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AMIKACIN 250MG/ML INJECTION

Active substance(s): AMIKACIN SULPHATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Amikacin 250 mg/ml Injection
Read all of this leaflet carefully before you start
using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.
In this leaflet:
1. What Amikacin Injection is and what it is used for
2. Before you use Amikacin Injection
3. How to use Amikacin Injection
4. Possible side effects
5. How to store Amikacin Injection
6. Further information

1. WHAT AMIKACIN INJECTION IS AND WHAT IT IS
USED FOR
Amikacin Injection is one of a group of antibiotic
medicines called ‘aminoglycosides’.
Amikacin Injection is used in the treatment of serious
infections caused by bacteria sensitive to amikacin.

2. BEFORE YOU USE AMIKACIN INJECTION
Do not use Amikacin Injection
• if you have shown signs of hypersensitivity (severe
allergy) to amikacin, or any of the other ingredients
listed in section 6, in the past
• if you suffer from a disorder called myasthenia gravis
(severe weakness of certain muscles of the body)
Tell your doctor if any of the above applies to you before
this medicine is used.

Take special care with Amikacin Injection

Driving and using machines

• if you have kidney problems
• if you have hearing difficulties or tinnitus (ringing or
buzzing in the ears)
• if you have shown signs of allergy to any of the
antibiotics related to amikacin (aminoglycosides) in
the past
• If you have a known allergy to sulphites

Do not drive or use machines if you experience any side
effect (e.g. dizziness) which may lessen your ability to
do so.

Amikacin should be used with caution in premature and
neonatal infants.
Tell your doctor if any of the above applies to you before
this medicine is used.

Taking/using other medicines
Special care is needed if you are taking/using other
medicines, as some could interact with amikacin for
example:
• diuretics (water tablets) such as furosemide and
ethacrynic acid
• other antibiotics that can affect your kidneys, hearing
or balance
• anaesthetics or muscle-relaxing drugs
• indomethacin (an anti-inflammatory medicine)
• other antibiotics called beta-lactamases such as
penicillins or cephalosporins
• bisphosphonates; drugs used to treat loss of bone
mass
• vitamin B1 (thiamine)
• platinum compounds used in chemotherapy such as
cisplatin
Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines obtained
without a prescription.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become
pregnant or breast-feeding. Your doctor will only use this
medicine if the expected benefits outweigh any potential
risk to your baby.
Ask your doctor or pharmacist for advice before taking
any medicine.

Important information about some of the
ingredients of Amikacin Injection
This medicine contains sodium metabisulphite, which
may rarely cause hypersensitivity (severe allergy)
reactions and bronchospasm (breathing difficulties).
This medicinal product contains less than 1 mmol
(23 mg) sodium per dose, i.e. essentially ‘sodium free’.

3. HOW TO USE AMIKACIN INJECTION
This medicine is usually injected into a muscle. It may
also be given into a vein, either as an injection or
(following dilution) as an infusion (drip).
Amikacin can also be given into the peritoneum
(abdominal cavity) during surgery, and can be used to
wash out abscess cavities, the lung cavity and brain
cavities.
Your doctor will ensure you are well hydrated before and
during treatment.

Dose
Your doctor will work out the correct dose of amikacin
for you and how often it must be given. This may require
blood tests before treatment.
The dose will depend upon your age, the infection you
have, how well your kidneys are working, if you have
poor hearing and any other medicines you may be
taking.
It will usually be given to you two or three times a day,
for up to 10 days.

Amikacin 250 mg/ml
Injection
The following information
is intended for medical or
healthcare professionals only
Further to the information
included in section 3,
practical information on the
preparation/handling of the
medicinal product is provided
here.

Incompatibilities
Amikacin is incompatible
with some penicillins and
cephalosporins, amphotericin
chlorothiazide sodium,
erythromycin gluceptate, heparin,
nitrofurantoin sodium, phenytoin
sodium, thiopentone sodium and
warfarin sodium, and depending
on the composition and strength
of the vehicle, tetracyclines,
vitamins of the B group with
vitamin C, and potassium
chloride.
At times, amikacin may be
indicated as concurrent therapy
with other antibacterial agents in
mixed or superinfections. In such
instances, amikacin should not
be physically mixed with other
antibacterial agents in syringes,
infusion bottles or any other
equipment. Each agent should
be administered separately.

Adults and children over 12 years: The usual dose is
15 mg per kg per day which is administered as a single
dose or divided into two equal doses of 7.5 mg per kg
administered every 12 hours. The total dose should not
exceed 1.5 g. When treatment is given in to a vein it is
usually administered over a 30 to 60 minute period.

