Tobramycin PF

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

tobramycin
CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common questions about Tobramycin PF. 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 PF 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 PF is used for

Tobramycin PF belongs to a group of medicines known as aminoglycoside antibiotics. Aminoglycoside antibiotics work by preventing bacteria from growing thereby killing them.
Tobramycin PF 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 PF

When you must not be given it

Do not use Tobramycin PF if you have an allergy to:
any medicine containing tobramycin
any of the ingredients listed at the end of this leaflet
any other similar medicines such as aminoglycoside antibiotics e.g. gentamicin, streptomycin, amikacin or neomycin.
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 PF if you have experienced serious reactions (such as hearing loss or kidney problems) to tobramycin or other aminoglycosides 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, 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 using it during 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
myasthenia gravis (a muscle disease)
Parkinson's disease (a disease of the brain affecting movement).

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:
antibiotics
fluid tablets (diuretics) such as frusemide, ethacrynic acid
anticancer drugs such as cisplatin
any drug that may cause kidney or hearing problems
amphotericin, an anti-fungal medicine
muscle relaxants such as suxamethonium.
These medicines may be affected by tobramycin works 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 PF.

How Tobramycin PF is given

Tobramycin PF must only be given by a doctor or nurse. Tobramycin PF can be given:
directly into a vein via an injection (intravenously), which is infused over a period of 20 to 60 minutes (Tobramycin PF will be diluted before being injected into your vein)
as a deep injection into a large muscle (intramuscular).

How much is given

Your doctor will decide how much Tobramycin PF 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.

If you are given too much (overdose)

As Tobramycin PF 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 are given too much tobramycin you may experience some of the effects listed under "Side effects" below.
Your doctor has information on how to recognise and treat an overdose.
Ask your doctor if you have any concerns.
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Tobramycin PF. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

While you are being given Tobramycin PF

Things your doctor should do

Your doctor or nurse should take regular blood and urine samples while you are receiving Tobramycin PF. 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 or pharmacist who treats you that you are taking this medicine.
Tell all doctors, dentists and pharmacists who are treating you that you are being given tobramycin.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking 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 PF affects you.
This medicine may cause tiredness 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 requiring attention such as riding bicycles or climbing.

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 PF.
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.
Do not be alarmed by the following list of possible side effects. You may not experience any of them.
Ask your doctor or nurse to answer any questions that you may have.
Tell your doctor or nurse if you notice any of the following and they worry you:
pain, swelling or red skin where you had the injection
fever
skin problems such as rash or itching
headache
signs of anaemia, such as tiredness, being short of breath and looking pale
bruising more easily than normal
confused state
disorientation
nausea
vomiting.
Tell your doctor or nurse immediately if you notice any of the following:
swelling of the lips, face, mouth, throat or limbs; breathing difficulty, or shortness of breath; rash, itching, hives
kidney problems, e.g. increase or decrease in urination
dizziness
ringing in the ears (known as tinnitus)
hearing loss
vertigo
muscle weakness
diarrhoea, even after stopping antibiotics for several weeks.
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 received Tobramycin PF

Storage

Tobramycin PF will be stored in the pharmacy or ward. It is kept refrigerated between 2-8°C protected from light. Refrigerate, do not freeze.

Product Description

What it looks like

Tobramycin PF is a clear solution in a plastic ampoule.

Ingredients

Active ingredient:
tobramycin (as tobramycin sulfate BP).
Other ingredients:
disodium edetate
Water for Injections.
This medicine does not contain preservatives.

Supplier

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
Tobramycin PF is available in the following strength and pack size:
Tobramycin 80 mg/2 mL (as tobramycin sulfate) x 5 ampoules (AUST R 10776).
This leaflet was prepared in August 2019.
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