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AMIKIN INJECTION 100MG/2ML

Active substance(s): AMIKACIN SULPHATE

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Package leaflet: Information for the patient

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AMIKIN INJECTION
100 mg/2mL
(Amikacin Sulfate)

Please read all of this leaflet carefully before you start
taking your medicine because it contains important
information for you.
- Please keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
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.
What is in this leaflet
1. What AMIKIN is and what it is used for
2. What you need to know before you are given AMIKIN
3. How AMIKIN is given
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information
1. What AMIKIN is and what it is used for
The name of this medicine is AMIKIN. Each 2 mL vial contains 100 mg
amikacin sulfate as the active ingredient.
Amikacin is an antibiotic and belongs to the group of medicines called
aminoglycosides.
AMIKIN is used to treat serious infections caused by certain bacteria.
2. What you need to know before you are given AMIKIN
Do not use AMIKIN if:
• You are allergic (hypersensitive) to any of the ingredients in AMIKIN or
other antibiotics.
• You suffer from myasthenia gravis (a disease that causes muscle
weakness).
If any of the above affects you, or you are unsure if they do, tell your doctor
who will be able to advise you.
You must tell your doctor if:
• You have any kidney problems
• You have any hearing problems or other problems with your ears.
• You have any muscular disorders such as Parkinson’s Disease
Take caution if you are elderly
Take caution if you are dehydrated (ensure you are well hydrated during
treatment)
Other medicines and Amikin
Always tell your doctor or pharmacist about any other medicines you
may be taking or have recently taken including those obtained without a
prescription before you are given AMIKIN. Some medicines can have an
affect on the action of other medicines. It is especially important that you
tell your doctor if you are taking;
• Any diuretics e.g. frusemide (water tablet or injection)
• Any antibiotics including, penicillin-type antibiotics or cephalosporins
• Any muscle relaxing medication
• Cisplatin use in the treatment of cancers
• Amphotericin B, which is used in the treatment of fungal infections
• Bisphosphonates (which are used to treat osteoporosis and similar
diseases)
• Platinum compounds
• Thiamine (Vitamin B1) as it may lose its effectiveness
• Any other medicines which are bad for your kidneys or hearing
• Indomethacin (an anti-inflammatory). This can increase the amount of
AMIKIN which is absorbed in new born babies
Or
• If you have recently received an anaesthetic
AMIKIN is not recommended to be given by injection into the stomach in
young children.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or think you may be pregnant, you
should speak to your doctor before you are given AMIKIN.
Driving and using machines
If you feel unwell or suffer from any of the side effects do not drive or
operate machinery.
Amikin contains sodium metabisulfite and sodium
Amikin injection contains the inactive ingredient sodium metabisulfite which
may rarely cause severe hypersensitivity reactions and bronchospasm
(difficulty in breathing or wheezing).
This medicinal product contains less than 1 mmol (23mg) sodium per vial
and therefore, is essentially sodium free.
3. How AMIKIN is given
AMIKIN is given by injection into a muscle or vein, or occasionally into the
abdomen. The patient’s pre-treatment body weight should be obtained in
order to calculate the correct dosage. The usual duration of the treatment
is 7 to 10 days. The total daily dose by all routes of administration should
not exceed 15-20 mg/kg/day.
Adults and children over 12 years: The usual dose is
15 mg/kg/day which is given once a day or divided into two doses which
are given twice a day.
Elderly: Renal function should be assessed and dose adjusted as
described under impaired renal function.
Children aged 4 weeks to 12 years: The usual dose is 15 – 20 mg/kg/day
which is given once a day or divided into two doses which are given twice
a day.
Neonates: The usual dose is initially 10 mg/kg followed by 7.5 mg/kg which
is given twice a day.
Premature infants: The usual dose is 7.5 mg/kg twice a day.
Life-threatening infection and/or those caused by Pseudomonas:
The doses may be increased to 500 mg every eight hours, but should not
exceed 1.5 g/day or be administered for a period longer than 10 days.
Urinary tract infections: The usual dose is 7.5 mg/kg/day twice a day.
Impaired renal function: The daily dose should be reduced and/or the
interval between doses increased to avoid build up of drug.
The doses may be increased in certain infections.
You may require hearing and kidney tests while receiving AMIKIN as well

PLEASE DETACH BEFORE HANDING ABOVE
SECTION TO THE PATIENT
INFORMATION FOR HEALTH PROFESSIONALS
Below is a summary of the dosage and administration of AMIKIN.
Reference should be made to the Summary of Product Characteristics
(SmPC) for full prescribing information.
DOSAGE AND ADMINISTRATION:
At the recommended dosage level, uncomplicated infections due to
sensitive organisms should respond to therapy within 24 to 48 hours. If
clinical response does not occur within three to five days consideration
should be given to alternative therapy.
Intramuscular or intravenous administration:
For most infections the intramuscular route is preferred, but in
life-threatening infections, or in patients in whom intramuscular injection
is not feasible, the intravenous route, either slow bolus (2 to 3 minutes) or
infusion (0.25% over 30 minutes) may be used.
Adults and children over 12 years:
The recommended intramuscular or intravenous dosage for adults and
adolescents with normal renal function (creatinine clearance ≥ 50 mL/min)
is 15 mg/kg/day which may be administered as a single daily dose or
divided into 2 equal doses i.e. 7.5 mg/kg every 12 hours. The total daily
dose should not exceed 1.5 g. In endocarditis and in febrile neutropenic
patients dosing should be twice daily, as there is not enough data to
support once daily dosing.
Children 4 weeks to 12 years:
The recommended intramuscular or intravenous (slow intravenous
infusion) dose in children with normal renal function is 15-20 mg/kg/day
which may be administered as 15-20 mg/kg, once a day; or as 7.5 mg/kg
every 12 hours. In endocarditis and in febrile neutropenic patients dosing
should be twice daily, as there is not enough data to support once daily
dosing.
Neonates:
An initial loading dose of 10 mg/kg followed by 7.5 mg/kg every
12 hours.
Premature infants:
The recommended dose in premature infants is 7.5 mg/kg in every
12 hours.
Aminoglycosides should be used with caution in premature and
neonatal infants because of the renal immaturity of these patients
and the resulting prolongation of serum half-life of these drugs.
Specific recommendation for intravenous administration
The solution for intravenous use should be prepared by adding the desired
dose to 100mL or 200mL of sterile diluent such as normal saline or 5%

