Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)
Alembic Pharmaceuticals Limited
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 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 WARNINGS). Hypersensitivity to metoprolol and related deriv
Metoprolol Tartrate Tablets, USP are available containing 25 mg, 50 mg or 100 mg of metoprolol tartrate, USP. The 25 mg tablets are white to off white film coated, round, biconvex tablets debossed with ‘L150’ on one side and breakline on other side. They are available as follows: NDC 46708-290-30 bottles of 30 tablets NDC 46708-290-31 bottles of 100 tablets NDC 46708-290-71 bottles of 500 tablets NDC 46708-290-91 bottles of 1000 tablets NDC 46708-290-10 100 (10 x 10) Tablets Unit-dose blisters The 50 mg tablets are pink, film coated, round, biconvex tablets debossed with ‘L151’ on one side and breakline on other side. They are available as follows: NDC 46708-291-30 bottles of 30 tablets NDC 46708-291-31 bottles of 100 tablets NDC 46708-291-91 bottles of 1000 tablets NDC 46708-291-10 100 (10 x 10) Tablets Unit-dose blisters The 100 mg tablets are blue, film coated, round, biconvex tablets debossed with ‘L152’ on one side and breakline on other side. They are available as follows: NDC 46708-292-30 bottles of 30 tablets NDC 46708-292-31 bottles of 100 tablets NDC 46708-292-91 bottles of 1000 tablets NDC 46708-292-10 100 (10 x 10) Tablets Unit-dose blisters 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Alembic Pharmaceuticals Limited Manufactured in India Revised: 03/2023
Abbreviated New Drug Application
METOPROLOL TARTRATE - METOPROLOL TABLET ALEMBIC PHARMACEUTICALS LIMITED ---------- METOPROLOL TARTRATE TABLETS USP RX ONLY PRESCRIBING INFORMATION DESCRIPTION Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 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, 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. Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents. 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, metoprolol also inhibits beta2- 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. _Hypertension_ The mechanism of the antihypertensive effects of beta-blocking agents has not been fully elucidated.However, several possible mechanisms have been Lugege kogu dokumenti