APO-SOTALOL sotalol 80mg (as hydrochloride) tablet bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

sotalol hydrochloride, Quantity: 80 mg

Disponible desde:

Arrotex Pharmaceuticals Pty Ltd

formulario farmacéutico:

Tablet, uncoated

Composición:

Excipient Ingredients: colloidal anhydrous silica; methylcellulose; dextrates; magnesium stearate; indigo carmine aluminium lake

Vía de administración:

Oral

Unidades en paquete:

60 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Prevention and treatment of supraventricular and ventricular arrhythmias.

Resumen del producto:

Visual Identification: Blue, capsule-shaped, biconvex tablet, engraved APO-80 on one side, other side scored.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Estado de Autorización:

Licence status A

Fecha de autorización:

2002-10-24

Información para el usuario

APO-SOTALOL
_Sotalol hydrochloride_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
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.
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.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Sotalol is used to prevent and treat an
irregular heart rhythm or heartbeat,
also known as an 'arrhythmia'.
Sotalol belongs to a group of
medicines called beta-blockers.
_HOW IT WORKS_
Sotalol 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.
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.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
sotalol
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
bronchospasm (e.g. bronchial
asthma or chronic obstructive
airway disease)
•
allergic disorders, such as allergic
rhinitis
•
severe

Ficha técnica

AUSTRALIAN PRODUCT INFORMATION
APO-SOTALOL (SOTALOL HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Sotalol hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sotalol hydrochloride as the active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
80MG TABLETS
Blue capsule shaped, biconvex tablets, engraved APO-80 on one side and
scored on the other.
160MG TABLETS
Blue, capsule-shaped, biconvex tablets, engraved APO-160 on one side
and scored on the
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of supraventricular and ventricular
arrhythmias.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Sotalol tablets are intended for oral administration.
DOSAGE
Sotalol is administered orally for the prevention and treatment of
arrhythmias.
As with other antiarrhythmic agents, sotalol should be initiated and
doses increased in a facility
capable of monitoring and assessing cardiac rhythm. The dosage must be
individualised for each
patient on the basis of therapeutic response and tolerance.
Proarrhythmic events can occur not
only at commencement of therapy, but also with each upward dosage
adjustment.
Sotalol should be taken preferably 1 to 2 hours before meals.
Oral dosage of sotalol should be adjusted gradually allowing 2 to 3
days between dosing
increments in order to attain steady-state and to allow monitoring of
QT intervals. Graded dose
adjustment will help prevent the use of doses which are higher than
necessary to control the
arrhythmia. The recommended initial oral dosing schedule is 160
mg/day, given in two divided
doses at approximately 12 hour intervals. This dose may be increased,
if necessary, after
appropriate evaluation to 240 or 320 mg/day. In most patients, a
therapeutic response is obtained
at a total daily dose of 160 to 320 mg/day, given in 2 divided doses.
Some patients with life-
threatening refractory ventricular arrhythmias may require doses as
high as 480 to 640 mg/day;
however, these doses should