Chemmart Sotalol

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

Sotalol hydrochloride

Tilgængelig fra:

Apotex Pty Ltd

Klasse:

Medicine Registered

Indlægsseddel

CHEMMART SOTALOL

_Contains the active ingredient, sotalol hydrochloride_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about sotalol. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT SOTALOL IS USED
FOR
The name of your medicine is
Chemmart Sotalol. It contains the
active ingredient sotalol (as sotalol
hydrochloride).
It is used to prevent and treat an
irregular heart rhythm or heartbeat.
This is called "arrhythmia".
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Sotalol belongs to a group of
medicines called beta-blockers. It
works by changing the body's
response to some nervous impulses,
especially in the heart. By doing so,
sotalol helps the heart to beat more
regularly and reduce the effort to
which the heart has to pump blood.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN_
There is not enough information to
recommend the use of this medicine
in children.
BEFORE YOU TAKE
SOTALOL
_WHEN YOU MUST

Produktets egenskaber

Product Information 
– Australia 
Chemmart Sotalol Tablets 
Page 1 
CHEMMART SOTALOL 

COMPOSITION 
Sotalol hydrochloride. 

DESCRIPTION 
The active ingredient sotalol hydrochloride is the hydrochloride salt of _(RS)_-4'-(1-hydroxy-2-
isopropylaminoethyl)-methanesulfonanilide. 

Molecular Formula:  
C
12
H
20
N
2
O
3
S.HCl  

Molecular Weight:  
308.83 

CAS Number:  
959-24-0 

Sotalol hydrochloride is a white crystalline solid, freely soluble in water (50% w/v) and has a melting point 
of 210°C. 

Each Chemmart Sotalol tablet contains 160 mg of sotalol hydrochloride as the active ingredient, for oral 
administration.  Each tablet also contains the following as inactive excipients: dextrates, methylcellulose, 
magnesium stearate, colloidal anhydrous silica and indigo carmine CI 73015. 

PHARMACOLOGY 
PHARMACODYNAMICS 
Sotalol is a nonselective beta-adrenoreceptor antagonist without sympathomimetic activity or membrane 
stabilising activity.  It causes a decrease in heart rate and a limited reduction in the force of contraction of 
the  heart.    There  is  a  reduction  in  cardiac  work  and  in  myocardial  oxygen  demand.    Sotalol  does  not 
decrease blood pressure in normotensive subjects. 

Sotalol  also  possesses  Class  III  antiarrhythmic  activity.    Sotalol  has  no  known  effect  on  the  upstroke 
velocity  of  the  action  potential  and  therefore  no  known  effect  on  the  depolarisation  phase.    Its  major 
effects are prolongation of the atrial, ventricular and accessory pathway effective refractory periods.  The 
effect on the ventricular myocardium may be reflected by a lengthening of the QTc interval (QT interval 
corrected for heart rate) on electr