PATIENT
INFORMATION LEAFLET
AMIKIN
INJECTION 500mg/2ml
(Amikacin Sulphate)
AMIKIN
INJECTION 100mg/2ml
(Amikacin Sulphate)
Your doctor
has prescribed AMIKIN. This leaflet gives a summary of
information about your medicine. If you want to know
more, or are not sure about anything, ask your doctor or
pharmacist.
WHAT IS
IN AMIKIN?
The active
ingredient in AMIKIN is amikacin sulphate. AMIKIN is
available in two strengths: amikacin sulphate equivalent
to amikacin activity 100mg in 2ml or amikacin sulphate
equivalent to amikacin activity 500mg in 2ml. Amikacin
is an antibiotic and a member of the family of medicines
called aminoglycosides.
The other
ingredients are: sodium bisulphite, sodium citrate,
sulphuric acid and water for injection.
Amikin
Injection is supplied in a pack of 5 vials. injection.
WHAT IS
THIS MEDICINE FOR?
AMIKIN is
for the treatment of serious infections caused by
bacteria which require an antibiotic injection.
BEFORE
YOUR MEDICINE IS ADMINISTERED
What should
my doctor know before I receive AMIKIN?
Tell your
doctor if you are allergic to any of the ingredients in
AMIKIN or other antibiotics. Also make sure that your
doctor knows if you have had any kidney or hearing
problems after receiving other antibiotics or if you
suffer from myasthenia gravis or nerve problems, as
large doses can aggravate these conditions.
Your doctor
will not give you AMIKIN by injection into your abdomen
if you are still under the effects of an anaesthetic or
muscle relaxing drugs, as this may cause problems with
your breathing. Also, it will not be given by injection
into the abdomen if you are a young child.
What if I am pregnant?
If you are
pregnant or may become pregnant, you should speak to
your doctor before receiving AMIKIN.
What if I have problems with my
kidneys?
Tell your
doctor as the dose of AMIKIN may need to be reduced or
the interval between doses extended.
Can I take other medicines?
Not unless
these have been discussed with your doctor or
pharmacist. These include medicines bought at a pharmacy
or elsewhere, e.g. supermarket. If you are taking a
diuretic, e.g. frusemide (water tablet or injection),
indomethacin (antiinflammatory) or any penicillin-type
antibiotic remind your doctor before AMIKIN is given.
ADMINISTRATION OF YOUR MEDICINE
How is AMIKIN given and what is the
usual dose?
AMIKIN will
be given by injection into a muscle or vein or
occasionally into the abdomen. The usual dose for adults
is 250 – 500 mg twice daily. The usual dose in children
is 7.5 –15 mg/kg/day divided in two doses. The doses may
be increased in certain infections. You may require
hearing and kidney tests while receiving AMIKIN; also
blood tests to check the amount of amikacin received.
UNDESIRABLE EFFECTS
Are there any unwanted effects of
AMIKIN?
All
medicines may cause some unwanted or "side-effects". In
a few patients, AMIKIN may cause ringing in the ears,
dizziness, deafness, rash, fever, headache, pins and
needles, nausea and vomiting, and kidney problems
including a reduction in urine output. If you notice any
of these, or any other effects, tell your doctor,
pharmacist or nurse. On rare occasions, it may be
necessary to inject Amikin directly into the eyeball
which can lead to visual disturbances.
LOOKING
AFTER YOUR MEDICINE
You will see
an "expiry date" on the packaging of AMIKIN. The
injection should not be used after this date. It should
not be stored above 25°C and must be kept out of the
reach and sight of children. The vial is to be used once
only. Any unused solution in the vial should be thrown
away.
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 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:
15 mg/kg/day in two equally divided doses
(equivalent to 500 mg b.i.d. in adults). Use of the
100mg/2ml strength is recommended for children for
the accurate measurement of the appropriate dose.
Neonates and Premature
Infants:
An initial loading dose of 10 mg/kg followed by 15
mg/kg/day in two equally divided doses.
Elderly: As amikacin is
excreted by the renal route, renal function should
be assessed whenever possible and dosage adjusted as
described under impaired renal function.
Life-Threatening Infections
and/or Those Caused by
Pseudomonas:
The
adult dose may be increased to 500mg 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 b.i.d. 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
1.5mg/100ml. A suggested method for estimating
dosage in patients with known or suspected
diminished renal function is to multiply the serum
creatinine clearance (in mg/100ml) 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
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.
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