NADOLOL- nadolol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

NADOLOL

Composition:

NADOLOL 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nadolol Tablets USP are indicated for the long-term management of patients with angina pectoris. Nadolol Tablets USP 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 Tablets USP. 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 Pres

Product summary:

Nadolol Tablets USP, 20 mg are available as white, round tablets debossed “20” on one side, and a bisect on the other side with “Z” on the upper half and “4235” on the lower half, containing 20 mg of nadolol, USP packaged in bottles of 100 tablets. Nadolol Tablets USP, 40 mg are available as white, round tablets debossed “40” on one side, and a bisect on the other side with “Z” on the upper half and “4236” on the lower half, containing 40 mg of nadolol, USP packaged in bottles of 100 tablets. Nadolol Tablets USP, 80 mg are available as white, round tablets debossed “80” on one side, and a bisect on the other side with “Z” on the upper half and “4237” on the lower half, containing 80 mg of nadolol, USP packaged in bottles of 100 tablets. Store 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). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. B 8/2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NADOLOL- NADOLOL TABLET
TEVA PHARMACEUTICALS USA, INC.
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NADOLOL TABLETS USP
RX ONLY
DESCRIPTION
Nadolol Tablets USP are 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.
The structural formula is:
C H NO MW 309.40
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, and slightly
soluble in chloroform.
Nadolol Tablets USP are available for oral administration as 20 mg, 40
mg, and 80 mg tablets and
contain the following inactive ingredients: citric acid anhydrous,
corn starch, magnesium stearate,
microcrystalline cellulose and povidone. In addition, the 80 mg
tablets contain sodium starch glycolate.
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 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. 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
studies show that nadolol slows the sinus rate and depresses AV
conduction. In dogs, only minimal
amounts of nadolol were detected in the brain relative