Linezolid Injection - Consumer Medicine Information
|Manufacture:||Fresenius Kabi USA, LLC|
|Condition:||Bacteremia, Bacterial Infection, Methicillin-Resistant Staphylococcus Aureus Infection, Nosocomial Pneumonia, Pneumonia, Skin and Structure Infection|
|Form:||Liquid solution, Intravenous (IV)|
About This Medication
What the Medication is Used For
Linezolid is a medicine your doctor has chosen to treat your bacterial infection.
What It Does
Linezolid belongs to the class of medicines called antibiotics. It works by stopping the production of some bacterial proteins needed for growth, leading to bacterial death and reduction of the infection.
When It Should not be Used
- If you have ever had any unusual or allergic reaction to linezolid.
- If you are allergic to any ingredients in the product (see what the important nonmedicinal ingredients are).
- If you are taking medications that inhibit monoamine oxidases (e.g., phenelzine, isocarboxazid) or within 2 weeks of taking these medications.
- If you have uncontrolled high blood pressure, pheochromocytoma (e.g., tumor of adrenal gland), thyrotoxicosis (condition from overactive thyroid gland), and/or taking sympathomimetic agents (e.g., pseudoephedrine, phenylpropanolamine*), vasopressive agents (e.g., epinephrine, norepinephrine) or dopaminergic agents (dopamine, dobutamine) unless you are monitored for potential increases in blood pressure.
- If you have carcinoid syndrome and/or are taking selective serotonin re-uptake inhibitors (SSRI’s), tricyclic antidepressants, serotonin 5-HT1 receptor agonists (e.g., “triptans”), meperidine or buspirone except as advised by your doctor.
* phenylpropanolamine is no longer marketed in Canada
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
Linezolid Injection contains: citric acid, dextrose, hydrochloric acid (pH adjustment), sodium citrate, sodium hydroxide (pH adjustment), and water for injection.
What Dosage Form It Comes In
Injection 2 mg/mL
Warnings and Precautions
BEFORE you use linezolid talk to your doctor or pharmacist if:
- You have a history of high blood pressure.
- You are taking any cold or flu remedies or decongestants containing pseudoephedrine.
- You are taking any antidepressants especially those known as serotonin re-uptake inhibitors.
- You are taking any other medicines, including those you have bought without a prescription.
- You have a history of anemia (low haemoglobin), thrombocytopenia (low platelets), neutropenia (low white blood cells) or any other blood related disorders.
- You have a history of bleeding problems.
- You ever had any unusual or allergic reaction to Linezolid or its ingredients (such as preservatives or dyes).
- You are pregnant or trying to become pregnant.
- You are breast-feeding.
- You have a history of seizures or convulsions
Interactions With This Medication
Drugs that may interact with linezolid include.
- Medications containing sympathomimetic agents such as pseudoephedrine HCl, often found in cold remedies and decongestants.
- Serotonin re-uptake inhibitors or other antidepressants.
Linezolid may react with a substance, which is naturally present in some foods called tyramine. Foods or beverages with high tyramine content should be avoided while taking linezolid. Quantities of tyramine consumed should be less than 100 mg per meal. Foods high in tyramine content include those that may have undergone protein changes by aging, fermentation, pickling, or smoking to improve flavour flavour, such as aged cheeses (0 to 15 mg tyramine per 28 g); fermented or air dried meats (0.1 to 8 mg tyramine per 28 g); sauerkraut (8 mg tyramine per 224 g); soy sauce (5 mg tyramine per 1 teaspoon); tap beers (4 mg tyramine per 360 mL); red wines (0 to 6 mg tyramine per 240 mL). The tyramine content of any protein-rich food may be increased if stored for long periods or improperly refrigerated. If you develop a throbbing headache after eating or drinking, tell your doctor or pharmacist.
Proper Use of This Medication
Usual Adult Dose
Each dose should be administered twice daily (every 12 hours). The safety and effectiveness of linezolid in children has not been established.
A course of treatment usually lasts 10 to 14 days, but may last up to 28 days.
If you have been administered too much linezolid by accident, call your doctor or pharmacist or contact your regional poison control centre, or contact/go to the nearest emergency centre immediately.
Side Effects and What to do About Them
- Like all medicines, linezolid can cause some unwanted effects in some people. These usually do not last very long and will not mean that you have to stop taking the medication.
- More common side effects reported include: headache,diarrhea, nausea, vomiting, dizziness, taste alteration, fungal infections, especially vaginal or white patches in mouth, tongue, or throat (oral “thrush”), tongue discolouration and fever.
- Less common side effects reported include: insomnia,constipation, rash, dry mouth, stomach discomfort, increased thirst, hyperglycemia (e.g., high blood sugar), ringing in the ear and high blood pressure.
If you notice any other side effects after taking this medicine that do not appear in the list above, tell your doctor or pharmacist.
Serious Side Effects, how Often They Happen and What to Do About Them
|Symptom / effect||Talk with your doctor or pharmacist||Stop taking drug and call your doctor or pharmacist|
|Only if severe||In all cases|
|Uncommon||Bleeding, bruising, unexplained fatigue, shortness of breath, fever, and/or weakness (blood disorders)||✓|
|Visual impairment, blurred vision or loss of vision||✓|
|Numbness, tingling, pricking sensations or burning pain||✓|
|Acute or recurrent nausea, vomiting and diarrhea (lactic acidosis)||✓|
|Rash, difficulty breathing (allergic reactions)||✓|
|Frequent bloody diarrhea (pseudo-membranous colitis)||✓|
|Agitation, confusion, delirium, rigidity, tremor, incoordination and seizure while also taking a serotonergic medication (serotonin syndrome)||✓|
This is not a complete list of side effects. For any unexpected effects while taking drug, contact your doctor or pharmacist.
How to Store Linezolid Injection
Store Linezolid Injection infusion bags in controlled room temperature between 15 °C – 25 °C. Protect from light. Protect from freezing. Keep the infusion bags in the overwrap until ready to use. Linezolid Injection may exhibit a yellow colour that can intensify over time without adversely affecting potency.
Linezolid Injection must be kept out of reach and sight of children and pets.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
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.
This document plus the full Product Monograph, prepared for health professionals, can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at: 1-877-821-7724
Fresenius Kabi Canada Ltd.
45 Vogell Rd, Suite 200
Richmond Hill, ON L4B 3P6
Last revision: March 5, 2015