AMIOHEXAL 200

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

AMIODARONE HYDROCHLORIDE

Boleh didapati daripada:

IMEKS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

AMIODARONE HYDROCHLORIDE

Unit dalam pakej:

50 Tablets; 20 Tablets; 100 Tablets

Dikeluarkan oleh:

Salutas pharma GmbH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
AMIOHEXAL 200
Amiodarone hydrochloride (200mg)
WHAT IS IN THIS LEAFLET
1.
What Amiohexal is used for
2.
How Amiohexal works
3.
Before you use Amiohexal
4.
How to use Amiohexal
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Amiohexal
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT AMIOHEXAL IS USED FOR
Amiohexal contains the active ingredient
Amiodarone hydrochloride.
Amiohexal is used to control fast or irregular
heartbeat.
HOW AMIOHEXAL WORKS
Amiohexal belongs to the group of
medicines called antiarrhythmics. It works
by lengthening the gap between one heart
beat and the next, thus helping to bring the
heart rate to a slower and more regular pace.
BEFORE YOU USE AMIOHEXAL_ _
_- When you must not use it _
Do not take Amiohexal if you:
• Have ever had allergic reaction to
Amiodarone hydrochloride, the active
ingredient or to any other ingredients in
Amiohexal.
• Have ever had allergic reaction to iodine
• Disease of thyroid gland
• Hypokalemia (low level of potassium salt
in blood)
• Sinus bradycardia (very slow heart beat)
• Have any other heart problems particularly
involving regulation of heart beat. If you are
using pacemaker, your doctor may allow the
use of it
• Are pregnant, think you are pregnant or
planning to become pregnant or are
breastfeeding
_ _
_- Before you start to use it _
Tell your doctor if you have allergies to any
other medicines, foods, preservatives or
dyes.
Tell your doctor if you:
• Have a history of swelling of the face, lips,
tongue, throat, hands or feet
• Have any breathing problems or asthma
• Suffer from any liver problems
• Suffer from any thyroid problems
• Have any eyes problems
• Have low blood pressure
• Other heart conditions
• Are about to have an operation
• Planning to become pregnant or are
pregnant or are breastfeeding
• An elderly patient
If you are not sure whether you should start
taking this medicine, consult your d

Ciri produk

DIRECTION FOR USE PLEASE READ CAREFULLY!
Each AMIOHEXAL 200 TABLET contains Amiodarone HCl 200 mg.
DESCRIPTION
White, round tablets, biconvex with one-sided score notch.
INDICATIONS
- Symptomatic and tachycardiac supraventricular disturbances of
heart rhythm such as AV-junctional tachycardias, supraventricular
tachycardias
associated
with
Wolff-Parkinson-White
syndrome
or
paroxysmal atrial fibrillation when other drugs cannot be used.
-
Severe
symptomatic
ventricular
tachycardiac
ventricular
disturbances of heart rhythm.
RECOMMENDED DOSAGE
AMIOHEXAL 200 is a highly toxic drug; therefore the lowest effective
dosage should be used so as to minimise the risk and occurrence of
adverse
effects.
Dosage
of
amiodarone
hydrochloride
must
be
carefully adjusted according to individual requirements and response,
patient tolerance, and the general condition and cardiovascular
status of the patient. Clinical and ECG monitoring of cardiac
function,
is
recommended
during
therapy
with
the
drug.
When
dosage
adjustment is necessary, the patient should be monitored closely for
an extended
period of
time
because of
the long and variable
elimination half-life of amiodarone and the difficulty in predicting
the
length
of
time
required
to
attain
a
new
steady-state
plasma
concentration of the drug.
LOADING DOSE: 600 mg amiodarone (corresponding to 3 tablets of
AMIOHEXAL 200) per day for 8-10 days; in some cases, dosages of up
to 1200 mg amiodarone (corresponding to 6 tablets of AMIOHEXAL 200)
may be required per day. The dosage is then reduced gradually to
maintenance
dose.
It
is
recommended
to
perform
loading-dose
phase of therapy in a hospital setting.
MAINTENANCE DOSE: Usually 200 mg amiodarone (corresponding to 1
tablet of AMIOHEXAL 200) per day for 5 days per week, with a pause of
2 days, and this is possible due to prolonged half-life of amiodarone.
AMIOHEXAL 200 may also be given on every second day (1 tablet of
AMIOHEXAL 200 may be given on every second day when a dose of
100 mg daily is recommended).
In
some
cases,
higher
dosages