País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)
Actavis Pharma, Inc.
METOPROLOL TARTRATE
METOPROLOL TARTRATE 50 mg
ORAL
PRESCRIPTION DRUG
Metoprolol tartrate tablets, USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Metoprolol tartrate tablets, USP are indicated in the long-term treatment of angina pectoris. Metoprolol tartrate tablets, USP 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 ). 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 (cross sensitivity between beta blockers can occur). Sick-sinus syndrome. Severe peripheral arterial circulato
Metoprolol Tartrate Tablets, USP 50 mg - round, scored pink tablets embossed with Watson 462 , supplied in bottles of 100 and 1000. Metoprolol Tartrate Tablets, USP 100 mg - round, scored light blue tablets embossed with Watson 463 , supplied in bottles of 100 and 1000. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Do not store above 30°C (86°F). Dispense in a tight, light-resistant container (USP). To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: October 2014
Abbreviated New Drug Application
METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED ACTAVIS PHARMA, INC. ---------- METOPROLOL TARTRATE TABLETS A074217 METOPROLOL TARTRATE TABLETS, USP Revised: October 2014 RX ONLY DESCRIPTION Metoprolol tartrate, USP, is a selective beta -adrenoreceptor blocking agent, available as 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate, USP is (±)-1-(Isopropylamino)-3-[_p_-(2- methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) 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. _Inactive Ingredients:_ Tablets contain lactose anhydrous, microcrystalline cellulose, sodium starch glycolate, talc, povidone, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and polysorbate 80. The 50 mg dosage strength also contains D&C Red No. 30 aluminum lake and the 100 mg dosage strength also contains FD&C Blue No. 2 aluminum lake. CLINICAL PHARMACOLOGY MECHANISM OF ACTION: Metoprolol tartrate 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 (espe Leer el documento completo