AMIODARONE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMIODARONE HYDROCHLORIDE

Available from:

Stragen UK Limited

ATC code:

C01BD01

INN (International Name):

AMIODARONE HYDROCHLORIDE

Dosage:

50 Mg/Ml

Pharmaceutical form:

Concentrate for Soln for Inj

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

amiodarone

Authorization status:

Not Marketed

Authorization date:

2007-12-19

Patient Information leaflet

05368
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMIODARONE 50MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION
Amiodarone hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Amiodarone is and what it is used for
2.
What you need to know before you are given Amiodarone
3.
How Amiodarone is given
4.
Possible side effects
5.
How to store Amiodarone
6.
Contents of the pack and other information
1.
WHAT AMIODARONE IS AND WHAT IT IS USED FOR
Amiodarone is used to treat certain heart conditions, for example,
when the heart is beating much too
rapidly. Amiodarone is used when the patient is not responding to
other treatments or when other
treatments cannot be used.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AMIODARONE
DO NOT USE AMIODARONE
-
if you are allergic to amiodarone hydrochloride, iodine or the other
ingredients of this medicine
(listed in section 6)
-
if you have a heart condition causing a very slow heart rate (such as
heart block or sinus
bradycardia), any other heart condition causing very fast or irregular
pulse or dizziness
-
if you have or have had thyroid problems
-
if you have severe breathing problems, severe blood circulatory
problems or very low blood
pressure
-
if you suffer from low blood pressure, heart failure or cardiomyopathy
(weakness of the heart
muscle) you must not receive Amiodarone as a single injection but only
as a slow infusion
-
if you are taking certain drugs which may cause a heart condition
called Torsades de Pointes
(heart rhythm disturbance), such as:

other antiarrhythmic heart medicines e.g. quinidine, disopyramide,
procainamide, sotalol,
bretylium

some antibiotic injections e.g. erythromycin, c

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amiodarone 50 mg/ml Concentrate for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 50 mg of amiodarone hydrochloride
Each 3 ml ampoule contains 150 mg amiodarone hydrochloride.
Excipient with known effect: 60.6 mg of benzyl alcohol/ampoule of 3 ml
sterile concentrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for injection/infusion (Sterile concentrate).
The product is a clear, pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amiodarone is indicated only for the treatment of severe rhythm
disorders not responding to other therapies or when
other treatments cannot be used.
Tachyarrhythmias associated with Wolff-Parkinson-White syndrome.
All types of tachyarrhythmias including supraventricular, nodal and
ventricular tachycardias; atrial flutter and
fibrillation; ventricular fibrillation; when other drugs have been
proven ineffective or caused unacceptable side effects
or when invasive anti-arrhythmic procedure is contraindicated or not
effective.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Routes of administration:
Intravenous use
Treatment should be initiated and normally monitored only under
hospital or specialist supervision.
Amiodarone can be used where a rapid response is required or where
oral administration is not possible.
_Infusion:_
The standard recommended loading dose is 5 mg/kg bodyweight in 250 ml
of 5% dextrose infused within 20 minutes to
2 hours. This may be repeated 2 to 3 times during the following 24
hours (up to 1200 mg/24 hours [approximately 15
mg/kg bodyweight] in up to 500 ml 5% dextrose) and the rate of
infusion is to be controlled according to the clinical
response. (See section 4.4).
_Injection:_
In extreme clinical emergency the drug may, at the discretion of the
clinician, be given as a slow injection of 150-300
mg in 10-20 ml 5% dextrose over a minimum of 3 minutes. The solution
is prepared by drawin