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, 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 two types of glass containers called
ampoules and vials. Each millilitre (ml) of Gentamicin
Injection contains 40 milligrams (mg) of gentamicin (as
sulphate). The 1 ml ampoule contains 40 mg of gentamicin
(as sulphate), the 2 ml ampoule contains 80 mg of
gentamicin (as sulphate) and the 6 ml vial contains 240
mg of gentamicin (as sulphate). The ampoules are
available in packs containing 5 x 1 ml or 5 x 2 ml
ampoules. The vials are available in packs containing 1
or 5 vials. Not all packs sizes and presentations
mentioned may be marketed.
Gentamicin
Injection is used to treat a wide variety of infections
such as severe chest infections, urinary tract
infections and bloodstream infections.
2.
Before Gentamicin Injection is used
Gentamicin Injection should not be used:
-
if you have shown signs of hypersensitivity
(severe allergy) to gentamicin, other
aminoglycoside antibiotics, or any of the other
ingredients of this medicine on previous
occasions.
-
if you suffer from a disorder called myasthenia
gravis (severe weakness of selected muscles of
the body).
-
if you are taking the diuretic ethacrynic acid
(water tablet)
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 have severe burns
-
if you have heart problems
-
if you have cystic fibrosis or ascites
-
if the number of certain cells in your blood
decreases
-
if you are taking certain other medicines, such
as:
-
antibiotics that also affect your kidneys or
hearing such as aminoglycosides and
cephalothin
-
antibiotics which interact with gentamicin,
such as clindamycin and lincomycin
-
drugs containing penicillin, such as
ticarcillin
-
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
furosemide, piretanide
-
muscle relaxants used during general
anaesthesia (such as tubocurarine)
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
Important information about one of the ingredients
of Gentamicin Injection
This
medicine contains sodium metabisulphite, which can
cause an allergic type reaction (skin rash, swelling
of eyelids, face or lips, or difficulty in
breathing). This is rare but you may be more at risk
if you suffer from allergies or asthma.
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 may
be given as a single daily dose or divided into two or
three daily doses. Gentamicin Injection will not
normally be given to you for more than 7 days.
The amount
of gentamicin in your blood will be measured regularly
to check that the correct blood levels have been
achieved. 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 your doctor
or pharmacist if you have any concerns.
4.
Possible side-effects
Like all
medicines gentamicin sulphate can have side-effects.
Inform the
doctor immediately if you experience symptoms of a
severe allergic reaction: sudden itchy rash (hives),
breathing difficulties, cough, heart palpitations,
swelling of the face, lips or tongue. This very serious
side-effect is rare but you may need urgent medical
attention.
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
- a
fall in the number of a certain type of white blood
cells, which can make you prone to other infections
-
muscle weakness
-
stomach pain
- in
rare cases, diarrhoea with blood and mucus
Your doctor
may also do blood tests to check for changes in your
kidney function. Occasionally you may also be asked to
take a hearing test to check the drug is not affecting
your hearing.
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
ampoules/vials should not be stored above 25°C.
This
medicine should not be used after the expiry date
printed on the ampoule/vial.
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