Leaflet: information for the user

LinezolidAltan2mg/ml solution for infusion EFG

linezolid

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
  If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What isLinezolidAltanand what it is used for

2. What you need to know before you start usingLinezolidAltan

3. How to useLinezolidAltan

4. Possible side effects

5. Storage ofLinezolidAltan

6. Contents of the pack and additional information

Linezolid Altan is an antibiotic from the oxazolidinones group that actspreventing the growth of certainbacteria (germs) that cause infections.

It is used for the treatment of pneumonia and certain skin or subcutaneous tissue infections.Your doctor will have decided if linezolid is suitable for treating your infection.

No use LinezolidAltan:

• If you are allergic (hypersensitive) to linezolid or to any of the other components of this medicine (including those listed in section 6).
• If you are taking or have taken in the last 2 weeks any medicine called monoamine oxidase inhibitors (MAOIs such as, for example, phenelzine, isocarboxazid, selegiline, moclobemide). These medicines are usually used to treat depression or Parkinson's disease.
• If you are breastfeeding. This medicine passes into the milk and could affect the baby.

Advertencias y precauciones

Consult your doctor, pharmacist or nurse before starting to use Linezolid Altan.

Linezolid Altan may not be suitable for you if you answer yes to any of the following questions. In that case, inform your doctor, as he/she will need to monitor your general health and blood pressure before and during treatment or may decide that another treatment is better for you.

Ask your doctor if you are unsure whether any of these categories apply to your case.

• Do you have high blood pressure, whether or not you are taking medicines to treat it?
• Have you been diagnosed with hyperthyroidism?
• Do you have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumors in the hormonal system that present with symptoms of diarrhea, skin flushing, wheezing)?
• Do you suffer from bipolar disorder, schizophrenia, confusion or other mental health problems?
• Have you had a history of hyponatremia (low sodium levels in the blood) or are you taking medicines that reduce sodium levels in the blood, for example, certain diuretics (also called "water tablets") such as hydrochlorothiazide?
• Are you taking any opioids?

The use of certain medicines, including antidepressants and opioids, together with Linezolid may cause the serotonin syndrome, a potentially fatal condition (see section 2 "Other medicines and Linezolid Infusion" and section 4).

Tenga especial cuidado con LinezolidAltan

Inform your doctor before using this medicine if:

• You are elderly.
• You bruise easily and bleed.
• You have anaemia (low red blood cell count).
• You are prone to infections.
• You have a history of convulsions.
• You have liver or kidney problems, especially if you are on dialysis.
• You have diarrhoea.

Inform your doctor or pharmacist immediately if during treatment you experience:

• Visual problems such as blurred vision, changes in colour vision, difficulty seeing clearly or if you notice that your field of vision is reduced.
• Loss of sensation in your arms or legs, or a feeling of tingling or burning in your arms or legs.
• Diarhoea while taking or after taking antibiotics, including linezolid. If diarrhoea becomes severe, lasts a long time or if you notice that your stools contain blood or mucus, stop using Linezolid Altan immediately and consult your doctor. In this situation, do not take medicines that stop or reduce bowel movements.
• Recurring nausea or vomiting, abdominal pain or rapid breathing.
• A feeling of malaise with muscle weakness, headache, confusion and memory deterioration that may indicate hyponatremia (low sodium levels in the blood).

Otros medicamentos y Linezolid Altan

Occasionally, Linezolid Altan may interact with certain medicines and produce adverse effects such as changes in blood pressure, body temperature or heart rate.

Informe a su médico o farmacéutico si está utilizando, ha utilizado recientemente o pudiera tener que utilizar otro medicamento.

Informe a su médico si está tomando o ha estado tomando en las 2 últimas semanaslos siguientes medicamentos, ya queno debeusar Linezolid Altansi todavía los está tomando o si los ha tomado recientemente (ver también la sección 2 anterior “No use LinezolidAltan”).

• Monamine oxidase inhibitors (MAOIs, such as, for example, phenelzine, isocarboxazid, selegiline, moclobemide). These medicines are usually used to treat Parkinson's disease.

Inform your doctor also if you are taking the following medicines.

