Linezolid (Tablets, Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

J01XX08 (Linezolid)

Active Substance

Linezolid (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibiotic of the oxazolidinone group

Pharmacotherapeutic Group

Systemic antibacterial agents; other antibacterial agents

Pharmacological Action

Linezolid, a synthetic antibacterial drug, belongs to a new class of antimicrobial agents, oxazolidinones, which are active in vitro against aerobic gram-positive bacteria, some gram-negative bacteria, and anaerobic microorganisms.

Linezolid selectively inhibits bacterial protein synthesis. By binding to bacterial ribosomes, it prevents the formation of the functional 70S initiation complex, which is an essential component of the translation process in protein synthesis.

Sensitivity

The drug is active in vitro and in vivo.

Gram-positive aerobes: Enterococcus faecium (including vancomycin-resistant strains), Staphylococcus aureus (including methicillin-resistant strains), Streptococcus agalactiae, Streptococcus pneumoniae (including multidrug-resistant strains), Streptococcus pyogenes

The drug is active in vitro.

Gram-positive aerobes: Enterococcus faecalis (including vancomycin-resistant strains), Enterococcus faecium (vancomycin-sensitive strains), Staphylococcus epidermidis (including methicillin-resistant strains), Staphylococcus haemolyticus, Viridans group Streptococcus spp.

Gram-negative aerobes: Pasteurella multocida.

Linezolid-resistant microorganisms: Haemophilus influenzae, Moraxella catarrhalis, Neisseria spp., Enterobacteriaceae spp., Pseudomonas spp.

Resistance

The mechanism of action of linezolid differs from the mechanisms of action of antimicrobial drugs of other classes (e.g., aminoglycosides, beta-lactams, folic acid antagonists, glycopeptides, lincosamides, quinolones, rifamycins, streptogramins, tetracyclines, and chloramphenicol), therefore cross-resistance between linezolid and these drugs does not exist.

Linezolid is active against pathogens, both sensitive and resistant to these drugs. Resistance to linezolid develops slowly through multi-step mutation of 23S ribosomal RNA and occurs at a frequency of less than 1×10^-9-1×10^-11.

Pharmacokinetics

Absorption

The C_max and C_min of linezolid in plasma at steady state after IV administration twice daily at a dose of 600 mg were 15.1 mg/L and 3.68 mg/L, respectively.

C_ss of linezolid in blood is achieved on the 2nd day of drug administration.

Distribution

The V_d of linezolid at C_ss in a healthy adult is on average 40-50 L, which is approximately equal to the total body water content.

Binding to plasma proteins is 31% and does not depend on the concentration of linezolid in the blood.

Metabolism

It has been established that cytochrome P450 isoenzymes are not involved in the metabolism of linezolid in vitro.

Linezolid does not inhibit or potentiate the activity of clinically important cytochrome P450 isoenzymes (1A2, 2C9, 2C19, 2D6, 2E1, 3A4).

Metabolic oxidation leads to the formation of 2 inactive metabolites – hydroxyethyl glycine (is the main metabolite in humans and is formed as a result of a non-enzymatic process) and aminoethoxyacetic acid (formed in smaller quantities).

Other inactive metabolites have also been described.

Excretion

Non-renal clearance accounts for about 65% of linezolid clearance.

A slight degree of non-linearity of clearance is noted with increasing dose of linezolid. This may be explained by a decrease in renal and non-renal clearance at high doses of linezolid. However, the differences in clearance are small and do not affect the apparent T_1/2.

Linezolid in patients with normal renal function and with mild to moderate renal failure is excreted by the kidneys as hydroxyethyl glycine (40%), aminoethoxyacetic acid (10%) and unchanged (30-35%).

It is excreted by the intestine as hydroxyethyl glycine (6%) and aminoethoxyacetic acid (3%).

Linezolid is practically not excreted unchanged by the intestine.

The T_1/2 of linezolid averages 5-7 hours.

Pharmacokinetics in specific patient groups

Patients with renal failure

After a single dose of 600 mg of the drug in patients with severe renal failure (CrCl <30 ml/min), the concentration of its two main metabolites increased by 7-8 times. However, no increase in the AUC of the parent drug was observed. Although some of the main metabolites were removed by hemodialysis, their plasma concentration after administration of 600 mg of linezolid and the dialysis procedure in patients with severe renal failure remained significantly higher than the blood concentration in patients with normal renal function, mild or moderate renal failure.

Patients with hepatic impairment

There is limited data indicating that in patients with mild and moderate hepatic impairment (Child-Pugh classes A and B), the pharmacokinetics of linezolid and its two main metabolites do not change.

The pharmacokinetics of linezolid in patients with severe hepatic impairment (Child-Pugh class C) has not been studied. However, since Linezolid is metabolized by a non-enzymatic pathway, no significant impairment of its metabolism is expected in hepatic impairment.

Children and adolescents

In adolescents (12-17 years), the pharmacokinetics of linezolid taken at a dose of 600 mg did not differ from the kinetics in adults. Thus, when prescribing 600 mg of linezolid to adolescents every 12 hours, the drug concentration will be the same as in adults when prescribing the same dose.

In children aged from 1 week to 12 years, the use of linezolid at a dose of 10 mg/kg daily every 8 hours achieves the same exposure as in adults when using 600 mg of linezolid twice daily.

In newborns, the systemic clearance of linezolid increases rapidly during the first week of life (calculated per kg of body weight). Thus, when prescribed at a dose of 10 mg/kg every 8 hours, the maximum exposure to linezolid will be reached faster in a child on the first day of life on the first day after birth. However, excessive accumulation of the drug in the first week of administration with this regimen will still not occur due to the rapid increase in clearance.

Elderly

In elderly patients aged 65 years and older, the pharmacokinetics of linezolid does not change significantly.

Women

In women, the V_d of the drug is somewhat lower than in men; they also have a 20% lower average clearance when calculated per body weight.

The concentration of the drug in the plasma of women is higher than in men, which may be partly explained by differences in body weight. However, since the T_1/2 of linezolid in men and women does not differ significantly, there is no reason to expect an increase in the concentration of the drug in the blood of women above the tolerable level, so no dose adjustment is required.

Indications

Treatment of infectious and inflammatory diseases, if it is known or suspected that they are caused by linezolid-susceptible aerobic and anaerobic gram-positive microorganisms (including infections accompanied by bacteremia)

Community-acquired pneumonia caused by Streptococcus pneumoniae (including multidrug-resistant strains), including cases accompanied by bacteremia, or Staphylococcus aureus (only methicillin-susceptible strains);
Hospital-acquired pneumonia caused by Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) or Streptococcus pneumoniae (including multidrug-resistant strains);
Complicated skin and soft tissue infections, including infections in diabetic foot syndrome, not accompanied by osteomyelitis, caused by Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes or Streptococcus agalactiae;
Vancomycin-resistant infections caused by Enterococcus faecium, including those accompanied by bacteremia.

