CORDARONE X 100 amiodarone hydrochloride 100mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amiodarone hydrochloride, Quantity: 100 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Amiodarone hydrochloride

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: maize starch; magnesium stearate; lactose monohydrate; povidone; colloidal anhydrous silica

Administration route:

Oral

Units in package:

30

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Severe cases of tachyarrhythmias (eg. Wolff-Parkinson-White Syndrome, supraventricular, nodal and ventricular tachycardias, atrial flutter and fibrillation, ventricular fibrillation) not responding to other therapy. Treatment should be initiated in hospital. It is recommended that the patient should be regularly monitored for possible toxicity (eg. thyroid function, chest x-ray, ophthalmological examination, liver function etc.) during the entire course of therapy and for several months after discontinuation.

Product summary:

Visual Identification: White to off-white biconvex tablet embossed on oneside with '100' and 'action potential' and scored on other; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-30

Patient Information leaflet

CORDARONE X
®
_Amiodarone hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cordarone X tablets
and injection.
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. In deciding to give you
Cordarone X, your doctor has
weighed the risks of you taking
Cordarone X against the benefits it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT CORDARONE X IS
USED FOR
Cordarone X is used to control a fast
or irregular heart beat.
It works by lengthening the gap
between one heart beat and the next,
helping to bring the heart rate to a
slower and more regular pace.
Cordarone X is not recommended for
use in children.
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT USE_
_CORDARONE X_
1.
DO NOT USE CORDARONE X IF YOU
ARE ALLERGIC TO AMIODARONE OR
IODINE OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
The symptoms of an allergic
reaction may include a rash,
itching, swelling, coughing, an
asthma attack or hayfever.
2.
DO NOT USE CORDARONE X IF YOU
ARE PREGNANT OR INTENDING TO GET
PREGNANT.
Cordarone X is best avoided in
the 3 months before getting
pregnant and during pregnancy.
This is because it can stay in the
body for several months even
after you stop taking it.
3.
DO NOT BREASTFEED IF YOU ARE
USING CORDARONE X AS IT CAN BE
FOUND IN BREAST MILK.
If you are breastfeeding,
alternative feeding arrangements
such as bottle feeding should be
made for your baby. TALK TO YOUR DOCTOR ABOUT THE
RISKS AND BENEFITS OF TAKING
CORDARONE X DURING PREGNANCY
AND BREASTFEEDING.
4.
DO NOT USE CORDARONE X IF YOU
HAVE OR HAVE HAD ANY THYROID
PROBLEMS.
5.
DO NOT USE CORDARONE X

Summary of Product characteristics

cor-x-ccdsv21-piv19-25nov21
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION – CORDARONE X 100
®
,
CORDARONE X 200
® AND CORDARONE X INTRAVENOUS
®
(AMIODARONE HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Amiodarone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient of the Cordarone X range of products is
amiodarone hydrochloride.
Tablets
Each 200 mg tablet of amiodarone contains approximately 75 mg organic
iodine and in the
steady state, metabolism of 300 mg amiodarone yields 9 mg/day of
iodine.
Injection
Each ampoule contains 150 mg amiodarone hydrochloride in 3 mL.
For the full list of excipients, see Section 6.1 List of excipients.
Excipient with known effect: Tablets contain Lactose monohydrate
3
PHARMACEUTICAL FORM
TABLETS
Cordarone X 100 - white to off-white biconvex tablet embossed on one
side with '100'
and 'action potential' and scored on other.
Cordarone X 200 - white to off-white biconvex tablet embossed with
'200' and 'action
potential' on one side and scored on the other.
INJECTION
Cordarone X Intravenous is a clear, pale yellow solution for
intravenous administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe cases of tachyarrhythmias (eg. Wolff-Parkinson-White Syndrome,
supraventricular,
nodal and ventricular tachyardias, atrial flutter and fibrillation,
ventricular fibrillation) not
responding to other therapy. Treatment should be initiated in
hospital. It is recommended
cor-x-ccdsv21-piv19-25nov21
Page 2 of 27
that the patient should be regularly monitored for possible toxicity
(eg. thyroid function, chest
X-ray, ophthalmological examination, liver function etc.) during the
entire course of therapy
and for several months after discontinuation.
Cordarone X Intravenous may be used for treatment initiated in a
hospital for severe cases of
tachyarrhythmias (atrial, junctional and ventricular) not responding
to other therapy and when
a rapid response is required. Cordarone X Intravenous should only be
used where facilities
exist for cardiac monitoring and defibrill