CORGARD- nadolol tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

nadolol (UNII: FEN504330V) (nadolol - UNII:FEN504330V)

Disponível em:

USWM, LLC

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

CORGARD (nadolol) is indicated for the long-term management of patients with angina pectoris. CORGARD (nadolol) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with CORGARD. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Pro

Resumo do produto:

CORGARD Tablets (Nadolol Tablets USP) are available in bottles of 100 in the following strengths: 20 mg tablets (NDC 78670-100-01), imprinted CORGARD 20 40 mg tablets (NDC 78670-101-01), imprinted CORGARD 40 All tablets are scored (bisect bar) and easy to break. USWM is imprinted above the bisect bar. Store at room temperature; avoid excessive heat. Protect from light. Keep bottle tightly closed.

Status de autorização:

New Drug Application

Características técnicas

CORGARD- NADOLOL TABLET
USWM, LLC
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CORGARD TABLETS
(NADOLOL TABLETS, USP)
RX ONLY
DESCRIPTION
CORGARD (nadolol) is a synthetic nonselective beta-adrenergic receptor
blocking agent
designated chemically as
1-(_tert_-butyl-amino)-3-[(5,6,7,8-tetrahydro-_cis_-6,7-dihydroxy-1-
naphthyl) oxy]-2- propanol. Structural formula:
C
H
NO MW 309.40
Nadolol is a white crystalline powder. It is freely soluble in
ethanol, soluble in hydrochloric
acid, slightly soluble in water and in chloroform, and very slightly
soluble in sodium
hydroxide.
CORGARD (nadolol) is available for oral administration as 20 mg and 40
mg tablets.
Inactive ingredients: microcrystalline cellulose, colorant (FD& C Blue
No. 2), corn starch,
magnesium stearate, and other ingredients.
CLINICAL PHARMACOLOGY
CORGARD (nadolol) is a nonselective beta-adrenergic receptor blocking
agent. Clinical
pharmacology studies have demonstrated beta-blocking activity by
showing (1)
reduction in heart rate and cardiac output at rest and on exercise,
(2) reduction of
systolic and diastolic blood pressure at rest and on exercise, (3)
inhibition of
isoproterenol-induced tachycardia, and (4) reduction of reflex
orthostatic tachycardia.
CORGARD (nadolol) specifically competes with beta-adrenergic receptor
agonists for
available beta receptor sites; it inhibits both the beta receptors
located chiefly in cardiac
muscle and the beta receptors located chiefly in the bronchial and
vascular
musculature, inhibiting the chronotropic, inotropic, and vasodilator
responses to beta-
adrenergic stimulation proportionately. CORGARD has no intrinsic
sympathomimetic
®
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4
1
2
activity and, unlike some other beta-adrenergic blocking agents,
nadolol has little direct
myocardial depressant activity and does not have an anesthetic-like
membrane-
stabilizing action. Animal and human studies show that CORGARD slows
the sinus rate
and depresses AV conduction. In dogs, only minimal amounts of nadolol
were detected
in the brain relative to amounts in blood and other organs and
tissues. CO