If the causative agents of the infection include gram-negative microorganisms, combination therapy is clinically indicated.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
E10.5	Insulin-dependent diabetes mellitus with peripheral circulatory complications (including ulcer, gangrene)
E11.5	Non-insulin-dependent diabetes mellitus with peripheral circulatory complications (including ulcer, gangrene)
J15	Bacterial pneumonia, not elsewhere classified
L01	Impetigo
L02	Cutaneous abscess, furuncle and carbuncle
L03	Cellulitis
L08.0	Pyoderma
L08.8	Other specified local infections of skin and subcutaneous tissue
T79.3	Posttraumatic wound infection, not elsewhere classified

ICD-11 code	Indication
1B70.1	Streptococcal cellulitis of the skin
1B70.2	Staphylococcal cellulitis of the skin
1B70.Z	Bacterial cellulitis or lymphangitis caused by unspecified bacterium
1B72.0	Bullous impetigo
1B72.1	Nonbullous impetigo
1B72.Z	Impetigo, unspecified
1B75.0	Furuncle
1B75.1	Carbuncle
1B75.2	Furunculosis
1B75.3	Pyogenic skin abscess
1B7Y	Other specified pyogenic bacterial infections of skin or subcutaneous tissue
1C44	Non-pyogenic bacterial infections of skin
5A10	Type 1 diabetes mellitus
5A11	Type 2 diabetes mellitus
CA40.0Z	Bacterial pneumonia, unspecified
EA50.3	Staphylococcal scarlet fever
EB21	Pyoderma gangrenosum
NF0A.3	Posttraumatic wound infection, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

The dosage regimen and duration of treatment depend on the pathogen, location and severity of the infection, as well as on clinical efficacy.

Administered IV as infusions at a dose of 600 mg at 12-hour intervals. The duration of treatment is 14-28 days.

Patients who were initially prescribed the drug IV can subsequently be switched to any oral dosage form. In this case, dose selection is not required, because the bioavailability when taken orally is almost 100%.

Solution

The drug is intended for IV administration. The duration of infusion is 30-120 minutes. The dosage regimen and duration of treatment depend on the pathogen, location and severity of the infection, as well as on clinical efficacy.

Recommended dosage regimen for adults and children over (12 years and older)

Indications (including infections accompanied by bacteremia)	Single dose and frequency of administration	Recommended duration of treatment
Community-acquired pneumonia caused by Streptococcus pneumoniae (including multidrug-resistant strains), including cases accompanied by bacteremia, or Staphylococcus aureus (only methicillin-susceptible strains)	600 mg IV every 12 hours	10-14 days
Hospital-acquired pneumonia caused by Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) or Streptococcus pneumoniae (including multidrug-resistant strains)	600 mg IV every 12 hours	10-14 days
Skin and soft tissue infections, including infections in diabetic foot syndrome, not accompanied by osteomyelitis, caused by Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes or Streptococcus agalactiae	600 mg IV every 12 hours	10-14 days
Vancomycin-resistant infections caused by Enterococcus faecium, including those accompanied by bacteremia	600 mg IV every 12 hours	14-28 days

Recommended dosage regimen for children (newborns* and children under 12 years):

Indications (including infections accompanied by bacteremia)	Single dose and frequency of administration	Recommended duration of treatment
Community-acquired pneumonia caused by Streptococcus pneumoniae (including multidrug-resistant strains), including cases accompanied by bacteremia, or Staphylococcus aureus (only methicillin-susceptible strains)	10 mg/kg IV every 8 hours	10-14 days
Hospital-acquired pneumonia caused by Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) or Streptococcus pneumoniae (including multidrug-resistant strains)	10 mg/kg IV every 8 hours	10-14 days
Skin and soft tissue infections, including infections in diabetic foot syndrome, not accompanied by osteomyelitis, caused by Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes or Streptococcus agalactiae	10 mg/kg IV every 8 hours	10-14 days
Vancomycin-resistant infections caused by Enterococcus faecium, including those accompanied by bacteremia	10 mg/kg IV every 8 hours	14-28 days

* In premature newborns under 7 days of age (gestation less than 34 weeks), the systemic clearance of linezolid is lower and the AUC values are higher than in most newborns and children. By day 7 after birth, the clearance of linezolid and AUC values in premature newborns approach those in full-term newborns and children.

Maximum dose for adults and children – 1.2 g/day.

Adverse Reactions

The frequency of adverse reactions is presented according to the following classification recommended by the World Health Organization: very common: ≥10%, common: ≥1% and <10%, uncommon: ≥0.1% and <1%, rare: ≥0.01% and <0.1%, very rare: <0.01%.

Adult patients

Adverse events associated with linezolid are usually mild or moderate in severity. Diarrhea, headache and nausea are most commonly reported.

From the digestive system common – diarrhea, nausea, vomiting, oral mucosal candidiasis, dyspepsia; uncommon – tongue discoloration, pancreatitis, gastritis, abdominal distension, dry mouth, glossitis, loose stools, stomatitis; rare – pseudomembranous colitis, tooth enamel discoloration.

Laboratory parameters: common – anemia, increased creatine kinase activity, increased fasting glucose concentration; decreased total protein, albumin, sodium or calcium; increased or decreased potassium or bicarbonate; neutrophilia, eosinophilia; decreased hemoglobin, hematocrit or red blood cell count; uncommon – increased blood triglyceride concentration, increased activity of “liver” enzymes (including ALT, AST, ALP), LDH, lipase, amylase, increased total bilirubin and creatinine concentration, increased prolactin concentration; increased sodium or calcium content; decreased fasting glucose; increased or decreased chloride, leukopenia, neutropenia, thrombocytopenia; rare – pancytopenia.

From the cardiovascular system: common – increased blood pressure; uncommon – tachycardia, transient ischemic attack, phlebitis, thrombophlebitis.

From the senses: uncommon – blurred vision, tinnitus; rare – visual field defect.

From the nervous system: common – taste perversion (“metallic” taste), headache, dizziness; uncommon – paresthesia, hypesthesia, seizures (see section “Special Instructions”).

From the CNS: common – insomnia.

From the genitourinary system: common – increased blood urea nitrogen, vaginal candidiasis; uncommon – renal failure, vulvovaginal disorders, vaginitis, polyuria.

From the skin: common – rash, itching; uncommon: dermatitis, increased sweating, urticaria.

Other: common – fever, local pain; uncommon – chills, fatigue, injection site pain, thirst, hyponatremia, opportunistic fungal infection.

Children and adolescents

From the digestive system: common – diarrhea, nausea, vomiting, abdominal pain (localized and generalized), gastrointestinal bleeding, oral mucosal candidiasis, loose stools.

Laboratory parameters: common – thrombocytopenia, anemia, hypokalemia, thrombocythemia; uncommon – eosinophilia, increased blood triglyceride concentration, increased ALT activity, lipase, amylase, total bilirubin and creatinine concentration.

From the nervous system: common – headache, seizures (see section “Special Instructions”), vertigo.

From the skin: common – rash; uncommon – itching (not at the injection site).

From the respiratory system: common – breathing disorders, apnea, upper respiratory tract infections, pharyngitis, pneumonia, cough.

