Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)
McKesson Contract Packaging
METOPROLOL TARTRATE
METOPROLOL TARTRATE 25 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED MCKESSON CONTRACT PACKAGING ---------- DESCRIPTION Metoprolol tartrate, USP 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 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. Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. In addition, the 50 mg product contains FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake as coloring agents. CLINICAL PHARMACOLOGY Metoprolol tartrate is a beta-adrenergic receptor blocking agent._ In vitro _and _in vivo _animal studies have shown that it has a preferential effect on beta adrenoreceptors, chiefly located in cardiac muscle. This preferential effect is not absolute, however, and at higher doses, metoprolol also inhibits beta adrenoreceptors, chiefly located in the bronchial and vascular musculature. Clinical pharmacology studies have confirmed the beta-blocking activity of metoprolol in man, 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. Relative beta selectivity has been confirmed by the Citiți documentul complet