PROPRANOLOL HYDROCHLORIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ)

Tilgjengelig fra:

NuCare Pharmaceuticals,Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Propranolol hydrochloride tablets, USP are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets, USP are not indicated in the management of hypertensive emergencies. Propranolol hydrochloride tablets, USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Propranolol hydrochloride tablets, USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Propranolol hydrochloride tablets, USP are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Propranolol hydrochloride tablets, USP are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is no

Produkt oppsummering:

Propranolol Hydrochloride Tablets, USP, 40 mg are green, round, convex, scored tablets, debossed 54 bisect 84 on one side and debossed V on the reverse side. They are available as follows: NDC 68071-4794-3 BOTTLES OF 30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed, light-resistant container as defined in the USP. Protect from light.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE TABLET
NUCARE PHARMACEUTICALS,INC.
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PROPRANOLOL HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Propranolol hydrochloride is a synthetic beta-adrenergic receptor
blocking agent
chemically described as 2-Propanol,
1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-,
hydrochloride,(±)-. Its molecular and structural formulae are:
Propranolol hydrochloride is a stable, white, crystalline solid which
is readily soluble in
water and ethanol. Its molecular weight is 295.80.
Propranolol hydrochloride is available as 10 mg, 20 mg, 40 mg, 60 mg,
and 80 mg
tablets for oral administration.
The inactive ingredients contained in propranolol hydrochloride
tablets, USP are:
anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium,
D&C Yellow #10 (10
mg, 40 mg and 80 mg tablets), FD&C Blue #1 (20 mg tablet), FD&C Blue
#2 (40 mg
tablet), FD&C Red #40 (60 mg tablet), FD&C Yellow #6 (10 mg and 80 mg
tablets),
magnesium stearate, and microcrystalline cellulose.
CLINICAL PHARMACOLOGY
GENERAL
Propranolol is a nonselective beta-adrenergic receptor blocking agent
possessing no
other autonomic nervous system activity. It specifically competes with
beta-adrenergic
receptor agonist agents for available receptor sites. When access to
beta-receptor sites
is blocked by propranolol, the chronotropic, inotropic, and
vasodilator responses to
beta-adrenergic stimulation are decreased proportionately. At dosages
greater than
required for beta blockade, propranolol also exerts a quinidine-like
or anesthetic-like
membrane action, which affects the cardiac action potential. The
significance of the
membrane action in the treatment of arrhythmias is uncertain.
MECHANISM OF ACTION
The mechanism of the antihypertensive effect of propranolol has not
been established.
Factors that may contribute to the antihypertensive action include:
(1) decreased
cardiac output, (2) inhibition of renin release by the kidneys, and
(3) diminution of tonic
sympathetic nerve outflow from vasomotor centers i