Other: common – fever, sepsis, generalized edema, reactions at the injection site.

Spontaneous (post-registration) data

Laboratory parameters sideroblastic anemia.

From the senses changes in visual acuity, optic neuritis, optic neuropathy, loss of vision, changes in color vision (see section “Special Instructions”).

Allergic reactions anaphylaxis.

From the skin alopecia, angioedema; bullous skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

From metabolism lactic acidosis.

From the nervous system peripheral neuropathy.

Other serotonin syndrome (see sections “Drug Interactions” and “Special Instructions”).

Contraindications

Hypersensitivity to linezolid and/or other components of the drug;
Simultaneous use of linezolid with MAO A or B inhibitors (e.g., phenelzine, isocarboxazid) within 14 days before starting or after finishing linezolid therapy.

In the absence of careful patient monitoring and blood pressure monitoring, Linezolid should not be prescribed

To patients with uncontrolled arterial hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome, bipolar disorders, schizoaffective disorders, and acute confusional state;
To patients receiving the following types of drugs: adrenomimetics (e.g., pseudoephedrine, phenylpropanolamine, epinephrine, norepinephrine, dobutamine), dopamine mimetics (e.g., dopamine), serotonin reuptake inhibitors, tricyclic antidepressants, 5-HT₁ receptor agonists (triptans), meperidine, or buspirone.

With caution

Severe renal failure, myelosuppressive conditions, visual disturbances, ischemic lesions of organs and tissues, pressure sores, diabetic foot, gangrene, hepatic insufficiency, history of seizures. Linezolid is used with caution in patients with systemic infections that are life-threatening, such as infections associated with venous catheters in intensive care units.

Use in Pregnancy and Lactation

Pregnancy

No studies on the safety of linezolid use during pregnancy have been conducted; therefore, the use of Linezolid during pregnancy is only possible if the intended therapeutic benefit for the mother outweighs the potential risk to the fetus.

Breastfeeding

Linezolid passes into the breast milk of nursing women; therefore, if it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Use in Renal Impairment

Use the drug with caution in patients with severe renal insufficiency.

Pediatric Use

For the recommended dosing regimen for children under 12 years of age, see the “Dosage Regimen” section.

Special Precautions

In established infection (or suspected infection) caused by concomitant gram-negative microorganisms, the additional use of agents active against gram-negative flora is indicated.

Myelosuppression

Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients taking Linezolid. After discontinuation of linezolid, the altered blood parameters returned to the values observed before the start of treatment. The risk of developing these effects is likely related to the duration of treatment. In elderly patients, the use of linezolid may be associated with a higher risk of blood abnormalities compared to younger individuals. In patients with severe renal failure (regardless of whether they are undergoing dialysis procedures), an increased frequency of thrombocytopenia may occur.

Therefore, careful monitoring of hematological parameters is recommended in the following categories of patients

Patients with pre-existing anemia, granulocytopenia, or thrombocytopenia;
Patients receiving concomitant therapy with drugs that may decrease hemoglobin levels, reduce blood cell counts, or adversely affect platelet count or functional activity;
Patients with severe renal failure;
Patients receiving linezolid therapy for more than 10-14 days. It is advisable to use Linezolid for the treatment of such patients only in combination with careful monitoring of hemoglobin levels, complete blood count, and, if possible, platelet count.

If clinically significant myelosuppression develops during linezolid treatment, therapy should be discontinued. An exception is cases where continuation of treatment is deemed absolutely necessary. In such situations, careful monitoring of complete blood count parameters and implementation of appropriate treatment strategies are necessary.

In addition, it is recommended to perform weekly monitoring of complete blood count parameters (including hemoglobin levels, platelet count, total white blood cell count, and detailed leukocyte formula) in patients undergoing linezolid treatment, regardless of baseline blood test results.

In the group of patients treated with Linezolid for >28 days (the maximum recommended duration of treatment), an increased frequency of serious anemia was observed. Such patients more frequently required blood transfusion. Cases of anemia requiring blood transfusion have also been reported in the post-marketing period. Such anemia occurred more frequently in patients treated with Linezolid for >28 days.

Cases of sideroblastic anemia have also been reported in the post-marketing period. Among the cases for which the treatment start time was known, most patients received Linezolid for >28 days. After discontinuation of linezolid, most patients recovered completely or partially as a result of anemia treatment or even without treatment.

Mortality discrepancy in a clinical study involving patients with catheter-related bloodstream infections caused by gram-positive pathogens

In an open-label study involving patients with severe intravascular catheter-related infections, an increase in mortality was observed in the group of patients using Linezolid compared to the vancomycin/dicloxacillin/oxacillin treatment groups (78/363 (21.5%) vs. 58/363 (16.0%)). The main factor influencing mortality rate was the baseline status of gram-positive infection.

The mortality rate in patients with infections caused exclusively by gram-positive organisms was comparable (odds ratio 0.96, 95% confidence interval 0.58-1.59), but in the linezolid treatment group, the mortality rate was significantly higher in patients with any other pathogen or no pathogens at baseline (odds ratio 2.48, 95% confidence interval 1.38-4.46). The greatest discrepancy was observed during treatment and within 7 days of discontinuation of the study drug. During the study, the linezolid treatment group had a larger number of individuals who developed gram-negative infections during the study, as well as patients who died from infections caused by gram-negative pathogens and from polymicrobial infections. Therefore, in complicated skin and soft tissue infections in patients with established or suspected associated gram-negative pathogen infection, Linezolid should be used only when there are no other treatment options. Under such circumstances, parallel treatment of the gram-negative infection must be initiated.

Pseudomembranous colitis

Diarrhea and colitis associated with antibiotic use, including pseudomembranous colitis and Clostridium difficile-associated diarrhea, have been reported with the use of almost all antibiotics, including Linezolid. The severity of manifestations can range from moderate diarrhea to fatal colitis. Therefore, it is important to consider this diagnosis in patients who develop diarrhea during or after the use of linezolid. If antibiotic-associated diarrhea or colitis is suspected or confirmed, current antibacterial treatment (including Linezolid) should be discontinued and appropriate therapeutic measures should be initiated immediately. The use of drugs that inhibit intestinal peristalsis is contraindicated.

Lactic acidosis

Lactic acidosis has been reported with the use of linezolid. Patients who develop symptoms and manifestations of lactic acidosis during linezolid use, including recurrent nausea or vomiting, abdominal pain, low bicarbonate levels, or hyperventilation, should seek immediate medical attention. If lactic acidosis develops, the benefit of continued linezolid treatment should be weighed against the potential risks.

Mitochondrial dysfunction

Linezolid inhibits mitochondrial protein synthesis. As a result of this inhibition, adverse reactions such as lactic acidosis, anemia, and neuropathy (peripheral and optic) may develop. These phenomena are more frequently observed when linezolid is used for >28 days.