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as blood tests to check the amount of amikacin received.
You should start to see an improvement in 1-2 days. If there has been no
improvement after 3-5 days, go back to see your doctor.
If you are given too much or too little Amikin Injection
Amikin Injection will be given by a qualified healthcare professional
(doctor or nurse) who will ensure you are given the correct dose. On rare
occasions, you may be given too much Amikin Injection. If this happens,
your doctor will make sure that it is removed from your blood so that you
do not suffer too many side effects.
4. Possible side effects
As with all medicines, AMIKIN can cause unwanted side effects, although
not everybody gets them.
If you notice any of the following, stop taking AMIKIN and contact your
doctor immediately:
- swelling of the face, lips, or tongue
- skin rash
- difficulty breathing
As these may be signs of an allergic reaction
The frequency of possible side effects listed below is defined using the
following convention:
very common:
common:
uncommon:
rare:
very rare:

affects more than 1 user in 10
affects 1 to less than 10 users in 100
affects 1 to less than 10 users in 1,000
affects 1 to less than 10 users in 10,000
affects less than 1 user in 10,000

Patients treated with AMIKIN have reported the following side effects:
Uncommon
• feeling sick (nausea) and being sick (vomiting)
• skin rash
• infections with resistant bacteria or yeasts
Rare
• abnormal white blood cells, which can be detected by blood tests
• reduced magnesium levels in the blood
• headache
• tremor
• muscle twitching
• pins and needles
• numbness
• blindness or other problems with your vision
• low blood pressure
• ringing in the ears
• loss of hearing
• joint pain
• itching and hives
• kidney problems including a reduction in urine output and increased
nitrogen in the urine
• fever
• dizziness
• anaemia (reduction in red blood cells which can make the skin pale and
cause weakness or breathlessness)
Other side effects where the frequencies are unknown include:
• inability of muscles to move
• wheezing, difficulty breathing
• temporarily stopping breathing
• deafness
On rare occasions, it may be necessary to inject AMIKIN directly into the
eyeball which can lead to visual disturbances.
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 the Yellow Card Scheme at:
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 your medicine
Keep all medicines out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging.
Please check the expiry date of the product, shown on the packaging of
AMIKIN.
Do not use after the last day of the month stated.
Do not use this medicine if it is discoloured or there are particles in the
solution.
Keep all medicines out of the sight and reach of children.
The vial is to be used once only. Any unused solution in the vial should be
thrown away.
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 Amikin contains
Each 2ml vial contains amikacin sulphate (equivalent to amikacin activity
100mg) as the active ingredient.
In addition, AMIKIN contains the following inactive ingredients: sodium
metabisulfite (E223), sodium citrate, sulphuric acid and water for injection.
What AMIKIN looks like and contents of the pack
Amikin Injection is a clear, colourless solution and is supplied in a cardboard
carton of five 2mL glass vials with rubber stoppers.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bristol-Myers Pharmaceuticals.
Uxbridge Business Park,
Sanderson Road,
Uxbridge,
Middlesex UB8 1DH
Tel.: 0800-7311736
UK
Manufacturer
Bristol-Myers Squibb Srl.,
Contrada Fontana del Ceraso, 03012 Anagni (Fr), Italy
This leaflet was last revised in: August 2014

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dextrose in water or any other compatible solution. In paediatric patients
the amount of diluents used will depend on the amount of amikacin
tolerated by the patient. The solution should normally be infused over a 30
to 60 minute period. Infants should receive a 1 to 2 hour infusion.
Life-threatening infections and/or those caused by Pseudomonas:
The adult dose may be increased to 500 mg every eight hours but should
neither exceed 1.5 g/day nor be administered for a period longer than
10 days. A maximum total adult dose of 15 g should not be exceeded.
Urinary tract infections (other than pseudomonal infections):
7.5 mg/kg/day in equally divided doses (equivalent to 250 mg twice a day
in adults). As the activity of amikacin is enhanced by increasing the pH, a
urinary alkalising agent may be administered concurrently.
Impaired renal function:
In patients with impaired renal function, the daily dose should be reduced
and/or the intervals between doses increased to avoid accumulation of
the drug. The critical serum creatinine concentration is 1.5 mg/100 mL.
A suggested method for estimating dosage in patients with known or
suspected diminished renal function is to multiply the serum creatinine
clearance (in mg/100 mL) by 9 and use the resulting figure as the interval
in hours between doses.
As renal function may alter appreciably during therapy, the serum
creatinine should be checked frequently and the dosage regimen modified
as necessary. Body fluid specimens taken for testing should be assayed
promptly, frozen or treated with beta lactamase, to avoid the continued
inactivation of the aminoglycoside leading to inaccurate readings.
Other Routes of Administration:
AMIKIN 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.
Date of Last revision August 2014

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