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AMIODARONE HYDROCHLORIDE 50MG/ML STERILE CONCENTRATE

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sterile concentrate
AMIODARONE HYDROCHLORIDE

PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before this medicine is given to
you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your
pharmacist.
In this leaflet :
1. What Amiodarone Hydrochloride 50 mg/ml sterile concentrate is
and what it is used for
2. Before Amiodarone Hydrochloride 50 mg/ml sterile concentrate
is given
3. How Amiodarone Hydrochloride 50 mg/ml sterile concentrate is
given
4. Possible side effects
5. How to store Amiodarone Hydrochloride 50 mg/ml sterile
concentrate
6. Further information
1. WHAT AMIODARONE HYDROCHLORIDE 50 MG/ML STERILE
CONCENTRATE IS AND WHAT IT IS USED FOR
Amiodarone Hydrochloride 50 mg/ml is an anti-arrhythmic drug
used to control an irregular or rapid heart rate. Treatment should
be initiated and normally monitored only under hospital or specialist
supervision.
2. BEFORE AMIODARONE HYDROCHLORIDE 50 MG/ML STERILE
CONCENTRATE IS GIVEN
Amiodarone Hydrochloride 50 mg/ml should not be given to you if
• you have heart block- which may cause a very slow, very fast or
irregular pulse, or dizziness
• you have or have had thyroid problems
• you have severe respiratory failure or very low blood pressure
• it is being given as a single injection and you have low blood
pressure, heart failure or cardiomyopathy (weakness of the heart
muscle)
• you have an allergy to amiodarone, iodine or any of the other
ingredients
• you are pregnant or likely to become pregnant. You should talk
to your doctor regarding this.
• you are breast-feeding
• you are taking certain other drugs including some other heart
drugs (e.g.sotalol), anti-arrhythmics (such as quinidine),
moxifloxacin and other antibiotics, antipsychotics,
antidepressants (including lithium), antihistamines, antimalarials,
anti-infectives or stimulant laxatives.
You must inform your doctor if you are taking any of these
medications.
Amiodarone must not be given to premature babies, neonates or
children up to 3 years old.
Amiodarone Hydrochloride 50 mg/ml should be given with care if
• it is being given as an infusion and you have low blood pressure,
severe heart failure or severe cardiomyopathy (weakness of the
heart muscle)
• you are going to have an anaesthetic or high dose oxygen therapy
• you are asthmatic.
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have
recently taken, any other medicine - even those which your doctor
has not prescribed for you, but which you have bought yourself
from your chemist/pharmacy.
Before using Amiodarone Hydrochloride 50 mg/ml please check
with your doctor if you are taking any of the following, in addition
to the drugs listed in section 2.

'Before Amiodarone Hydrochloride 50 mg/ml is given', Amiodarone
Hydrochloride 50 mg/ml should not be given to you if you are taking
any of the following medicines:
• digoxin
• anticoagulants - used to thin the blood (e.g. warfarin)
• phenytoin
• some calcium channel inhibitors - used to treat high blood
pressure and angina (e.g. verapamil, diltiazem)
• ciclosporin - used after transplant operations
• flecainide
• fluoroquinolones e.g. ciprofloxacin
• beta blockers e.g. atenolol
• stimulant laxatives e.g. senna
• lidocaine
• tacrolimus
• sildenafil
• fentanyl
• midazolam
• ergotamine
• simvastatin or other statins (used to lower cholesterol levels)
• drugs which may change the levels of potassium or magnesium
in your blood e.g. diuretics (water tablets), steroid tablets or the
antifungal amphotericin (when given directly into a vein).
Taking Amiodarone Hydrochloride 50 mg/ml with food and drink
Grapefruit juice can increase the blood level of Amiodarone
Hydrochloride 50 mg/ml and should be avoided during treatment
with Amiodarone Hydrochloride 50 mg/ml.
Pregnancy and breast-feeding
Your doctor will prescribe Amiodarone Hydrochloride 50 mg/ml
only if they consider the benefit of treatment outweighs the risks
during your pregnancy.
You should not be given Amiodarone Hydrochloride 50 mg/ml if you
are breast-feeding.
Important information about some of the ingredients of
Amiodarone Hydrochloride 50 mg/ml
This product contains benzylalcohol (20 mg/ml) as a preservative.
It may cause toxic reactions and allergic reactions in infants and
children up to 3 years old.
3. HOW AMIODARONE HYDROCHLORIDE 50 MG/ML IS GIVEN
Amiodarone Hydrochloride 50 mg/ml is given directly into the blood
stream using a drip (or central line). It should not be given too rapidly.
This medicine is given diluted in a sugar (5% dextrose) solution.
The usual dose of Amiodarone Hydrochloride 50 mg/ml is 5 mg for
every kg body weight given over 20 minutes to 2 hours. This may
then be followed by further infusions up to 1200 mg in 24 hours. The
correct dose and dilution for you will have been decided by the
doctor and will depend upon your condition. Children and the
elderly may be prescribed lower doses.
IV injection may be given at an initial dose at 5 mg for every kg body
weight. This dose should be given over a minimum of 3 minutes and
should not be repeated less than 15 minutes after initial dose.
This dose regimen may be considered only in exceptional
circumstances and emergencies.
If you think that you may have been given too much Amiodarone
Hydrochloride, please inform the doctor or nurse.
Children and adolescents
There are only limited data on the efficacy and safety in children.
Your doctor will decide on an appropriate dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amiodarone Hydrochloride 50 mg/ml can have
side-effects.
.../...

