tobramycin sulfate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Tobramycin Injection.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking
Tobramycin Injection against the benefits this medicine is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What Tobramycin Injection is used for
Tobramycin Injection belongs to a group of medicines known as aminoglycoside antibiotics.
Aminoglycoside antibiotics work by preventing bacteria from growing, thereby killing
them.
Tobramycin Injection is used to treat serious bacterial infections in many different
parts of the body such as:
meningitis (infection of the brain)
septicaemia (infection of the blood)
respiratory tract infections (such as pneumonia, bronchitis)
gastrointestinal tract infections
skin and bone infections, including burns
urinary tract infections.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor's prescription.
Before you are given Tobramycin Injection
When you must not be given it
You must not be given Tobramycin Injection if you have an allergy to:
any medicine containing tobramycin
any other similar medicines such as aminoglycoside antibiotics e.g. gentamicin, streptomycin,
amikacin or neomycin
any of the ingredients listed at the end of this leaflet
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 Injection 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 this medicine, talk to your doctor.
Before you are given it
Tell your doctor 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 breastfeeding.
If there is a need for you to be given tobramycin, your doctor will discuss with you
the benefits and risks of being given Tobramycin Injection whilst you are breast-feeding.
Tell your doctor if you have or have had any medical conditions, especially the following:
kidney disease or any kidney problems
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
muscular disorders (e.g. myasthenia gravis, Parkinson's disease)
cystic fibrosis.
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 if you are taking any other medicines, including any that you get
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) such as 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 medicines, or you may need to take a different
medicine.
Your doctor has more information on medicines to be careful with or avoid while you
are receiving Tobramycin Injection.
How Tobramycin Injection is given
How much is given
Your doctor will decide how much Tobramycin Injection you will be given and for how
long. This depends on the type of infection and other factors, such as your weight
and your kidney function.
How it is given
Tobramycin Injection must only be given by a doctor or nurse.
Tobramycin Injection can be given:
directly into a vein via an injection (intravenously), which is infused over a period
of 20 to 60 minutes (Tobramycin Injection will be diluted before being injected into
your vein)
as a deep injection into a large muscle (intramuscular).
If you are given too much (overdose)
As Tobramycin Injection 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 Tobramycin Injection
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 who treats you 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.
Things to be careful of
Be careful driving or operating machinery until you know how Tobramycin Injection
affects you.
This medicine 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 given or using Tobramycin Injection.
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 attention if you
get some of the side effects.
If you are over 65 years of age you may have an increased chance of 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 possible side effects.
You may not experience any of them.
Ask your doctor, nurse or pharmacist to answer any questions that 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, swelling or red skin where you had the injection
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 lips, face, tongue, or other parts of the body; shortness of breath, wheezing
or difficulty breathing
hearing problems
ringing in the ears (tinnitus)
vertigo
muscle weakness
increase or decrease in urination
diarrhoea, even after stopping antibiotics for several weeks
bleeding or bruising more easily than normal.
The above list includes very serious side effects that may require 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 you have been given Tobramycin Injection
Storage
Tobramycin Injection will be stored in the pharmacy or on the ward. It is kept where
the temperature stays below 30°C and protected from light.
Product Description
What it looks like
Tobramycin Injection is a clear, colourless to pale brown, sterile aqueous solution
in a plastic ampoule.
Ingredients
Active ingredient:
tobramycin (as tobramycin sulfate) 80 mg/2 mL
Other ingredients:
disodium edetate
phenol
sulfuric acid
sodium hydroxide
sodium metabisulfite
Water for Injections.
Supplier
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
Tobramycin Injection is available in the following strength and pack size:
Tobramycin 80 mg/2 mL (as tobramycin sulfate) x 5 ampoules (AUST R 101217).
This leaflet was prepared in September 2022.
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