Consumer Information for: TOBRAMYCIN 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 Injection USP is used to treat certain bacterial infections:

  • of the chest and lungs (lower respiratory tract).
  • in the blood.
  • of the kidneys and urinary bladder (urinary tract).
  • in the brain, spinal cord and nerves (central nervous system).
  • of the skin and soft tissues.

    • Antibacterial drugs like Tobramycin 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 Injection USP should be used exactly as directed. Misuse or overuse of Tobramycin Injection USP could lead to the growth of bacteria that will not be killed by Tobramycin Injection USP (resistance). This means that Tobramycin Injection USP may not work for you in the future.

    What it does

    Tobramycin Injection USP is an antibiotic. It works by killing or slowing the growth of certain types of bacteria that cause the infection.

    When it should not be used
    • you are allergic to tobramycin or any ingredients in the drug (See What are the ingredients in Tobramycin Injection USP).
    • you are allergic to other aminoglycosides.
    What the medicinal ingredient is

    tobramycin sulfate

    What the non-medicinal ingredients are

    disodium etetate, phenol, sodium bisulfate, and water for injection. Tiny amounts of sulfuric acid or sodium hydroxide are sometimes added to maintain proper pH balance.

    What dosage form it comes in

    Solution, in 10 mg/mL and 40 mg/mL.

    Warnings and precautions

    To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Tobramycin Injection USP. Talk about any health conditions or problems you may have, including if you:

  • have kidney problems.
  • have hearing or balance problems.
  • have drug allergies.
  • have myasthenia gravis (a muscle condition).
  • have Parkinson’s Disease.
  • are pregnant or planning to become pregnant.
  • are breastfeeding or planning to breastfeed.

    • Other warnings you should know about:
    Tobramycin Injection USP and other similar aminoglycosides have been known to cause hearing and balance problems and kidney problems. Your doctor will observe you carefully for warning signs of these events after giving you Tobramycin Injection USP.

    Your doctor may monitor the level of Tobramycin Injection USP in your blood through blood tests, especially if you are taking, or have taken in the recent past, certain medications that can interact with tobramycin.

    Tell your healthcare professional about all the medicines you take, or have taken in the recent past, including any drugs (prescription and non-prescription), vitamins, minerals, natural supplements or alternative medicines.

    Interactions with this medication
    • aminoglycosides (e.g. amikacin, streptomycin, neomycin, kanamycin, gentamicin, paromomycin)
    • diuretics (specifically potent diuretics)
    • amphotericin B
    • cephaloridine
    • viomycin
    • polymyxin B
    • colistin
    • cisplatin
    • vancomycin
    • succinylcholine
    • tubocurarine
    • decamethonium
    Proper use of this medication

    Tobramycin Injection USP is for intramuscular injection or intravenous infusion after dilution. The usual intravenous infusion time is 20 to 60 minutes.

    Tobramycin Injection USP will be given to you by a doctor or nurse in a hospital or clinical setting.

    Usual Dose

    Your doctor will give you the most appropriate dose based on your age, weight, the type of infection you have, and any medical conditions you may have.

    You may receive Tobramycin Injection USP several times a day over a period of 7 to 10 days. Your doctor may decide to give it to you for a longer period depending on the type and severity of your bacterial infection.

    Overdose

    If you think you have taken too much Tobramycin Injection USP, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

    Missed Dose

    Side effects and what to do about them

    These are not all the possible side effects you may feel when taking Tobramycin Injection USP. If you experience any side effects not listed here, contact your healthcare professional.

    Stop taking Tobramycin Injection USP and contact your doctor if:

          a)  you have symptoms of an allergic reaction such as:
      •         rash, hives, itching or skin irritation.
      •         reaction at the injection site.

          b)  you have severe diarrhea (bloody or watery) with or without:
      •         fever
      •         stomach pain or tenderness
        • You may have Clostridium difficile colitis (bowel inflammation). See your doctor right away.

    Other side effects include:

  • diarrhea
  • fever
  • headache
  • nausea
  • tiredness
  • vomiting
    • Serious side effects and what to do about them
    Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
    UNCOMMON
    Hearing and balance problems (loss of hearing, ringing in the ears, roaring in the ears, dizziness, loss of balance)   ✔ ✔
    Anemia (symptoms include weakness, exhaustion, pale skin)   ✔ ✔
    Unusual respiratory difficulties (difficulty breathing)   ✔ ✔
    Symptoms of a severe bowel condition (Clostridium difficile colitis):
  • persistent diarrhea
  • abdominal or stomach pain/cramping
  • bloody or watery diarrhea
  • blood/mucus in stool
    		•      ✔

    If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

    How to store

    Store in the original container between 15°C and 30°C, protected from light.

    Keep out of reach and sight of children.

    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
    • Talk to your healthcare professional.
    • For questions or concerns contact the manufacturer, Sandoz Canada Inc. (medinfo@sandoz.com).
    • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.

    This leaflet was prepared by Sandoz Canada Inc., Boucherville, Quebec, J4B 7K8

    Last Revised: July 17, 2017

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