NADOLOL tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Rebel Distributors Corp

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

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 21695-802-30 bottles of 30, 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 21695-799-30 bottles of 30, 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 21695-800-30 bottles of 30, 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. 05-2009M 7394 Sandoz Inc. Princeton, NJ 08540 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

NADOLOL- NADOLOL TABLET
REBEL DISTRIBUTORS CORP
----------
NADOLOL TABLETS, USP
DESCRIPTION
Nadolol tablets are synthetic nonselective beta-adrenergic receptor
blocking agents 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
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 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 of
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 tablets slow the sinus rate
and depress AV conduction. In
dogs, only minimal amounts of nadolol were detected in the brain
relative to amounts i