labetalol hydrochloride- Labetalol Hydrochloride tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

Labetalol Hydrochloride (UNII: 1GEV3BAW9J) (Labetalol - UNII:R5H8897N95)

Disponible des:

Mutual Pharmaceutical Company, Inc.

Designació comuna internacional (DCI):

Labetalol Hydrochloride

formulario farmacéutico:

TABLET, FILM COATED

Composición:

100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Labetalol hydrochloride tablets are indicated in the management of hypertension. Labetalol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics. Labetalol 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.

Resumen del producto:

LABETALOL HYDROCHLORIDE TABLETS, USP are available as follows: Labetalol hydrochloride tablets, 100 mg, beige, film coated, round, scored, debossed MP 277 Bottles of 30 unit of use            NDC 53489-354-07 Bottles of 60 unit of use            NDC 53489-354-06 Bottles of 100                            NDC 53489-354-01 Bottles of 250                            NDC 53489-354-03 Bottles of 500                            NDC 53489-354-05 Bottles of 1000                          NDC 53489-354-10 Labetalol hydrochloride tablets, 200 mg, white, film coated, round, scored, debossed MP 271 Bottles of 30 unit of use            NDC 53489-355-07 Bottles of 60 unit of use            NDC 53489-355-06 Bottles of 100                            NDC 53489-355-01 Bottles of 250                            NDC 53489-355-03 Bottles of 500                            NDC 53489-355-05 Bottles of 1000                          NDC 53489-355-10 Labetalol hydrochloride tablets, 300 mg, blue, film coated, round, unscored, debossed MP 272 Bottles of 30 unit of use            NDC 53489-356-07 Bottles of 60 unit of use            NDC 53489-356-06 Bottles of 100                            NDC 53489-356-01 Bottles of 250                            NDC 53489-356-03 Bottles of 500                            NDC 53489-356-05 Bottles of 1000                          NDC 53489-356-10 Store at controlled room temperature 15°-30°C (59°-86°F). DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Fitxa tècnica

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
MUTUAL PHARMACEUTICAL COMPANY, INC.
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LABETALOL HYDROCHLORIDE
TABLETS, USP
RX ONLY
DESCRIPTION
Labetalol HCl is an adrenergic receptor blocking agent that has both
selective alpha - and nonselective
beta-adrenergic receptor blocking actions in a single substance.
Labetalol HCl is a racemate, chemically designated as
5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)
amino] ethyl] salicylamide monohydrochloride, and has the following
structure:
Labetalol HCl 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 HCl is a white or off-white crystalline powder, soluble in
water.
Each tablet, for oral administration contains 100 mg, 200 mg, or 300
mg of labetalol HCl.
In addition, each 100 mg tablet has the following inactive
ingredients: anhydrous lactose, carnauba wax,
pregelatinized starch (corn), hydroxypropyl methylcellulose, magnesium
stearate, polyethylene glycol,
polysorbate 80, synthetic yellow iron oxide, synthetic red iron oxide,
titanium dioxide.
In addition, each 200 mg tablet has the following inactive
ingredients: anhydrous lactose, carnauba wax,
pregelatinized starch (corn), hydroxypropyl methylcellulose, magnesium
stearate, polyethylene glycol,
polydextrose, titanium dioxide, triacetin.
In addition, each 300 mg tablet has the following inactive
ingredients: anhydrous lactose, carnauba wax,
pregelatinized starch (corn), hydroxypropyl methylcellulose, magnesium
stearate, polyethylene glycol,
polysorbate 80, titanium dioxide, FD&C Blue #2 aluminum lake.
CLINICAL PHARMACOLOGY
Labetalol 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 foll