Your doctor may decide to treat you with Linezolid Altan, but will need to assess your general health and blood pressure before and during treatment. In other cases, your doctor may decide that another treatment is better for you.

• Decongestants for colds that contain pseudoephedrine or phenylpropanolamine.
• Some medicines for asthma such as salbutamol, terbutaline, fenoterol.

Certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many medicines of this type including amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine or sertraline; or certain medicines used to treat opioid dependence, such as buprenorphine. These medicines may interact with linezolid and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.

• Migraine medicines such as sumatriptan or zolmitriptan.
• Medicines for severe allergic reactions such as adrenaline (epinephrine).
• Medicines that increase blood pressure, such as noradrenaline (norepinephrine), dopamine and dobutamine.
• Opioids, for example, pethidine, used to treat moderate or severe pain.
• Medicines used to treat anxiety disorders, such as buspirone.
• Medicines that prevent blood clotting, such as warfarin.
• An antibiotic called rifampicin.

Uso deLinezolidAltancon alimentos,bebidas y alcohol

• You can take Linezolid Altan before, during or after meals.
• Avoid eating large amounts of cheese, yeast extracts or soybean extracts (for example, soy sauce) and alcoholic beverages, especially draught beer and wine. The reason is that Linezolid Altan may react with a substance called tyramine that is naturally present in some foods, causing an increase in your blood pressure.
• If you start with a headache after eating or drinking, inform your doctor, pharmacist or nurse immediately.

Embarazo,lactanciay fertilidad

The effect of Linezolid Altan on pregnant women is unknown. Therefore, pregnant women should not use Linezolid Altan unless advised by their doctor.

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist.

You should not breastfeed while using Linezolid Altan because this medicine passes into the milk and could affect your baby.

Conducción y uso de máquinas

Linezolid Altan may cause dizziness or visual problems. If this happens, do not drive or use machines.Remember that if you do not feel well you may be affected in your ability to drive or use machines.

LinezolidAltancontains glucose and sodium

Glucose

This medicine contains glucose.

Patients with diabetes mellitus should note that this medicine contains (13.7 g of glucose per bag). Each ml of this medicine contains 45.7 mg of glucose.

Sodium

This medicine contains 114 mg of sodium (main component in table salt / cooking salt) per 300 ml infusion bag. This amount is equivalent to 5.7% of the maximum daily recommended intake of sodium for an adult. Please inform your doctor or nurse if you are following a low-sodium diet.

Adults

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

This medication will be administered to you by a doctor or other healthcare professional through an infusion (by perfusion within a vein). The recommended dose for adults (18 years or older) is 300 ml (600 mg of linezolid) twice a day administered directly into the bloodstream (by intravenous route), through an infusion over a period of 30 to 120 minutes.

If you are on dialysis, you will be givenLinezolid Altan after each session.

The normal duration of treatment is 10-14 days, but it may be extended up to 28 days. The safety and efficacy of this medication have not been established in treatment periods exceeding 28 days. Your doctor will decide the duration of your treatment.

While using Linezolid Altan, your doctor will perform periodic blood tests to monitor your blood count

If you use Linezolid Altan for more than 28 days, your doctor should monitor your vision.

Use in childrenand adolescents

Linezolid Altan is not normally used in children or adolescents (under 18 years).

If you use more LinezolidAltanthan you should

If you think you may have been given more Linezolid Altan than you should, inform your doctor or nurse.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone:91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use LinezolidAltan

Since this medication is administered under close supervision, it is very unlikely that you will forget a dose. If you think you may have forgotten to administer a dose of treatment, inform your doctor or nurse.Do not take a double dose to make up for missed doses.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor, nurse or pharmacist immediatelyif you notice any of these side effects during your treatment with Linezolid:

The most serious side effects of Linezolid (frequency in parentheses) are:

