What Zyvoxam is used for and how to use it
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Zyvoxam - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Bacteremia, Bacterial Infection, Methicillin-Resistant Staphylococcus Aureus Infection, Nosocomial Pneumonia, Pneumonia, Skin and Structure Infection
Class: Oxazolidinone antibiotics
Form: Liquid solution, Intravenous (IV), Tablets, Powder, Syrup
Ingredients: inezolid, 2-ethoxyethanol, ammonium hydroxide, carnauba wax, corn starch, ethanol, ethyl acetate, hydroxypropylcellulose, hypromellose, iron oxide black, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac, sodium starch glycolate, and titanium dioxide; citric acid, dextrose, hydrochloric acid (pH adjustment), sodium citrate, sodium hydroxide (pH adjustment), and water for injection; sucrose, citric acid, sodium citrate, microcrystalline cellulose and carboxymethylcellulose sodium, aspartame, xanthan gum, mannitol, sodium benzoate, colloidal silicon dioxide, sodium chloride, flavors

linezolid tablets

linezolid injection

linezolid powder for oral suspension

About This Medication

What the Medication is Used For

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

What It Does

ZYVOXAM 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 ZYVOXAM (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 Important the Nonmedicinal Ingredients Are

ZYVOXAM (tablets) contains: 2-ethoxyethanol, ammonium hydroxide, carnauba wax, corn starch, ethanol, ethyl acetate, hydroxypropylcellulose, hypromellose, iron oxide black, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac, sodium starch glycolate, and titanium dioxide.

ZYVOXAM (injection) contains: citric acid, dextrose, hydrochloric acid (pH adjustment), sodium citrate, sodium hydroxide (pH adjustment), and water for injection.

ZYVOXAM (oral suspension) contains: sucrose, citric acid, sodium citrate, microcrystalline cellulose and carboxymethylcellulose sodium, aspartame, xanthan gum, mannitol, sodium benzoate, colloidal silicon dioxide, sodium chloride, and flavors.

What Dosage Form It Comes In

Tablets: 600 mg

Injection: 2 mg/mL

Oral Suspension: 100 mg/ 5 mL when reconstituted (following constitution of linezolid powder for oral suspension by the pharmacist, each 5 mL contains 100 mg of linezolid)

Warnings and Precautions

BEFORE you use ZYVOXAM 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 ZYVOXAM 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
  • you have diabetes, as ZYVOXAM may cause low blood sugar (hypoglycemia)

Interactions With This Medication

Drugs that may interact with ZYVOXAM include:

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

ZYVOXAM 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 ZYVOXAM. 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 Adult Dose

ZYVOXAM (tablets, injection and oral suspension):

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

The safety and effectiveness of ZYVOXAM 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

In case of drug overdose, contact a healthcare practitioner, hospital emergency department or your regional poison control centre, even if there are no symptoms.

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, ZYVOXAM 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 Athrush), 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 ZYVOXAM 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.

Symptom / effectTalk with your
doctor or
pharmacist
Stop taking
drug and
call your
doctor or
pharmacist
Only if
severe
In all
cases
UncommonBleeding, bruising, unexplained fatigue, shortness of breath, fever, and/or weakness (blood disorders)
Visual impairment, blurred vision or loss of vision
Numbness, tingling, prickling sensations or burning pain
Acute or recurrent nausea, vomiting and diarrhea (lactic acidosis)
Rash, difficulty breathing (allergic reactions)
Frequent bloody diarrhea (pseudomembranous 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 It

Zyvoxam (Tablets)

Store at room temperature, 15 to 30 C. Protect from light. Keep out of the reach and sight of children.

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

Zyvoxam (Injection)

Store ZYVOXAM (injection) infusion bags in controlled room temperature between 15-30°C. Protect from light. Protect from freezing. Keep the infusion bags in the overwrap until ready to use. ZYVOXAM (injection) may exhibit a yellow color that can intensify over time without adversely affecting potency.

Zyvoxam (Oral Suspension)

Store ZYVOXAM (oral suspension) in controlled room temperature between 15-30°C. Use within 21 days after reconstitution. Protect from light. Keep bottles tightly closed to protect from moisture.

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 0701C
      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 at: www.pfizer.ca or can be obtained by contacting the sponsor, Pfizer Canada Inc., at:
1-800-463-6001