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:

Carilion Materials Management

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:

Product: 68151-3727 NDC: 68151-3727-1 1 mL in a SYRINGE, PLASTIC

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE SOLUTION
CARILION MATERIALS MANAGEMENT
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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:
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 295.81.
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 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
16
21
2
Propranolol Hydrochloride USP ………………………….20 mg or
40 mg
The mechanism of the antihypertensive effect of propranolol has not
been established. Factors that may
contri