LABETALOL HCL- labetalol hcl tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Mylan Institutional Inc.

Designació comuna internacional (DCI):

LABETALOL HYDROCHLORIDE

Composición:

LABETALOL HYDROCHLORIDE 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 is 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.

Resumen del producto:

Labetalol Hydrochloride Tablets USP, for oral administration, are available as: 100 mg : Round, white, film-coated tablets, debossed “ E” over “ 10” on one side and bisected on the other side and supplied as: NDC 51079-928-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 200 mg : Round, white, film-coated tablets, debossed “ E” over “ 117” on one side and bisected on the other side and supplied as: NDC 51079-929-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Sandoz Inc. Princeton, NJ 08540 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12183 4/15

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

LABETALOL HCL- LABETALOL HCL TABLET, FILM COATED
MYLAN INSTITUTIONAL INC.
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LABETALOL HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION
Labetalol hydrochloride tablets USP are an adrenergic receptor
blocking agent that has both selective
alpha
-adrenergic and nonselective beta-adrenergic receptor blocking actions
in a single substance.
Labetalol hydrochloride 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 hydrochloride has the molecular formula C
H
N
O
•HCl and a molecular weight of
364.87. 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 hydrochloride 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
labetalol hydrochloride USP.
In addition, each tablet contains the following inactive ingredients:
corn starch, hypromellose, lactose
monohydrate, magnesium stearate, polyethylene glycol, polysorbate,
sodium starch glycolate (potato)
and titanium dioxide.
CLINICAL PHARMACOLOGY
Labetalol hydrochloride 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
1
19
24
2
3
1
2
1
The capacity of labetalol hydrochloride to block alpha receptors in
man has been demonstrated by
attenuation of the pressor effect of phenylephrine an