• Severe skin changes (rare), swelling, particularly around the face and neck (rare), shortness of breath or difficulty breathing (rare). This may be a sign of an allergic reaction and may require discontinuation of Linezolid Altan treatment. Skin reactions such aspurple rash due to inflammation of blood vessels (rare),red, painful, and scaly skin (dermatitis) (rare), skin rash (frequent), itching (frequent).
• Visual problems (rare), such as blurred vision (rare), changes in color perception (unknown), difficulty seeing in detail (unknown), or if you notice a reduction in your visual field (rare).
• Severe diarrhea containing blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in rare cases may lead to complications that can be life-threatening (rare).
• Repeated nausea or vomiting, abdominal pain, or rapid breathing (rare).
• There have been reported cases of seizures or convulsions (rare).
• Serotonin syndrome (unknown). Inform your doctor if you experience agitation, confusion, delirium, rigidity, tremors, loss of coordination,seizures, rapid heartbeats, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome) while also being treated with antidepressants called ISRSs or opioids (see section 2).
• Unexplained bleeding or bruising, which may be due to an alteration in the number of certain blood cells that can affect blood clotting or produce anemia (frequent).
• Reduction in the number of white blood cells that can affect the ability to fight infections (rare). Some signs of infection include: fever (frequent), sore throat (rare), mouth ulcers (rare), and fatigue (rare).
• Pancreatitis (rare).
• Seizures (rare).
• Transient ischemic attacks. (Temporary alteration of blood flow to the brain that causes short-term symptoms such as loss of vision, weakness in arms and legs, difficulty speaking, and loss of consciousness) (rare).
• Tinnitus (ringing in the ears) (rare).

There have been reported cases of numbness, tingling, or blurred vision in patients who have used Linezolid Altan for more than 28 days. If you experience vision difficulties, consult your doctor as soon as possible.

Otherside effects include:

Frequent(may affect up to 1 in 10 people):

• Fungal infections, especially in the vagina or mouth.
• Headache.
• Metalllic taste.
• Diarrhea, vomiting, nausea.
• Alteration of some blood test results,proteins, salts, or enzymes that measureliver, kidney function test results, or blood sugar levels.
• Difficulty sleeping.
• Increased blood pressure.
• Anemia (reduction in the number of red blood cells).
• Itching.
• Dizziness.
• Abdominal pain, general or localized.
• Constipation.
• Indigestion.
• Localized pain.
• Reduction in the number of platelets.

Rare(may affect up to 1 in 100 people):

• Vaginal or genital area inflammation in women.
• Sensation of numbness or tingling.
• Swelling, discomfort, changes in color of the tongue.
• Dry mouth.
• Pain at the injection site (route) or around it.
• Vein inflammation (including the location where the infusion is administered).
• Increased need to urinate.
• Chills.
• Thirst.
• Increased sweating.
• Hyponatremia (low sodium levels in the blood).
• Renal failure.
• Abdominal swelling.
• Pain at the injection site.
• Increased creatinine.
• Stomach pain.
• Changes in heart rhythm (e.g., increased heart rate).
• Decreased blood cell count.
• Weakness and/or sensory changes.

Rare(may affect up to 1 in 1,000 people):

• Change in the color of the tooth surface, which disappears with professional dental cleaning procedures.

Unknown (frequency cannot be estimated from available data):

• Alopecia (hair loss)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

The hospital staff will ensure that Linezolid Altan is not used after the printed use date and is administered immediately after breaking the seal. They will also visually inspect the solution before use and only use it if it is transparent and particle-free. They will also ensure that the solution is properly stored in its packaging and aluminum foil wrapping to protect it from light and keep it out of sight and reach of children until use.

After opening:

From a microbiological standpoint, unless the opening method prevents the risk of microbial contamination, the product must be used immediately. If not used immediately, the time and storage conditions are the responsibility of the user.

Medications should not be disposed of through drains or trash. Ask your pharmacisthow to dispose ofthepackaging andmedications that you no longerneed.This will help protect the environment.

Composition of LinezolidAltan

The active ingredient is linezolid. Each milliliter of solution contains 2 milligrams of linezolid. Each 300-milliliter infusion bag contains 600 milligrams of linezolid.

The other components are glucose monohydrate (a type of sugar, see section 2), sodium citrate (E331, see section 2), anhydrous citric acid (E330), hydrochloric acid (E507), sodium hydroxide (E524) to adjust the pH, and water for injection.

Appearance of the product and contents of the pack

Linezolid Altan is a transparent solution that is presented in individual infusion bags containing 300 milliliters (600 milligrams of linezolid) of solution.

