tobramycin
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about DBL Tobramycin Injection BP.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you being
given DBL Tobramycin Injection BP against the benefits they expect it will have for
you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet in a safe place. You may need to read it again.
What DBL Tobramycin Injection BP is used for
Tobramycin is an antibiotic that belongs to a group of medicines called aminoglycosides
(pronounced a-my-noe-GLY-koe-sides).
Tobramycin works by preventing bacteria from growing and thereby killing them. Tobramycin
is used for the treatment of serious infections caused by bacteria, including:
meningitis (infection of the brain)
septicaemia (infection of the blood)
respiratory tract infections
gastrointestinal tract infections
skin and skin structure infections, including infected burns
bone infections
urinary tract infections.
Your doctor may have prescribed tobramycin for another reason.
Ask your doctor if you have any questions about why tobramycin has been prescribed
for you.
This medicine is available only with a doctor’s prescription.
Before you are given DBL Tobramycin Injection BP
When you must not be given it
You must not be given DBL Tobramycin Injection BP if you have an allergy to:
any medicine containing tobramycin
any of the ingredients listed at the end of this leaflet
any similar medicines such as amikacin, streptomycin, gentamicin, or neomycin
sulfites.
Symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
You must not be given tobramycin if you have experienced serious reactions (such as
hearing loss or kidney problems) to tobramycin or other aminoglycosides, such as amikacin,
streptomycin, gentamicin, or neomycin, in the past.
If you are not sure whether you should be given tobramycin, talk to your doctor or
pharmacist.
Before you are given it
Tell your doctor or pharmacist if you have allergies to:
any other medicines
sulfites
foods, preservatives or dyes.
Tell your doctor if you are pregnant or intend to become pregnant.
Like most aminoglycoside antibiotics, tobramycin is not recommended for use during
pregnancy. If there is a need for you to be given tobramycin, your doctor will discuss
with you the benefits and risks of using it during your pregnancy.
Tell your doctor if you are breast-feeding or plan to breast-feed.
Tobramycin passes into breast milk and is not recommended for use during breast-feeding.
If there is a need for you to be given tobramycin, your doctor will discuss the possible
risks and benefits of being given it during breast-feeding.
Tell your doctor or pharmacist if you have or have had any medical conditions, especially
the following:
kidney disease or kidney problems
muscular disorders (e.g. myasthenia gravis, Parkinson’s disease)
cystic fibrosis
hearing problems, or if you or your family have a mitochondrial mutation disease,
or loss of hearing due to antibiotic medicines; certain mitochondrial mutations may
increase your risk of hearing loss with this product.
If you have not told your doctor or pharmacist about any of the above, tell them before
you are given tobramycin.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you buy without a prescription from your pharmacy, supermarket or health food
shop.
Some medicines and tobramycin may interfere with each other. These include:
fluid tablets (diuretics) e.g. furosemide (frusemide), etacrynic acid, bumetanide
cisplatin, a medicine used to treat cancer
other antibiotics to treat infections, including ciclosporins and cephalosporins,
particularly cefalotin
amphotericin, an antifungal medicine
opioid analgesics (e.g. codeine, morphine, pethidine, fentanyl)
some general anaesthetic agents
muscle relaxants such as suxamethonium
some medicines used to prevent blood clots, e.g. warfarin, phenindione
any drug that may cause kidney or hearing problems
neostigmine and pyridostigmine, medicines used to treat myasthenia gravis.
These medicines may be affected by tobramycin, or may affect how well it works. You
may need different amounts of your medicine, or you may need to take/use different
medicines. Your doctor or pharmacist will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with
or avoid while receiving tobramycin.
How DBL Tobramycin Injection BP is given
How much is given
Your doctor will decide what dose you will receive. This depends on your condition
and other factors, such as your weight and kidney function.
How it is given
Tobramycin is given as an injection into a muscle or as a slow injection into a vein
(intravenously).
Tobramycin should only be given by a doctor or nurse.
