Linelid

Linelid

linezolid

Manufacturer:

Yuria - Pharm

Distributor:

Uni-Pharma

Marketer:

Ambicare
Full Prescribing Info
Contents
Linezolid.
Description
1 mL of solution contains 2 mg of Linezolid (on 100% substance basis).
Active substance: Linezolid.
Excipients/Inactive Ingredients: sodium citrate; citric acid monohydrate; glucose monohydrate; water for injections.
Action
Pharmacotherapeutic group: Antibacterial agents for systemic use.
Pharmacology: Pharmacodynamics: Linezolid is a synthetic antibacterial agent, belonging to a new class of antimicrobial drugs-oxazolidinones. In vitro, it is active against aerobic gram-positive, some gram-negative bacteria and anaerobic microorganisms.
Linezolid selectively inhibits bacterial protein synthesis in bacterial cells via specific mechanism of action. Particularly, it binds to area on the bacterial ribosome (23S subunit to 50S), and prevents the formation of functional 70S initiation complex, which is a significant component of the translation process.
The following microorganisms are sensitive to Linezolid: gram-positive aerobes Enterococcus faecalis, Enterococcus faecium*, Staphylococcus aureus*, coagulase-negative staphylococci Streptococcus agalactiae*, Streptococcus pneumoniae*, Streptococcus pyogenes*, streptococci of group C, streptococci of group G; gram-positive anaerobes Clostridium perfringens, Peptostreptococcus anaerobius, Peptostreptococcus spp.
Resistant microorganisms: Haemophilus influenza, Moraxella catarrhalis, Neisseria species Enterobacteriaceae, Pseudomonas spp.
Pharmacokinetics: (S)-Linezolid is biologically active and metabolized in the body with formation of inactive derivatives. Solubility of Linezolid in water is approximately 3 mg/mL and doesn't depend on pH in the range 3-9. Maximum (Cmax) and minimum (Cmin) Linezolid plasma concentrations (mean value and [standard deviation]) at steady state after drug intravenous administration twice a day at the dose of 600 mg were 15.1 [2.5] mg/L and 3.68 [2.68] mg/L, respectively.
Distribution: At the average volume of distribution ate steady state accounts for 40-50 L in healthy volunteers, corresponding to total body water. Grade of binding to plasma proteins accounts for approximately 31%, and doesn't depend on drug plasma concentration.
Linezolid concentrations were found in different body fluids in limited number of volunteers within conducting the studies under course use of the drug. The ratio of Linezolid concentrations in saliva relative to plasma was 1.2:1, and for sweat relative to plasma was from 0.55:1, respectively. The ratio of concentrations in epithelial lining fluid and in lung alveolar cells to maximum plasma concentration at steady state was 4.5:1 and 0.15:1, respectively.
Pharmacokinetic data obtained in pediatric patients with ventriculoperitoneal shunts, demonstrated variability of Linezolid concentrations in cerebrospinal fluid after single and multiple drug administration; steady drug therapeutic concentration in cerebrospinal fluid has not been achieved and maintained. So, the use of Linezolid for empiric antimicrobial therapy in pediatric patients with infections of central nervous system is not recommended.
Metabolism: Linezolid is primarily metabolized by oxidation of morpholine ring that leads to formation of two inactive carboxylic acid derivatives with opened ring: aminoethoxyacetic acid metabolite (PNU-142300) and hydroxyethyl glycine metabolite (PNU-142586). Hydroxyethyl glycine metabolite (PNU-142586) is a predominant human metabolite, formed by means of non-enzymatic process. Aminoethoxyacetic acid metabolite (PNU-142300) is defined in smaller quantity. Other "small" inactive metabolites were identified as well.