The bags are presented in packs of 1, 10, or 25 bags.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1ª planta, Oficina F. Edificio Prisma

Las Rozas, 28230 Madrid, Spain

Responsible Person

Infomed Fluids S.R.L

50 Theodor Pallady blvd, District3,

032266 Bucharest, Romania

Tel: +40 21 345 02 22

Fax: +40 21 345 3185

E-mail: [email protected]

This medicinal product has been authorized in the Member States of the EUand in the United Kingdom (Northern Ireland)under the following names:

France: Linezolid Panpharma 2 mg/ml Solution pour Perfusion

Germany: Linezolid Panpharma 2 mg/ml Infusionslösung

Romania: Linezolid Infomed 2 mg/ml solución para perfusión

Spain: Linezolid Altan 2 mg/ml solución para perfusión EFG

Last update of thisleaflet:

March 2023

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

IMPORTANT: Consult the SmPC before prescribing.

Linezolid is not active against infections caused by Gram-negative pathogenic microorganisms. Concomitant treatment with antibiotics against Gram-negative microorganisms should be initiated if there is certainty or suspicion of co-infection with Gram-negative pathogenic microorganisms.

Description

Single-use intravenous infusion bags, latex-free, multi-layered polyolefin, sealed, with an outer aluminum laminated bag. Each bag contains 300 milliliters of solution and is presented in a pack. Each pack contains 1, 10, or 25 intravenous infusion bags.

Linezolid Altan 2 mg/ml infusion solution contains linezolid 2 mg/ml in an isotonic, transparent, yellowish-colored solution. The other components are glucose monohydrate, sodium citrate (E331), anhydrous citric acid (E330), hydrochloric acid (E507) or sodium hydroxide (E524), and water for injection.

Dosage and administration

Linezolid treatment should only be initiated in a hospital setting and after evaluation by a specialist doctor, such as a microbiologist or an infectious diseases specialist.

Patients who start treatment with the parenteral formulation can switch to any of the oral presentations when clinically indicated. In this case, no dose adjustment is required, as the oral bioavailability of linezolid is approximately 100%.

The infusion solution should be administered over a period of 30 to 120 minutes.

The recommended dose of linezolid should be administered intravenously (IV) twice a day.

Duration and recommended dosing for treatment in adults:

The duration of treatment depends on the microorganism, the site of the infection, the severity, and the patient's clinical response.

The treatment duration recommendations listed below reflect those used in clinical trials. For some types of infections, it may be advisable to prescribe shorter treatments, although this has not been evaluated in clinical trials.

The maximum duration of treatment is 28 days. The safety and efficacy of linezolid have not been established when administered for periods longer than 28 days (see section 4.4).

Infections associated with bacteremia do not require an increased dose or treatment duration. The recommended doses of linezolid are as follows:

Pediatric population:No safety and efficacy have been established in children under 18 years of age. The available data are described in sections 4.8, 5.1, and 5.2 of the Summary of Product Characteristics, but no posological recommendation can be made.

Geriatric population:No dose adjustment is required.

Renal impairment:No dose adjustment is required.

Severe renal impairment (i.e., CLCR<30>No dose adjustment is required in these patients. Since the clinical relevance of the exposure of these patients to high concentrations (up to 10 times) of the two main metabolites of linezolid is unknown, this medicinal product will be used with special caution in patients with severe renal impairment and will only be administered if the expected benefit outweighs the potential risk.

Since approximately 30% of the linezolid dose is eliminated during 3 hours of hemodialysis, linezolid will be administered after dialysis in patients who receive this treatment. The main metabolites of linezolid are eliminated in part by hemodialysis, but their concentrations are considerably higher after dialysis than in patients with normal renal function or mild to moderate renal impairment. Therefore, linezolid will be used with special caution in patients with severe renal impairment undergoing dialysis and only if the expected benefit outweighs the potential risk.

There is no experience with the administration of linezolid in patients undergoing continuous ambulatory peritoneal dialysis (CAPD) or alternative treatments for renal impairment (other than hemodialysis).

Hepatic impairment:Patients with mild to moderate hepatic impairment (Class A or B in the Child-Pugh scale): No dose adjustment is required.

