NADOLOL tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Nadolol Tablets USP, 20 mg are available as white round tablets debossed "730" on one side with break line and plain on other side, containing 20 mg of nadolol, USP packaged in bottles of 90 tablets (NDC 23155-730-09), 100 tablets (NDC 23155-730-01) and 1000 tablets (NDC 23155-730-10). Nadolol Tablets USP, 40 mg are available as white round tablets debossed "731" on one side with break line and plain on other side, containing 40 mg of nadolol, USP packaged in bottles of 90 tablets (NDC 23155-731-09), 100 tablets (NDC 23155-731-01) and 1000 tablets (NDC 23155-731-10). Nadolol Tablets USP, 80 mg are available as white round tablets debossed "732" on one side with break line and plain on other side, containing 80 mg of nadolol, USP packaged in bottles of 90 tablets (NDC 23155-732-09), 100 tablets (NDC 23155-732-01) and 1000 tablets (NDC 23155-732-10). 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 by: RA CHEM PHARMA LIMITED Hyderabad - 500 076, INDIA. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 12/2019

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

NADOLOL- NADOLOL TABLET
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS 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:
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 beta1 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 th