LABETALOL HYDROCHLORIDE tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Jina la Kimataifa):

LABETALOL HYDROCHLORIDE

Tungo:

LABETALOL HYDROCHLORIDE 100 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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.

Bidhaa muhtasari:

Labetalol Hydrochloride Tablets USP, 100 mg are available as yellow, round, film-coated tablets, debossed with a bisect, and "4364" on one side and “TEVA” on the other containing 100 mg of labetalol hydrochloride USP, packaged in blistercards of 30 tablets. Labetalol Hydrochloride Tablets USP, 200 mg are available as white, round, film-coated tablets, debossed with a bisect, and "4365" on one side and “TEVA” on the other containing 200 mg of labetalol hydrochloride USP, packaged in blistercards of 30 tablets. 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 blistercards of 30 tablets. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. D 12/2010

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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LABETALOL HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION
Labetalol HCl USP tablets are adrenergic receptor blocking agents that
have both selective alpha -
adrenergic 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 it 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 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 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 i