Mild to moderate hepatic impairment (Class C in the Child-Pugh scale):Since linezolid is metabolized by a non-enzymatic process, it is expected that liver impairment will not significantly affect its metabolism, and therefore no dose adjustment is recommended. However, there are insufficient clinical data, and linezolid should only be used in these patients if the expected benefit outweighs the theoretical risk (see sections 4.4 and 5.2 of the SmPC).

Contraindications

Hypersensitivity to linezolid or to any of the excipients listed in section 6.1.

Linezolid should not be used in patients taking medications that inhibit monoamine oxidases A or B (e.g., phenelzine, isocarboxazid, selegiline, moclobemide) or during the two weeks following the administration of such medication.

Unless there are means available to closely monitor and control blood pressure, linezolid should not be administered to patients with the following underlying clinical conditions or who are being treated with the following medications:

- Patients with uncontrolled hypertension, phaeochromocytoma, carcinoid syndrome, thyrotoxicosis, bipolar disorder, affective disorders, acute confusional state.

- Patients taking any of the following medications: selective serotonin reuptake inhibitors (see section 4.4), tricyclic antidepressants, 5-HT1 receptor agonists (triptans), direct or indirect sympathomimetics (including bronchodilators, pseudoephedrine, and phenylpropanolamine), vasopressors (e.g., epinephrine, norepinephrine), dopaminergic drugs (e.g., dopamine, dobutamine), meperidine, or buspirone.

The data from animal studies suggest that linezolid and its metabolites may pass into breast milk, so breastfeeding should be discontinued before and during treatment (see section 4.6).

Special warnings and precautions for use

Myelosuppression

Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients treated with linezolid. In patients who were monitored, it was seen that after discontinuing treatment, the affected hematological parameters returned to their pre-treatment levels. The risk of these effects appears to be associated with the duration of treatment. Elderly patients treated with linezolid may be at a higher risk of experiencing hematological disorders than younger patients. Thrombocytopenia may occur more frequently in patients with severe renal impairment, whether or not they are undergoing dialysis. Therefore, it is recommended to closely monitor the hemogram in patients who:

have pre-existing anemia, granulocytopenia, or thrombocytopenia;

are receiving concomitant medication that may decrease hemoglobin levels and hematocrit or reduce the count or affect the count or function of platelets;

have severe renal impairment;

or who are receiving more than 10-14 days of treatment. Linezolid should only be administered to these patients if it is possible to closely monitor their hemoglobin, blood cell count, and platelet levels.

If significant myelosuppression occurs during linezolid treatment, treatment should be discontinued, unless continuation is considered absolutely necessary, in which case, close monitoring of hematological parameters and appropriate therapeutic measures should be implemented.

It is also recommended to perform a complete blood count (including hemoglobin, platelets, absolute leukocyte count, and formula) weekly in patients receiving linezolid, regardless of their baseline hemogram.

In compassionate use studies, a higher incidence of severe anemia was reported in patients treated with linezolid for periods longer than the recommended maximum treatment duration of 28 days. These patients required more frequent blood transfusions. Cases of anemia requiring blood transfusion have also been reported during post-marketing experience, with a higher number of cases in patients who received linezolid for more than 28 days.

Cases of sideroblastic anemia have been reported during post-marketing experience. In cases where the onset is known, most patients were treated for more than 28 days. Most patients recovered partially or totally after discontinuing linezolid treatment, with or without treatment for anemia.

Unbalanced mortality in a clinical trial in patients with Gram-positive vascular infections related to catheters

In an open-label study in severely ill patients with catheter-related Gram-positive vascular infections, an excess of mortality was observed in patients treated with linezolid compared to those treated with vancomycin/dicloxacillin/oxacillin [78/363 (21.5%) vs. 58/363 (16.0%)]. The main factor influencing mortality rates was the baseline status of Gram-positive infection. Mortality rates were similar in patients with infections caused exclusively by Gram-positive microorganisms (odds ratio 0.96; 95% CI: 0.58-1.59), but were significantly higher (p = 0.0162) in the linezolid arm for patients infected with any other microorganism or in whom no baseline microorganism was isolated (odds ratio 2.48; 95% CI: 1.38-4.46???The greatest imbalance occurred during treatment and within 7 days following discontinuation of the study drug. In the linezolid arm, there were more patients who acquired Gram-negative infections during the study and who died from Gram-negative infections and polymicrobial infections. Therefore, linezolid should only be used in patients with complicated skin and soft tissue infections in whom there is suspicion or certainty of co-infection with Gram-negative microorganisms if there are no other available treatments (see section 4.1). In these circumstances, concomitant treatment with antibiotics against Gram-negative microorganisms should be initiated.