Elimination: In patients with normal renal function or with insignificantly or moderately expressed renal failure. Linezolid at steady state is primarily excreted with urine in form of metabolite PNU-142586 (40%), as unchanged (30%), and in form of metabolite PNU-142300 (10%). Unchanged drug is practically not found in feces, while part of each of main metabolites, PNU-142586 and PNU-142300, is 6% and 3%, respectively. Average Linezolid half-life is 5-7 hours. Non-renal clearance accounts for approximately 65% of Linezolid total clearance. Small degree of non-linearity in clearance was observed with increase in dose of Linezolid.
It is probably due to lower renal and non-renal drug clearance at high concentrations. However, changes in clearance were small and didn't affect the half-life.
Pharmacokinetics in special populations: Patients with renal failure: after single administration at dose of 600 mg, 7-8-fold increase of systemic exposure of two main Linezolid metabolite in plasma was observed in patients with severe renal failure (creatinine clearance <30 mL/min). But exposure value for area under curve "concentration-time" (AUC) for parent compound was unchanged. Though some quantity of main Linezolid metabolites is removed from the body by hemodialysis, level of metabolites in plasma after single administration at dose of 600 mg was still high after hemodialysis as compared to patients with normal renal function or with insignificant or moderately expressed renal failure. In 24 patients with expressed renal failure, 21 from which was on regular hemodialysis, maximum plasma concentration of two main metabolites in some days of drug administration were approximately 10-fold the concentrations observed in patients with normal renal function. Maximum Linezolid plasma levels were not altered. Clinical significance of these observations was not determined, as currently only limited data are available.
Patients with liver failure: limited data show that pharmacokinetics of Linezolid and their metabolites PNU-142300 and PNU-142586 is not altered in patients with mild or moderately expressed liver failure (Child-Pugh class A or B). Linezolid pharmacokinetic attributes in patients with severe liver failure (Child-Pugh class C) were not investigated. However, as Linezolid is metabolized by means of non-enzymatic process, it's not expected that impaired liver function could significantly affect its metabolism.
Elderly: pharmacokinetics in Linezolid in persons over 65 years and older is not substantially changed.
Women: lower volume of distribution is more specific for women than for men, and mean clearance (corrected according to body weight) is decreased approximately by 20%. Plasma concentrations are higher in women that could be partially explained by difference in body weight. As half-life mean value in women and men doesn't not substantially differ, it's not expected that plasma concentration in women will be substantially differ, it's not expected that plasma concentration in women will be substantially higher than well-tolerated one, and the dose adjustment is not necessary.
Indications/Uses
Treatment of infections caused by sensitive strains of anaerobic or aerobic gram-positive microorganisms, including the following infections, accompanied by bacteremia: nosocomial (hospital-acquired) pneumonia; community-acquired pneumonia; skin and soft tissue infections; infections caused by Enterococci, including vancomycin-resistant strains Enterococcus faecium and faecalis.
If infectious agents include gram-negative microorganisms, combination therapy is clinically indicated.
Dosage/Direction for Use
Before drug use, skin test for sensitivity to Linezolid should be carried out. Linezolid is given twice a day by intravenous injection. Solution for infusion should be administered within 30-120 minutes.
Patients, treatment of which has been started with Linezolid in form of intravenous infusions, could be allowed for treatment with oral Linezolid. In this case dose adjustment is not necessary, as oral administration bioavailability of Linezolid is approximately 100%.
Doses recommended for adults and children in age over 12 years: See Table 1.

