NADOLOL tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Alembic Pharmaceuticals Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Angina Pectoris Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension 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 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 tablets 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 ).

Resumen del producto:

Nadolol Tablets, USP are available containing 20 mg, 40 mg or 80 mg of nadolol, USP. The 20 mg tablets are light blue to blue color, round biconvex uncoated tablets with “L” and “19” debossed on either side of score line on one side and plain on other side. They are available as follows: NDC 62332-402-30                bottle of 30 tablets NDC 62332-402-31                bottle of 100 tablets NDC 62332-402-91                bottle of 1000 tablets   The 40 mg tablets are light blue to blue color, round biconvex uncoated tablets with “L” and “713” debossed on either side of score line on one side and plain on other side. They are available as follows: NDC 62332-403-30                bottle of 30 tablets NDC 62332-403-31                bottle of 100 tablets NDC 62332-403-91                bottle of 1000 tablets    The 80 mg tablets are light blue to blue color, round biconvex uncoated tablets with “L” and “714” debossed on either side of score line on one side and plain on other side. They are available as follows: NDC 62332-404-30                bottle of 30 tablets NDC 62332-404-31                bottle of 100 tablets NDC 62332-404-91                bottle of 1000 tablets  STORAGE Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Keep bottle tightly closed. Avoid excessive heat. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 01/2024

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

NADOLOL - NADOLOL TABLET
ALEMBIC PHARMACEUTICALS INC.
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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. Structural formula:
C
H
NO MW 309.40
Nadolol, USP is a white to off-white powder. It is freely soluble in
alcohol and in methanol,
soluble in water at pH 2, slightly soluble in chloroform, in methylene
chloride, in isopropyl
alcohol, and in water (between pH 7 and pH 10); insoluble in acetone,
in benzene, in
ether, in hexane, and in trichloroethane.
Each tablet for oral administration contains 20 mg, 40 mg, or 80 mg of
nadolol, USP and
the following inactive ingredients: povidone K-30, corn starch,
microcrystalline cellulose,
citric acid monohydrate, FD&C Blue No. 2 Aluminum Lake, 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 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
17
27
4
1
2
human studies show that nadolol slows the sinus rate and depresses AV
conduction. I