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Details for: TOBRAMYCIN

Company: FRESENIUS KABI CANADA LTD

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
00533688TOBRAMYCIN FOR INJECTIONTOBRAMYCIN (TOBRAMYCIN SULFATE)1.2 G / VIALPOWDER FOR SOLUTIONINTRAVENOUS
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Tobramycin Injection, USP and Tobramycin for Injection, USP are 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 muscle.

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

What it does

Tobramycin 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 and Tobramycin for Injection, USP).
  • you are allergic to other aminoglycosides.
What the medicinal ingredient is

Tobramycin Injection:

Medical ingredients: Tobramycin

Tobramycin for Injection:

Medical ingredients: Tobramycin supplied as Tobramycin sulfate

What the non-medicinal ingredients are

Tobramycin Injection:

Non-medical ingredients: edetate disodium, phenol, sodium metabisulfite in water for injection. May also contain sodium hydroxide and/or sulfuric acid for pH adjustment.

Tobramycin for Injection:

Non-medical ingredients: None

What dosage form it comes in

Tobramycin Injection, USP and Tobramycin for Injection, USP come in the following dosage forms:

Tobramycin Injection, USP:

  • Liquid for Injection - 10 mg / mL and 40 mg / mL

Tobramycin for Injection, USP:

  • Powder for Injection – 1.2g / vial
Warnings and precautions

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

  • have drug allergies.
  • have hearing or balance problems.
  • have kidney problems.
  • 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, Tobramycin for 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 or Tobramycin for Injection, USP.

Your doctor may monitor the level of Tobramycin Injection, USP and Tobramycin for 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 bon-prescription), vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

The following may interact with Tobramycin Injection, USP and Tobramycin for Injection, USP:

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

How to take Tobramycin Injection, USP and Tobramycin for Injection, USP:

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

Tobramycin Injection, USP and Tobramycin for 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 or Tobramycin for 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 or Tobramycin for Injection, USP, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you have missed a dose of medication, contact your healthcare professional.

Side effects and what to do about them

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

Stop taking Tobramycin Injection, USP and Tobramycin for Injection, USP and contact your doctor if:

  1. you have symptoms of an allergic reaction such as:
  • rash, hives, itching or skin irritation.
  • reaction at the injection site.
  • 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, how often they happen and what to do about them
    Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and talk with your doctor or pharmacist
    Uncommon
    Kidney problems (decreased urination)   ✔ ✔
    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
    • bloody or watery diarrhea
    • abdominal or stomach pain/cramping
    • blood/mucus in stool
    		    ✔

    If you have 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.

    Keep out of reach and sight of children.

    Reporting side effects

    You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

    • Report online at www.healthcanada.gc.ca/medeffect
    • Call toll-free at 1-866-234-2345
    • Complete a Canada Vigilance Reporting Form and:
      • Fax toll-free to 1-866-678-6789, or
      • Mail to:
        Canada Vigilance Program
        Health Canada
        Postal Locator 0701E
        Ottawa ON K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

    NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

    More information

    If you want more information about Tobramycin Injection, USP and Tobramycin for Injection, USP:

    • Talk to your healthcare professional
    • 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/healthcanada.html); Fresenius Kabi Canada’s website (https://www.fresenius-kabi.com/en-ca/), or by calling 1-877- 821-7724

    This leaflet was prepared by:

    Fresenius Kabi Canada Ltd.
    165 Galaxy Blvd, Suite 100
    Toronto, ON M9W 0C8

    Last revised: October 23, 2018

    Date modified: