Details for: SANDOZ LINEZOLID
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02422689 | SANDOZ LINEZOLID | LINEZOLID | 600 MG | TABLET | ORAL |
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
Sandoz Linezolid 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)
What it does
Sandoz Linezolid 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
- are allergic to linezolid or any other ingredients of Sandoz Linezolid (see What are the ingredients in Sandoz Linezolid?).
- 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
What the medicinal ingredient is
Linezolid
What the non-medicinal ingredients are
Colloidal silica anhydrous, hydroxypropylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide.
What dosage form it comes in
Tablets: 600 mg
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Linezolid. 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 Sandoz Linezolid
- Follow your doctor’s instructions carefully.
- Do not stop taking your medicine until your doctor tells you to, even if you are feeling better. Sandoz Linezolid is not normally used in children and teenagers under 18 years Sandoz Linezolid Page 38 of 42 old.
- If you develop severe diarrhea during or over 2 months after treatment with Sandoz Linezolid, call your healthcare professional immediately (see What are possible side effects from using Sandoz Linezolid? section below).
- Do not use any medicine to treat your diarrhea without first checking with your doctor.
Interactions with this medication
- All the medications listed under “Do not use Sandoz Linezolid if you” section above. Many other medications may also interact with Sandoz Linezolid. 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 Sandoz Linezolid.
Proper use of this medication
You may take Sandoz Linezolid (tablets) with or without food.
Usual Dose (adults, 18 years and older)
One tablet (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 Sandoz Linezolid.
Overdose
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
These are not all the possible side effects you may feel when taking Sandoz Linezolid. 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)
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional 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 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 | ✔ | ||
| 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
Store at room temperature, 15°C to 30°C. Keep out of the 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/medeffect-canada/adverse-reaction-reporting.html
- Call toll-free at 1-866-234-2345
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
- Talk to your healthcare professional
The most recent version of this document plus the full Product Monograph prepared for health professionals, can be found at:
- Health Canada website
- by contacting the sponsor, Sandoz Canada Inc., at:1-800-361-3062
- by written request at: 145, Jules-Léger Boucherville, (QC), Canada J4B 7K8
- or by e-mail at: medinfo@sandoz.com
Last revised: May 10, 2018