LABETALOL HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cadila Pharmaceuticals Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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.

Product summary:

Labetalol hydrochloride tablets, USP for oral administration, are available as: 100 mg : White, round, film coated tablets debossed with “C and 82”on either side of the breakline on one side and plain on the other side and supplied as: NDC 71209-083-03 bottles of 60 NDC 71209-083-05 bottles of 100 NDC 71209-083-10 bottles of 500 NDC 71209-083-11 bottles of 1000 200 mg : White, round, film coated tablets debossed with “C and 83”on either side of the breakline on one side and plain on the other side and supplied as: NDC 71209-084-03 bottles of 60 NDC 71209-084-05 bottles of 100 NDC 71209-084-10 bottles of 500 NDC 71209-084-11 bottles of 1000 300 mg : White, round, film coated tablets debossed with “C84” on one side and plain on the other side and supplied as: NDC 71209-085-03 bottles of 60 NDC 71209-085-05 bottles of 100 NDC 71209-085-10 bottles of 500 NDC 71209-085-11 bottles of 1000 Labetalol hydrochloride tablets, USP should be stored at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°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 Cadila Pharmaceuticals Limited at 1-202-355-9785 (Fax [phone]), or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Trademarks are the property of their respective owners. Manufactured by: Cadila Pharmaceuticals Limited 1389, Dholka, District - Ahmedabad, Gujarat State, INDIA.  Rev.09/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LABETALOL HYDROCHLORIDE - LABETALOL HYDROCHLORIDE TABLET, FILM COATED
CADILA PHARMACEUTICALS LIMITED
----------
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 to off-white powder, soluble
in water and in
alcohol. Insoluble in ether and in chloroform.
Labetalol hydrochloride tablets, USP for oral administration, contains
100 mg, 200 mg or
300 mg of labetalol hydrochloride USP.
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
corn starch, hydroxypropyl methyl cellulose, lactose monohydrate,
magnesium stearate,
opadry white, polysorbate, and sodium starch glycolate (potato).
Opadry white contains hypromellose, polyethylene glycol, titanium
dioxide, and talc.
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 alpha-
or beta-adrenergic
blockade, a membrane-stabilizing effect has been demon