NADOLOL- nadolol tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Sandoz Inc

INN (Medzinárodný Name):

NADOLOL

Zloženie:

NADOLOL 20 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Nadolol tablets USP are indicated for the long-term management of patients with angina pectoris. Nadolol tablets USP 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 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 Pres

Prehľad produktov:

Nadolol tablets USP for oral administration are available as: 20 mg: White, round, uncoated tablets stamped SZ above and 465 below the bisect line on one side and plain on the other side and supplied as: NDC 0781-1181-92 bottles of 90 NDC 0781-1181-01 bottles of 100 NDC 0781-1181-10 bottles of 1000 40 mg: White, round, uncoated tablets stamped SZ above and 466 below the bisect line on one side and plain on the other side and supplied as: NDC 0781-1182-92 bottles of 90 NDC 0781-1182-01 bottles of 100 NDC 0781-1182-10 bottles of 1000 80 mg: White, round, uncoated tablets stamped SZ above and 467 below the bisect line on one side and plain on the other side and supplied as: NDC 0781-1183-92 bottles of 90 NDC 0781-1183-01 bottles of 100 NDC 0781-1183-10 bottles of 1000 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container as defined in the USP. 07-2013M 7394 Sandoz Inc. Princeton, NJ 08540

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

NADOLOL- NADOLOL TABLET
SANDOZ 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:
C H NO M.W. 309.4 0
C
H NO M.W. 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 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
tablets have 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