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 nurse.
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.
This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used.
If you have any concerns about taking this medicine, ask your doctor or nurse.
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
Tobramycin Injection may be prescribed for other reasons that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed it.
This medicine is available only with a doctor's prescription.
Before you are given Tobramycin Injection
Do not use Tobramycin Injection if:
you have an allergy to tobramycin or any of the ingredients listed at the end of this leaflet
you have an allergy to other aminoglycoside antibiotics such as 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 Injection 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 any of these apply to you, check with your doctor.
Before you are given it
Tell your doctor if:
1. you have any allergies to:
any other medicine
any other substances, such as foods, preservatives or dyes
2. you are pregnant or intend to become pregnant
Tobramycin may affect your developing baby if you take it during pregnancy. If it is necessary for you to be given Tobramycin Injection, your doctor will discuss with you the benefits and risks of using it during pregnancy.
3. you are breastfeeding or plan to breastfeed
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 breastfeeding.
4. 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 affecting movement)
Taking other medicines
Tell your doctor 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:
antibiotics
fluid tablets (diuretics) such as frusemide, ethacrynic acid, bumetanide
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 affect the way tobramycin works or may be affected by tobramycin. You may need different amounts of your medicine, or you may need to take a different medicine.
Your doctor will advise you about continuing to take other medicines while you are receiving Tobramycin Injection.
How Tobramycin Injection is given
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)
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.
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 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.
If you experience severe side effects, tell your doctor immediately or go to the nearest hospital emergency department.
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
Tell all doctors and dentists who are treating you that you are using tobramycin.
While you are using tobramycin, tell your doctor, nurse or pharmacist before you start any new medicine.
If you become pregnant while being treated with tobramycin, tell your doctor immediately.
Things to be careful of
As with other aminoglycoside medicines, tobramycin may cause feelings of tiredness or drowsiness in some people. Make sure you know how you react to tobramycin before you drive a car, operate machinery, or do anything else that could be dangerous if you are tired or drowsy. If this occurs, do not drive.
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.
Like other medicines, tobramycin may cause some unwanted side effects. These are likely to vary from patient to patient. Some side effects may be related to the dose of tobramycin. Hence, it is important that you tell your doctor as soon as possible about any unwanted effects. Your doctor may then decide to adjust the dose of tobramycin you are given.
Ask your doctor or nurse to answer any questions that you may have.
Do not be alarmed by the following list of possible side effects. You may not experience any of them.
If any of the following happen tell your doctor or nurse immediately or if you are not already in hospital, go to the emergency department at your nearest hospital:
swelling of the lips, face, mouth, throat or limbs
breathing difficulty, or shortness of breath
rash, itching, hives
These may be symptoms of an allergic reaction to tobramycin.
Tell your doctor or nurse immediately if you notice any of the following:
kidney problems, e.g. increase or decrease in urination
dizziness
ringing in the ears (known as tinnitus)
hearing loss
vertigo
These are serious side effects of Tobramycin Injection. You may need urgent medical attention.
Tell your doctor or nurse if you notice any of the following side effects 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
diarrhoea
After you have received Tobramycin Injection
Tell your doctor or nurse immediately if you notice any of the following side effects, even if they occur several weeks after stopping treatment with Tobramycin Injection:
kidney problems, e.g. increase or decrease in urination
dizziness
ringing in the ears (known as tinnitus)
hearing loss
vertigo
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor. Some side effects may only be seen by your doctor.
Storage
Tobramycin Injection will be stored in the pharmacy or 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
Tobramycin Injection contains tobramycin (as Tobramycin Sulfate BP) 80mg/2mL, Disodium Edetate BP, Phenol BP, 40% v/v Sulfuric Acid and Sodium Metabisulfite BP in Water for Injections BP.