Diarrhea and antibiotic-associated colitis

With the use of almost all antibiotics, including linezolid, cases of antibiotic-associated diarrhea and antibiotic-associated colitis, including pseudomembranous colitis and Clostridium difficile-associated diarrhea, have been reported, whose severity can range from mild diarrhea to fatal colitis. Therefore, it is essential to consider this diagnosis in patients who develop severe diarrhea during or after treatment with linezolid. If suspected or confirmed antibiotic-associated diarrhea or colitis is suspected, treatment with antibiotics, including linezolid, should be discontinued and appropriate therapeutic measures should be implemented immediately. In this situation, medications that inhibit peristalsis are contraindicated.

Lactic acidosis

Cases of lactic acidosis have been reported with the use of linezolid. Patients who develop signs or symptoms of metabolic acidosis, including recurrent nausea or vomiting, abdominal pain, low bicarbonate levels, or hyperventilation while being treated with linezolid should receive immediate medical attention. If lactic acidosis occurs, the benefits of continuing linezolid treatment should be weighed against the potential risks.

Mitochondrial dysfunction

Linezolid inhibits mitochondrial protein synthesis. As a result of this inhibition, adverse events such as lactic acidosis, anemia, and neuropathy (optic and peripheral) may occur, which are more frequent when treatment duration exceeds 28 days.

Serotonin syndrome

Spontaneous reports of serotonin syndrome, a potentially life-threatening condition, have been associated with the concomitant administration of linezolid and serotoninergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and opioids (see section 4.5). Therefore, concomitant administration of linezolid and serotoninergic agents is contraindicated (see section 4.3), except when the concomitant administration of linezolid and serotoninergic agents is absolutely necessary. In these cases, patients should be closely monitored for signs and symptoms of serotonin syndrome, such as cognitive dysfunction, hyperpyrexia, hyperreflexia, and ataxia. If signs or symptoms occur, one or both agents should be discontinued; if the agent causing the serotonin syndrome is discontinued, symptoms may resolve.

The onset of serotonin syndrome has also been associated with the concomitant administration of linezolid and buprenorphine.

Hypontremia and SIADH

Hyponatremia and/or syndrome of inappropriate antidiuretic hormone secretion (SIADH) have been observed in some patients treated with linezolid. Regular monitoring of serum sodium levels is recommended in patients at risk of hyponatremia, such as elderly patients or those taking medications that may reduce serum sodium levels (e.g., thiazide diuretics such as hydrochlorothiazide).

Optic and peripheral neuropathy

Cases of peripheral neuropathy, as well as optic neuropathy and optic neuritis, which in some cases progressed to loss of vision in patients treated with linezolid, have been reported; these cases have occurred mainly in patients treated for periods longer than the recommended maximum duration of 28 days.

Patients should be advised to report any visual symptoms, such as changes in visual acuity, changes in color vision, blurred vision, or defects in the visual field. In such cases, visual function should be evaluated as soon as possible, and an ophthalmologist should be consulted if necessary. Regular monitoring of visual function should be performed in any patient treated with linezolid for a period longer than 28 days.

The continuation of treatment with linezolid in patients who have experienced optic or peripheral neuropathy should be evaluated against the potential risks.

A higher risk of neuropathy may exist when linezolid is used in patients who are currently taking or who have recently taken antimycobacterial medication for the treatment of tuberculosis.

Seizures

Cases of seizures have been reported in patients treated with linezolid. In most cases, a history of seizures or risk factors for seizures was reported. Patients should be advised to report any history of seizures.

Inhibitors of monoamine oxidase

Linezolid is a reversible and non-selective inhibitor of monoamine oxidase (MAO). However, it does not exert any antidepressant effect at the doses used for antibacterial treatment. There are very limited data on pharmacological interaction and safety studies of linezolid in patients receiving linezolid and underlying conditions and/or concomitant treatment with medications that increase this risk. Therefore, linezolid should not be used in these circumstances, except when it is possible to closely monitor and control the patient (see sections 4.3 and 4.4).

