देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)
Vensun Pharmaceuticals, Inc.
METOPROLOL TARTRATE
METOPROLOL TARTRATE 100 mg
ORAL
PRESCRIPTION DRUG
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 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. Oral Metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Hypertension and Angina Metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WAR
Metoprolol Tartrate Tablets, USP are available containing 25 mg, 50 mg, or 100 mg of metoprolol tartrate, USP. The 25 mg tablets are film-coated, pink colored, round, biconvex tablets debossed with R 25 on one side and scored on the other side. NDC 42543-001-01: Bottles of 100 NDC 42543-001-10: Bottles of 1000 The 50 mg tablets are film-coated, pink colored, round, biconvex tablets debossed with R 50 on one side and scored on the other side. NDC 42543-002-01: Bottles of 100 NDC 42543-002-10: Bottles of 1000 The 100 mg tablets are film-coated, pink colored, round, biconvex tablets debossed with R 100 on one side and scored on the other side. NDC 42543-003-01: Bottles of 100 NDC 42543-003-10: Bottles of 1000 Store at 20° to 25°C (68° to 77°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. To report SUSPECTED ADVERSE REACTIONS, contact Vensun Pharmaceuticals, Inc. at 1-800-385-1540 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067 Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506, INDIA Rev. 01, January 2017
Abbreviated New Drug Application
METOPROLOL TARTRATE - METOPROLOL TARTRATE TABLET, FILM COATED METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED VENSUN PHARMACEUTICALS, INC. ---------- METOPROLOL TARTRATE - METOPROLOL TARTRATE TABLET, FILM COATED VENSUN PHARMACEUTICALS, INC. R ONLY DESCRIPTION Metoprolol tartrate is a selective beta -adrenoreceptor blocking agent, available as 25 mg, 50 mg, and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[_p_-2- methoxyethyl)phenoxy]-2-propanol (2:1) _dextro_-tartrate salt. Its structural formula is: Metoprolol tartrate, USP is a white, 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. Each tablet for oral administration contains 25 mg, 50 mg, or 100 mg of metoprolol tartrate and the following inactive ingredients: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, sodium starch glycolate, talc and D & C Red #30 Aluminium Lake. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Metoprolol is a beta -selective (cardioselective) adrenergic receptor blocker. This preferential effect is not absolute, however, and at higher plasma concentrations, metoprolol also inhibits beta adrenoreceptors, chiefly located in the bronchial and vascular musculature. Clinical pharmacology studies have demonstrated the beta-blocking activity of metoprolol, as shown by (1) reduction in heart rate and cardiac output at rest and upon exercise, (2) reduction of systolic blood pressure upon exercise, (3) inhibition of isoproterenol-induced tachycardia, and (4) reduction of reflex orthostatic tachycardia. _HYPERTENSION_ The mechanism of the antihypertensive effects of beta-blocking agents has not been fully elucidated. However, several possible mechanisms have been proposed: (1) competitive antagonism of catecholamines at peripheral (especially c पूरा दस्तावेज़ पढ़ें