PATIENT INFORMATION LEAFLET
This
leaflet contains important information about your
medicine; read it carefully.
Keep
this leaflet; you may want to read it again.
If you
have any questions or are not sure about anything,
ask your doctor or pharmacist.
Gentamicin 40 mg/ml Injection
- The
active substance is gentamicin sulphate
- The
other ingredients are sodium metabisulphite (E223),
disodium edetate, methyl hydroxybenzoate, propyl
hydroxybenzoate, sulphuric acid, sodium hydroxide
and Water for Injections.
1. What
Gentamicin Injection is and what it is used for
Gentamicin
Injection is an aminoglycoside antibiotic medicine, in
the form of a solution for injection (a solution which
can be given as an injection).
The medicine
is presented in glass containers called vials. Each
millilitre (ml) of Gentamicin Injection contains 40
milligrams (mg) of gentamicin (as sulphate). The 2 ml
vial contains 80 mg of gentamicin (as sulphate). It is
available in packs containing 5 vials.
Gentamicin
Injection is used to treat a wide variety of infections
such as chest, wound and blood infections.
2.
Before Gentamicin Injection is used
Gentamicin Injection should not be used:
-
if you have shown signs of hypersensitivity
(severe allergy) to gentamicin on previous
occasions.
Gentamicin Injection will not normally be used:
-
if you are pregnant or breast feeding
Special care will be taken:
-
if treating premature babies
-
if you are an elderly patient
-
if your kidneys are not working properly
-
if you have diabetes
-
if you have an ear, hearing or balance disorder,
a history of ear infections or if you have been
treated with medicines that affect hearing in
the past
-
if you are taking certain other medicines, such
as:
-
antibiotics that also affect your kidneys or
hearing such as other aminoglycosides,
cephalothin and methicillin
-
medicines used to thin the blood, such as
warfarin and phenindione
-
amphotericin (medicine used to treat fungal
infections)
-
neostigmine and pyridostigmine (medicines
used in the treatment of muscle weakness)
-
cyclosporin (a medicine that reduces the
activity of the body’s immune system)
-
cisplatin (anti-cancer medicine)
-
some diuretics (water tablets), such as
ethacrynic acid and furosemide
-
muscle relaxants used during general
anaesthesia (such as tubocurarine and
succinylcholine)
Please
tell your doctor if you are taking, or have recently
taken, any other medicines, including ones that are
not prescribed for you.
Do
not drive or use machines:
if you
experience any effect which may impair your ability
to drive or use machines.
3. How
Gentamicin Injection is used
The dose of
medicine given to you will depend on how serious the
infection is, your age, body weight and how well your
kidneys are working.
The medicine
is usually injected into a muscle but may also be
injected into a vein in some patients. If it is given
into a vein, it can either be given as an injection or
dissolved with, e.g. saline or 5% glucose in water and
given as a slow injection via a drip (infusion). It will
be given daily, with your dose usually divided into two
or three separate doses.
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 you doctor or pharmacist if you have
any concerns.
The amount
of gentamicin in your blood will be measured regularly
to check that the correct blood levels have been
achieved. Treatment with gentamicin may cause damage to
hearing and also to kidney function. In some cases, your
doctor may carry out blood tests to check your kidney
function before and during treatment with gentamicin.
Occasionally you may also be asked to take a hearing
test to check the drug is not affecting your hearing.
4.
Possible side-effects
Like all
medicines gentamicin sulphate can have side-effects.
If any of
the following happen, tell your doctor immediately:
-
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.
This is a
very serious side-effect. You may need urgent medical
attention. This very serious side-effect is rare.
If you
experience any of the following tell your doctor as soon
as possible:
-
hearing problems (if you have this side-effect your
doctor may need to change your dose or give you
other treatments)
-
feeling or being sick
- skin
rash or development of raised coloured blotches
which may be itchy
-
fever
- sore
throat
-
muscle weakness
Your doctor
may also carry out blood tests to check for changes in
your kidney function.
If you
notice any side-effects not mentioned in this leaflet,
please tell your doctor or pharmacist.
5.
Storing Gentamicin Injection
Keep out of
the reach of children.
The vials
should not be stored above 25°C.
This
medicine should not be used after the expiry date
printed on the vial.