Use with foods rich in tyramine

Patients should be advised not to consume large amounts of foods rich in tyramine (see section 4.5).

Superinfection

The effects of linezolid treatment on normal flora have not been evaluated in clinical trials.

Occasionally, the use of antibiotics may lead to the overgrowth of non-susceptible microorganisms. Approximately 3% of patients who received linezolid at the recommended doses during clinical trials presented with candidiasis associated with treatment. In cases of superinfection during treatment, appropriate measures should be taken.

Special populations

Linezolid should be used with caution in patients with severe renal impairment and only if the expected benefit outweighs the potential risk (see sections 4.2 and 5.2 of the Summary of Product Characteristics).

Linezolid should only be administered to patients with severe hepatic impairment if the expected benefit outweighs the potential risk (see sections 4.2 and 5.2).

Effects on fertility

In studies with adult male rats, linezolid caused a reversible decrease in fertility and abnormal sperm morphology. The potential effects of linezolid on human male reproductive systems are unknown (see section 5.3).

Clinical trials

The safety and efficacy of linezolid have not been established when administered for periods longer than 28 days.

Clinical trials did not include patients with diabetic foot lesions, pressure ulcers, ischemic lesions, severe burns, or gangrene. Therefore, there is limited experience with the use of linezolid in the treatment of these conditions.

Warnings about excipients

Glucose

Each milliliter of solution contains 45.7 milligrams of glucose (13.7 grams in 300 milliliters), which should be taken into account in the treatment of patients with diabetes mellitus.

Sodium

This medicinal product contains 114 milligrams of sodium per 300-milliliter infusion bag (0.38 milligrams per milliliter), equivalent to 5.7% of the maximum recommended daily sodium intake by the WHO of 2 grams of sodium for an adult. The sodium content should be taken into account in patients with a controlled sodium diet.

The linezolid infusion solution can be prepared additionally for administration with solutions containing sodium (see sections 4.2, 6.2, and 6.6) and this should be considered in relation to the total sodium from all sources administered to the patient.

Interactions with other medicinal products and other forms of interaction

Inhibitors of monoamine oxidase

Linezolid is a reversible and non-selective inhibitor of monoamine oxidase (MAO). The data from studies of pharmacological interaction and safety of linezolid administered to patients at risk of MAO inhibition are very limited. Therefore, linezolid should not be used in these circumstances, except when it is possible to closely monitor and control the patient (see sections 4.3 and 4.4).

Potential interactions that increase blood pressure

Linezolid increased the hypertensive effect produced by pseudoephedrine and phenylpropanolamine in healthy normotensive volunteers. Simultaneous administration of linezolid with pseudoephedrine or phenylpropanolamine produced mean increases in systolic blood pressure of 30-40 mmHg, compared with 11-15 mmHg produced by linezolid alone, 14-18 mmHg produced by pseudoephedrine or phenylpropanolamine alone, and 8-11 mmHg produced by placebo. No similar studies have been conducted in hypertensive patients. It is recommended that if linezolid is administered with vasopressor medications (including dopaminergic agents), the doses of these medications should be titrated carefully to achieve the desired response.

Potential serotoninergic interactions

In healthy volunteers, the potential pharmacological interaction of linezolid with dextromethorphan was studied. Two doses of 20 milligrams of dextromethorphan were administered with a 4-hour interval, with or without linezolid. In healthy volunteers who received linezolid and dextromethorphan, no serotoninergic syndrome effects were observed.

During post-marketing experience, a case of a patient who experienced symptoms similar to those of serotoninergic syndrome during the administration of linezolid and dextromethorphan was reported, which resolved after discontinuing both treatments.

Linezolid should be used with caution when administered concomitantly with buprenorphine due to the increased risk of serotoninergic syndrome, a potentially life-threatening condition (see section 4.4 of the SmPC).

