Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: 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 is indicated in the long-term treatment of angina pectoris. 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 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
Metoprolol tartrate tablets, USP 50 mg are available as 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. NDC 67046-473-07 blisterpacks of 7 NDC 67046-473-14 blisterpacks of 14 NDC 67046-473-15 blisterpacks of 15 NDC 67046-473-20 blisterpacks of 20 NDC 67046-473-21 blisterpacks of 21 NDC 67046-473-28 blisterpacks of 28 NDC 67046-473-30 blisterpacks of 30 NDC 67046-473-60 blisterpacks of 60 Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from moisture and heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Ingenus Pharmaceuticals, LLC 4190 Millenia Boulevard Orlando, FL 32839-6408 Customer complaint toll free number : 877-748-1970 by: Ipca Laboratories Limited 48, Kandivli Ind. Estate, Mumbai 400 067, India July 2013
Abbreviated New Drug Application
METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED CONTRACT PHARMACY SERVICES-PA ---------- 473 METOPROLOL 50 MG METOPROLOL TARTRATE TABLETS, USP RX ONLY PRESCRIBING INFORMATION 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. Its structural formula is: Metoprolol tartrate, USP is a white, practically odorless, crystalline powder with a molecular weight of 684.81. 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 USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, polyethylene glycol, pregelatinized starch, and titanium dioxide. In addition the 25 MG and 100 MG tablet contain propylene glycol and sodium lauryl sulfate; the 50 MG tablet contains D&C Red #30 and talc. CLINICAL PHARMACOLOGY _Mechanism of Action:_ Metoprolol tartrate is a beta1-selective (cardioselective) adrenergic receptor blocker. This preferential effect is not absolute, however, and at higher plasma concentrations, metaprolol tartrate also inhibits beta2-adrenorecepttors, chiefly located in the bronchial and vascular musculature. Clinical pharmacology studies have confirmed 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 Aqra d-dokument sħiħ