NADOLOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Nadolol tablets are   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. 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

Product summary:

NDC: 71335-0697-1: 30 Tablets in a BOTTLE NDC: 71335-0697-2: 28 Tablets in a BOTTLE NDC: 71335-0697-3: 90 Tablets in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NADOLOL- NADOLOL TABLET
BRYANT RANCH PREPACK
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NADOLOL TABLETS, USP
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:
Nadolol, USP is a white to off-white, practically odorless crystalline
powder. It is freely
soluble in alcohol and in methanol, soluble in water at pH 2, slightly
soluble in
chloroform,,methylenechloride, isopropylalcohol and in water(between
pH 7 and pH 10);
insoluble in acetone, benzene, ether, hexane and trichloroethane.
Nadolol tablets, USP are available for oral administration as 20 mg,
40 mg and 80 mg
tablets. Inactive ingredients: anhydrous citric acid, colloidal
silicon dioxide, corn starch,
magnesium stearate, microcrystalline cellulose, povidone, and sodium
starch glycolate.
Additionally each 40 mg tablet contains ferric oxide yellow and each
80 mg tablet
contains FD&C blue 2.
CLINICAL PHARMACOLOGY
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.
Nadolol specifically competes with beta-adrenergic receptor agonists
for available beta
receptor sites; it inhibits both the beta1 receptors located chiefly
in cardiac muscle and
the beta2 receptors located chiefly in the bronchial and vascular
musculature, inhibiting
the chronotropic, inotropic, and vasodilator responses to
beta-adrenergic stimulation
proportionately. Nadolol 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