If you are given too much (overdose)
As DBL Tobramycin Injection BP is usually given to you in hospital under the supervision
of your doctor, it is very unlikely that you will receive an overdose.
However, if you experience severe side effects tell your doctor or nurse immediately
or if you are not already in hospital, immediately telephone your doctor or the Poisons
Information Centre (telephone 13 11 26) for advice, or go to Emergency at the nearest
hospital.
You may need urgent medical attention.
Symptoms of a tobramycin overdose may include the side effects listed below in the
‘Side Effects’ section, but are usually of a more severe nature.
While you are being given DBL Tobramycin Injection BP
Things your doctor should do
Your doctor or nurse should take regular blood and urine samples while you are receiving
Tobramycin Injection. This is to ensure that you are receiving the correct dose of
tobramycin.
Things you must do
If you are about to be started on any new medicine, remind your doctor, dentist or
pharmacist that you are being given this medicine.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being given this medicine.
If you are going to have surgery tell the surgeon or anaesthetist that you are being
given this medicine.
It may affect other medicines used during surgery.
If you become pregnant while being treated with tobramycin, tell your doctor immediately.
If you develop a serious rash (peeling, blistering and shedding of the skin, often
with fever) during treatment with this medicine, tell your doctor or nurse immediately.
Things to be careful of
Be careful driving or operating machinery until you know how DBL Tobramycin Injection
BP affects you.
As with other aminoglycoside medicines, DBL Tobramycin Injection BP may cause tiredness,
dizziness, or drowsiness in some people. If you have any of these symptoms, do not
drive, operate machinery, or do anything else that could be dangerous. Children should
be careful performing activities requiring attention such as riding bicycles or climbing.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your
body get used to the change in position and blood pressure. If this problem continues
or gets worse, talk to your doctor.
Side effects
Tell your doctor or nurse as soon as possible if you do not feel well while you are
being treated with DBL Tobramycin.
This medicine helps most people with certain infections, but it may have unwanted
side effects in a few people. All medicines can have side effects. Sometimes they
are serious, most of the time they are not. You may need medical treatment if you
get some of the side effects.
If you are over 65 years of age you may have an increased chance of getting side effects.
If you are dehydrated you may have an increased chance of getting side effects.
Do not be alarmed by the following list of side effects.
You may not experience any of them.
Ask your doctor, nurse or pharmacist to answer any questions you may have.
Tell your doctor or nurse if you notice any of the following and they worry you:
tiredness or weakness
dizziness or headache
fever
nausea or vomiting
sore mouth and gums
pain at the injection site
rash or itching
signs of anaemia, such as tiredness, being short of breath and looking pale
confusion or disorientation.
Tell your doctor or nurse immediately if you notice any of the following:
signs of an allergic reaction, such as rash, itching or hives on the skin; swelling
of the face, lips, tongue or other parts of the body; shortness of breath, wheezing
or difficulty breathing
hearing problems
ringing in the ears (tinnitus)
vertigo
muscle weakness
increased or decreased urination
diarrhoea, even after stopping antibiotics for several weeks
bleeding or bruising more easily than normal.
The above list includes very serious side effects. You may need urgent medical attention
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After being given DBL Tobramycin Injection BP
Storage
DBL Tobramycin Injection BP will be stored in the pharmacy or on the ward. The injection
is kept in a cool dry place, protected from light, where the temperature stays below
25°C.
Product description
What it looks like
DBL Tobramycin Injection BP is a clear, colourless liquid and comes in glass vials.
Ingredients
Active ingredient:
tobramycin.
Other ingredients:
disodium edetate
sodium metabisulfite
sulfuric acid
sodium hydroxide
Water for injections.
DBL Tobramycin Injection BP does not contain lactose, sucrose, gluten, tartrazine
or any other azo dyes.
Supplier
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
DBL Tobramycin Injection BP is available in the following strength and pack size:
Tobramycin 80 mg/2 mL x 5 vials. (AUST R 75686)
This leaflet was prepared in: November 2024
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