Common side-effects (reported by more than 1 in 10 people) are:

Store in the original container in order to protect from light.

Heart and blood vessels
• a slow pulse
• a decrease in blood pressure

For single use only. Please discard any unused solution.

Skin
• local injection site reactions including swelling, pain, redness,
infection and pigmentation changes
Other side-effects, which are very rare (reported in less than 1 in
100,000 people), are:
Heart and blood vessels
• chest pain or palpitations, or abnormal heart rhythm
• hot flushes
Digestive system
• nausea
Bones
• bone marrow granuloma (abnormal growth of cells in bone marrow)
Liver
• liver disorders including jaundice (yellowing of the eyes or skin)
Body as a whole (immune system)
• generalised allergic reactions such as swelling of the face, lips
and/or tongue, shortness of breath, headaches
Respiratory system
• breathing difficulties (with or without fever), inability to breathe
Skin
• skin rash
• sweating

Do not use Amiodarone Hydrochloride 50 mg/ml after the expiry
date which is stated on the ampoules and outer carton after EXP.
The expiry date refers to the last day of that month.
This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about anything,
ask your doctor or pharmacist.
6. FURTHER INFORMATION
What Amiodarone Hydrochloride 50 mg/ml contains
The active substance is Amiodarone Hydrochloride. Each 3 ml
ampoule contains 150 mg Amiodarone hydrochloride.
The other ingredients are Benzyl alcohol, Polysorbate 80 and
Water for Injections.
What Amiodarone Hydrochloride 50 mg/ml looks like and contents
of the pack
Amiodarone Hydrochloride 50 mg/ml is a clear solution.
It is supplied in boxes of 5 or 10 ampoules.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
STRAGEN UK Ltd
CASTLE COURT
41 LONDON ROAD
REIGATE SURREY RH2 9RJ
The Manufacturer is:
FISIOPHARMA S.r.l.
NUCLEO INDUSTRIALE
84020 - PALOMONTE (SA)
ITALY

If you notice any side effects not mentioned in this leaflet, please
inform your doctor or pharmacist.
5. HOW TO STORE AMIODARONE HYDROCHLORIDE 50 MG/ML

This leaflet was last approved in
06/2011.

Keep out of the reach and sight of children.
Do not store above 30°C.

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY
Iodine content: One ampoule contains 56 mg iodine
For single use only.
Discard any unused solution.
The dilution is to be made under aseptic conditions. The solution is
to be inspected visually for particulate matter and discoloration
prior to administration. The solution should only be used if the
solution is clear and free from particles.
Amiodarone should be administered in 5% dextrose solution only.
Amiodarone must not be mixed with other medicinal products in
the same syringe.
Solutions containing less than 300 mg amiodarone (2 ampoules) in
500 ml of dextrose are not stable and must not be used. Do not mix
any other compounds with amiodarone infusion solution.
The standard recommended dose is 5 mg/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% dextrose per 24 hours, the
rate of infusion being adjusted on the basis of clinical response.
In an 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. This should not be
repeated for at least 15 minutes. Patients treated in this way with
Amiodarone Hydrochloride must be closely monitored, e.g. in an
intensive care unit.

Changeover from Intravenous to Oral Therapy
As soon as an adequate response has been obtained, oral therapy
should be initiated concomitantly at the usual loading dose (200 mg
three times a day). Amiodarone Hydrochloride should then be
phased out gradually.
Paediatric population
The safety and efficacy of amiodarone in children has not been
established.
Currently available data are described in sections 5.1 and 5.2 of the
Summary of Product Characteristics
Due to the presence of benzyl alcohol, amiodarone intravenous
administration is contraindicated in neonates, infants and children
up to 3 years old.
Elderly
As with all patients it is important that the minimum effective dose
is used. Whilst there is no evidence that dosage requirements are
different for this group of patients they may be more susceptible to
bradycardia and conduction defects if too high a dose is employed.
Particular attention should be paid to monitoring thyroid function.
Cardiopulmonary resuscitation
The recommended dose for ventricular fibrillations/pulseless
ventricular tachycardia resistant to defibrillation is 300 mg (or
5 mg/kg body-weight) diluted in 20 ml 5% dextrose and rapidly
injected. An additional 150 mg (or 2.5 mg/kg body-weight) IV dose
may be considered if ventricular fibrillation persists.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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