NADOLOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BluePoint Laboratories

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 Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol 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 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 100s ( NDC 68001-317-00) 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 100s ( NDC 68001-318-00) 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 100s ( NDC 68001-319-00) 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 by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 For BluePoint Laboratories Revised: 01/2024

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NADOLOL- NADOLOL TABLET
BLUEPOINT LABORATORIES
----------
NADOLOL TABLETS, USP
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
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