Consumer Information for: COLISTIMETHATE FOR INJECTION U.S.P.

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

Colistimethate for Injection USP is used to treat infections:

  • that are sudden and severe
  • or are chronic
  • caused by certain bacteria
  • that are proven or strongly suspected to be caused by certain bacteria

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

What it does

Colistimethate for Injection USP is an antibiotic that kills bacteria in your body by damaging the cell wall of the bacteria.

When it should not be used

Do not use Colistimethate for Injection USP if you:

  • are allergic or you have a sensitivity to this medicine.
  • are pregnant.
What the medicinal ingredient is

Medicinal ingredients: colistin (as colistimethate sodium).

What the non-medicinal ingredients are

Non-medicinal ingredients: none.

What dosage form it comes in

As a sterile powder for solution in a vial containing 150 mg colistin.

Warnings and precautions

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

  • have kidney problems.

Other warnings you should know about:
Colistimethate for Injection USP may cause dizziness or light-headedness. Do not drive or use machines while you are receiving this medicine.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

The following medicines may interact with Colistimethate for Injection USP:

  • Other antibiotics such as kanamycin, streptomycin, dihydrostreptomycin, polymyxin, and neomycin.
  • Muscle relaxants such as ether, tubocurarine, succinylcholine, gallamine, decamethonium and sodium citrate. These should be used with extreme caution.
Proper use of this medication

How to take Colistimethate for Injection USP:

  • Colistimethate for Injection USP will be given to you by a healthcare professional.
  • It will either be infused directly into your vein or;
  • It will be injected into your muscle.
  • Follow all instructions given to you by your healthcare professional.

Usual Dose

  • Your healthcare professional will decide how much Colistimethate for Injection USP you will receive.
  • You will receive it 2, 3 or 4 times a day.
  • Your healthcare professional will decide how often and for how long you will receive Colistimethate for Injection USP.

Overdose

Overdosage can result in kidney problems, muscle weakness and difficulty breathing.

If you think you have received too much Colistimethate for Injection USP, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Side effects and what to do about them

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

Side effects may include:

  • dizziness or vertigo (light-headedness)
  • tingling of the tongue
  • itching of the skin
  • hives
  • fever
  • nausea and vomiting
  • upset stomach
  • diarrhea

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 Get Immediate Medical Help
Rare
Breathing difficulty, breathing stops    
Kidney problems: abdominal or back pain, dark urine, decreased urination, nausea, swelling of the arms or legs, vomiting, weakness    
Slow or slurred speech    
Tingling, prickling, numbness or burning of hands or feet or around the mouth    

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 Colistimethate for Injection USP in powder form at controlled room temperature (15°C-30°C).
  • After reconstitution, Colistimethate for Injection USP solution should be stored refrigerated (2°C-8°C) or at room temperature (15°C-30°C) and used within 7 days.
  • Infusion solution containing colistimethate sodium should be freshly prepared and used for no longer than 24 hours.

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 Colistimethate 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://health-products.canada.ca/dpd-bdpp/index-eng.jsp), the manufacturer’s website (www.sterimaxinc.com), or by calling 1-800-881-3550.

This leaflet was prepared by SteriMax Inc.

SteriMax Inc., Oakville, ON L6H 6R4

www.sterimaxinc.com

Last Revised: October 19, 2018