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AMIODARONE HYDROCHLORIDE 50 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION

Active substance(s): AMIODARONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution
for Injection and Infusion
Amiodarone hydrochloride
Read all of this leaflet carefully before you start taking 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 pharmacist
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Amiodarone Hydrochloride 50 mg/ml
Concentrate for Solution for Injection and
Infusion is and what it is used for
2. What you need to know before Amiodarone
Hydrochloride 50 mg/ml Concentrate for
Solution for Injection and Infusion is given
3. How Amiodarone Hydrochloride 50 mg/ml
Concentrate for Solution for Injection and
Infusion is used
4. Possible side effects
5. How to store Amiodarone Hydrochloride
50 mg/ml Concentrate for Solution for
Injection and Infusion
6. Contents of the pack and other information

1

What Amiodarone Hydrochloride
50 mg/ml Concentrate for
Solution for Injection and Infusion
is and what it is used for




Amiodarone Hydrochloride belongs to group of
medicines called class III antiarrhythmics that
are given to treat severe disturbances in heart
rhythm and rapid heart rate.
Amiodarone Hydrochloride 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
Amiodarone Hydrochloride
50 mg/ml Concentrate for Solution
for Injection and Infusion is given

Amiodarone Hydrochloride must not be
given if you:
• are allergic (hypersensitive) to amiodarone
hydrochloride or/and iodine or any of the
ingredients in this medicine (listed in section 6).
• have certain heart problems such as a
very slow heart beat (sinus bradycardia)
• you have any other problems with your
heartbeat and do not have a pacemaker
fitted
• have or have previously had thyroid
problems
• have severe breathing problems
• have severe blood circulation problems
or very low blood pressure are being
treated with any other medicines which
may cause heart rhythm disturbance
(called torsades de pointes) - for list of
medicines see section “Taking other
medicines” below.
• are pregnant or breastfeeding (use is
allowed only in life-threatening
circumstances)
This product must not be given to children,
premature babies or neonates.
If you think any of the above situations applies
to you, consult your doctor or pharmacist.
Warnings and precautions
Amiodarone Hydrochloride should be given
with care if you:
• have low blood pressure.
• have a weak heart (“cardiomyopathy”) or
heart failure.
• are an elderly person (> 60 years).
• have liver problems. Treatment is to be
started and normally monitored only under
hospital or specialist supervision. This
medicine contains benzylalcohol (see section
“Important information about some of the
ingredients of Amiodarone Hydrochloride”).
• have any problems with your eyesight. This
includes an illness called ‘optic neuritis’.
• are to undergo a general anaesthetic.
• require oxygen treatment.
• are taking certain other medicines - for list of
medicines see section - “Other medicines
and Amiodarone Hydrochloride 50 mg/ml
Concentrate for Solution for Injection and
Infusion” below.
Other medicines and Amiodarone
Hydrochloride 50 mg/ml Concentrate for
Solution for Injection and Infusion
Tell your doctor or pharmacist if you are taking
or have recently taken or might take any other
medicines, herbal medicines or natural
products. In particular, you should check with
your doctor if you are taking any of the
following to be sure that it is safe to give
Amiodarone Hydrochloride:
Medicines which may cause heart rhythm
disturbance (called torsades de pointes):
• other medicines to treat irregular heart
beat (e.g. quinidine, procainamide,
disopyramide, sotalol, bretylium, flecainide).
• some medicines used to treat infections
(e.g. erythromycin injections, pentamide
injections, co-trimoxazole, moxifloxacin and
fluoroquinolones such as ciprofloxacin,
ofloxacin, levofloxacin).
• some medicines used to treat mental
illness (e.g. chlorpromazine, thioridazine,
fluphenazine, pimozide, haloperidol,
amisulpride and sertindole).
• lithium and tricyclic anti-depressants (e.g.
doxepin, maprotiline, amitriptyline).
• certain antihistamines (e.g. terfenadine,
astemizole, mizolastine).
• anti-malarials e.g. (quinine, mefloquine,
chloroquine, halofantrine).
Or some other medicines such as:
• digoxin (taken for heart problems)
• warfarin (blood thinning medications)
• phenytoin (most often used to treat
epilepsy)
• some medicines used to treat high blood
pressure and angina (e.g. verapamil,
diltiazem, beta-blockers)
• ciclosporin, tacrolimus – used after










