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Details for: LINEZOLID INJECTION

Company: JAMP PHARMA CORPORATION

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02481278LINEZOLID INJECTIONLINEZOLID2 MG / MLSOLUTIONINTRAVENOUS
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

LINEZOLID INJECTION is an antibiotic medicine. It is used to treat the following bacterial infections in adults:

  • abdomen infections
  • skin infections
  • infections of system that carries urine out of body (urinary tract)
  • lung infections (pneumonia)

    • Antibacterial drugs like LINEZOLID INJECTION treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, LINEZOLID INJECTION should be used exactly as directed. Misuse or overuse of LINEZOLID INJECTION could lead to the growth of bacteria that will not be killed by LINEZOLID INJECTION (resistance). This means that LINEZOLID INJECTION may not work for you in the future. Do not share your medicine.
    What it does

    LINEZOLID INJECTION belongs to the class of medicines called oxazolidinones antibiotics. It works by stopping the growth of bacteria responsible for your infection.

    When it should not be used

    Do not use LINEZOLID INJECTION if you:

  • are allergic to linezolid or any other ingredients of LINEZOLID INJECTION (see What are the ingredients in LINEZOLID INJECTION?).
  • have uncontrolled high blood pressure
  • have pheochromocytoma [a tumor of small part of the body, located on top of each kidney (adrenal gland)]
  • have thyrotoxicosis (an overactive thyroid)
  • have carcinoid syndrome (a condition caused by tumours of the hormone system with signs of diarrhea, skin flushing, rapid heartbeat, wheezing)
  • have taken certain medications used for low mood (depression) like isocarboxazid, phenelzine or tranylcypromine or medications used for Parkinson's disease like selegiline or rasagiline in the last 14 days
  • are taking any cold or flu medication containing pseudoephedrine or phenylpropanolamine*
  • are taking epinephrine, a medication used for severe allergic reactions
  • are taking any other medication that increases blood pressure like norepinephrine, dopamine or dobutamine
  • are taking any medication known as selective serotonin re-uptake inhibitors (SSRI’s) (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) or serotonin norepinephrine reuptake inhibitors (SNRIs) (e.g., desvenlafaxine, duloxetine, venlafaxine ). These medications may be used for low mood (depression).
  • are taking tricyclic antidepressants, medications for low mood such as amitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline
  • are taking medications for migraine such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
  • are taking meperidine, a medication for pain
  • are taking buspirone, a medication for anxiety

    • * phenylpropanolamine is no longer marketed in Canada
    What the medicinal ingredient is

    Linezolid

    What the non-medicinal ingredients are

    citric acid anhydrous, Glucose (dextrose) monohydrate, hydrochloric acid (pH adjustment), sodium citrate dihydrate, sodium hydroxide (pH adjustment), and water for injection.

    What dosage form it comes in

    LINEZOLID INJECTION comes in the following dosage forms:
    LINEZOLID INJECTION comes as a liquid to give as a shot slowly into a vein.
    LINEZOLID INJECTION is supplied as a 300 mL single-dose infusion bag.
    Each 300 mL infusion bag of LINEZOLID INJECTION contains 600 mg of linezolid.

    Warnings and precautions

    To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LINEZOLID INJECTION. Talk about any health conditions or problems you may have, including if you:

  • have a history of high blood pressure.
  • have taken a drug for low mood (depression) within the last 2 weeks (14 days).
  • have a history of anemia (low red blood cells), thrombocytopenia [(low cells in the blood that help the blood clot ( platelets)], neutropenia (low white blood cells) or any other blood related problems.
  • have a history of bleeding problems.
  • have a history of seizures or convulsions.
  • have diabetes. You will need to watch your blood sugar closely.
  • are pregnant or trying to become pregnant.
  • are breast-feeding.

