NADOLOL tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Mylan Pharmaceuticals Inc.

INN (Medzinárodný Name):

NADOLOL

Zloženie:

NADOLOL 20 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 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 Educati

Prehľad produktov:

Nadolol Tablets, USP are available containing 20 mg, 40 mg or 80 mg of nadolol, USP. The 20 mg tablets are yellow round, scored tablets debossed with M above the score and 28 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0028-01 bottles of 100 tablets The 40 mg tablets are yellow round, scored tablets debossed with M above the score and 171 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1171-01 bottles of 100 tablets NDC 0378-1171-10 bottles of 1000 tablets The 80 mg tablets are yellow round, scored tablets debossed with M above the score and 132 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1132-01 bottles of 100 tablets NDC 0378-1132-10 bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED NOVEMBER 2013 NAD:R12

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

NADOLOL- NADOLOL TABLET
MYLAN PHARMACEUTICALS INC.
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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.
Its structural
formula is:
C H NO M.W. 309.4 1
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.
Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of
nadolol, USP and the following
inactive ingredients: anhydrous lactose, croscarmellose sodium,
magnesium stearate, microcrystalline
cellulose, sodium lauryl sulfate, and D&C Yellow No. 10 Aluminum Lake.
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 other organs and tissues.
Nadolol has l