NADOLOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Nadolol (UNII: FEN504330V) (Nadolol - UNII:FEN504330V)

Available from:

Rebel Distributors Corp

INN (International Name):

Nadolol

Composition:

Nadolol 20 mg

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 in the management of hypertension; they may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure (see WARNINGS ).

Product summary:

Nadolol Tablets USP, 20 mg are available as white, round tablet 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 30 tablets. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Iss. 6/2011 Repackaged by: REBEL DISTRIBUTORS CORP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NADOLOL- NADOLOL TABLET
REBEL DISTRIBUTORS CORP
----------
NADOLOL TABLETS USP
RX ONLY
DESCRIPTION
Nadolol USP 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.
The
structural formula is:
Nadolol USP is a white to off-white, practically odorless, crystalline
powder. It is freely soluble in
water at pH2, in alcohol, and in methanol and slightly soluble in
chloroform. Nadolol USP is available
for oral administration as 20 mg, 40 mg, and 80 mg tablets and
contains the following inactive
ingredients: citric acid, 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 to amounts in
blood and other organs and tissues.
Nadolol has