    • Other warnings you should know about:

    While taking LINEZOLID INJECTION
  • Follow your doctor’s instructions carefully.
  • Do not stop taking your medicine until your doctor tells you to, even if you are feeling better. LINEZOLID INJECTION is not normally used in children and teenagers under 18 years old.
  • If you develop severe diarrhea during or over 2 months after treatment with LINEZOLID INJECTION, call your healthcare professional immediately (see What are possible side effects from using LINEZOLID INJECTION? Section below).
  • Do not use any medicine to treat your diarrhea without first checking with your doctor.
    • Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
    Interactions with this medication

  • All the medications listed under “Do not use LINEZOLID INJECTION if you” section above. Many other medications may also interact with LINEZOLID INJECTION. Tell your healthcare professional about all the medications you are taking, even those that do not appear on this list.
  • Tyramine, a chemical naturally present in some pickled, smoked, or fermented foods or drinks like aged cheese and red wines. This interaction may cause a sudden increase in your blood pressure. If you develop a throbbing headache after eating or drinking, tell your healthcare professional. To prevent these problems, get a list of tyramine-rich foods to avoid from your healthcare professional while taking LINEZOLID INJECTION.
    • Proper use of this medication

    Your healthcare professional will give LINEZOLID INJECTION (injection) by intravenous infusion (slow drip through a needle (into a large vein) over a period of 30 to 120 minutes.

    Usual dose (adults, 18 years and older):

    600 mg twice a day (every 12 hours) for 10 to 28 days.

    Your healthcare professional will tell you how long you need to take LINEZOLID INJECTION (injection).

    Overdose:

    If you think you have been given 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

    These are not all the possible side effects you may feel when taking LINEZOLID INJECTION. If you experience any side effects not listed here, contact your healthcare professional.

    Side effects may include:

    • Headache
    • Diarrhea
    • Nausea
    • Vomiting
    • Dizziness
    • Change in taste
    • Fungal infection
      • white patches in mouth, tongue or throat (oral thrush)
      • for women, vaginal yeast infection with itching and irritation in the vagina, pain or burning when urinating (peeing), vaginal discharge
    • Tongue discoloration
    • Fever
    • Insomnia
    • Constipation
    • Rash
    • Dry mouth
    • Stomach discomfort
    • Increased thirst
    • High blood sugar (blurred vision, unusual thirst, increased frequency and amount of urination, a fruit-like breath odor, rapid breathing)
    • Low blood sugar (dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating)
    • Ringing in the ear
    • High blood pressure (watch your blood pressure closely)
    Serious side effects and what to do about them
    Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and get immediate medical help
    UNCOMMON
    Blood problems (decrease in the level of blood cells): Unusual bleeding or bruising, feeling very tired or weak shortness of breath, fever and chills, sore throa   ✔  
    Vision problems: blurred vision, changes in colour vision, loss of vision   ✔  
    Numbness, tingling, prickling sensations or burning pain   ✔  
    Signs of too much lactic acid in the blood (lactic acidosis): feeling very tired or weak, feeling cold, severe nausea with or without vomiting, stomach pain, fast breathing, fast heartbeat, a heartbeat that does not feel normal, muscle pain or cramps     ✔
    Allergic reactions: rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing; swelling of the mouth, face, lips, tongue, or throat     ✔
    Clostridium difficile colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness     ✔
    Serotonin syndrome (occur within several hours of starting a new medicine or increasing the dose of a drug you are already taking): severe headache, agitation, fever, fast heartbeat, flushing, seizures, shakiness, sweating a lot, change in balance, change in thinking clearly, severe upset stomach and throwing up, severe loose stools     ✔

    If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

    How to store

    The healthcare professional will store the product under appropriate conditions. Keep out of reach and sight of children.

    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 (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
    • Calling toll-free at 1-866-234-2345.

    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.

    More information

    If you want more information about LINEZOLID INJECTION:

    • Talk to your healthcare professional.
    • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/healthcanada.html); or by calling 1 866-399-9091.
    This leaflet was prepared by Jamp Pharma Corporation

    Date Prepared: 27 September 2018
    Date modified: