TRANDATE- labetalol hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

labetalol hydrochloride (UNII: 1GEV3BAW9J) (labetalol - UNII:R5H8897N95)

Available from:

Prometheus Laboratories Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TRANDATE Tablets are indicated in the management of hypertension. TRANDATE Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics. TRANDATE 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 cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

Product summary:

TRANDATE Tablets, 100 mg, light orange, round, scored, film-coated tablets engraved on one side with "TRANDATE 100," bottles of 100 (NDC 65483-391-10) and 500 (NDC 65483-391-50) and unit dose packs of 100 tablets (NDC 65483-391-11). TRANDATE Tablets, 200 mg, white, round, scored, film-coated tablets engraved on one side with "TRANDATE 200," bottles of 100 (NDC 65483-392-10) and 500 (NDC 65483-392-50) and unit dose packs of 100 tablets (NDC 65483-392-22). TRANDATE Tablets, 300 mg, mid-orange, round, scored, film-coated tablets engraved on one side with "TRANDATE 300," bottles of 100 (NDC 65483-393-10) and 500 (NDC 65483-393-50) and unit dose packs of 100 tablets (NDC 65483-393-33). TRANDATE Tablets should be stored between 2° and 30°C (36° and 86°F). TRANDATE Tablets in the unit dose boxes should be protected from excessive moisture. Prometheus Laboratories Inc. Manufactured in Canada by WellSpring Pharmaceutical Canada Corp. Oakville, ON L6H 1M5 for Prometheus Laboratories Inc. San Diego, CA 92121 TRANDATE is a registered trademark of Prometheus Laboratories, Inc. TOXI-LAB is a registered trademark of Varian, Inc. EMIT and EMIT-d.a.u. are registered trademarks of Siemens Healthcare Diagnostics, Inc. © 2010 Prometheus Laboratories Inc. All rights reserved November 2010 TR002C

Authorization status:

New Drug Application

Summary of Product characteristics

TRANDATE- LABETALOL HYDROCHLORIDE TABLET
PROMETHEUS LABORATORIES INC.
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TRANDATE
(LABETALOL HYDROCHLORIDE)
TABLETS
DESCRIPTION
TRANDATE Tablets are adrenergic receptor blocking agents that have
both selective alpha -
adrenergic and nonselective beta-adrenergic receptor blocking actions
in a single substance.
Labetalol hydrochloride (HCl) 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 HCl has the empirical formula C
H N O •HCl and a molecular weight of 364.9. 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 HCl is a white or off-white crystalline powder, soluble in
water.
TRANDATE Tablets contain 100, 200, or 300 mg of labetalol HCl and are
taken orally. The tablets
also contain the inactive ingredients corn starch, FD&C Yellow No. 6
(100- and 300-mg tablets only),
hydroxypropyl methylcellulose, lactose, magnesium stearate,
pregelatinized corn starch, sodium
benzoate (200-mg tablet only), talc (100-mg tablet only), and titanium
dioxide.
CLINICAL PHARMACOLOGY
Labetalol HCl 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 HCl to block alpha
receptors in man has been
demonstrated by attenuation of the pressor effect of phenylephrine and
by a significant reduction of the
pressor response ca