LABETALOL HYDROCHLORIDE tablet, film coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95)

Fáanlegur frá:

Physicians Total Care, Inc.

INN (Alþjóðlegt nafn):

LABETALOL HYDROCHLORIDE

Samsetning:

LABETALOL HYDROCHLORIDE 100 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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.

Vörulýsing:

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

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

LABETALOL HYDROCHLORIDE - LABETALOL HYDROCHLORIDE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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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