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.

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 include 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
www.pfizermedinfo.com.au

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: September 2022.

™ = Trademark

© Copyright

Published by MIMS November 2022

1 Name of Medicine

Tobramycin.

2 Qualitative and Quantitative Composition

The vials of DBL Tobramycin Injection BP contain 80 mg/2 mL tobramycin. The vials contain disodium edetate 0.2 mg, sodium metabisulfite 4.8 mg, sulfuric acid 34.6 mg and water for injections. In the manufacture of the vials, additional sulfuric acid and/or sodium hydroxide may have been added to adjust the pH.
Excipients with known effect. Sodium metabisulfite.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
DBL Tobramycin Injection BP is a clear, colourless solution. The pH of the solution is approximately 5.5.

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. The severity of the signs and symptoms following a tobramycin overdose are dependent on the dose administered, the patient's renal function, state of hydration, age, and whether or not other medications with similar toxicities are being administered concurrently. Toxicity may occur in patients treated for more than 10 days, given more than 5 mg/kg/day, children given more than 7.5 mg/kg/day, or patients with reduced renal function whose dose has not been appropriately adjusted.
Nephrotoxicity following the parenteral administration of an aminoglycoside is most closely related to the area under the curve of the serum concentration versus time graph. Nephrotoxicity is more likely if trough blood concentrations fail to fall to below 2 microgram/mL and is also proportional to the average blood concentration. Patients who are elderly, have abnormal renal function, are receiving other nephrotoxic or ototoxic drugs or are volume depleted are at greater risk for developing acute tubular necrosis. Auditory and vestibular toxicities have been associated with aminoglycoside overdose.
These toxicities occur in patients treated longer than 10 days, in patients with abnormal renal function, in dehydrated patients or in patients receiving medications with additive auditory toxicities. These patients may not have signs or symptoms or may experience dizziness, tinnitus, vertigo and loss of high tone acuity as ototoxicity progresses. Ototoxicity signs and symptoms may not begin to occur until long after the drug has been discontinued.
Neuromuscular blockade or respiratory paralysis may occur following administration of aminoglycosides. Neuromuscular blockade, prolonged respiratory paralysis and respiratory failure may occur more commonly in patients with myasthenia gravis or Parkinson's disease. Prolonged respiratory paralysis may also occur in patients receiving decamethonium, tubocurarine or suxamethonium.
If tobramycin were ingested, toxicity would be less likely because aminoglycosides are poorly absorbed from an intact gastrointestinal tract.
Treatment. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics in the patient. If neuromuscular blockade occurs, it may be reversed by the administration of calcium salts but controlled or assisted ventilation may be necessary.
The initial intervention in a tobramycin overdose is to establish an airway and ensure oxygenation and ventilation. Resuscitative measures should be initiated promptly if respiratory paralysis occurs.
Patients who have received an overdose of tobramycin and have normal renal function should be adequately hydrated to maintain a urine output of 3 to 5 mL/kg/hr. Fluid balance, creatinine clearance and tobramycin plasma levels should be carefully monitored until the serum tobramycin level falls below 2 microgram/mL.
Patients in whom the elimination half-life is greater than 2 hours or whose renal function is abnormal may require more aggressive therapy. In such patients, haemodialysis may be beneficial.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Tobramycin is a white or almost white hygroscopic powder. It is freely soluble in water, very slightly soluble in alcohol and practically insoluble in chloroform and in ether.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTOBRAM.gif Chemical name: 6-O-(3-amino-3-deoxy-alpha-D-glucopyranosyl)-2-deoxy-4-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyl)-D-streptamine.
Molecular formula: C₁₈H₃₇N₅O₉.
Molecular weight: 467.5.
CAS number. 32986-56-4.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TOBRAMST.gif