LABETALOL HYDROCHLORIDE tablet, film coated

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Bryant Ranch Prepack

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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.

পণ্য সারাংশ:

Labetalol Hydrochloride Tablets USP, for oral administration, white, circular, biconvex, film coated tablets debossed with '20' on one side and score-line and 'R' on other side of the tablet. NDC: 71335-2169-1: 30 Tablets in a BOTTLE NDC: 71335-2169-2: 90 Tablets in a BOTTLE NDC: 71335-2169-3: 60 Tablets in a BOTTLE Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° 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/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
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, USP 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, USP 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, USP 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:
lactose monohydrate,
maize starch, hypromellose (Methocel E5), sodium starch glycolate,
magnesium
stearate, titanium dioxide, polyethylene glycol, polysorbate 80,
hypromellose (3 mPas)
and hypromellose (6 mPas)
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
1
19
24
2
3
1
2
1
alpha- or beta-adrenergic blockade, a membrane-stabilizing effect has
been
demonstrated.
PHARMACODYNAMICS
The capacity of labetalol hydrochloride to block alpha receptor