transplant operation to suppress the
immune system
medications to lower cholesterol levels
(statins - such as simvastatin, atorvastatin,
lovastatin)
tetracosactrin (used in some blood tests or
sometimes in the treatment of Crohn's
disease)
drugs which may change the levels of
potassium or magnesium in your blood e.g.
diuretics (water tablets), steroid tablets or
amphotericin injection (an antifungal)
sildenafil (known as “Viagra”)
fentanyl (used for pain relief)
lidocaine (medication for regional
anaesthesia)
midazolam, triazolam (used to relieve
anxiety or to help you relax before
surgery)
ergotamine, dihydroergotamine (medication
against migraine)

Ask your doctor if you are not sure what these
medicines are.
Amiodarone Hydrochloride with food, drink
and alcohol
Grapefruit juice can increase the blood level of
amiodarone and should be avoided during
treatment with Amiodarone Hydrochloride.
You should limit the amount of alcohol you drink
whilst being treated with this medicine.
Protect your skin from sunlight
Keep out of direct sunlight while taking this
medicine and for a few months after you have
finished taking it. This is because your skin will
become much more sensitive to the sun and
may burn, tingle or severely blister if you do not
take the following precautions:
• Make sure you use high factor sun cream
• Always wear a hat and clothes which cover
your arms and legs
Pregnancy and breast-feeding
Your doctor will prescribe Amiodarone
Hydrochloride only if he/she considers the
benefit of treatment outweighs the risks during
your pregnancy. Amiodarone Hydrochloride can
be used during pregnancy in the
life-threatening circumstances only.
You should not be given Amiodarone
Hydrochloride if you are breast-feeding. If you
are given Amiodarone Hydrochloride during
pregnancy or breast-feeding, breast-feeding
should be stopped.
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
Driving and using machines
Your doctor will tell you how long to wait before
driving a car or using machines after you are
given this medicine.
Amiodarone Hydrochloride 50 mg/ml
Concentrate for Solution for Injection and
Infusion contains benzyl alcohol
This product contains benzylalcohol (20 mg/ml)
as 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 Concentrate for Solution
for Injection and Infusion is used

Amiodarone Hydrochloride 50 mg/ml
Concentrate for Solution for Injection and
Infusion is given intravenously (into a vein)
after dilution with 5% glucose solution and
administered to you by your healthcare
professional.
The dose of medicine given will depend upon
your medical condition, your age and your
bodyweight.
Adults (including elderly)
Starting dose
The standard recommended dose is 5 mg/kg
bodyweight. However, this may vary
depending upon your age and how well you
respond to treatment.
This medicine will be diluted using 5%
glucose solution before it is given to you over
a period of 20 minutes to 2 hours. It will be
given slowly, usually via a drip into a vein in
your arm or chest. Depending on your
response, you may be given further infusions
up to 1200 mg (approximately 15 mg/kg
bodyweight) in up to 500 ml 5% glucose per
24 hours.

