BRETYLIUM TOSYLATE INJECTION USP SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

BRETYLIUM TOSYLATE

Tersedia dari:

SANDOZ CANADA INCORPORATED

Kode ATC:

C01BD02

INN (Nama Internasional):

BRETYLIUM TOSILATE

Dosis:

50MG

Bentuk farmasi:

SOLUTION

Komposisi:

BRETYLIUM TOSYLATE 50MG

Rute administrasi :

INTRAMUSCULAR

Unit dalam paket:

10ML

Jenis Resep:

Prescription

Area terapi:

CLASS III ANTIARRYTHMICS

Ringkasan produk:

Active ingredient group (AIG) number: 0107636001; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2021-04-21

Karakteristik produk

PRODUCT MONOGRAPH
PR
BRETYLIUM TOSYLATE INJECTION USP
50 MG/ML
ANTIARRHYTHMIC
Sandoz Canada Inc.
Date of preparation: July 4, 2007
145, Jules-Léger
Date of revision:
Boucherville, QC, Canada
J4B 7K8
Control No: 115036
Page 2 of 11
BRETYLIUM TOSYLATE INJECTION USP
50 MG/ML
THERAPEUTIC CLASSIFICATION
Antiarrhythmic
ACTIONS AND CLINICAL PHARMACOLOGY
Bretylium, a quaternary ammonium compound is an adrenergic neuron
blocking
agent.
It suppresses ventricular fibrillation and ventricular arrhythmias.
The mechanisms of
the antifibrillatory and antiarrhythmic actions of bretylium are not
established.
Bretylium selectively accumulates in sympathetic ganglia and their
postganglionic
adrenergic neurons where it inhibits norepinephrine release by
depressing adrenergic
nerve terminal excitability.
Catecholamine stores are not depleted by bretylium and parenteral
administration of
the
drug
results
in
initial
release
of
norepinephrine
from
the
adrenergic
postganglionic
nerve
terminals.
Subsequently,
bretylium
blocks
the
release
of
norepinephrine in response to neuron stimulation.
Reports indicate that the drug has a positive inotropic effect on the
myocardium but
it is not yet certain that the effect is direct or mediated by
catecholamine release.
Peripheral adrenergic blockade regularly causes orthostatic
hypotension but has less
effect on supine blood pressure.
The plasma half-life of bretylium is 5 to 10 hours. In 4 normal
volunteers who were
given a single 4 mg/kg dose of IV bretylium, the half-life averaged
7.8 hours.
Bretylium is eliminated intact by the kidneys. Seventy to 80% is
excreted unchanged
in the urine within 24 hours and an additional 10% excreted over the
next 3 days.
It is unknown whether bretylium crosses the placenta, but it does not
cross the
blood-brain barrier.
The concentration of bretylium in plasma has not been correlated with
the intensity
of its antiarrhythmic action and cannot be used to guide
individualization of dosage.
Page 3 of 11
INDICATIONS AND CLINICAL USE
Bretylium Tosylate Injection USP ma