PROPRANOLOL HYDROCHLORIDE solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Carilion Materials Management

INN:

PROPRANOLOL HYDROCHLORIDE

composition:

PROPRANOLOL HYDROCHLORIDE 20 mg in 5 mL

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Propranolol Hydrochloride Oral Solution is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol is not indicated in the management of hypertensive emergencies. Propranolol Hydrochloride Oral Solution is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Propranolol Hydrochloride Oral Solution is indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Propranolol Hydrochloride Oral Solution is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Propranolol Hydrochloride Oral Solution is 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 not indicated for such use. Pr

leaflet_short:

NDC:68151-0821-8 in a BOTTLE of 1 SOLUTIONS Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in USP/NF.   4071708//06 Revised January 2012 © RLI, 2012

authorization_status:

Abbreviated New Drug Application

SPC

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE SOLUTION
CARILION MATERIALS MANAGEMENT
----------
PROPRANOLOL HYDROCHLORIDE ORAL SOLUTION 20 MG PER 5 ML AND 40 MG PER 5
ML
RX ONLY
DESCRIPTION
Each 5 mL of Oral Solution for oral administration contains:
Propranolol Hydrochloride...................... 20 mg or 40 mg
Alcohol.....................................................................
0.6%
INACTIVE INGREDIENTS
The oral solution contains flavorings, citric acid, disodium edetate,
methylparaben, propylene glycol,
propylparaben, saccharin sodium, sorbitol, and water.
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 formula, as well as molecular weight are:
Propranolol Hydrochloride is a stable, white, crystalline solid which
is readily soluble in water and
ethanol.
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 in
the brain. Although total peripheral resistance may increase
initially, i