meals. The usual initial dosage is 100 mg daily, given in two divided doses. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is a pronounced slowing of the heart rate. The effective dosage range of metoprolol tartrate tablets is 100 to 400 mg per day. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, reduce the dosage gradually over a period of 1 to 2 weeks [see Warnings and Precautions (5.1) ]. 2.3 Myocardial Infarction See prescribing information of intravenous metoprolol for dosage instructions for intravenous therapy. In patients who tolerate the full intravenous dose, initiate metoprolol tartrate tablets, 50 mg every 6 hours, 15 minutes after the last intravenous dose of metoprolol and continue for 48 hours. In the case of intolerance, reduce dose to 25 mg and administer for 48 hours. Titrate, based on tolerability, to a maintenance dosage of 100 mg twice daily. Continue therapy for at least 3 months. Although the efficacy of metoprolol tartrate tablets beyond 3 months has not been conclusively established, data from studies with other beta-blockers suggest that treatment should be continued for 1 to 3 years.