LABETALOL HYDROCHLORIDE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

REMEDYREPACK INC.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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.

Povzetek izdelek:

Labetalol Hydrochloride Tablets USP for oral administration are available as: 200 mg: White to off-white, biconvex, film coated tablets with “ET21” debossed on one side and non-functional scoring on the other side and supplied as: NDC: 70518-2903-00 PACKAGING: 30 in 1 BLISTER PACK Labetalol Hydrochloride Tablets should be stored between 2° and 30°C (36° and 86°F). Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
REMEDYREPACK 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 action
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 HCl Tablets contain 100, 200, or 300 mg of labetalol HCl and
are taken orally.
The tablets also contain the inactive ingredients lactose
monohydreate, magnesium
stearate, pregelatinized corn starch, sodium starch glycolate.
FDA approved dissolution test specifications differ from USP.
CLINICAL PHARMACOLOGY:
Labetalol HCl combines both selective, competitive, alpha
-adrenergic blocking and
1
19
24
2
3
1
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. Beta2-agonist
activity has been demonstrated in animals with minimal beta1-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 pressor response caused by immersing the
hand in ice-cold
wate