NADOLOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

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 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. 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 Educati

Product summary:

Nadolol Tablets, USP are available containing 20 mg or 40 mg of nadolol, USP. The 20 mg tablets are yellow round, scored tablets debossed with M above the score and 28 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-812-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 40 mg tablets are yellow round, scored tablets debossed with M above the score and 171 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-813-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12686 5/21

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NADOLOL- NADOLOL TABLET
MYLAN INSTITUTIONAL INC.
----------
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. Its structural formula is:
Nadolol, USP 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.
Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of
nadolol, USP and
the following inactive ingredients: anhydrous lactose, croscarmellose
sodium,
magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate,
and D&C Yellow
No. 10 Aluminum Lake.
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 low lipophilicity as