NADOLOL tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Aizant Drug Research Solutions Pvt Ltd

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Nadolol is 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 Pressure Educati

Proizvod sažetak:

Nadolol tablets, USP for oral administration are supplied as: 20 mg: Round, light blue colored, mottled tablets debossed with “VP” and “20” separated by bisect line on one side and plain on other side. They are available as: NDC 72664- 211 -01 bottle of 100 tablets 40 mg: Round, light blue colored, mottled tablets debossed with “VP” and “40” separated by bisect line on one side and plain on other side. They are available as: NDC 72664- 212 -01 bottle of 100 tablets 80 mg: Round, light blue colored, mottled tablets debossed with “VP” and “80” separated by bisect line on one side and plain on other side. They are available as: NDC 72664- 213 -01 bottle of 100 tablets STORAGE Store at 20° to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]; avoid excessive heat. Protect from light. Dispense in a tight, light-resistant container. Manufactured by: Aizant Drug Research Solutions PVT LTD Hyderabad, Telangana 500100, India Distributed by: VGYAAN Pharmaceuticals LLC Skillman, NJ 08558 Rev: 02/2019

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

NADOLOL- NADOLOL TABLET
AIZANT DRUG RESEARCH SOLUTIONS PVT LTD
----------
NADOLOL TABLETS, USP
RX ONLY
DESCRIPTION
Nadolol is a synthetic nonselective beta-adrenergic receptor blocking
agent designated chemically as
1-(
_tert_-butylami-no)-3-[(5,6,7,8-tetrahy-dro-cis-6,7-dihydroxy-1-naphthyl)oxy]-2-propanol.
Structural
formula:
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,
povidone, purified water, FD&C blue
No.2 and magnesium stearate.
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 low lipophilicity as determined by