Peripheral neuropathy and optic neuropathy

Peripheral neuropathy, as well as optic neuropathy, which sometimes progressed to vision loss, has been reported in patients treated with Linezolid. Such reports primarily concerned patients treated for >28 days (the maximum recommended duration of treatment). All patients should be advised to report symptoms of visual impairment, such as changes in visual acuity, changes in color perception, blurred vision, or partial visual field loss. In such cases, an urgent ophthalmological examination is recommended, with referral to an ophthalmologist if necessary. If a patient takes Linezolid for more than the recommended 28 days, vision should be regularly monitored. If peripheral neuropathy or optic neuropathy develops, the risk/benefit ratio of continuing linezolid therapy in these patients should be assessed.

An increased risk of neuropathy may occur with the use of linezolid in patients receiving or having recently received antibacterial drugs for the treatment of tuberculosis.

Seizures

Cases of seizures have been reported in patients receiving linezolid therapy. In most cases, a history of seizures was reported as a risk factor. Patients should inform their doctor if they have previously experienced seizures.

Hypoglycemia

Cases of hypoglycemia have been reported during linezolid treatment in diabetic patients receiving insulin or oral hypoglycemic drugs. Although a causal relationship between linezolid use and hypoglycemia has not been established, diabetic patients should be warned about the possibility of hypoglycemic conditions during linezolid treatment.

MAO inhibitors

Linezolid is a non-selective, reversible MAO inhibitor. Very limited data are available from drug interaction studies and linezolid safety studies on the use of linezolid in patients with underlying diseases and/or concomitant treatment with drugs for which certain risks arise due to MAO inhibition. Therefore, the use of linezolid concomitantly with MAO A or B inhibitors (e.g., phenelzine, isocarboxazid) is contraindicated within 14 days before starting or after finishing linezolid therapy (see sections “Contraindications” and “Drug Interactions”).

Serotonin syndrome

Spontaneous reports of serotonin syndrome associated with the concomitant use of linezolid and serotonergic drugs, including antidepressants (such as selective serotonin reuptake inhibitors), have been received. Therefore, the concomitant use of linezolid and serotonergic drugs is contraindicated. If concomitant use is necessary, the patient should be under close observation for the purpose of detecting symptoms of serotonin syndrome, such as cognitive dysfunction, hyperpyrexia, hyperreflexia, and impaired coordination. If such symptoms occur, the physician should consider discontinuing one or the other drug. After discontinuation of the serotonergic drug, symptoms of “withdrawal” syndrome may be observed.

Use in combination with tyramine-rich foods

No significant vasopressor effect was observed in patients receiving Linezolid and tyramine in amounts of <100 mg. This indicates the need to avoid only excessive consumption of foods and beverages high in tyramine (namely, aged cheeses, yeast extracts, undistilled alcoholic beverages, and fermented soybean products such as soy sauce).

Superinfection

The effect of linezolid on normal flora was not studied during clinical trials. The use of antibiotics can sometimes lead to the overgrowth of non-susceptible microorganisms. For example, in about 3% of patients receiving Linezolid at recommended doses, the occurrence of candidiasis associated with the use of the drug was observed during clinical studies. If superinfection occurs during treatment, appropriate measures should be taken.

Special patient groups

Linezolid should be used for the treatment of patients with severe renal failure with caution and only in situations where the expected benefit outweighs the risk.

Linezolid should be used for the treatment of patients with severe hepatic insufficiency only in situations where the expected benefit outweighs the risk.

Controlled clinical trials did not include patients with diabetic foot lesions, pressure sores, ischemic lesions, severe burns, or gangrene. Therefore, experience with the use of linezolid for the treatment of these conditions is limited.

Tooth enamel discoloration

Cases of reversible superficial tooth enamel discoloration have been reported with the use of linezolid. These discolorations were removed by professional teeth cleaning.

Excipients

1 ml of solution contains 55.5 mg of dextrose monohydrate (equivalent to 50.0 mg of dextrose). This should be taken into account when treating patients with diabetes mellitus or other conditions associated with glucose intolerance.

1 ml of solution also contains 1.8 mg of sodium citrate dihydrate. The sodium content should be taken into account by patients on a sodium-restricted diet.

Effect on ability to drive and operate machinery

During linezolid treatment, driving vehicles, operating special machinery, or engaging in activities associated with increased risk, and activities requiring increased concentration and speed of psychomotor reactions is not recommended due to the possibility of developing dizziness or symptoms of visual impairment.

Overdose

No cases of linezolid overdose have been reported. Symptomatic treatment is recommended (including maintaining glomerular filtration rate). There are no data on the acceleration of linezolid elimination by peritoneal dialysis or hemoperfusion.

Drug Interactions

It is prohibited to add other drugs to the infusion solution. If it is necessary to administer Linezolid with other drugs, all medications should be prescribed separately according to the recommended doses and routes of administration.

Linezolid for injection is pharmaceutically incompatible with the following drugs amphotericin B, chlorpromazine, diazepam, pentamidine, phenytoin, erythromycin, co-trimoxazole (trimethoprim+sulfamethoxazole), ceftriaxone.

Compatible infusion solutions

5% dextrose injection solution;
0.9% sodium chloride injection solution;
Ringer-Locke injection solution.

Patients who were initially prescribed the drug intravenously can subsequently be switched to any oral dosage form of the drug, with no dose adjustment required, as the bioavailability of oral linezolid is almost 100%.

Potential interactions leading to increased blood pressure

In the absence of the possibility of careful patient monitoring and blood pressure monitoring, the concomitant use of linezolid with adrenomimetics (e.g., pseudoephedrine, phenylpropanolamine, epinephrine, norepinephrine, dobutamine) and dopamine mimetics (e.g., dopamine) is contraindicated (see section “Contraindications”).

Potential serotonergic interactions

The concomitant use of linezolid and serotonergic drugs is contraindicated. If concomitant therapy is necessary, careful monitoring of the patient is required for the timely detection of signs of serotonin syndrome (see sections “Contraindications”, “Special Precautions”).

MAO inhibitors

Linezolid is a non-selective, reversible MAO inhibitor. The concomitant use of linezolid and MAO inhibitors is contraindicated for at least 14 days before starting or after finishing linezolid therapy (see sections “Contraindications”, “Special Precautions”).

Drugs metabolized via the cytochrome P450 system

Cytochrome P450 isoenzymes have been found not to be involved in the metabolism of linezolid in vitro. Linezolid does not inhibit or potentiate the activity of clinically important cytochrome P450 isoenzymes (1A2, 2C9, 2C19, 2D6, 2E1, 3A4). Therefore, CYP450-induced interaction is not expected with linezolid intake. With the concomitant use of linezolid and (S)-warfarin, which is largely metabolized by the CYP2C9 isoenzyme, the pharmacokinetic characteristics of warfarin do not change. Drugs such as warfarin and phenytoin, which are substrates of the CYP2C9 isoenzyme, can be used concomitantly with linezolid without dose adjustment.

Rifampicin caused a decrease in the C_max and AUC of linezolid by an average of 21% and 32%, respectively.

Storage Conditions

The drug should be stored out of the reach of children at a temperature between 2°C and 25°C (77°F).

