Consumer Information for: COLISTIMETHATE FOR INJECTION

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.

Interactions with this medication

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

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
  • 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 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
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
  • Colistimethate for Injection, USP in powder form should be stored at controlled room temperature (between 15 °C to 30 °C).
  • Reconstituted Colistimethate for Injection, USP solution can be stored at room temperature (15 °C to 30 °C) for up to 7 days.
  • Infusion solution containing Colistimethate for Injection, USP should be freshly prepared and used within 24 hours.

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

If you want more information about Colistimethate for Injection, USP:

  • Talk to your healthcare professional
  • Find the full prescribing information 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 (https://www.fresenius-kabi.com/en-ca), or by calling 1-877-821-7724.

Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Questions or Concerns? 1-877-821-7724

Last revised: January 27, 2020

Fresenius Kabi is a registered trademark of Fresenius SE.

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