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:

Major Pharmaceuticals

INN (International Name):

LABETALOL HYDROCHLORIDE

Composition:

LABETALOL HYDROCHLORIDE 100 mg

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 HCl 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:

Labetalol HCl Tablets, USP 100 mg are available as round, beige, film-coated tablets debossed with “WATSON 605 ” on one side and scored on the other side. Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5928-61 Labetalol HCl Tablets, USP 200 mg are available as round, white, film-coated tablets debossed with “WATSON 606 ” on one side and scored on the other side. Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5929-61 Labetalol HCl Tablets, USP 300 mg are available as round, blue, film-coated tablets debossed with “WATSON 607 ” on one side and plain on the other side. Carton of 100 tablets (10 tablets each blister pack x 10) NDC0904-5930-61 Labetalol HCl Tablets, USP should be stored between 2° to 30°C (36° to 86° F).  Dispense in a tight, light resistant container as defined in USP/NF. Brands listed are trademarks of their respective owners. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 Revised: December 2015                             

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
MAJOR PHARMACEUTICALS
----------
LABETALOL HYDROCHLORIDE TABLETS, USP
REVISED : DECEMBER 2015
RX ONLY
DESCRIPTION
Labetalol hydrochloride (HCl) is an adrenergic receptor blocking agent
that has both
selective alpha -adrenergic and nonselective beta-adrenergic receptor
blocking actions
in a single substance.
Labetalol 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.
Labetalol Hydrochloride Tablets, USP for oral administration contain
100 mg, 200 mg, or
300 mg of labetalol HCl. Each tablet also contains the following
inactive ingredients:
anhydrous lactose, colloidal silicon dioxide, crospovidone,
hydroxypropyl
methylcellulose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol,
polysorbate 80, pregelatinized starch, purified water, and titanium
dioxide. Labetalol HCl
Tablets, USP 100 mg also contain synthetic red iron oxide and
synthetic yellow iron
oxide. Labetalol HCl Tablets, USP 300 mg also contain FD & C blue No.
2 aluminum lake.
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
1
19
24
2
3
1
2
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-adrene