LABETALOL HYDROCHLORIDE tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

REMEDYREPACK INC.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 cardio selectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

ملخص المنتج:

Labetalol Hydrochloride Tablets USP for oral administration are available as: Labetalol Hydrochloride Tablets USP, 100 mg are yellow colored, round, biconvex, film-coated tablets debossed with "7" and "98" on either side of score line on one side and plain on other side and are supplied as: NDC: 70518-1132-00 NDC: 70518-1132-01 NDC: 70518-1132-02 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 180 in 1 BOTTLE PLASTIC PACKAGING: 90 in 1 BOTTLE PLASTIC Labetalol Hydrochloride Tablets USP should be Stored at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. 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

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
REMEDYREPACK 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 mono hydrochloride and it has the
following
structure:
Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 •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, USP is a white or almost white powder. It is
sparingly soluble in
water and in ethanol (96%), practically insoluble in ether and in
methylene chloride.
Labetalol hydrochloride tablet, 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, sodium starch glycolate (botanical
source: potato) and
titanium dioxide. Additionally, 100 mg tablets contain D&C yellow #10
Aluminum lake,
iron oxide yellow, iron oxide red and talc. 300 mg tablets contain
FD&C blue #1
Aluminum lake, iron oxide yellow and talc.
CLINICAL PHARMACOLOGY
Labetalol hydrochloride combines both selective, competitive, alpha
-adrenergic
blocking and nonselective, competitive, beta-adrenergic blocking
activity in a single
1
1
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 dose