Skip to Content

UK Edition. Click here for US version.



View full screen / Print PDF » Download PDF ⇩

PDF Transcript




$%&  '
 ( )    (    & * + *& (   
*&)+&(  (   *&.
,  ( (   -/&*) ) , *&0*& 1&( (2(*&) ()(+(+)*& *-3 ((
   (- * 20 (( ((
 ((*&(*& *() (2   *&) ( -
( &)(*((+ () (  ( ) (   -

4 ( (  
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
-4   ()5  (&()
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
"-4 *&) 5+*&0  
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 have any kidney problems
% You have any hearing problems or other problems with your ears.
Take caution if you are elderly
Take caution if you are dehydrated (ensure you are well hydrated
during treatment)
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
% 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
amount of AMIKIN which is absorbed in new born babies

% If you have recently received an anaesthetic
AMIKIN is not recommended to be given by injection into the
stomach in young children.
*)+( ,)
If you are pregnant or breast-feeding, or think you may be pregnant,
you should speak to your doctor before you are given AMIKIN.
If you feel unwell or suffer from any of the side effects do not drive
or operate machinery.
 (()& +(& 6 )()&
Amikin injection contains the inactive ingredient sodium
 !  "            # 
     # $!    %" & %
This medicinal product contains less than 1 mmol (23mg) sodium
per vial and therefore, is essentially sodium free.
7-85  (0
AMIKIN is given by injection into a muscle or vein, or occasionally
 #  #  
 " % 
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.
)& () )0"*( 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.
 ) * Renal function should be assessed and dose adjusted
as described under impaired renal function.
 ) ) 9 5(  " *(  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.
 ( The usual dose is initially 10 mg/kg followed by 7.5 mg/kg
which is given twice a day.
 & ( The usual dose is 7.5 mg/kg twice a day.
#,     )! ( &() +*
(&)( The doses may be increased to 500 mg every
eight hours, but should not exceed 1.5 g/day or be administered



#%38=:;83 <=>% 8 
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.
An initial loading dose of 10 mg/kg followed by
7.5 mg/kg every12 hours.
Premature infants:
The recommended dose in premature
infants is 7.5 mg/kg in every 12 hours.
 *()( (& ) + &() 5 
&  &)   (
+&(   & * (  (
) (&   (& , 


:; :;8#8;:%% #%
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.
3%<33  %; 
At the recommended dosage level, uncomplicated
infections due to sensitive organisms should
respond to therapy within 24 to 48 hours. If clinical
     "     !   
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
  $           * +9 <=  
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


for a period longer than 10 days.
?*   ( The usual dose is 7.5 mg/kg/day
twice a day.
) &  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 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.
*&0 &    @ 
?    @   "   %     G!    
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.
9-((+ () (
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
 $!   %
As these may be signs of an allergic reaction
  $ G   $ #     $$       "    ! 
using the following convention:
very common: 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
very rare:
affects less than 1 user in 10,000
Patients treated with AMIKIN have reported the following side
% feeling sick (nausea) and being sick (vomiting)
% skin rash
% infections with resistant bacteria or yeasts
% abnormal white blood cells, which can be detected by blood
% 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
% &&
% 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
% " & %J$!   %
% temporarily stopping breathing
% deafness
On rare occasions, it may be necessary to inject AMIKIN directly
into the eyeball which can lead to visual disturbances.
; () (
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
         #   $$          "
Card Scheme at:
By reporting side effects you can help provide more information
on the safety of this medicine.
A-85 ( *&)
 )(&  ( ) )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.
 )(&  ( ) )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.
B-  ( )  
4  (
Each 2ml vial contains amikacin sulphate (equivalent to amikacin
activity 100mg) as the active ingredient.
In addition, AMIKIN contains the following inactive ingredients:
   ! QXXZJ   J # 
water for injection.
4    ( )  ( 
Amikin Injection is a clear, colourless solution and is supplied in
 $! X <%  "  ##  
 & ( 8 ))& &
 & ( 8 )
Bristol-Myers Pharmaceuticals.
Uxbridge Business Park,
Sanderson Road,
Middlesex UB8 1DH
Tel.: 0800-7311736
& &
Bristol-Myers Squibb Srl.,
Contrada Fontana del Ceraso, 03012 Anagni (Fr), Italy
(   5( ( 0() August 2014



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
   %!%        "

As renal function may alter appreciably during
therapy, the serum creatinine should be checked
$ G        %   %

  \   # 
   $   %
   # # J$&   "
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.
3 #( 0(August 2014



[# ! 
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%
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
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
Urinary tract infections (other than pseudomonal
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

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.