NADOLOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V)

Available from:

Greenstone LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nadolol tablet is indicated for the long-term management of patients with angina pectoris. Nadolol tablet 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 nadolol tablet. 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 Pr

Product summary:

20 mg tablets in bottles of 100 (NDC 59762–0810–1), 40 mg tablets in bottles of 100 (NDC 59762–0811–1) and 80 mg tablets in bottles of 100 (NDC 59762–0812–1). All tablets are scored (bisect bar) and easy to break. Tablet identification numbers: 20 mg, 232 ; 40 mg, 207 ; and 80 mg, 241 . Store at room temperature; avoid excessive heat. Protect from light. Keep bottle tightly closed.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

NADOLOL- NADOLOL TABLET
GREENSTONE LLC
----------
NADOLOL TABLETS, USP
PRODUCT OVERVIEW:
NADOLOL TABLET
RX ONLY
DESCRIPTION
Nadolol is a synthetic nonselective beta-adrenergic receptor blocking
agent designated
chemically as
1-(_tert_-butylamino)-3-[(5,6,7,8-tetrahydro-_cis_-6,7-dihydroxy-1-
naphthyl)oxy]-2-propanol. Structural formula:
C17H27NO4 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.
Nadolol tablet is available for oral administration as 20 mg, 40 mg,
and 80 mg tablets.
Inactive ingredients: microcrystalline cellulose, colorant (FD&C Blue
No. 2), corn starch,
magnesium stearate, povidone (except 20 mg and 40 mg), and other
ingredients.
CLINICAL PHARMACOLOGY
Nadolol tablet 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.
Nadolol tablet specifically competes with beta-adrenergic receptor
agonists for available
beta receptor sites; it inhibits both the beta receptors located
chiefly in cardiac muscle
1
and the beta receptors located chiefly in the bronchial and vascular
musculature,
inhibiting the chronotropic, inotropic, and vasodilator responses to
beta-adrenergic
stimulation proportionately. Nadolol tablet has no intrinsic
sympathomimetic 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 nadolol tablet slows the sinus rate
and depresses
AV conduction. In dogs, only minimal amounts of nadolol were detected
in the brain
relative to amount