NADOLOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cipla 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 is 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 Program's

Product summary:

Nadolol Tablets, USP are supplied as: 20 mg tablets : Yellow, round, biconvex tablets debossed "347" on one side and 'I' on the left side of the bisect and 'G' on the right side of bisect on other. Supplied in bottles of 30s (NDC 69097-867-02), 100s (NDC 69097-867-07) and 1000s (NDC 69097-867-15) 40 mg tablets: Yellow, round, biconvex tablets debossed "348" on one side and 'I' on the left side of the bisect and 'G' on the right side of bisect on other. Supplied in bottles of 30s (NDC 69097-868-02), 100s (NDC 69097-868-07) and 1000s (NDC 69097-868-15) 80 mg tablets: Yellow, round, biconvex tablets debossed "349" on one side and 'I' on the left side of the bisect and 'G' on the right side of bisect on other. Supplied in bottles of 30s (NDC 69097-869-02), 100s (NDC 69097-869-07) and 1000s (NDC 69097-869-15) STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Revised: 05/2020 Barcode: 869-05-2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NADOLOL- NADOLOL TABLET
CIPLA USA INC.
----------
RX ONLY
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 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.
Nadolol tablets, USP are available for oral administration as 20 mg,
40 mg, and 80 mg tablets. Inactive
ingredients: lactose monohydrate, microcrystalline cellulose,
povidone, D&C yellow No. 10,
croscarmellose sodium, and magnesium stearate.
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
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 determined by octanol/water partitio