Patient Medication Information: uses, side effects, how to take - Linezolid Injection (Fresenius Kabi Canada)
What is Linezolid Injection 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.
How does Linezolid Injection work?
Linezolid Injection belongs to the class of medicines called oxazolidinone antibiotics. It works by stopping the growth of bacteria responsible for your infection.
What are the ingredients in Linezolid Injection?
Medicinal ingredient: linezolid
Non-medicinal ingredients: citric acid, dextrose, hydrochloric acid (pH adjustment), sodium citrate, sodium hydroxide (pH adjustment), and water for injection.
Linezolid Injection comes in the following dosage forms:
Injection 2 mg / mL
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.
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)
- are taking any of the medications listed in the Serious Drug Interactions box below.
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)
- are taking diuretics (water pills)
- 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 liver problems
- have kidney 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. Linezolid Injection passes in breast milk. Your healthcare professional may advise you to monitor your baby for diarrhea or vomiting while being breastfed
Other warnings you should know about:
Rhabdomyolysis (breakdown of damaged muscle):
- Linezolid Injection may cause rhabdomyolysis which is the breakdown of damaged muscle. In some cases, this led to sudden kidney failure.
Your healthcare professional should do tests regularly if you:
- are at increased risk of rhabdomyolysis or myopathy (disease of the muscles).
- have recently taken or are currently taking other medicines that can cause rhabdomyolysis or myopathy.
- get symptoms of rhabdomyolysis such as muscle pain, weakness, or dark urine. Your healthcare professional may then stop your treatment with Linezolid Injection.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions Do not take Linezolid Injection if you:
* phenylpropanolamine is no longer marketed in Canada |
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The following may interact with Linezolid Injection:
- 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.
How to take 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.
- Your healthcare professional will give Linezolid 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.
Overdose:
| If you think you, or a person you are caring for, have taken too much Linezolid Injection, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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What are possible side effects from using Linezolid Injection?
These are not all the possible side effects you may have when taking Linezolid Injection. If you experience any side effects not listed here, tell 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 discolouration
- 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 to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| 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 throat | √ | ||
| 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 | √ | ||
| Clostridioides difficile colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | √ | ||
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| 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 | √ | ||
Severe Cutaneous Adverse Reactions (SCAR): severe skin reactions that may also affect other organs:
| √ | ||
| UNKNOWN | |||
| Rhabdomyolysis (breakdown of damaged muscle): muscle pain, weakness or spasms, red-brown urine. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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Storage:
Store Linezolid Injection infusion bags in controlled room temperature between 15 °C to 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.
Keep out of reach and sight of children.
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/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the Fresenius Kabi Canada website https://www.fresenius-kabi.com/en-ca, or by calling 1-877-821-7724.
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8