LABETALOL HYDROCHLORIDE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Unichem Pharmaceuticals (USA), Inc.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

Labetalol Hydrochloride Tablets, USP, for oral administration, are available as 100 mg White to off-white, round film coated tablets debossed with "252" on one side &"U" on either side of score line on other side and supplied as: NDC 29300-252-01 bottles of 100 NDC 29300-252-05 bottles of 500 200 mg White to off-white, round film coated tablets debossed with "253" on one side &"U" on either side of score line on other side and supplied as: NDC 29300-253-01 bottles of 100 NDC 29300-253-05 bottles of 500 300 mg White to off-white, round film coated tablets debossed with "254" on one side &"U" on other side and supplied as: NDC 29300-254-01 bottles of 100 NDC 29300-254-05 bottles of 500 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. To report SUSPECTED ADVERSE REACTIONS, contact Unichem Pharmaceuticals (USA) Inc. at 1-866-562-4616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India. Manufactured for: East Brunswick, NJ 08816. 01-R-08/2022

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

LABETALOL HYDROCHLORIDE - LABETALOL HYDROCHLORIDE TABLET, FILM COATED
UNICHEM PHARMACEUTICALS (USA), 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, 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 powder, sparingly
soluble in water
and ethanol (96%), insoluble in ether and chloroform.
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:
hypromellose, lactose
monohydrate, magnesium stearate, polyethylene glycol, sodium starch
glycolate
(potato) and titanium dioxide.
CLINICAL PHARMACOLOGY
Labetalol hydrochloride combines both selective, competitive,
alpha1-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
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 hydrochloride to block alpha receptors in
man has been
d