Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics. Labetalol hydrochloride tablets are contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product (see WARNINGS ). Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.
Labetalol hydrochloride tablets, USP 300 mg, white, round, film-coated tablets with bisect, debossed “N” on top and “T” on bottom of the bisect on one side and "043" on the other side of the tablet. Product: 71335-1410 NDC: 71335-1410-1 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-1410-2 60 TABLET, FILM COATED in a BOTTLE NDC: 71335-1410-3 58 TABLET, FILM COATED in a BOTTLE NDC: 71335-1410-4 90 TABLET, FILM COATED in a BOTTLE NDC: 71335-1410-5 180 TABLET, FILM COATED in a BOTTLE Labetalol hydrochloride tablets, USP should be stored at 20° to 25°C (68° to 77°F)[ See USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Abbreviated New Drug Application
LABETALOL HCL- LABETALOL HYDROCHLORIDE TABLET, FILM COATED BRYANT RANCH PREPACK ---------- LABETALOL HYDROCHLORIDE TABLETS, USP 100 MG, 200 MG AND 300 MG RX ONLY DESCRIPTION Labetalol hydrochloride tablets, USP are adrenergic receptor blocking agents that have both selective alpha -adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1- hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride, and it has the following structure: Labetalol HCl has the molecular formula C H N O •HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R, R´stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets contain 100, 200, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients lactose monohydrate, corn starch, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide and talc. CLINICAL PHARMACOLOGY Labetalol HCl combines both selective, competitive, alpha -adrenergic blocking and nonselective, competitive, beta-adrenergic blocking activity in a single substance. In man, the ratios of alpha- to beta-blockade have been estimated to be approximately 1:3 and 1:7 following oral and intravenous (IV) administration, respectively. Beta -agonist activity has been demonstrated in animals with minimal beta -agonist (ISA) activity 1 19 24 2 3 1 2 1 detected. In animals, at doses greater than those required for alpha- or beta-adrenergic blockade, a membrane stabilizing effect has been demonstrated. PHARMACODYNAMICS: The capacity of labetalol HCl to block alpha receptors in man has been demonstrated by attenuation of the pressor effect of phenylephrine and by a significant reduction of the press Đọc toàn bộ tài liệu