LABETALOL HYDROCHLORIDE tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

LABETALOL (UNII: R5H8897N95) (LABETALOL - UNII:R5H8897N95)

可用日期:

Method Pharmaceuticals, LLC

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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.

產品總結:

Labetalol Hydrochloride Tablets, USP, for oral administration, are available as 100 mg Round, beige film-coated tablets, plain on one side, scored and debossed with “I/126” on the other side: NDC 58657-602-01 bottles of 100 NDC 58657-602-50 bottles of 500 NDC 58657-602-10 bottles of 1000 200 mg Round, white film-coated tablets, plain on one side, scored and debossed with “I/127” on the other side: NDC 58657-603-01 bottles of 100 NDC 58657-603-50 bottles of 500 NDC 58657-603-10 bottles of 1000 300 mg Round, blue film-coated tablets, plain on one side, and debossed with “I/130” on the other side: NDC 58657-604-01 bottles of 100 NDC 58657-604-50 bottles of 500 NDC 58657-604-10 bottles of 1000 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 REACTI ONS, contact 1-844-466-6469 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Distributed by: Method Pharmaceuticals, LLC Fort Worth, TX 76118 Rev. 11/2019

授权状态:

Abbreviated New Drug Application

产品特点

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
METHOD PHARMACEUTICALS, LLC
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LABETALOL HCL TABLETS
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 100 mg tablet contains the following inactive
ingredients: anhydrous
lactose, carnauba wax, hypromellose, magnesium stearate, polyethylene
glycol,
polysorbate 80, pregelatinized starch (corn), red iron oxide, titanium
dioxide and yellow
iron oxide.
In addition, each 200 mg tablet contains the following inactive
ingredients: anhydrous
lactose, carnauba wax, hypromellose, magnesium stearate, polydextrose,
polyethylene
glycol, pregelatinized starch (corn), titanium dioxide and triacetin.
1
19
24
2
3
In addition, each 300 mg tablet contains the following inactive
ingredients: anhydrous
lactose, carnauba wax, FD&C Blue #2, hypromellose, magnesium stearate,
polyethylene
glycol, polysorbate 80, pregelatinized starch (corn), titanium
dioxide.
CLINICAL PHARMACOLOGY
Labetalol hydrochloride combines both selective, competitive, alpha
-adrenergic
blocking and nonselective, competitive, beta-adrenergic blocking
activity in a single
substance.