Shelf Life

The shelf life is 2 years. Freezing of the drug is not allowed.

Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Linezolid [Jivdhara Pharma, Private Limited (India)]
Film-coated tablets, 300 mg: 10 pcs.

Marketing Authorization Holder

Jivdhara Pharma, Private Limited (India)

Manufactured By

NPC Scan Biotek, LLC (Russia)

Rozlex Pharm LLC (Russia)

Dosage Form

Linezolid

Film-coated tablets, 300 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex; the film coating and a white core are visible on the break.

	1 tab.
Linezolid	300 mg

Excipients : microcrystalline cellulose – 100 mg, lactose monohydrate – 77.5 mg, povidone K30 – 5 mg, talc – 5 mg, magnesium stearate – 2.5 mg, colloidal silicon dioxide (aerosil) – 2.5 mg, sodium carboxymethyl starch – 2.5 mg, croscarmellose sodium – 5 mg.

Film coating composition : hypromellose – 10 mg; titanium dioxide – 1.25 mg; propylene glycol – 0.25 mg; macrogol 6000 – 0.75 mg.

10 pcs. – blisters made of aluminum foil/PVC (1) – cardboard packs.

Linezolid [Jivdhara Pharma, Private Limited (India)]
Film-coated tablets, 200 mg: 10 pcs.
Film-coated tablets, 400 mg: 10 pcs.
Film-coated tablets, 600 mg: 10 pcs.

Marketing Authorization Holder

Jivdhara Pharma, Private Limited (India)

Manufactured By

Rozlex Pharm LLC (Russia)

NPC Scan Biotek, LLC (Russia)

Dosage Forms

	Linezolid	Film-coated tablets, 200 mg: 10 pcs.
		Film-coated tablets, 400 mg: 10 pcs.
		Film-coated tablets, 600 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex, with a score on one side; the tablet core is white on the break.

	1 tab.
Linezolid	200 mg

Excipients: microcrystalline cellulose 102 – 66.667 mg, lactose monohydrate – 51.667 mg, povidone K30 – 3.333 mg, talc – 3.333 mg, magnesium stearate – 1.667 mg, colloidal silicon dioxide – 1.667 mg, sodium carboxymethyl starch – 1.667 mg, croscarmellose sodium – 3.333 mg.

Film coating composition ready-made white coating mixture – 8.17 mg (polyvinyl alcohol – 49%, titanium dioxide (E171) – 25%, talc – 16%, polyethylene glycol 4000 – 7%, soy lecithin – 3%).

10 pcs. – blisters (1) – cardboard packs.

Film-coated tablets white, round, biconvex; the tablet core is white on the break.

	1 tab.
Linezolid	400 mg

Excipients: microcrystalline cellulose 102 – 133.333 mg, lactose monohydrate – 103.333 mg, povidone K30 – 6.667 mg, talc – 6.667 mg, magnesium stearate – 3.333 mg, colloidal silicon dioxide – 3.333 mg, sodium carboxymethyl starch – 3.333 mg, croscarmellose sodium – 6.667 mg.

Film coating composition ready-made white coating mixture – 16.33 mg (polyvinyl alcohol – 49%, titanium dioxide (E171) – 25%, talc – 16%, polyethylene glycol 4000 – 7%, soy lecithin – 3%).

10 pcs. – blisters (1) – cardboard packs.

Film-coated tablets white, capsule-shaped; the tablet core is white on the break.

	1 tab.
Linezolid	600 mg

Excipients: microcrystalline cellulose 102 – 200 mg, lactose monohydrate – 155 mg, povidone K30 – 10 mg, talc – 10 mg, magnesium stearate – 5 mg, colloidal silicon dioxide – 5 mg, sodium carboxymethyl starch – 5 mg, croscarmellose sodium – 10 mg.

Film coating composition ready-made white coating mixture – 24.5 mg (polyvinyl alcohol – 49%, titanium dioxide (E171) – 25%, talc – 16%, polyethylene glycol 4000 – 7%, soy lecithin – 3%).

10 pcs. – blisters (1) – cardboard packs.

Linezolid [Avexima Siberia LLC (Russia)]
Solution for infusion 2 mg/ml: containers 100 ml, 200 ml, or 300 ml

Marketing Authorization Holder

Avexima Siberia LLC (Russia)

Dosage Form

Linezolid

Solution for infusion 2 mg/ml: containers 100 ml, 200 ml, or 300 ml

Dosage Form, Packaging, and Composition

Solution for infusion clear, from colorless to brownish-yellow.

	1 ml
Linezolid	2 mg

Excipients: dextrose monohydrate – 50.24 mg, sodium citrate dihydrate – 1.64 mg, citric acid monohydrate (calculated as anhydrous citric acid) – 0.85 mg, sodium hydroxide solution 1M – to pH 4.6-5, hydrochloric acid solution 1M – to pH 4.6-5, water for injections – to 1 ml.

Theoretical osmolarity – 286 mOsm/l

100 ml – containers (1) – bags.
200 ml – containers (1) – bags.
300 ml – containers (1) – bags.

Linezolid [Avis Rus LLC (Russia)]
Solution for infusion 2 mg/1 ml: bottles 100 ml, 150 ml, 200 ml, 300 ml, or 400 ml

Marketing Authorization Holder

Avis Rus LLC (Russia)

Manufactured By

Mosfarm LLC (Russia)

Dosage Form

Linezolid

Solution for infusion 2 mg/1 ml: bottles 100 ml, 150 ml, 200 ml, 300 ml, or 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion clear, colorless or with a brownish tint.

	1 ml
Linezolid	2 mg

Excipients: dextrose monohydrate – 55.27 mg (calculated as dextrose 50.24 mg), sodium citrate dihydrate – 1.87 mg (calculated as sodium citrate 1.64 mg), citric acid monohydrate – 0.85 mg, water for injections – to 1 ml.

100 ml – bottles – cardboard packs.
150 ml – bottles – cardboard packs.
200 ml – bottles – cardboard packs.
300 ml – bottles – cardboard packs.
400 ml – bottles – cardboard packs.

Linezolid [Amedart LLC (Russia)]
Film-coated tablets, 200 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
Film-coated tablets, 300 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
Film-coated tablets, 400 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.

Marketing Authorization Holder

Amedart LLC (Russia)

Dosage Forms

	Linezolid	Film-coated tablets, 200 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
		Film-coated tablets, 300 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
		Film-coated tablets, 400 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Linezolid	200 mg

Excipients: low-substituted hypromellose – 39.6 mg, crospovidone – 28 mg, colloidal silicon dioxide – 5.6 mg, hypromellose – 4 mg, magnesium stearate – 2.8 mg.

Film coating composition Opadry^® AMB II white 88A180040 (polyvinyl alcohol (E1203) – 37%, talc (E553b) – 31%, titanium dioxide (E171) – 25%, glycerol monocaprylocaprate (type 1) – 4%, sodium lauryl sulfate – 3%) – 7 mg.