Reports of serotoninergic syndrome have been associated with the concomitant use of linezolid and serotoninergic agents, including antidepressants such as SSRIs and opioids. Therefore, concomitant administration of linezolid and serotoninergic agents is contraindicated (see section 4.3), except when the concomitant administration of linezolid and serotoninergic agents is absolutely necessary. In these cases, patients should be closely monitored for signs and symptoms of serotonin syndrome, such as cognitive dysfunction, hyperpyrexia, hyperreflexia, and ataxia. If signs or symptoms occur, one or both agents should be discontinued; if the agent causing the serotonin syndrome is discontinued, symptoms may resolve.

Use with foods rich in tyramine

No significant pressor response was observed in volunteers who received linezolid and less than 100 milligrams of tyramine. This suggests that only large amounts of foods or beverages high in tyramine (e.g., aged cheese, yeast extracts, non-distilled alcoholic beverages, and fermented soy products such as soy sauce) need to be avoided.

Medicinal products metabolized through cytochrome P450

Linezolid is not metabolized in a detectable manner by the cytochrome P450 (CYP) enzyme system or inhibits any of the clinically significant human CYP isoforms (1A2, 2C9, 2C19, 2D6, 2E1, and 3A4). Similarly, linezolid does not induce CYP450 isoenzymes in rats. Therefore, no CYP450-induced pharmacological interactions with linezolid are expected.

Rifampicin

The effect of rifampicin on the pharmacokinetics of linezolid was studied in 16 healthy male volunteers who received 600 milligrams of linezolid twice daily for 2.5 days, with and without 600 milligrams of rifampicin once daily for 8 days. Rifampicin reduced the Cmax and AUC of linezolid by a mean of 21% [90% CI, 15, 27] and 32% [90% CI, 27, 37], respectively. The mechanism of this interaction and its clinical relevance are unknown.

Warfarin

The simultaneous administration of warfarin and linezolid (in steady-state) produced a 10% mean maximum decrease in INR (International Normalized Ratio) and a 5% decrease in AUC of INR. The data from patients who received warfarin and linezolid are insufficient to evaluate the clinical relevance, if any, of these findings.

Fertility, pregnancy, and lactation

Pregnancy

The data on the use of linezolid in pregnant women are limited. Animal studies have shown reproductive toxicity (see section 5.3). A potential risk in humans exists.

Linezolid should not be used during pregnancy, except when clearly necessary. That is, only if the potential benefit outweighs the possible risk.

Lactation

The data from animal studies suggest that linezolid and its metabolites may pass into breast milk, so breastfeeding should be discontinued before and during treatment.

Fertility

Studies with animals have shown that linezolid caused a decrease in fertility (see section 5.3).

Effects on the ability to drive and use machines

Patients should be advised that they may experience dizziness or visual symptoms (as described in sections 4.4 and 4.8) while receiving linezolid, and they should be advised not to drive or operate machinery if any of these symptoms occur.

Adverse reactions

The following table lists all adverse reactions to this medicinal product and their frequencies based on all causality data from clinical trials in which more than 6,000 adult patients received the recommended doses of linezolid for a maximum of 28 days. The most frequently reported adverse reactions were diarrhea (8.49%), nausea (6.9%), vomiting (4.3%), and headache (4.2%).

The adverse reactions related to the medicinal product most frequently reported that led to treatment discontinuation were headache, diarrhea, nausea, and vomiting. Approximately 3% of patients discontinued treatment due to an adverse reaction related to the medicinal product.

The additional adverse reactions reported during post-marketing experience are included in the table in the "Unknown frequency" category, as the frequency cannot be estimated from the available data.

The following adverse reactions have been observed and reported during treatment with linezolid with the following frequencies: Very common (≥ 1/10), common (≥ 1/100 to <1

Країна реєстрації

Spain

Активна речовина

Linezolid

Потрібен рецепт

Так

Виробник

Altan Pharmaceuticals Sa

Склад

Glucosa monohidrato (50,24 mg/ml mg), Citrato sodico anhidro (1,64 mg/ml mg), Hidroxido de sodio (e 524) (Q.S 4,6-5 mg/ml mg)

Информация носит справочный характер и не является медицинской рекомендацией. Перед приёмом любых препаратов проконсультируйтесь с врачом. Oladoctor не несёт ответственности за медицинские решения, принятые на основе этого контента.

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