NADOLOL tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Bryant Ranch Prepack

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Nadolol tablets, USP is indicated for the long-term management of patients with angina pectoris. Nadolol tablets, USP 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 tablets, USP. 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, USP 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).

Povzetek izdelek:

All tablets are blue color with mottling, round, biconvex, having a score line on one side and debossed with the product code on the other. Nadolol Tablets are available in the following strengths: 80 mg tablets (NDC 72162-2198-1), Bottle of 100's, debossed ‘022’ STORAGE Store at room temperature; avoid excessive heat. Protect from light. Keep bottle tightly closed. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

NADOLOL- NADOLOL TABLET
BRYANT RANCH PREPACK
----------
NADOLOL TABLETS, USP
PRODUCT OVERVIEW:
NADALOL TABLETS USP
RX ONLY
DESCRIPTION
Nadolol tablets, USP is a synthetic nonselective beta-adrenergic
receptor blocking agent
designated chemically as
1-(_tert_-butyl-amino)-3-[(5,6,7,8-tetrahydro-_cis_-6,7-dihydroxy-1-
naphthyl) oxy]-2-propanol. Structural formula:
C
H NO MW 309.40
Nadolol 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 is available for oral administration as 20 mg, 40
mg, and 80 mg
tablets. INACTIVE INGREDIENTS: Microcrystalline Cellulose (Type 101),
Dried Maize Starch,
FD&C Blue#2, Indigo carmine Aluminum Lake, Copovidone, Citric Acid
Monohydrate,
Sodium Starch Glycolate, Magnesium Stearate and Purified Water.
CLINICAL PHARMACOLOGY
Nadolol tablets, USP 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 tablets, USP 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. CORGARD has no intrinsic
sympathomimetic
17
27
4
1
2
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 CORGARD slows
the sinus rate
and depresses AV cond