10 pcs. – jars – cardboard packs.
20 pcs. – jars – cardboard packs.
30 pcs. – jars – cardboard packs.
40 pcs. – jars – cardboard packs.
50 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
100 pcs. – jars – cardboard packs.

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Linezolid	300 mg

Excipients: low-substituted hypromellose – 59.4 mg, crospovidone – 42 mg, colloidal silicon dioxide – 8.4 mg, hypromellose – 6 mg, magnesium stearate – 4.2 mg.

Film coating Opadry ^® AMB II white 88A180040 (Polyvinyl alcohol (E1203) – 37%, talc (E553) – 31%, titanium dioxide (E171) – 25%, glycerol monocaprylocaprate (type 1) – 4%, sodium lauryl sulfate – 3%) – 10.5 mg.

Film-coated tablets white or almost white, oval, biconvex.

	1 tab.
Linezolid	400 mg

Excipients: low-substituted hypromellose – 79.2 mg, crospovidone – 56 mg, colloidal silicon dioxide – 11.2 mg, hypromellose – 8 mg, magnesium stearate – 5.6 mg.

Linezolid [Amedart LLC (Russia)]
Film-coated tablets, 600 mg: 10 or 30 pcs.

Marketing Authorization Holder

Amedart LLC (Russia)

Manufactured By

Rapharma, JSC (Russia)

PharmVILAR NPO, LLC (Russia)

Dosage Form

Linezolid

Film-coated tablets, 600 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oval, biconvex.

	1 tab.
Linezolid	600 mg

Excipients: low-substituted hypromellose – 118.8 mg, crospovidone – 84 mg, colloidal silicon dioxide – 16.8 mg, hypromellose – 12 mg, magnesium stearate – 8.4 mg.

Film coating composition Opadry white YS-1-18202-A (titanium dioxide – 31%, hypromellose – 63%, macrogol – 6%) – 21 mg.

10 pcs. – jars (1) – cardboard packs.
10 pcs. – jars (3) – cardboard packs.

Linezolid [Atoll LLC (Russia)]
Film-coated tablets, 200 mg: 5, 10, 14, 15, 20, 25, 28, 30, 35, 40, 42, 45, 50, 60, 70, 80, 90, 98, 100, 112, 120, 125, 126, 150, 175, 180, 200, 210, 225, 240, 250, 270 or 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Dosage Form

Linezolid

Film-coated tablets, 200 mg: 5, 10, 14, 15, 20, 25, 28, 30, 35, 40, 42, 45, 50, 60, 70, 80, 90, 98, 100, 112, 120, 125, 126, 150, 175, 180, 200, 210, 225, 240, 250, 270 or 300 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a score; on cross-section – 2 layers: a core of white or almost white color and a film coating.

	1 tab.
Linezolid	200 mg

Excipients: microcrystalline cellulose – 66 mg, corn starch – 21 mg, sodium carboxymethyl starch – 15.5 mg, hypromellose – 5.3 mg, magnesium stearate – 2.2 mg.

Film coating composition hypromellose – 4.06 mg, macrogol-4000 – 1.05 mg, titanium dioxide – 1.89 mg.

5 pcs. – contour cell packaging (PVC/aluminum foil) (1) – cardboard packs.
5 pcs. – contour cell packaging (PVC/aluminum foil) (2) – cardboard packs.
5 pcs. – contour cell packaging (PVC/aluminum foil) (3) – cardboard packs.
5 pcs. – contour cell packaging (PVC/aluminum foil) (4) – cardboard packs.
5 pcs. – contour cell packaging (PVC/aluminum foil) (5) – cardboard packs.
5 pcs. – contour cell packaging (PVC/aluminum foil) (6) – cardboard packs.
5 pcs. – contour cell packaging (PVC/aluminum foil) (7) – cardboard packs.
5 pcs. – contour cell packaging (PVC/aluminum foil) (8) – cardboard packs.
5 pcs. – contour cell packaging (PVC/aluminum foil) (9) – cardboard packs.
5 pcs. – contour cell packaging (PVC/aluminum foil) (10) – cardboard packs.
10 pcs. – contour cell packaging (PVC/aluminum foil) (1) – cardboard packs.
10 pcs. – contour cell packaging (PVC/aluminum foil) (2) – cardboard packs.
10 pcs. – contour cell packaging (PVC/aluminum foil) (3) – cardboard packs.
10 pcs. – contour cell packaging (PVC/aluminum foil) (4) – cardboard packs.
10 pcs. – contour cell packaging (PVC/aluminum foil) (5) – cardboard packs.
10 pcs. – contour cell packaging (PVC/aluminum foil) (6) – cardboard packs.
10 pcs. – contour cell packaging (PVC/aluminum foil) (7) – cardboard packs.
10 pcs. – contour cell packaging (PVC/aluminum foil) (8) – cardboard packs.
10 pcs. – contour cell packaging (PVC/aluminum foil) (9) – cardboard packs.
10 pcs. – contour cell packaging (PVC/aluminum foil) (10) – cardboard packs.
14 pcs. – contour cell packaging (PVC/aluminum foil) (1) – cardboard packs.
14 pcs. – contour cell packaging (PVC/aluminum foil) (2) – cardboard packs.
14 pcs. – contour cell packaging (PVC/aluminum foil) (3) – cardboard packs.
14 pcs. – contour cell packaging (PVC/aluminum foil) (4) – cardboard packs.
14 pcs. – contour cell packaging (PVC/aluminum foil) (5) – cardboard packs.
14 pcs. – contour cell packaging (PVC/aluminum foil) (6) – cardboard packs.
14 pcs. – contour cell packaging (PVC/aluminum foil) (7) – cardboard packs.
14 pcs. – contour cell packaging (PVC/aluminum foil) (8) – cardboard packs.
14 pcs. – contour cell packaging (PVC/aluminum foil) (9) – cardboard packs.
14 pcs. – contour cell packaging (PVC/aluminum foil) (10) – cardboard packs.
25 pcs. – contour cell packaging (PVC/aluminum foil) (1) – cardboard packs.
25 pcs. – contour cell packaging (PVC/aluminum foil) (2) – cardboard packs.
25 pcs. – contour cell packaging (PVC/aluminum foil) (3) – cardboard packs.
25 pcs. – contour cell packaging (PVC/aluminum foil) (4) – cardboard packs.
25 pcs. – contour cell packaging (PVC/aluminum foil) (5) – cardboard packs.
25 pcs. – contour cell packaging (PVC/aluminum foil) (6) – cardboard packs.
25 pcs. – contour cell packaging (PVC/aluminum foil) (7) – cardboard packs.
25 pcs. – contour cell packaging (PVC/aluminum foil) (8) – cardboard packs.
25 pcs. – contour cell packaging (PVC/aluminum foil) (9) – cardboard packs.
25 pcs. – contour cell packaging (PVC/aluminum foil) (10) – cardboard packs.
30 pcs. – contour cell packaging (PVC/aluminum foil) (1) – cardboard packs.
30 pcs. – contour cell packaging (PVC/aluminum foil) (2) – cardboard packs.
30 pcs. – contour cell packaging (PVC/aluminum foil) (3) – cardboard packs.
30 pcs. – contour cell packaging (PVC/aluminum foil) (4) – cardboard packs.
30 pcs. – contour cell packaging (PVC/aluminum foil) (5) – cardboard packs.
30 pcs. – contour cell packaging (PVC/aluminum foil) (6) – cardboard packs.
30 pcs. – contour cell packaging (PVC/aluminum foil) (7) – cardboard packs.
30 pcs. – contour cell packaging (PVC/aluminum foil) (8) – cardboard packs.
30 pcs. – contour cell packaging (PVC/aluminum foil) (9) – cardboard packs.
30 pcs. – contour cell packaging (PVC/aluminum foil) (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
14 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
24 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Linezolid [Atoll LLC (Russia)]
Film-coated tablets, 300 mg: from 5 to 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Linezolid

Film-coated tablets, 300 mg: from 5 to 300 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on cross-section the core is white or almost white.

