Linezolid Injection (Mda): Uses, Side Effects and Dosage

What the medication is used for:

Linezolid Injection is a medicine your doctor has chosen to treat your bacterial infection.

What it does:

Linezolid Injection 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 Injection (linezolid).

• If you are allergic to any ingredients in the product (see

  what the 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:

linezolid

What the nonmedicinal ingredients are:

Linezolid Injection contains glucose monohydrate 50.24 mg, sodium citrate 1.64 mg; citric acid 1.05 mg; water for injection, q.s.: pH adjusted with hydrochloric acid and sodium hydroxide.

What dosage forms it comes in:

Injection: 2 mg/mL

BEFORE you use Linezolid Injection 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 hemoglobin), 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

  Injection or its ingredients.

• you are pregnant or trying to become pregnant.

• you are breast-feeding.
• you have a history of seizures or convulsions
• you have diabetes, as Linezolid Injection may cause low blood sugar (hypoglycemia).

Drugs that may interact with Linezolid Injection include:

• medications containing sympathomimetic agents such as pseudoephedrine HCl, often found in cold remedies and decongestants.
• serotonin re-uptake inhibitors or other antidepressants. ABOUT THIS MEDICATION

WARNINGS AND PRECAUTIONS

INTERACTIONS WITH THIS MEDICATION

Linezolid Injection 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 Injection. 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 flavor, such as aged cheeses (0 to 15 mg tyramine per 28 gm); fermented or air-dried meats (0.1 to 8 mg tyramine per 28 gm); sauerkraut (8 mg tyramine per 224 gm); 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.

Usual adult dose:

Each dose should be taken twice daily (every 12 hours).

The safety and effectiveness of Linezolid Injection in children has not been established.

A course of treatment usually lasts 10 to 14 days, but may last up to 28 days.

Remember: This medicine has been prescribed for you personally and you should not let other people use it. It may harm them, even if their symptoms are the same as yours.

Overdose:

• 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 discoloration and fever.
• Less common side effects reported include: insomnia, constipation, rash, dry mouth, stomach discomfort, increased thirst, hyperglycemia (e.g. high blood sugar), hypoglycemia (e.g. low blood sugar), ringing in the ear and high blood pressure.

If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking Linezolid Injection and contact your healthcare professional immediately.

If you notice any other side effects after taking this medicine that do not appear in the list above, tell your doctor or pharmacist.

Missed Dose:

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule as prescribed by your doctor. Do not take double doses to make up for missing a dose.

• Like all medicines, Linezolid Injection 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 linezolid.

PROPER USE OF THIS MEDICATION

If you think you have taken too much Linezolid Injection, 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

This is not a complete list of side effects. For any unexpected effects while taking Linezolid Injection, contact your doctor or pharmacist.

HOW TO STORE IT

Linezolid Injection: Store Linezolid Injection infusion bags at controlled room temperature between 15-30°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.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting

  (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

This document plus the full product monograph prepared for health professionals can be found by contacting the sponsor at 1-855-819-0505

206-2401 Bristol Circle

Oakville, Ontario

L6H 5S9

Last revised: March 8, 2017