Instructions for use and
handling

Children up to 12 years: The usual dose is 15 - 20 mg
per kg of body weight once a day or divided into two
equal doses of 7.5 mg per kg which is administered
every 12 hours.

The solution may darken from
colourless to a pale yellow but
this does not indicate a loss of
potency.

Single use only
Discard any unused contents

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If required, suitable diluents
for intravenous use are normal
saline or 5% dextrose in water.
Amikacin in concentrations of
0.25% (2.5 mg/ml) may be used
satisfactorily as an irrigating
solution in abscess cavities, the
pleural space, the peritoneum
and the cerebral ventricles.

In use storage precautions
Following dilution in 0.9%
sodium chloride and 5% glucose
solutions, chemical and physical
in-use stability has been
demonstrated for 24 hours at a
temperature not above 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.

Neonates: The initial dose is 10 mg per kg of body
weight followed by 7.5 mg per kg every 12 hours.

If any of the following happens, tell your doctor as
soon as possible:

Premature infants: The recommended dosing in
premature babies is 7.5 mg per kg every 12 hours.

Uncommon side-effects which may affect more than
1 person in 1000 are listed below:
• skin rash
• nausea and vomiting
• an excessive build up of bacteria or yeast which are
resistant to amikacin

Keep out of the reach and sight of children

Rare side-effects which may affect less than 1 person in
1000 are listed below:
• dizziness or vertigo (spinning sensation)
• headache
• fever
• unusually low amount of red blood cells in the blood
(anaemia) or excessive amounts of the white blood
cells known as eosinophils in the blood (eosinophilia)
• low levels of magnesium in the blood
• abnormal tingling or ‘pins and needles’ sensation
• muscle tremors
• joint pain
• low blood pressure
• itching or hives

Storage

During treatment you may undergo blood tests and be
asked to provide urine samples. You will possibly also
have hearing tests before and during treatment to look
for signs of side effects. Your doctor may change your
dose depending upon the results of these tests.

If you are given too much or too little Amikacin
Injection
This medicine will be given to you in a hospital, under
the supervision of a doctor. It is unlikely that you will be
given too much or too little, however, tell your doctor or
nurse if you have any concerns.

4. POSSIBLE SIDE EFFECTS
Like all medicines, amikacin can cause side effects,
although not everybody gets them.
If any of the following happens, tell your doctor
immediately as these are all serious. You may need
urgent medical attention or hospitalisation.
Rare side-effects which may affect less than 1 person in
1000 are listed below:
• ringing in your ears or loss of hearing
• decrease in the amount of urine you produce
Not known; numbers of sufferers cannot be estimated
from available data are listed below:
• 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), and you may feel
you are going to faint
• paralysis
• deafness
• sudden loss of breathing
• severe kidney failure
These are serious side effects. You may need urgent
medical attention.

Amikacin may lead to changes in your kidney function.
Your doctor may take blood and urine samples to
monitor for changes such as increased levels of
creatinine or nitrogen in the blood and protein or
red/white blood cells in urine. Your doctor may also ask
you to undergo hearing tests.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not
listed in this leaflet.
You can also report side effects directly via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE AMIKACIN INJECTION
Expiry
This medicine must not be used after the expiry date
which is stated on the vial and carton after ‘EXP’. Where
only a month and year is stated, the expiry date refers to
the last day of that month.
The vials should be stored at, or below, 25°C.
Unused portions of opened vials must not be stored for
later use.
Prepared injections or infusions should be used
immediately, however, if this is not possible they can be
stored for up to 24 hours.

6. FURTHER INFORMATION
What Amikacin Injection contains
The active substance is amikacin. Each millilitre (ml) of
solution contains 250 milligrams (mg) of amikacin (as
amikacin sulphate).
The other ingredients are sodium citrate, sodium
metabisulphite and Water for Injections. See section 2
for further information about sodium metabisulphite.

What Amikacin Injection looks like and contents of
the pack
Amikacin Injection is a clear, colourless to pale yellow
solution for injection which comes in glass containers
called vials.
It may be supplied in packs containing 5 x 500 mg/2 ml
vials

Marketing authorisation holder and manufacturer
responsible for batch release in Europe
Hospira UK Limited, Horizon, Honey Lane, Hurley,
Maidenhead, SL6 6RJ, UK

Manufacturer
Hospira Australia Pty Ltd,1-5, 7-23 and 25-39 Lexia
Place, Mulgrave, Victoria 3170, Australia.
This leaflet was last revised in 08/2015

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434649

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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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