Continued on the next page >>

The following technical information is intended for medical or healthcare professionals
only:
For single dose use only. Discard any unused solution immediately after initial use as specified in
the Summary of product characteristics.
The dilution is to be made under aseptic conditions. The solution is to be inspected visually for
particulate matter and discolouration prior to administration. The solution should only be used if the
solution is clear and free from particles.
Solutions containing less than 300 mg of amiodarone (two vials) in 500 ml of glucose are not stable
and must not be used. It should also be stressed that no other compounds are to be mixed to
amiodarone infusion solution.
Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion should be
administered solely in 5% glucose solution.
Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion must not
be mixed with other medicinal
products in the same syringe.
Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion must not
be used with saline or any other equipment or devices containing plasticizers such as DEHP.
Continued on the next page >>

Maintenance dose:
10 - 20 mg per kg bodyweight in physiological
glucose solution can be given every 24 hours
(on average 600 to 800 mg/ 24 hours up to a
maximum of 1200 mg/ 24 hours accordingly
4-5 ampoules, maximum 8 ampoules) for a
few days.
In some conditions the medicine may be given
as a slow injection of 150-300 mg in 10-20 ml
5% glucose over a minimum of 3 minutes. If
Amiodarone Hydrochloride 50 mg/ml
Concentrate for Solution for Injection and
Infusion is given in this way you will be closely
monitored.
As soon as an adequate response has been
obtained using intravenous treatment, you may
be switched to oral treatment.
Elderly patients should be closely monitored
during treatment, particularly for thyroid
function.
Use in children and adolescents
There are only limited data on the efficacy and
safety in children. Your doctor will decide on an
appropriate dose.
Patients with liver and kidney problems
Although no dosage adjustment for patients
with kidney or liver abnormalities has been
defined during chronic treatment with oral
amiodarone, close clinical monitoring is prudent
for elderly patients.
If you have any further questions on the use of
this product, ask your doctor or the other
healthcare professionals.
If you are given more Amiodarone
Hydrochloride 50 mg/ml Concentrate for
Solution for Injection and Infusion than you
should
As this medicine will be given to you whilst you
are in hospital it is unlikely that you will be
given too little or too much. However, tell your
doctor or pharmacist if you have any concerns.

4

Not known (frequency cannot be estimated
from the available data)
• hives (itchy, lumpy rash)
• back pain
• weakness, bleeding or bruising more easily
than normal, pale skin, breathlessness and
frequent infections. These can all occur if
you have a very low number of the blood
cells.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the
Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By reporting
side affects you can help provide more
information on the safety of this medicine.

5

How to store Amiodarone
Hydrochloride 50 mg/ml
Concentrate for Solution for
Injection and Infusion

Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the outer carton and vials
after EXP. The expiry date refers to the last day
of that month.
Concentrate
Do not store above 25°C. Keep the vials in the
outer carton in order to protect from light.
Diluted medicinal product
Chemical and physical in-use stability has been
demonstrated for 24 hours at 25°C.
From a microbiological point of view, the
product should be used immediately. If not used
immediately, in-use storage times and
conditions prior to use are the responsibility of
the user and would normally not be longer than
24 hours at 2 to 8°C, unless dilution has taken
place in controlled and validated aseptic
conditions.
For single use only.
Discard any unused solution.

Possible side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets them.
If any of the following happen, tell your
doctor immediately. These are very serious
side effects and you may need urgent
medical attention.
• breathing difficulties
• chest pain
• severe allergic reaction - you may
experience a sudden itchy rash (hives),
swelling of the hands, feet, ankles, face,
lips, mouth or throat (which may cause
difficulty in swallowing or breathing), you
may feel you are going to faint and there
may be inflammation of some of your
blood vessels.
If you experience any of the following tell
your doctor as soon as possible.
Very common (may affect more than 1 in 10
people)
• blurred eyesight or seeing a coloured halo
in dazzling light
• burning more easily in the sun (see ‘Protect
your skin from sunlight’ in Section 2)
Common (may affect up to 1 in 10 people)
• generally moderate slow heart rate
• decrease in blood pressure
• local injection site reactions including
swelling, pain, redness, infection, and
pigmentation changes (blue or grey marks
on parts of your skin exposed to sunlight,
especially the face)
• feeling extremely restless or agitated, weight
loss, increased sweating and being unable to
stand the heat.These could be signs of an
illness called ‘hyper-thyroidism’
• feeling extremely tired, weak or ‘run-down’,
weight gain, being unable to stand the cold,
constipation and aching muscles. These
could be signs of an illness called
‘hypo-thyroidism’
• trembling when you move your arms or legs
• muscle weakness
• nightmares
• problems sleeping
Uncommon (may affect up to 1 in 100 people)
• feeling numb or weak, tingling or burning
feelings in any part of your body
• dizziness

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help
protect the environment.

