PROPRANOLOL HYDROCHLORIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medical Purchasing Solutions, LLC

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Intravenous administration is usually reserved for life-threatening arrhythmias or those occurring under anesthesia. 1.  Supraventricular arrhythmias Intravenous propranolol is indicated for the short-term treatment of supraventricular tachycardia, including Wolff‑Parkinson‑White syndrome and thyrotoxicosis, to decrease ventricular rate. Use in patients with atrial flutter or atrial fibrillation should be reserved for arrythmias unresponsive to standard therapy or when more prolonged control is required. Reversion to normal sinus rhythm has occasionally been observed, predominantly in patients with sinus or atrial tachycardia. 2.  Ventricular tachycardias With the exception of those induced by catecholamines or digitalis, propranolol is not the drug of first choice. In critical situations when cardioversion techniques or other drugs are not indicated or are not effective, propranolol may be considered. If, after consideration of the risks involved, propranolol is used, it shoul

Product summary:

Each mL contains 1 mg of Propranolol Hydrochloride, USP in Water for Injection, USP. The pH is adjusted with anhydrous Citric Acid, USP. Supplied as: 1 mL vials in boxes of 10 (NDC 0143-9872-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from freezing or excessive heat. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD PHARMACEUTICAL CORP. Eatontown, NJ 07724 USA Rev.: 05/2015 PIN166-WES/4

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE INJECTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
PROPRANOLOL HYDROCHLORIDE INJECTION, USP
RX ONLY
DESCRIPTION
Propranolol Hydrochloride, USP is a synthetic beta-adrenergic receptor
blocking agent
chemically described as
(+)-1-(isopropylamino)-3-(1-naphthyloxy)-2-propanol
hydrochloride. Its structural formula is:
C
H
NO
•HCl
Propranolol Hydrochloride, USP is a stable, white, crystalline solid
which is readily soluble
in water and ethanol. Its molecular weight is 295.80.
Propranolol Hydrochloride Injection, USP is available as a sterile
injectable solution for
intravenous administration. Each mL contains 1 mg of Propranolol
Hydrochloride, USP in
Water for Injection, USP. The pH is adjusted with anhydrous Citric
Acid, USP.
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 stimulating agents for available receptor sites. When access
to beta‑receptor
sites is blocked by propranolol, chronotropic, inotropic, and
vasodilator responses to
beta-adrenergic stimulation are decreased proportionately. At doses
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 effects of propranolol are due to selective blockade of
beta-adrenergic receptors,
16
21
2
leaving alpha-adrenergic responses intact. There are two
well-characterized subtypes of
beta receptors (beta
and beta
); propranolol interacts with both subtypes equally.
Beta
-adrenergic receptors are found primarily in the heart. Blockade of
cardiac beta
-
adrenergic receptors leads to a decrease in the activity of both
normal and ectopic
pacemaker cells and a decrease in A-V nodal conduction velocity. All
of these actions can
contribute to an