NADOLOL tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Physicians Total Care, Inc.

INN (nemzetközi neve):

NADOLOL

Összetétel:

NADOLOL 20 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Nadolol tablets are indicated in the management of hypertension; it may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Nadolol tablets are contraindicated in bronchial asthma, sinus bradycardia and greater than first-degree conduction block, cardiogenic shock, and overt cardiac failure (see WARNINGS).

Termék összefoglaló:

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: 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: Store at 20° to 25°C (68° to 77°F). [See USP for 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 REV OCTOBER 2006 NAD:R9 Distributed and Repackaged by: Physicians Total Care, Inc. Tulsa, Oklahoma        74146

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

NADOLOL - NADOLOL TABLET
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal
Hypersensitivity to catecholamines has been observed in patients
withdrawn from beta-blocker
therapy; exacerbation of angina and, in some cases, myocardial
infarction have occurred after
_abrupt_ discontinuation of such therapy. When discontinuing
chronically administered nadolol,
particularly in patients with ischemic heart disease, the dosage
should be gradually reduced over
a period of 1 to 2 weeks and the patient should be carefully
monitored. If angina markedly
worsens or acute coronary insufficiency develops, nadolol
administration should be reinstituted
promptly, at least temporarily, and other measures appropriate for the
management of unstable
angina should be taken. Patients should be warned against interruption
or discontinuation of
therapy without the physician's advice. Because coronary artery
disease is common and may be
unrecognized, it may be prudent not to discontinue nadolol therapy
abruptly even in patients treated
only for hypertension.
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:
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.
Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of
nadolol, USP and the following
inactive ingredients: croscarmellose sodium, lactose (anhydrous),
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 exe