Click on icon to see table/diagram/image

Doses recommended for children (from birth* up to 11 years): See Table 2.

Click on icon to see table/diagram/image

*Premature neonates aged up to 7 days (gestational age is less than 34 weeks) have lower systemic clearance of Linezolid and higher value for AUC than full-term neonates and older infants. Starting from the 7th day of life, values of Linezolid clearance and AUC in premature neonates are the same as in full-term neonates and older infants.
Treatment duration depends on causative agent, infection localization and severity, as well as on clinical effect.
Administration instructions: Infusion is administered within 30-120 minutes.
Don't connect infusion bags in series. Immediately before use remove protective wrapping, and for about 1 minute firmly squeeze the bag in order to make sure of its integrity. If leaks are detected, the solution is non-sterile. The residues of unused solution should be utilized. Don't use partially filled packages.
Compatible solutions for infusion: 5% glucose (dextrose) solution for injection, 0.9% sodium chloride solution, lactated Ringer's solution for injection.
Use in elderly patients: dose adjustment is not necessary.
Use in patients with renal failure: dose adjustment is not necessary.
Patients with severe renal failure (in particular, with creatinine clearance <30 mL/min): Dose adjustment is not necessary.
Due to unknown clinical significance of higher systemic exposure (up to 10 times) of two main Linezolid metabolites in patients with severe renal failure, the drug should be used with caution in these patients, and only if expected therapy benefit exceeds potential risk. Approximately 30% dose of Linezolid is eliminated during 3-hour hemodialysis session, therefore Linezolid should be administered after use of dialysis for patients receiving such a therapy. Main Linezolid metabolites are removed from the body by hemodialysis at a certain quantity, however, concentrations of these metabolites remained considerably higher after dialysis procedure than concentrations observed in patients with normal renal function or with insignificantly or moderately expressed renal failure. Therefore, Linezolid should be prescribed with caution to patients with severe renal failure undergoing hemodialysis, and only if expected therapy benefit exceeds potential risk.
To date there is no clinical experience of Linezolid use in patients undergoing continuous ambulatory peritoneal dialysis or alternative treatment for liver failure (other than hemodialysis).
Use in patients with liver failure: dose adjustment is not necessary. However clinical data on this issue are limited, so it is recommended to prescribe Linezolid only if expected treatment benefit exceeds potential risk.
Overdosage
In case of overdosage, symptomatic treatment is advised, with maintenance of glomerular filtration. During hemodialysis approximately 30% of administered drug dose is eliminated from the body.
Contraindications
Known hypersensitivity to Linezolid or any other drug component. Linezolid shouldn't be used in patients receiving any medicinal products inhibiting monoamine oxidases A or B (e.g., Phenelzine, Isocarboxazid, Selegiline, Moclobemid) or within two weeks after administration of such drugs.
Except cases when there is a possibility of close monitoring of blood pressure, Linezolid should not be prescribed in patients with the following concomitant clinical conditions or concurrent administration of such drugs: non-controlled arterial hypertension, pheochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder, acute episodes of dizziness; serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptanes), directly and indirectly acting sympathomimetics (including adrenergic bronchodilators, pseudoephedrine, phenylpropanolamine), vasopressors (epinephrine, norepinephrine), dopaminergic compounds (dopamine, dobutamine), pethidine or buspirone.
Special Precautions
Administration details: Linezolid is a reversible, non-selective inhibitor of monoamine oxidase (MAO); however at doses used for antibacterial therapy, the drug has no antidepressant effect. Data on Linezolid interaction and safety in case of prescription to patients with concurrent diseases or taking concomitant drugs, which could put them at risk of MAO inhibiting, are limited. That's why under described conditions, use of Linezolid is not recommended. If only there is an opportunity of patient close monitoring.
Patients should be warned of necessity to refrain from intake of tyramine-enriched food. Every mL of solution contains 45.7 mg (13.7 g/300 mL) of glucose. It should be taken into account in patients with diabetes mellitus or other conditions characterized by impaired tolerance to glucose. Every mL of solution also contains 0.38 g (114 g/300 mL) of sodium. Reversible myelosuppression in some patients receiving Linezolid (anemia, thrombocytopenia, leukopenia and pancytopenia) was reported, intensity of which could depend on drug dose and therapy duration. In cases with known outcome, when Linezolid was discontinued, the affected hematologic parameters have risen toward pre-treatment levels. Risk of these effects' development could be associated with therapy duration. Thrombocytopenia could occur more frequently in patients with severe renal failure, regardless of dialysis. That's why complete blood cout should be monitored for patients with pre-existing anemia, granulocytopenia, thrombocytopenia; for those ones receiving drugs, able to decrease hemoglobin level or platelet count in peripheral blood or suppress their function; severe liver failure; increased risk of bleeding occurrence; previously identified myelosuppression; or receiving Linezolid for longer than 2 weeks. Linezolid (Linelid) should be prescribed to such patients only under possibility to monitor hemoglobin level, parameters of complete blood count and platelets. In case of considerable myelosuppression during course of therapy with Linezolid, the treatment should be discontinued, excluding cases when treatment prolongation was considered vital. In such situations, close monitoring of complete blood count parameters and implementation of strategy of relevant patients management are necessary.
