LABETALOL HYDROCHLORIDE- labetalol hydrochloride tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

ELYSIUM PHARMACEUTICALS LIMITED

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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.

Produkt oppsummering:

Labetalol Hydrochloride Tablets USP for oral administration are available as: 100 mg: White to off-white, biconvex, film coated tablets with “ET20” debossed on one side and non-functional scoring on the other side and supplied as: NDC 13811-649-10 bottles of 100 NDC 13811-649-50 bottles of 500 NDC 13811-649-01 bottles of 1000 200 mg: White to off-white, biconvex, film coated tablets with “ET21” debossed on one side and non-functional scoring on the other side and supplied as: NDC 13811-650-10 bottles of 100 NDC 13811-650-50 bottles of 500 NDC 13811-650-01 bottles of 1000 300 mg: White to off-white, biconvex, film coated tablets with “ET22” debossed on one side and non-functional scoring on the other side and supplied as: NDC 13811-651-10 bottles of 100 NDC 13811-651-50 bottles of 500 NDC 13811-651-01 bottles of 1000 Labetalol Hydrochloride Tablets should be stored between 2° and 30°C (36° and 86°F). Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Trigen Laboratories, LLC at 1-888-6-TRIGEN (1-888-987-4436). Manufactured for: Trigen Laboratories LLC Bridgewater, NJ 08807 www.trigenlab.com Rev. 04/2018

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
ELYSIUM PHARMACEUTICALS LIMITED
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LABETALOL HYDROCHLORIDE
DESCRIPTION:
Labetalol Hydrochloride Tablets are adrenergic receptor blocking
agents that have both selective
alpha1-adrenergic and nonselective beta-adrenergic receptor blocking
action 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 C19H24N2O3•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 HCl Tablets contain 100, 200, or 300 mg of labetalol HCl and
are taken orally. The tablets
also contain the inactive ingredients lactose monohydreate, magnesium
stearate, pregelatinized corn
starch, sodium starch glycolate.
FDA approved dissolution test specifications differ from USP.
CLINICAL PHARMACOLOGY:
Labetalol HCl 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 and 1:7 following
oral and intravenous (IV)
administration, respectively. Beta2-agonist activity has been
demonstrated in animals with minimal beta1-
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 caused by immersing the hand in ice-cold water
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