NADOLOL tablet

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

VGYAAN Pharmaceuticals LLC

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

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. Distributed by: VGYAAN Pharmaceuticals LLC Skillman, NJ 08558 Rev: 11/2020

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

NADOLOL- NADOLOL TABLET
VGYAAN PHARMACEUTICALS LLC
----------
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
1
2
blood and other organs and tissues. Nadolol has low lipophilicity as
determined by
octano