LABETALOL HYDROCHLORIDE tablet, film coated

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Alvogen Inc.

INN（国際名）:

labetalol hydrochloride

構図:

labetalol hydrochloride 100 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Labetalol Hydrochloride Tablets are indicated in the management of hypertension. Labetalol Hydrochloride Tablets 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.

製品概要:

Labetalol Hydrochloride Tablets, 100 mg, light orange, round, scored, film-coated tablets debossed on one side with “CL 37” and “100”, bottles of 100 (NDC 47781-552-01) and bottles of 500 (NDC 47781-552-05). Labetalol Hydrochloride Tablets, 200 mg, white, round, scored, film-coated tablets debossed on one side with “CL 38” and “200”, bottles of 100 (NDC 47781-553-01) and bottles of 500 (NDC 47781-553-05). Labetalol Hydrochloride Tablets, 300 mg, mid-orange, round, scored, film-coated tablets debossed on one side with “CL 39” and “300”, bottles of 100 (NDC 47781-554-01). Labetalol Hydrochloride Tablets should be stored between 2° and 30°C (36° and 86°F).

認証ステータス:

New Drug Application

製品の特徴

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
ALVOGEN INC.
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LABETALOL HYDROCHLORIDE TABLETS
DESCRIPTION
Labetalol Hydrochloride Tablets 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 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 contain 100 mg, 200 mg, or 300 mg of
labetalol HCl and
are taken orally. The tablets also contain the inactive ingredients
corn starch, FD&C
Yellow No. 6 (100-mg and 300-mg tablets only), hydroxypropyl
methylcellulose, lactose,
magnesium stearate, pregelatinized corn starch, sodium benzoate
(200-mg tablet only),
talc (100-mg tablet only), and titanium dioxide.
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 in man has been
demonstrated by
1
19
24
2
3
1
2
1
attenuation of the pressor effect of phenylephrine and b