	1 tab.
Linezolid	300 mg

Excipients: microcrystalline cellulose (MCC-101) – 99 mg, corn starch – 31.5 mg, sodium carboxymethyl starch – 23.25 mg, hypromellose – 7.95 mg, magnesium stearate – 3.3 mg.

Coating composition: hypromellose – 3.045 mg, hypromellose – 3.045 mg, macrogol-4000 – 1.575 mg, titanium dioxide – 2.835 mg.

From 5 to 30 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.
From 7 to 100 pcs. – jars^x (1) – cardboard packs.

^x with first opening control

Linezolid [Atoll LLC (Russia)]
Film-coated tablets, 400 mg: 5, 10, 14, 15, 20, 25, 28, 30, 35, 40, 42, 45, 50, 60, 70, 80, 90, 98, 100, 112, 120, 125, 126, 150, 175, 180, 200, 210, 225, 240, 250, 270 or 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Dosage Form

Linezolid

Film-coated tablets, 400 mg: 5, 10, 14, 15, 20, 25, 28, 30, 35, 40, 42, 45, 50, 60, 70, 80, 90, 98, 100, 112, 120, 125, 126, 150, 175, 180, 200, 210, 225, 240, 250, 270 or 300 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a score; on the cross-section – 2 layers: a core of white or almost white color and a film coating.

	1 tab.
Linezolid	400 mg

Excipients: microcrystalline cellulose – 132 mg, corn starch – 42 mg, sodium carboxymethyl starch – 31 mg, hypromellose – 10.6 mg, magnesium stearate – 4.4 mg.

Film coating composition: hypromellose – 8.12 mg, macrogol-4000 – 2.1 mg, titanium dioxide – 3.78 mg.

Linezolid [Atoll LLC (Russia)]
Film-coated tablets, 600 mg: 5, 10, 14, 15, 20, 25, 28, 30, 35, 40, 42, 45, 50, 60, 70, 80, 90, 98, 100, 112, 120, 125, 126, 150, 175, 180, 200, 210, 225, 240, 250, 270 or 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Dosage Form

Linezolid

Film-coated tablets, 600 mg: 5, 10, 14, 15, 20, 25, 28, 30, 35, 40, 42, 45, 50, 60, 70, 80, 90, 98, 100, 112, 120, 125, 126, 150, 175, 180, 200, 210, 225, 240, 250, 270 or 300 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, capsule-shaped, biconvex, with a score; on the cross-section – 2 layers: a core of white or almost white color and a film coating.

	1 tab.
Linezolid	600 mg

Excipients: microcrystalline cellulose – 198 mg, corn starch – 63 mg, sodium carboxymethyl starch – 46.5 mg, hypromellose – 15.9 mg, magnesium stearate – 6.6 mg.

Film coating composition: hypromellose – 12.18 mg, macrogol-4000 – 3.15 mg, titanium dioxide – 5.67 mg.

Linezolid [Belmedpreparaty RUP (Republic of Belarus)]
Film-coated tablets, 300 mg: 40 pcs.

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Linezolid

Film-coated tablets, 300 mg: 40 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Linezolid	300 mg

Excipients: corn starch – 30 mg, sodium starch glycolate (type A) – 21 mg, hydroxypropylcellulose – 6 mg, magnesium stearate – 4.2 mg, microcrystalline cellulose (type 101) – to obtain a tablet weighing 420 mg (without coating), Opadry II white (85F48105)* – 15 mg.

*Composition of Opadry II white (85A48105): polyvinyl alcohol, partially hydrolyzed – 7.035 mg, macrogol (polyethylene glycol) – 3.54 mg, talc – 2.61 mg, titanium dioxide – 1.815 mg.

40 pcs. – dark glass bottles with a capacity of 30 ml (1) – cardboard packs.

Linezolid [Belmedpreparaty RUP (Republic of Belarus)]
Film-coated tablets, 600 mg: 20 pcs.

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Linezolid

Film-coated tablets, 600 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Linezolid	600 mg

Excipients: corn starch – 60 mg, sodium starch glycolate (type A) – 42 mg, hydroxypropylcellulose – 12 mg, magnesium stearate – 8.4 mg, microcrystalline cellulose (type 101) – to obtain a tablet weighing 840 mg (without coating), Opadry II white (85F48105)* – 30 mg.

*Composition of Opadry II white (85A48105): polyvinyl alcohol, partially hydrolyzed – 14.07 mg, macrogol (polyethylene glycol) – 7.08 mg, talc – 5.22 mg, titanium dioxide – 3.63 mg.

20 pcs. – dark glass bottles with a capacity of 30 ml (1) – cardboard packs.

Linezolid [Belmedpreparaty RUP (Republic of Belarus)]
Solution for infusion 2 mg/ml: 100 ml, 200 ml, or 300 ml fl.

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Linezolid

Solution for infusion 2 mg/ml: 100 ml, 200 ml, or 300 ml fl.

Dosage Form, Packaging, and Composition

Solution for infusion clear, colorless or slightly yellowish.

	1 ml
Linezolid (form III)	2 mg

Excipients: dextrose (anhydrous glucose), sodium citrate, anhydrous citric acid, water for injections.

100 ml – glass bottles (1) – cardboard packs.
200 ml – glass bottles (1) – cardboard packs.
300 ml – glass bottles (1) – cardboard packs.
100 ml – glass bottles (24) – cardboard boxes (for hospitals).
100 ml – glass bottles (48) – cardboard boxes (for hospitals).
200 ml – glass bottles (40) – cardboard boxes (for hospitals).
300 ml – glass bottles (24) – cardboard boxes (for hospitals).

Linezolid [Jodas Expoim, LLC (Russia)]
Film-coated tablets, 600 mg: 10, 20, 30, 50, 60, or 100 pcs.

Marketing Authorization Holder

Jodas Expoim, LLC (Russia)

Manufactured By

Jodas Expoim, Pvt. Ltd. (India)

Dosage Form

Linezolid

Film-coated tablets, 600 mg: 10, 20, 30, 50, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oval, biconvex.

