Amiodarone 150mg/3ml concentrate for solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amiodarone hydrochloride

Available from:

Bowmed Ibisqus Ltd

ATC code:

C01BD01

INN (International Name):

Amiodarone hydrochloride

Dosage:

50mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02030200; GTIN: 5060130130898

Patient Information leaflet

1. WHAT AMIODARONE IS AND WHAT IT IS USED FOR
Amiodarone 150 mg/3 ml Concentrate for Solution for
Injection/Infusion (called Amiodarone in this leaflet)
contains a medicine called amiodarone hydrochloride.
This belongs to a group of medicines called
anti-arrhythmics.
It works by controlling the uneven beating of your heart
(called ‘arrhythmias’). Having the injection helps your
heartbeat to return to normal.
Amiodarone is normally only given in a hospital when a
quick response is needed or when tablets cannot be
given.
Amiodarone can be used to:
•
Treat uneven heartbeats where other medicines either
have not worked or cannot be used
•
Treat an illness called Wolff-Parkinson-White
Syndrome. This is where your heart beats unusually fast
•
Treat other types of fast or uneven heartbeats known as
‘atrial flutter’ or ‘atrial fibrillation’. Amiodarone is used
only
when other medicines cannot be used
•
Treat fast heartbeats which may happen suddenly
and may be uneven. Amiodarone is used only when
other medicines cannot be used 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
AMIODARONE
DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR,
PHARMACIST OR NURSE IF YOU:
•
are allergic to iodine, amiodarone, or any of the other
ingredients of Amiodarone (listed in Section 6 below).
Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face, throat
or tongue
•
have a slower than usual heartbeat (called ‘sinus
bradycardia’) or an illness called ‘sino-atrial’ heart block
•
have any other problems with your heartbeat and do
not have a pacemaker fitted
•
have or have previously had thyroid problems. Your
doctor should test your thyroid before giving you this
medicine
•
have severe breathing problems
•
have serious blood circulation problems
•
have very low blood pressure
•
are taking certain other medicines which could affect
your heartbeat (see ‘Other medicines and Amiodarone’
below)
•
are pregnant or breast-feeding (see ‘Pregnancy and
bre

Summary of Product characteristics

OBJECT 1
AMIODARONE 150MG/3ML CONCENTRATE FOR SOLUTION
FOR INJECTION AMPOULES
Summary of Product Characteristics Updated 07-Dec-2017 | Bowmed
Ibisqus Limited
1. Name of the medicinal product
Amiodarone 150 mg/3 ml Concentrate for Solution for
Injection/Infusion.
2. Qualitative and quantitative composition
Each 3 ml ampoule contains 150 mg amiodarone hydrochloride.
Excipient with known effect: benzyl alcohol
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for Solution for Injection/Infusion.
4. Clinical particulars
4.1 Therapeutic indications
Treatment should be initiated and normally monitored only under
hospital or specialist supervision.
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
• life-threatening ventricular arrhythmias, including persistent or
non-persistent ventricular tachycardia or
episodes of ventricular fibrillation, cardiopulmonary resuscitation in
case of cardiac arrest related to
ventricular fibrillation resistant to defibrillation; when other
active substances cannot be used
• all other types of tachyarrhythmias including supraventricular,
nodal and ventricular tachycardias; atrial
flutter and fibrillation.
Amiodarone can be used where a rapid response is required or where
oral administration is not possible.
4.2 Posology and method of administration
Amiodarone should only be used when facilities exist for cardiac
monitoring, defibrillation, and cardiac
pacing. See section 6.6.
Amiodarone may be used prior to direct current (DC) cardioversion.
Posology
Adults
_Infusion _
_Loading dose_:
The standard recommended dose is 5mg/kg bodyweight given by
intravenous infusion over a period of 20
minutes to 2 hours. This should be administered as a dilute solution
in 250 ml 5% dextrose. This may be
followed by repeat infusion up to 1200 mg (approximately 15 mg/kg
bodyweight) in up to 500 ml 5%
dextr