LABETALOL HCL 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:

St. Mary's Medical Park Pharmacy

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Labetalol Hydrochloride Tablets, USP, for oral administration, are available as 100 mg Round, white, film-coated tablets, debossed “ E” over “ 10” on one side and bisected on the other side and supplied as: NDC 60760-610-90 BOTTLES OF 90 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by Sandoz Inc. Princeton, NJ 08540 Rev. October 2016 MF0010REV10/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LABETALOL HCL- LABETALOL HCL TABLET, FILM COATED
ST. MARY'S MEDICAL PARK PHARMACY
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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 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:
corn starch, hypromellose, lactose
monohydrate, magnesium stearate, polyethylene glycol, polysorbate,
sodium starch glycolate (potato)
and titanium dioxide.
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 demonstrated.
PHARMACODYNAMICS
The capacity of labetalol hydrochloride to block alpha receptors in
man has been demonstrated by
1
19
24
2
3
1
2
1
attenuation of the pressor