6

Contents of the pack and other
information

What Amiodarone Hydrochloride 50 mg/ml
Concentrate for Solution for Injection and
Infusion contains
• The active substance is amiodarone
hydrochloride. Each 3 millilitre vial contains
150 mg of amiodarone hydrochloride.
One millilitre sterile concentrate contains 50
mg of amiodarone hydrochloride.
• The other ingredients are benzyl alcohol
(20.2 mg/ml), polysorbate 80, hydrochloric
acid (for pH adjustment), sodium hydroxide
(for pH adjustment) and water for injections.
What Amiodarone Hydrochloride 50 mg/ml
Concentrate for Solution for Injection and
Infusion looks like and contents of the pack
Amiodarone Hydrochloride 50 mg/ml
Concentrate for Solution for Injection and
Infusion is a clear yellowish, sterile solution free
from particles, contained in an amber glass vial
closed with a rubber stopper and aluminium
seal with a grey flip-off button.
The vials are packed in cartons containing 1, 5,
6, 10 or 25 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
or
Salutas Pharma GmbH
Dieselstrasse 5
70839 Gerlingen
Germany
or

Rare (may affect up to 1 in 1,000 people)
• the excipients benzyl alcohol may cause
hypersensitivity reactions
Very rare (may affect up to 1 in 10,000 people)
• chest pain or palpitations, or abnormal heart
rhythm
• nausea
• liver disorders
• generalised allergic reactions such as
swelling of the face, lips and/or tongue,
shortness of breath, headaches, breathing
difficulties (with or without fever)
• inability to breathe
• hot flushes
• sweating
• red, scaly patches of skin, loss of hair or
loosening of nails (called ‘exfoliative dermatitis’)
• loss of eyesight in one eye or your eyesight
becomes dim and colourless. Your eyes may
feel sore or tender and feel painful to move.
This could be an illness called ‘optic
neuropathy or neuritis’
• skin rash
• skin redness during radio-therapy
• moving unsteadily or staggering, slurred or
slow speech
• headache (which is usually worse in the
morning or happens after coughing or strain
ing), feeling sick (nausea) fits, fainting, eye
sight problems or confusion can occur.
These could be signs of problems with your
brain
• headache
• feeling unwell, confused or weak, feeling
sick (nausea), loss of appetite, feeling
irritable. This could be an illness called
“syndrome of inappropriate anti-diuretic
hormone secretion” (SIADH)

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia
This leaflet was last revised in 04/2015

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Intravenous infusion:
The calculated dose is diluted with 250 ml 5% glucose. See section 4.2 of the Summary of product
characteristics.
Intravenous injection:
150-300 mg (corresponding to 3-6 ml Amiodarone Hydrochloride 50 mg/ml Concentrate for
Solution for Injection and Infusion) is
diluted with 10-20 ml 5% glucose. See section 4.2 of the Summary of product characteristics.
Any unused product or waste material should be disposed of in accordance with local requirements.
The use of administration equipment or devices containing plasticizers such as DEHP
(di-2-ethylhexylphthalate) in the presence of amiodarone may result in leaching out of DEHP. In
order to minimise patient exposure to DEHP, in any case when the administration will take more
than 2 hours, the final amiodarone dilution for infusion should preferably be administered through
non DEHP-containing sets, like glass or polyolefin sets (PE, PP).
Diluted medicinal product
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a
microbiological point of view, the product should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the responsibility of the user and would
normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in
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controlled and validated aseptic conditions.
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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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