Country: United States
Language: English
Source: NLM (National Library of Medicine)
METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)
MedVantx, 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 when used alone or in conjunction with intravenous metoprolol tartrate. Oral metoprolol tartrate therapy can be initiated after intravenous metoprolol tartrate therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (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 tartrate and related derivatives, or to any of the excipients; hypersens
Metoprolol Tartrate Tablets USP are available as follows: 50 mg: Pink, round, biconvex, film coated tablets, scored in half on one side with the numbers "93" and "733" on each side of the score. Plain on the other side. They are packaged in bottles of 100 and 1000 tablets. 100 mg: Mottled blue, round, biconvex, film coated tablets, scored in half on one side with the numbers "93" and "734" on each side of the score. Plain on the other side. They are packaged in bottles of 100 and 1000 tablets. Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Protect from moisture and heat. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872, X6351 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. M 3/2013
Abbreviated New Drug Application
METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED MEDVANTX, INC. ---------- METOPROLOL TARTRATE TABLETS USP 0733 0734 RX ONLY DESCRIPTION Metoprolol tartrate, USP is a selective beta -adrenoreceptor blocking agent, available as 50 and 100 mg tablets for oral administration. Metoprolol tartrate, USP 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 M.W. 684.82 Metoprolol tartrate, USP is a white, practically odorless, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol Tartrate Tablets USP, for oral administration, contain 50 mg or 100 mg of metoprolol tartrate, USP. In addition, each tablet contains the inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, propylene glycol, sodium starch glycolate, talc, and titanium dioxide. The 50 mg tablets contain D&C Red No. 30 Aluminum Lake, and the 100 mg tablets contain FD&C Blue No. 1 Lake and 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 tartrate 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. 1 15 25 3 2 4 6 6 1 2 However, several possible mechanisms have b Read the complete document