LABETALOL HYDROCHLORIDE- labetalol hydrochloride tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Golden State Medical Supply, Inc.

INN (International Name):

LABETALOL HYDROCHLORIDE

Sammensetning:

LABETALOL HYDROCHLORIDE 100 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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.

Produkt oppsummering:

Labetalol HCl Tablets, USP 100 mg are available as round, beige, film-coated tablets debossed with “ WATSON 605 ” on one side and scored on the other side. They are supplied in bottles of 100 (NDC 60429-277-01) and 500 (60429-277-05). Labetalol HCl Tablets, USP 200 mg are available as round, white, film-coated tablets debossed with “ WATSON 606 ” on one side and scored on the other side. They are supplied in bottles of 100 (NDC 60429-278-01) and 500 (60429-278-05). Labetalol HCl Tablets, USP 300 mg are available as round, blue, film-coated tablets debossed with “ WATSON 607 ” on one side and plain on the other side. They are supplied in bottles of 100 (NDC 60429-279-01). Labetalol HCl Tablets, USP should be stored between 2° to 30°C (36° to 86° F).  Dispense in a tight, light resistant container as defined in USP/NF. Brands listed are trademarks of their respective owners. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Marketed/ Packaged by: GSMS, Inc. Camarillo, CA 93012 USA Revised: December 2015                             

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
LABETALOL HYDROCHLORIDE TABLETS, USP
REVISED: DECEMBER 2015
RX ONLY
DESCRIPTION
Labetalol hydrochloride (HCl) is an adrenergic receptor blocking agent
that has both selective alpha
-
adrenergic and nonselective beta-adrenergic receptor blocking actions
in a single substance.
Labetalol 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 empirical 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, USP for oral administration contain
100 mg, 200 mg, or 300 mg of
labetalol HCl. Each tablet also contains the following inactive
ingredients: anhydrous lactose, colloidal
silicon dioxide, crospovidone, hydroxypropyl methylcellulose,
magnesium stearate, microcrystalline
cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,
purified water, and titanium
dioxide. Labetalol HCl Tablets, USP 100 mg also contain synthetic red
iron oxide and synthetic yellow
iron oxide. Labetalol HCl Tablets, USP 300 mg also contain FD & C blue
No. 2 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-
adrenerg