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:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 20 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypertension 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. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride is indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction Propranolol hydrochloride is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine 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 pro

Product summary:

Propranolol Hydrochloride Oral Solution 20 mg per 5 mL oral solution is supplied as a (strawberry-mint flavor) clear, colorless to slightly colored, viscous solution. NDC 0054-3727-63: Bottle of 500 mL 40 mg per 5 mL oral solution is supplied as a (strawberry-mint flavor) clear, colorless to slightly colored, viscous solution. NDC 0054-3730-63: Bottle of 500 mL Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in USP/NF. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000633/01 Revised September 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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PROPRANOLOL 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:
C
H
NO • HCl
Propranolol Hydrochloride, USP is a stable, odorless, white to
off-white crystalline
powder which is readily soluble in water and ethanol. Its molecular
weight is 295.80.
Each 5 mL of Oral Solution for oral administration contains:
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
16
21
2
Propranolol Hydrochloride, USP ………………………….20 mg or
40 mg
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 co