PROPRANOLOL HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ATLANTIC BIOLOGICALS CORP.

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 20 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Propranolol hydrochloride 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 is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Propranolol hydrochloride is indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Propranolol hydrochloride is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Propranolol hydrochloride 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. Propranolol hydrochloride is indicated in the management of familial or

Product summary:

Product: 17856-3728 NDC: 17856-3728-01 PROPRANOLOL HCL 20MG/5ML - 5 ML CUP 72 ct UD DISTRIBUTED BY:  ATLANTIC BIOLOGICALS CORP.  MIAMI, FL 33179

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE SOLUTION
ATLANTIC BIOLOGICALS CORP.
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PROPANOLOL HYDROCHLORIDE ORAL SOLUTION
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 formula, as well as
molecular weight are:
Propranolol Hydrochloride USP is a stable, odorless, white to
off-white crystalline powder
which is readily soluble in water and ethanol.
Each 5 mL of Oral Solution for oral administration contains:
Propranolol Hydrochloride USP ………………………….20 mg or
40 mg
Alcohol……………………………………………………0.6%.
INACTIVE INGREDIENTS
Propranolol Hydrochloride Oral Solution is available for oral
administration containing
either 20 mg per 5 mL or 40 mg per 5 mL of propranolol hydrochloride
USP. The oral
solution contains the following inactive ingredients: citric acid
anhydrous, crème de
menthe flavor, disodium edetate, methyl paraben, propylene glycol,
propylparaben,
purified water, saccharin sodium, sorbitol solution and strawberry
flavor.
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 antihypertens