NADOLOL tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Zydus Pharmaceuticals USA Inc.

INN (Kansainvälinen yleisnimi):

NADOLOL

Koostumus:

NADOLOL 40 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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. 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). Safety and effectiveness in pediatric patients have not been established.

Tuoteyhteenveto:

20 mg tablets: White to off-white colored, round shaped, flat faced, beveled edge uncoated tablets, debossed with ''N" on upper half of the breakline and "20" on lower half of the breakline on one side and plain on other side and are supplied as : NDC 68382-732-16 in bottle of 90 tablets with child-resistant closure NDC 68382-732-01 in bottle of 100 tablets with child-resistant closure NDC 68382-732-10 in bottle of 1000 tablets NDC 68382-732-77 in cartons of 100 tablets (10 x 10 unit-dose) 40 mg tablets: Light yellow colored, round shaped, flat faced, beveled edge uncoated tablets, debossed with  "N" on upper half of the breakline and  "40" on lower half of the breakline on one side and plain on the other side and are supplied as : NDC 68382-733-16 in bottle of 90 tablets with child-resistant closure NDC 68382-733-01 in bottle of 100 tablets with child-resistant closure        NDC 68382-733-10 in bottle of 1000 tablets NDC 68382-733-77 in cartons of 100 tablets (10 x 10 unit-dose) 80 mg tablets: Light blue colored, spotted, round shaped, flat faced, beveled edge uncoated tablets debossed with  "N" on upper half of the breakline and  "80" on lower half of the breakline on one side and plain on the other side and are supplied as : NDC 68382-734-16 in bottle of 90 tablets with child-resistant closure NDC 68382-734-01 in bottle of 100 tablets with child-resistant closure        NDC 68382-734-10 in bottle of 1000 tablets NDC 68382-734-77 in cartons of 100 tablets (10 x 10 unit-dose) STORAGE Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from light. Keep bottle tightly closed. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 01/24

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

NADOLOL- NADOLOL TABLET
ZYDUS PHARMACEUTICALS USA INC.
----------
NADOLOL TABLETS, USP
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 to off-white, practically odorless crystalline
powder. It is freely
soluble in alcohol and in methanol, soluble in water at pH 2, slightly
soluble in
chloroform,,methylenechloride, isopropylalcohol and in water(between
pH 7 and pH 10);
insoluble in acetone, benzene, ether, hexane and trichloroethane.
Nadolol tablets, USP are available for oral administration as 20 mg,
40 mg and 80 mg
tablets. Inactive ingredients: anhydrous citric acid, colloidal
silicon dioxide, corn starch,
magnesium stearate, microcrystalline cellulose, povidone, and sodium
starch glycolate.
Additionally each 40 mg tablet contains ferric oxide yellow and each
80 mg tablet
contains FD&C blue 2.
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 an