BRETYLIUM TOSYLATE- bretylium tosylate injection

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

BRETYLIUM TOSYLATE (UNII: 78ZP3YR353) (BRETYLIUM - UNII:RZR75EQ2KJ)

Disponible desde:

Pharmaceutics International, Inc. (Pii)

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Bretylium Tosylate Injection, USP is indicated in the prophylaxis and therapy of ventricular fibrillation. Bretylium Tosylate Injection, USP is also indicated in the treatment of life-threatening ventricular arrhythmias, such as ventricular tachycardia that have failed to respond to adequate doses of a first-line antiarrhythmic agent, such as lidocaine. Use of Bretylium Tosylate Injection, USP should be limited to intensive care units, coronary care units or other facilities where equipment and personnel for constant monitoring of cardiac arrhythmias and blood pressure are available. Following injection of bretylium tosylate there may be a delay of 20 minutes to 2 hours in the onset of antiarrhythmic action, although it appears to act within minutes in ventricular fibrillation. The delay in effect appears to be longer after intramuscular than after intravenous injection. There are no contraindications to use in treatment of ventricular fibrillation or life-threatening refractory ventricular arrhythmias, excep

Resumen del producto:

Bretylium Tosylate Injection, USP is supplied in 10 mL single-dose  cyclic olefin copolymer (COC) vials. Store at 20o to 25o C (68o to 77o F); [see USP Controlled Room Temperature]. Manufactured by: Pharmaceutics International, Inc. Hunt Valley, Maryland Revision Date: November 11, 2014

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

BRETYLIUM TOSYLATE- BRETYLIUM TOSYLATE INJECTION
PHARMACEUTICS INTERNATIONAL, INC. (PII)
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BRETYLIUM TOSYLATE INJECTION, USP
RX ONLY
AQUEOUS SOLUTION FOR THE ACUTE MANAGEMENT OF CARDIAC ARRHYTHMIAS
PLASTIC VIAL
FOR INTRAMUSCULAR OR INTRAVENOUS USE ONLY
DESCRIPTION
Bretylium Tosylate Injection, USP is a sterile, nonpyrogenic solution
for use in the management of
ventricular arrhythmias.
Each milliliter contains 50 mg bretylium tosylate in water for
injection. The osmolarity is 0.174
mOsm/mL (approx.). May contain sodium hydroxide and hydrochloric acid
for pH adjustment. pH is
approximately 5.2.
The solution contains no bacteriostatic, antimicrobial agent or added
buffer (except for pH adjustment)
and is intended only for use as a single-dose administration. When
smaller doses are required, the
unused portion should be discarded.
Bretylium tosylate, a bromobenzyl quaternary ammonium compound is
chemically designated (o-
Bromobenzyl) ethyldimethyl-ammonium p-toluenesulfonate, a white powder
freely soluble in water. It
has the following structural formula:
The semi-rigid vial is fabricated from a specially formulated
polyolefin. It is a copolymer of ethylene
and propylene. The safety of the plastic has been confirmed by tests
in animals according to USP
biological standards for plastic containers. The container requires no
vapor barrier to maintain the
proper drug concentration.
Therapeutic class: Bretylium tosylate is classified as an
antiarrhythmic agent.
CLINICAL PHARMACOLOGY
Bretylium tosylate selectively accumulates in sympathetic ganglia and
their postganglionic adrenergic
neurons when administered slowly or incrementally where it inhibits
norepinephrine release by
depressing adrenergic nerve terminal excitability.
Bretylium tosylate also suppresses ventricular fibrillation and
ventricular arrhythmias. The mechanisms
of the antifibrillatory and antiarrhythmic actions of bretylium
tosylate are not established.
In efforts to define these mechanisms, the following
electrophysiologic actions of bretylium t