LABETALOL HCL- labetalol hydrochloride tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

A-S Medication Solutions

INN (International Name):

LABETALOL HYDROCHLORIDE

Sammensætning:

LABETALOL HYDROCHLORIDE 100 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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 oversigt:

Product: 50090-1161 NDC: 50090-1161-0 60 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-1161-1 90 TABLET, FILM COATED in a BOTTLE, PLASTIC Product: 50090-1290 NDC: 50090-1290-0 100 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-1290-1 90 TABLET, FILM COATED in a BOTTLE, PLASTIC Product: 50090-1291 NDC: 50090-1291-0 100 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-1291-1 90 TABLET, FILM COATED in a BOTTLE, PLASTIC

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

LABETALOL HCL- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
LABETALOL HYDROCHLORIDE TABLETS, USP 100 MG, 200 MG AND 300 MG
RX ONLY
DESCRIPTION
Labetalol hydrochloride tablets, USP are adrenergic receptor blocking
agents that have
both selective alpha -adrenergic and nonselective beta-adrenergic
receptor blocking
actions in a single substance.
Labetalol hydrochloride (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 molecular 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 contain 100, 200, or 300 mg of
labetalol HCl and are
taken orally. The tablets also contain the inactive ingredients
lactose monohydrate, corn
starch, crospovidone, colloidal silicon dioxide, magnesium stearate,
polyvinyl alcohol,
polyethylene glycol, titanium dioxide and talc.
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
1
19
24
2
3
1
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 in man has
been demonstrated by attenuation of the pressor effect of
phenylephrine and by a
significant reduction of the press