In addition, it is recommended to monitor complete blood count parameters (including hemoglobin level, platelets, total and differential leukocyte count) in patients receiving Linezolid once a week regardless of baseline parameters of complete blood count.
In studies, higher grade of development of severe anemia was reported in patients who received Linezolid for a period longer than recommended 28 days. These patients required hemotransfusion more frequently. Cases of anemia that required hemotransfusion were reported during post-marketing observation. Most cases occurred in patients who received Linezolid for a period longer than recommended 28 days.
Development of lactic acidosis was reported at use of Linezolid. Patients receiving Linezolid in which repeated nausea or vomiting, unexplained acidosis or decrease in blood bicarbonate level, requiring urgent medical examination, were observed. Increased mortality rate was observed in patients who received Linezolid as compared to combination vancomycin/dicloxacillin/oxacillin during open-label, randomized clinical study in seriously ill patients with catheter-related infections caused by gram-positive causative agents.
Treatment regimens with the use of Linezolid (600 mg every 12 hours intravenously/orally) and vancomycin (1 g intravenously every 12 hours) or oxacillin (2 g intravenously every 6 hours)/dicloxacillin (500 mg orally every 6 hours) were compared at treatment duration from 7 to 28 days. Frequency of lethal outcomes in this study was 78/363 (21.5%) and 58/363 (16.0%) at the use of Linezolid and comparator drug, respectively. On the basis of results of logistic regression the expected relative risk is 1.426 [95% confidence interval 0.970, 2.098]. Although causal link was not defined, observed imbalance occurred more frequently in patients who received Linezolid, and in which before treatment initiation gram-negative causative agents or mixed gram-negative and gram-positive infection were identified, or causative agent was not identified.
Controlled clinical studies didn't include patients with diabetic foot, decubuti, ischemic injuries, severe burns or gangrene. So, Linezolid experience for treatment of these conditions is limited. In patients selected randomly for treatment with Linezolid, and in which before treatment initiation only gram-positive causative agents were identified, including subgroup of patients with gram-positive bacteremia, the same survival rate was observed as in patients of comparator group.
Linezolid has no clinical activity against gram-negative causative agents, so its use for infections caused by these microorganisms, is not indicated. In case when presence of concomitant gram-negative infection is established or suspected, the use of specific antimicrobial therapy against gram-negative microorganisms is indicated. Linezolid should be used with caution in patients with high risk of life-threatening systemic infections, particularly infections caused by installed central venous catheter in patients of intensive care unit. The use of Linezolid for treatment of patients with septic infection caused by installed venous catheters was not approved. Linezolid (Linelid) should be used with caution in patients with severe renal failure, and only in the cases when expected drug benefit is higher that potential risk.
In patients with severe liver injury the use of Linezolid (Linelid) is recommended only in the cases when expected drug benefit is higher that potential risk.
Cases of pseudomembranous colitis were reported with the use of almost all antibacterial agents, including Linezolid; its severity could vary from insignificant to life-threatening. Diarrhea associated with Clostridium difficile was reported at the use of almost all antibacterial agents, including Linezolid; its severity could vary from insignificant diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal colon microflora that leads to excessive growth of C. difficile. C. difficile produces toxins A and B, causing diarrhea development. Hypertoxin produced by strains of C. difficile leads to increase in morbidity and lethality, as these infections can be refractory to antimicrobial therapy and may require colectomy. Diarrhea associated with C. difficile should be suspected in all patients with diarrhea, occurred after use of antibiotics. Medical history should be collected with caution, as cases of C. difficile-asociated diarrhea could develop in more than 2 months after administration of antibacterial agents.
Peripheral and optic neuropathy were reported in patients receiving Linezolid, more often at drug use for a period longer than recommended 28 days. In case of optic neuropathy that had progressed to loss of vision, patients had received the drug for a period longer than recommended treatment duration.
