Novo-Linezolid: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NOVO-LINEZOLID is a medicine your doctor has chosen to treat your bacterial infection.

What it does:

NOVO-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

  NOVO-LINEZOLID (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:

linezolid

What the important nonmedicinal ingredients are: NOVO-LINEZOLID Tablets contain: crospovidone, Croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol and titanium dioxide.

What dosage forms it comes in: Tablets: 600 mg

WARNINGS AND PRECAUTIONS

BEFORE you use NOVO-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 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 NOVO-

  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 NOVO-LINEZOLID include:

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

NOVO-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 NOVO-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 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.

PROPER USE OF THIS MEDICATION

Usual dose:

NOVO-LINEZOLID Tablets:

Each dose should be taken twice daily (every 12 hours). NOVO-LINEZOLID may be taken with or without food.

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.

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:

If you take too much NOVO-LINEZOLID by accident, call your doctor or pharmacist or contact your regional poison control centre, or contact/go to the nearest emergency centre immediately.

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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

• Like all medicines, NOVO-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 tablets.

• 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), 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.

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

HOW TO STORE IT

NOVO-LINEZOLID Tablets:

Store at room temperature, 15 to 30°C. Protect from light. Keep bottles tightly closed to protect from moisture. Keep out of the reach of children.

You should not use your medication after the expiration date printed on the label.

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:

------------------------------------------------------------- $ 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, ON 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 Teva Canada Limited at:

1-800-268-4127 ext. 5005 (English);

1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: November 17, 2010