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Drug Catalog - Product Detail

METOPROLOL TARTRATE (OBL) TB 50MG 100

NDC Mfr Size Str Form
57664-0166-52 SUN PHARMACEUTICALS 100 50MG TABLET
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Description
DESCRIPTION Metoprolol tartrate, USP is a selective beta 1 -adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p -(2-methoxyethyl) phenoxy]-2-propanol (2:1) dextro -tartrate salt, and its structural formula is: (C 15 H 25 NO 3 ) 2 • C 4 H 6 O 6 Metoprolol tartrate 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. Inactive Ingredients. Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide. chemical-structure
How Supplied
HOW SUPPLIED Metoprolol Tartrate Tablets USP, 50 mg - Round, white film coated tablets with “477” debossed on one side and scored on the other side Bottles of 100 NDC 57664-477-52 Bottles of 1000 NDC 57664-477-58 Metoprolol Tartrate Tablets USP, 50 mg - capsule-shaped, biconvex, white, scored (debossed 166) Bottles of 100 NDC 57664-166-52 Bottles of 1000 NDC 57664-166-58 Metoprolol Tartrate Tablets USP, 100 mg - round-shaped, film coated, white colored tablets debossed with ‘162’ on one side and ‘scored’ on the other side. Bottles of 90 NDC 57664-162-59 Bottles of 100 NDC 57664-162-52 Bottles of 1000 NDC 57664-162-58 Metoprolol Tartrate Tablets USP, 100 mg - capsule-shaped, biconvex, white, scored (debossed 167) Bottles of 90 NDC 57664-167-59 Bottles of 100 NDC 57664-167-52 Bottles of 1000 NDC 57664-167-58 Samples, when available, are identified by the word SAMPLE appearing on each bottle. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP). Protect from Moisture. To report SUSPECTED ADVERSE REACTIONS, contact Caraco Pharmaceutical Laboratories, Ltd. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by: Sun Pharmaceutical Industries Dadra 396 191, India Distributed by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive C.S. No.: 5094T84 Detroit, MI 48202 Iss.: 04/11 Metoprolol Tartrate Tablets, USP 25 mg and 50 mg are available from Cardinal Health in cards of 14 tablets and in cards of 30 tablets. Cardinal Health Zanesville, OH 43701 IT47584470912
Indications & Usage
INDICATIONS AND USAGE Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient’s clinical condition allows (see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , and WARNINGS ). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION ).
Dosage and Administration
DOSAGE AND ADMINISTRATION Hypertension The dosage of metoprolol tartrate tablets should be individualized. Metoprolol tartrate tablets should be taken with or immediately following meals. The usual initial dosage of Metoprolol tartrate tablets is 100 mg daily in single or divided doses, whether used alone or added to a diuretic. The dosage may be increased 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 to 450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing is effective and 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, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta 1 selectivity diminishes as the dose of metoprolol is increased. 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 of Metoprolol tartrate tablets is 100 mg daily, given in two divided doses. The dosage may be gradually increased at weekly intervals until optimum clinical response has been obtained or there is 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, the dosage should be reduced gradually over a period of 1 to 2 weeks (see WARNINGS ). Myocardial Infarction Early Treatment During the early phase of definite or suspected acute myocardial infarction, treatment with metoprolol tartrate can be initiated as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized. Treatment in this early phase should begin with the intravenous administration of three bolus injections of 5 mg of metoprolol tartrate each; the injections should be given at approximately 2-minute intervals. During the intravenous administration of metoprolol, blood pressure, heart rate, and electrocardiogram should be carefully monitored. In patients who tolerate the full intravenous dose (15 mg), metoprolol tartrate tablets, 50 mg every 6 hours, should be initiated 15 minutes after the last intravenous dose and continued for 48 hours. Thereafter, patients should receive a maintenance dosage of 100 mg twice daily (see Late Treatment below). Patients who appear not to tolerate the full intravenous dose should be started on metoprolol tartrate tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, treatment with metoprolol should be discontinued (see WARNINGS ). Late Treatment Patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason should be started on metoprolol tartrate tablets, 100 mg twice daily, as soon as their clinical condition allows. Therapy should be continued for at least 3 months. Although the efficacy of metoprolol 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.