País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95)
Physicians Total Care, Inc.
LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE 100 mg
ORAL
PRESCRIPTION DRUG
Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics. Labetalol HCl 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, 100 mg are available as yellow, round, film-coated tablets, debossed with a bisect, “4364” and on one side and “TEVA” on the other containing 100 mg of labetalol hydrochloride USP, packaged in Labetalol Hydrochloride Tablets USP, 200 mg are available as white, round, film-coated tablets, debossed with a bisect, “4365” and on one side and “TEVA” on the other containing 200 mg of labetalol hydrochloride USP, packaged in Labetalol Hydrochloride Tablets USP, 300 mg are available as green, round, film-coated, unscored tablets, debossed with ”4366” and on one side and “TEVA” on the other containing 300 mg of labetalol hydrochloride USP, packaged in Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rev. A 7/2008 Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Relabeling and Rapackaging by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
LABETALOL HYDROCHLORIDE - LABETALOL HYDROCHLORIDE TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- DESCRIPTION Labetalol HCl USP is an adrenergic receptor blocking agent that has both selective alpha -and non- selective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl USP is a racemate, chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3- phenylpropyl)amino]ethyl] salicylamide monohydrochloride, and has the following structural formula: C H N O •HCl M.W. 364.87 Labetalol HCl USP 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 USP is a white or off-white crystalline powder, soluble in water. Each tablet, for oral administration, contains 100 mg, 200 mg, or 300 mg of labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and colorants (100 mg: D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake; and 300 mg: D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake and FD&C blue #1 aluminum lake). CLINICAL PHARMACOLOGY Labetalol 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 administration, respectively. Beta - agonist activity has been demonstrated in animals with minimal beta -agonist (ISA) activity 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 to block alpha receptors in man has been demonstrated by attenuation of the pressor effect of phenylephrine and by a si Llegiu el document complet