Patient Medication Information: uses, side effects, how to take - Polymyxin B for Injection USP
ABOUT THIS MEDICATION
What the medication is used for:
Polymyxin B for Injection USP is used in the treatment of
serious infections caused by “gram-negative” bacteria such as Pseudomonas aeruginosa.
What it does:
Polymyxin B for Injection USP works to reduce the bacteria that cause serious infections by weakening the cell membrane of the harmful bacteria.
When it should not be used:
Polymyxin B for Injection USP should not be used if:
you have or have had an allergic reaction to polymyxin B or
other polymyxins
- you have myasthenia gravis
What the medicinal ingredient is:
Polymyxin B Sulphate
What the important nonmedicinal ingredients are:
There are no additional ingredients in Polymyxin B for Injection USP.
What dosage forms it comes in:
Polymyxin B for Injection USP is available as powder for solution. It is available in single vial cartons containing polymyxin B 50 mg/vial (500,000 units) as polymyxin B sulphate
WARNINGS AND PRECAUTIONS
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Where injection of Polymyxin B for Injection USP into the body is required it should be restricted to hospitalized patents where adequate laboratory control facilities are available, and constant supervision of the patient is possible.
Before you use Polymyxin B for Injection USP talk to your doctor or pharmacist if:
- You have a kidney disease.
Are pregnant or planning to get pregnant.
- You are taking any prescription medications, over the counter medications or herbal/natural products or remedies.
- You have a prior allergy to a medication.
- You have porphyria (disease of pigment metabolism to the body).
If you develop severe or persistent diarrhea, this may be a sign of a more serious condition and you should contact a doctor immediately.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicine you can buy without a prescription, and natural health products.
Drugs that may interact with Polymyxin B for Injection USP, and should not be used, include:
bacitracin, kanamycin, streptomycin, tobramycin, amikacin, cephaloridine, paromycin, polymyxin E (colistin), neomycin, gentamicin, vancomycin, tubocurarine, succinylcholine, gallamine, decamethonium and sodium citrate
PROPER USE OF THIS MEDICATION
Usual dose:
Polymyxin B for Injection USP will be administered by a health care professional in a hospital or under direct supervision and monitoring by a healthcare professional. Although it is common to feel better early in the course of therapy, the medication should be used exactly as directed.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
IMPORTANT: PLEASE READ
Polymyxin B for Injection Page 26 of 26
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effects are kidney problems such as albuminuria, cellular casts, diminishing urine output and rising BUN, neurological problems such as apnea, numbness, vertigo, blurred vision, facial flushing, and slurring of speech, pain at the injection site, skin redness and itching.
A hypersensitivity (allergic, anaphylactic) reaction with symptoms such as bronchoconstriction (narrowing of the breathing tubes) and interruption in breathing (apnea), rash, hives, itching, and swelling of tissues have been reported with inhaled polymyxin B sulphate.
This is not a complete list of side effects. For any unexpected effects while taking Polymyxin B for Injection USP, contact your doctor or pharmacist.
HOW TO STORE IT
Before reconstitution: Store at room temperature 15- 30°C. Protect from light.
After reconstitution for Intravenous, Intramuscular, Intrathecal and Ophthalmic (Subconjunctival): Reconstituted solutions should be stored under refrigeration (2-8°C) and the unused portion should be discarded after 24 hours. After reconstitution for Ophthalmic (Topical): Reconstituted solutions should be stored under refrigeration (2-8°C). Any unused portion should be discarded after 72 hours.
REPORTING SUSPECTED 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 3 ways:
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- 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 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, SteriMax Inc. at:
1-800-881-3550
SteriMax Inc.
1-2735 Matheson Blvd. East Mississauga, ON
L4W 4M8