In case of occurrence of such symptoms as visual impairment, change in colour perception, blurring of vision or visual field defects, immediate ophthalmological examination is recommended. Visual function should be monitored in all patients receiving Linezolid for a long-term period (3 months or more), and in all patients complaining of occurrence of new eye disorders regardless of duration of therapy with Linezolid. In case of development of peripheral and optic neuropathy, advisability of further use of Linezolid associated potential risk should be considered.
Seizures were rarely reported among patients receiving Linezolid. In most cases, there were seizures or factors of seizure occurrence risk in history of patients.
There were spontaneous reports of serotonin syndrome, related to concomitant administration of Linezolid and serotonergic drugs, including antidepressant drug, in particular, selective serotonin reuptake inhibitors (SSRIs). When concomitant administration of Linezolid and serotonergic drugs is clinically necessary, a patient should be under close medical supervision for early detection of signs and symptoms of serotonin syndrome, such as cognitive dysfunction, hyperpyrexia, hyperreflexia and loss of coordination. In case of occurrence of these signs and symptoms, a physician should consider necessity of discontinuation of the use of one of two or both these drugs. After serotonergic drug rechallenge, these symptoms could disappear.
In adult male rats, Linezolid reversibly reduces fertility and causes abnormal sperm morphology at exposure levels approximately similar to those in human. Possible drug effects on human reproductive system are unknown.
Effect on ability to drive and operate other machines: Linezolid effect on ability to drive and use machines was not systemically evaluated.
Use in Children: Drug is used since the first days of life.
n adolescents (ranging in age from 12 to 17 years) pharmacokinetics of Linezolid is similar to that in adults, when the drug is used at dose of 600 mg. Therefore, in adolescents receiving the drug at dose of 600 mg every 12 hours on daily basis, the same exposure would be observed as in adults at administration of the drug at the same dose.
In age from 1 week to 12 years: drug administration at dose of 10 mg/kg every 8 hours on daily basis ensures exposure, which is close to that one achieved in adults in case of drug administration at dose of 600 mg twice a day.
In neonates of less than one week of age: Linezolid systemic clearance (on the basis per 1 kg of body weight) rapidly increases during the first week of life. Therefore, in neonates receiving the drug at dose of 10 mg/kg every 8 hours on daily basis, higher systemic drug exposure on the first postnatal day is observed. However, excessive drug body accumulation is expected at such a dosage during the first week of infant life (due to rapidly increased drug clearance during first 7 days of life).
Use In Pregnancy & Lactation
Adequate and well-controlled studies on use of Linezolid by pregnant women were not conducted, therefore drug should be prescribed only if expected treatment benefit for mother exceeds potential risk for fetus.
It is unknown, if Linezolid is excreted into breast milk, so caution should be exercised while prescribing Linezolid to breastfeeding patients.
Adverse Reactions
Infections and infestations: common: candidiasis (particular oral and vaginal candidiasis) or fungal infections; uncommon: vaginitis.
Blood and lymphatic system disorders: uncommon (frequency according to clinical reports: eosinophilia, leucopenia, neutropenia, thrombocytopenia.
Psychiatric disorders: uncommon: insomnia.
Nervous system disorders: common: headache, taste perversiona (metallic aftertaste); uncommon: dizziness, hypesthesia, paresthesia.
Eye disorders: uncommon: visual loop.
Ear disorders: uncommon: tinnitus.
Cardiovascular disorders: uncommon: arterial hypertension, phlebitis/thrombophlebitis.
Digestive tract disorders: common: diarrhea, nausea, vomiting; uncommon: local and general abdominal pain, constipation, dry mouth, dyspepsia, gastritis, glossitis, abnormal stool, pancreatitis, stomatitis, change in tongue color.
Hepatobiliary disorders: common: abnormal liver function tests.
Skin and subcutaneous tissue disorders: uncommon: dermatitis, hyperhidrosis, itching, rash, urticaria.
Urinary disorders: uncommon: polyuria.
Reproductive and breast disorders: uncommon: vulvovaginal disorders.
General disorders and administration site conditions: uncommon: fever, fatigue, pain at injection site, dipsosis, local pain.
Laboratory findings: Biochemistry: common: increase AST, ALT, LDH, alkaline phosphatase, blood urea nitrogen, creatine phosphokinase, lipase, amylase or glucose without starvation; decrease in total protein, albumin, sodium and calcium; increase of decrease of potassium or bicarbonate; uncommon: increase in total bilirubin, creatinine, sodium and calcium; decrease in glucose without starvation; increase of decrease of chlorides.
Haematology: common: increase in neutrophil and eosinophil counts; decrease in hemoglobin, hematocrit or erythrocytes count; increase of decrease of platelet or leucocyte counts; uncommon: increase in reticulocyte count; decrease in neutrophil count.
The following side reactions were evaluated as serious in isolated cases: localized abdominal pain, transient ischemic attacks, arterial hypertension, pancreatitis and renal failure.
During clinical studies, one case of drug-induced arrhythmia (tachycardia) was reported.
In controlled clinical studies in which Linezolid was given for a period up to 28 days, anemia was reported in less than 0.1% of patients. In treatment program for patients with life-threatening infections and concurrent diseases, rate of patients with anemia developed under administration of Linezolid within <28 days was 2.5%, as compared to 12.3%, when treatment lasted for >28 days.
