MINT-MEXILETINE CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

MEXILETINE HYDROCHLORIDE

Disponibil de la:

MINT PHARMACEUTICALS INC

Codul ATC:

C01BB02

INN (nume internaţional):

MEXILETINE

Dozare:

100MG

Forma farmaceutică:

CAPSULE

Compoziție:

MEXILETINE HYDROCHLORIDE 100MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Rezumat produs:

Active ingredient group (AIG) number: 0116151001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2023-03-31

Caracteristicilor produsului

- 1 -
PRODUCT MONOGRAPH
PR
MINT-MEXILETINE
Mexiletine Hydrochloride Capsules
Capsules, 100 mg and 200 mg Mexiletine Hydrochloride, Oral
USP
Antiarrhythmic Agent
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario, L5T 2M3
Date of Initial Authorization: March 30, 2023
Submission Control Number: 264506
- 2 -
PRODUCT MONOGRAPH
MINT-MEXILETINE
(Mexiletine Hydrochloride)
USP
100 mg and 200 mg Capsules
THERAPEUTIC CLASSIFICATION
Antiarrhythmic Agent
ACTION AND CLINICAL PHARMACOLOGY
MINT-MEXILETINE (mexiletine hydrochloride) is a class 1B
antiarrhythmic agent, according to
the Vaughan–Williams classification system, with local anesthetic
properties, similar in structure
and activity to lidocaine.
Mexiletine blocks the fast sodium channel in cardiac tissues,
especially the Purkinje network,
without involvement of the autonomic system. Mexiletine reduces the
rate of rise and amplitude
of the action potential and decreases automatically (increases the
threshold of excitability) in the
Purkinje fibers.
It shortens the action potential duration and, to a lesser extent,
decreases the
effective refractory period in the Purkinje fibers.
It does not usually alter conduction velocity,
although it may slow conduction in patients with pre- existing
conduction abnormalities. In those
with pre-existing sick sinus syndrome, mexiletine produces a more
pronounced depression of the
sinus rate and/or prolongation of sinus node recovery time. It does
not significantly affect resting
membrane potential or sinus node automaticity, left ventricular
function, systolic arterial blood
pressure, atrioventricular (AV) conduction velocity, QRS or QT
intervals.
Hemodynamic studies with oral mexiletine conducted in patients with
normal or abnormal
myocardial function have demonstrated that the drug usually has only
minor effects on cardiac
output, pulmonary capillary wedge pressure, left ventricular
end–diastolic pressure, pulmonary
diastolic pressure, blood pressure or heart rate.
Small increases in vascular resistance without signi