Consumer Information for: TOBRAMYCIN FOR INJECTION USP

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Tobramycin for Injection USP is an antibiotic for intravenous infusion used to treat resistant infections of the respiratory tract, blood, urinary tract and central nervous system, as well as serious skin and soft tissue infections.

Antibacterial drugs like Tobramycin for Injection USP treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Tobramycin for Injection USP should be used exactly as directed. Misuse or overuse of Tobramycin for Injection USP could lead to the growth of bacteria that will not be killed by Tobramycin for Injection USP (resistance). This means that Tobramycin for Injection USP may not work for you in the future. Do not share your medicine.

Tobramycin for Injection USP may be indicated for the treatment of the following infections when caused by susceptible organisms: septicemia, complicated and recurrent urinary tract infections, lower respiratory infections, serious skin and soft tissue infections including burns and peritonitis and central nervous system infections caused by organisms resistant to antibiotics usually considered efficacious in these infections.

Tobramycin for Injection USP is usually active against most strains of the following organisms in vitro and in clinical infections:

  • Pseudomonas aeruginosa Proteus sp. (Indole-positive and indole- negative), including Proteus mirabilis, Morganella morganii, Providencia rettgeri, and Proteus vulgaris Escherichia coli Klebsiella-Enterobacter-Serratia group Citrobacter sp. Providencia sp. Staphylococci, including Staphylococcus aureus (coagulase-positive and coagulase-negative)
What it does

Tobramycin for Injection USP is believed to interfere with the bacteria’s normal protein synthesis so that it cannot grow or function properly.

When it should not be used

If you are allergic (hypersensitive) to tobramycin or other aminoglycosides.

What the medicinal ingredient is

tobramycin sulphate

What the non-medicinal ingredients are

Sulfuric Acid and/or Sodium Hydroxide may have been added during manufacturing to adjust pH.

What dosage form it comes in

Each vial contains tobramycin sulphate equivalent to 1.2 g tobramycin.

Warnings and precautions

Serious Warnings and Precautions

Patients treated with Tobramycin for Injection USP or other aminoglycosides should be under close clinical observation because these drugs have an inherent potential for causing ototoxicity and nephrotoxicity.

Tobramycin for Injection USP and other similar aminoglycosides have been known to cause hearing and balance problems (ototoxicity) and kidney problems (nephrotoxicity). Your doctor will observe you carefully for warning signs of these events after giving you Tobramycin for Injection USP.

Before using Tobramycin for Injection USP, tell your doctor if you (or your child) have or have had:

  • Drug allergies
  • Hearing or balance problem
  • Kidney problems
  • Myasthenia gravis (a muscle condition)
  • Parkinson’s Disease

Tell your doctor if you are pregnant, breastfeeding, are planning to become pregnant.

Your doctor may monitor the level of Tobramycin for Injection USP in your blood through blood tests, especially if you are taking medications.

Interactions with this medication

Tobramycin for Injection USP may interact with other medications. Tell your doctor if you (or your child) are taking any medications, especially the following:

  • Aminoglycosides (e.g. amikacin, streptomycin, neomycin, kanamycin, gentamycin, paramomycin)
  • Amphotericin B
  • Anaesthetics
  • Cephaloridin
  • Cisplatin
  • Diuretics (specifically potent diuretics)
  • Polymyxin B
  • Succinylcholine
  • Tubocurarine
  • Vancomycin
  • Viomycin
Proper use of this medication

Tobramycin for Injection USP is for intravenous infusion only.

Usual Dose

The amount of antibiotic you (or your child) will receive will be determined by your healthcare professional. It is dependant upon a number of factors, including your age, weight, type of infection, and any pre-existing medical conditions.

You may receive Tobramycin for Injection USP several times a day over a period of 7-10 days.

Overdose

Your healthcare professional is trained to recognize the symptoms of an overdose, and deal with its symptoms.

Side effects and what to do about them

You may experience side effects from using Tobramycin for Injection USP including:

  • Diarrhea
  • Fever
  • Headache
  • Hives
  • Itching or skin irritation
  • Nausea
  • Rash
  • Reaction at the injection site
  • Tiredness
  • Vomiting

Tell your doctor if you notice any of the above.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect Talk with your doctor or pharmacist
Only if severe		 Talk with your doctor or pharmacist
In all cases		 Stop taking drug and call your doctor or pharmacist
Uncommon
Kidney problems (decreased urination)   ✔ ✔
Hearing and balance problems (loss of hearing, ringing in the ears, dizziness, loss of balance)   ✔ ✔
Anemia (symptoms include weakness, exhastion, pale skin)   ✔ ✔
Unusual respiratory difficulties (difficulty breathing)   ✔ ✔

There are also other effects which can occur while you are taking tobramycin. These more rarely include kidney and respiratory difficulties. Nerve problems such as hearing, balance, or dizziness, which you may not have experienced before, can occur when you are being administered the drug or may appear weeks after taking it. It is important that you immediately advise your doctor of such events.

This is not a complete list of side effects. For any unexpected effects while taking Tobramycin for Injection, USP contact your doctor or pharmacist.

How to store

Tobramycin for Injection USP in powder form should be stored at room temperature (15 - 30 ° C).

Protect from light.

Do not use if the solution is hazy, discoloured, leaking, or contains particulate matter (precipitate)

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Note: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be found at: http://www.sterimaxinc.com or by contacting the sponsor, SteriMax Inc., at: 1-800-881-3550

This leaflet was prepared by SteriMax Inc.

Last revised: August 15, 2018

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