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언어: 영어
출처: NLM (National Library of Medicine)
METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)
Contract Pharmacy Services-PA
METOPROLOL TARTRATE
METOPROLOL TARTRATE 50 mg
ORAL
PRESCRIPTION DRUG
Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. 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 ). Metoprolol tartrate is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS ). Hypersensitivity to metoprolol and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cr
Metoprolol Tartrate Tablets USP, 50 mg - Pink colored, round, film-coated tablets debossed with "RE" above the bisect and "75" below the bisect on one side and plain on the other side Blisterpacks of 30 NDC 67046-474-30 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 the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ipca Laboratories Limited 48, Kandivli Ind. Estate, Mumbai 400 067, India March 2009 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--1/2011--NJW
Abbreviated New Drug Application
METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET CONTRACT PHARMACY SERVICES-PA ---------- METOPROLOL TARTRATE _ISCHEMIC HEART DISEASE: _Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered metoprolol, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, metoprolol administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue metoprolol therapy abruptly even in patients treated only for hypertension. DESCRIPTION Metoprolol tartrate, USP is a selective beta -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 H NO ) • C H O 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 anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, D&C red No. 30, hypromellose, magnesium stearate, polyethylene glycol, colloidal silicon dioxide, sodium starch glycolate, corn starch, talc and titanium dioxide. CLINICAL PHARMACOLOGY Metoprolol tartrate is a beta-adrenergic receptor blocking agent. _In vitro_ and _in vivo_ animal studies have shown th 전체 문서 읽기