Post-marketing experience: Blood and lymphatic system disorders: anemia, leukopenia, neutropenia, thrombocytopenia, pancytopenia and myelosuppression. In case of anemia developing, more patients needed hemotransfusion under treatment with Linezolid for a period longer than recommended 28 days.
Immune system disorders: anaphylaxis; trophic and metabolic disorders: lactate acidosis.
Nervous system disorders: peripheral neuropathy, seizures, serotonin syndrome. Peripheral neuropathy was reported among patients receiving Linezolid. These reports concern primarily the patients receiving drug for a period longer than recommended 28 days.
Seizures were reported among patients receiving Linezolid. In most cases, there were seizures or factors of seizure occurrence risk in history of patients.
Cases of serotonin syndrome were reported.
Eye disorders: optic neuropathy, sometimes progressing to loss of vision (cases were primarily observed in patients receiving drug for a period longer than recommended 28 days).
Skin and subcutaneous tissue disorders: angioedema, skin blisters, such as Stevens-Johnson syndrome.
Drug Interactions
Linezolid is a weak reversible non-selective inhibitor of monoamine oxidase (MAO). Data on Linezolid interaction and safety in case of prescription to patients with concurrent diseases or taking concomitant drugs, which could put them at risk of MAO inhibiting, are limited. Therefore, under described conditions, use of Linezolid is not recommended, if only there is an opportunity of patient close monitoring.
In normotensive healthy volunteers who received Linezolid, insignificant and transient intensification of pressor effect of Pseudoephedrine hydrochloride or Phenylpropanolamine hydrochloride was observed sometimes. Concomitant use of Linezolid and Pseudoephedrine or Phenylpropanolamine leads to increase in average systolic arterial pressure by 30-40 mmHg, as compared to increase by 11-15 mmHg at use of only Linezolid, by 14-18 mmHg at use of only Pseudoephedrine or Phenylpropanolamine, by 8-11 mmHg at placebo use. The same studies in patients with arterial hypertension were not performed. It is recommended to reduce the initial dose of adrenergic drugs such as dopamine or dopamine agonists, and gradually titrate for achievement of desired clinical response.
Spontaneous reports on cases of serotonin syndrome at concurrent administration of Linezolid and serotonergic agents were very rare.
Antibiotics: Linezolid pharmacokinetics was not changed at concurrent use with Aztreonam or Gentamycin.
Potential interactions between Linezolid and Dextromethorphan were studied in healthy volunteers. They were given Dextromethorphan (two doses of 20 mg prescribed separately in 4 hours) together with Linezolid or without it. In normal individuals, effects of serotonin syndrome (confusion, delirium, irritability, tremor, flushing, hyperhidrosis, hyperpyrexia) were not observed at concurrent administration of Linezolid and Dextromethorphan.
Post-marketing experience: there was one case of development of serotonin syndrome in patient who received Linezolid and Dextromethorphan; it has been solved after discontinuation of both drugs. During clinical use of Linezolid with serotonin reuptake inhibitors, cases of development of serotonin syndrome were rarely reported.
Significant pressor effects were not observed in patients who received Linezolid and less than 100 mg of tyramine. Consequently it is necessary to refrain from use of excessive quantity of food and drinks with high tyramine (hard pressed cheese, yeast extract, undistilled alcoholic drinks, products containing enzymated soybeans, such as soy sauce). Linezolid is not metabolized by human cytochrome P-450 (CYP), and doesn't inhibit any clinically significant human CYP isoforms (1A2, 2C9, 2C19, 2D6, 2E1, 3A4). In the same way, Linezolid doesn't induce P450 isoenzymes in animals. Consequently, under Linezolid use, CYP450-induced interactions are not expected.
At addition of Warfarin to therapy with Linezolid, at steady state 10% decrease in average maximum international normalized ratio (INR) was observed in combination with 5% decrease in area under curve concentration-time (AUC). Data from the patients, who received Warfarin and Linezolid, are note enough for assessment of clinical significance of these observations.
Caution For Usage
Incompatibility: Linezolid (Linelid) for injection is not physically compatible with the following drugs for administration via Y-like connector of infusion system: Amphotericin B, Chlorpromazine hydrochloride, Diazepam, Pentamidine isethionate, Phenytoin sodium, Erythromycin lactobionate and Trimethoprim/Sulfamethoxazole.
Linezolid for injection is not chemically compatible in combination with Ceftriaxone sodium. Don't inject additives to solution for infusion. If injectable Linezolid is prescribed concomitantly with other drug, each drug should be injected separately in accordance to recommendations on dosage and method of administration for any product.
Storage
Store below 30°C. Do not freeze.
After opening, content of a bag should be used immediately.
Shelf life: 24 months.
MIMS Class
ATC Classification
J01XX08 - linezolid ; Belongs to the class of other antibacterials. Used in the systemic treatment of infections.
Presentation/Packing
Soln for infusion 2 mg/mL (transparent colourless or slightly yellowish liquid) x 300 mL x 1's.
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