NADOLOL tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Sandoz Inc

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Nadolol is 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 Nationa

Dettagli prodotto:

Nadolol tablets, USP for oral administration are available as: 20 mg: Round, white, standard cup tablet, scored, debossed “SZ 465” on one side and scored on the reverse side and supplied as: NDC 0781-8004-92 bottles of 90 NDC 0781-8004-01 bottles of 100 NDC 0781-8004-10 bottles of 1000 40 mg: Round, white, standard cup tablet, scored, debossed “SZ 466” on one side and plain on the reverse side and supplied as: NDC 0781-8005-92 bottles of 90 NDC 0781-8005-01 bottles of 100 NDC 0781-8005-10 bottles of 1000 80 mg: Round, white, standard cup tablet, scored, debossed “SZ 467” on one side and plain on the reverse side and supplied as: NDC 0781-8006-92 bottles of 90 NDC 0781-8006-01 bottles of 100 NDC 0781-8006-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure. KEEP OUT OF THE REACH OF CHILDREN. Manufactured by Sandoz Inc. Princeton, NJ 08540 Rev. September 2018

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

NADOLOL- NADOLOL TABLET
SANDOZ INC
----------
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 M.W. 309.40
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,
pregelatinized starch, croscarmellose
sodium, hydroxypropyl cellulose, silicon dioxide, magnesium stearate,
and purified water.
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 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 othe