	1 tab.
Linezolid	600 mg

Excipients: corn starch – 66 mg, microcrystalline cellulose – 97 mg, povidone K30 – 14 mg, croscarmellose sodium – 17 mg, magnesium stearate – 8 mg, colloidal silicon dioxide – 4 mg, calcium hydrogen phosphate – 40 mg, sodium lauryl sulfate – 4 mg.

Film coating composition: Ineta Moistshield white IC-MS-218 – 11 mg (hypromellose – 63%, titanium dioxide – 31%, talc – 5%, ethylcellulose – 1%).

10 pcs. – contour cell packaging (aluminum/PVC) (1) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (2) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (3) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (5) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (6) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (10) – cardboard packs.
20 pcs. – plastic bottles (1) – cardboard packs.
30 pcs. – plastic bottles (1) – cardboard packs.
50 pcs. – plastic bottles (1) – cardboard packs.
100 pcs. – plastic bottles (1) – cardboard packs.

Linezolid [IST-Pharm, LLC (Russia)]
Solution for infusion 2 mg/1 ml: bottles 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, or 400 ml

Marketing Authorization Holder

IST-Pharm, LLC (Russia)

Dosage Form

Linezolid

Solution for infusion 2 mg/1 ml: bottles 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, or 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion clear, colorless or with a brownish tint.

	1 ml
Linezolid	2 mg

Excipients: dextrose monohydrate (corresponds to 50 mg dextrose) – 55 mg, anhydrous citric acid – 0.75 mg, sodium citrate dihydrate – 1.8 mg, water for injections – to 1 ml.

Theoretical osmolarity 295 mOsm/l.

100 ml – polyethylene bottles (1) – cardboard packs.
150 ml – polyethylene bottles (1) – cardboard packs.
200 ml – polyethylene bottles (1) – cardboard packs.
250 ml – polyethylene bottles (1) – cardboard packs.
300 ml – polyethylene bottles (1) – cardboard packs.
400 ml – polyethylene bottles (1) – cardboard packs.

Linezolid [MBA-Group, LLC (Russia)]
Film-coated tablets, 100 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
Film-coated tablets, 200 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
Film-coated tablets, 300 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
Film-coated tablets, 400 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
Film-coated tablets, 600 mg: 10 pcs.

Marketing Authorization Holder

MBA-Group, LLC (Russia)

Manufactured By

Amedart LLC (Russia)

Dosage Forms

	Linezolid	Film-coated tablets, 100 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
		Film-coated tablets, 200 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
		Film-coated tablets, 300 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
		Film-coated tablets, 400 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
		Film-coated tablets, 600 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Linezolid	100 mg

Excipients: low-substituted hypromellose, crospovidone, colloidal silicon dioxide, hypromellose, magnesium stearate.

Film coating composition Opadry^® AMB II white 88A180040: polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1), sodium lauryl sulfate.

10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Linezolid	200 mg

Excipients: low-substituted hypromellose, crospovidone, colloidal silicon dioxide, hypromellose, magnesium stearate.

Film coating composition Opadry^® AMB II white 88A180040: polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1), sodium lauryl sulfate.

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Linezolid	300 mg

Excipients: low-substituted hypromellose, crospovidone, colloidal silicon dioxide, hypromellose, magnesium stearate.

Film coating composition Opadry^® AMB II white 88A180040: polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1), sodium lauryl sulfate.

Film-coated tablets white or almost white, oval, biconvex.

	1 tab.
Linezolid	400 mg

Excipients: low-substituted hypromellose, crospovidone, colloidal silicon dioxide, hypromellose, magnesium stearate.

Film coating composition Opadry^® AMB II white 88A180040: polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1), sodium lauryl sulfate.

Film-coated tablets white or almost white, oval, biconvex.

	1 tab.
Linezolid	600 mg

Excipients: low-substituted hypromellose, crospovidone, colloidal silicon dioxide, hypromellose, magnesium stearate.

Film coating composition Opadry^® AMB II white 88A180040: polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1), sodium lauryl sulfate.

10 pcs. – jars (1) – cardboard packs.

100 ml – plastic bottles^x (1) – cardboard packs.
200 ml – plastic bottles^x (1) – cardboard packs.
250 ml – plastic bottles^x (1) – cardboard packs.
300 ml – plastic bottles^x (1) – cardboard packs.

^x if necessary, one bottle is placed in a sealed Al/PVC bag.

Linezolid [S.P. Incomed, LLC (Russia)]
Film-coated tablets, 200 mg: 10, 14, 20, 24, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
Film-coated tablets, 300 mg: 10, 14, 20, 24, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
Film-coated tablets, 400 mg: 10, 14, 20, 24, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
Film-coated tablets, 600 mg: 10, 14, 20, 24, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Marketing Authorization Holder

S.P. Incomed, LLC (Russia)

Manufactured By

Interpharma, LLC (Russia)

Dosage Forms

	Linezolid	Film-coated tablets, 200 mg: 10, 14, 20, 24, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
		Film-coated tablets, 300 mg: 10, 14, 20, 24, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
		Film-coated tablets, 400 mg: 10, 14, 20, 24, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
		Film-coated tablets, 600 mg: 10, 14, 20, 24, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from white to almost white in color, round in shape, with a biconvex surface; the cross-section is white or almost white in color.

	1 tab.
Linezolid	200 mg

Excipients: betadex (beta-cyclodextrin) – 10 mg, copovidone – 9 mg, pregelatinized starch – 18 mg, colloidal silicon dioxide – 3 mg, sodium stearyl fumarate – 5 mg, magnesium hydrogen carbonate – 28 mg.

Coating: film coating – 7 mg.
Film coating composition hypromellose – 79.3 %, talc – 2.9 %, macrogol – 14.3 %, titanium dioxide E171 – 3.5 %.

10 pcs. – contour cell packs – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars – cardboard packs.
14 pcs. – jars – cardboard packs.
20 pcs. – jars – cardboard packs.
24 pcs. – jars – cardboard packs.
30 pcs. – jars – cardboard packs.
40 pcs. – jars – cardboard packs.
50 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
100 pcs. – jars – cardboard packs.

Film-coated tablets from white to almost white in color, round in shape, with a biconvex surface; the cross-section is white or almost white in color.

	1 tab.
Linezolid	300 mg

Excipients: betadex (beta-cyclodextrin) – 15 mg, copovidone – 13.5 mg, pregelatinized starch – 27 mg, colloidal silicon dioxide – 4.5 mg, sodium stearyl fumarate – 7.5 mg, magnesium hydrogen carbonate – 42 mg.

Coating: film coating – 10.5 mg.
Film coating composition hypromellose – 79.3 %, talc – 2.9 %, macrogol – 14.3 %, titanium dioxide E171 – 3.5 %.

Film-coated tablets from white to almost white in color, round in shape, with a biconvex surface; the cross-section is white or almost white in color.

	1 tab.
Linezolid	400 mg

Excipients: betadex (beta-cyclodextrin) – 20 mg, copovidone – 18 mg, pregelatinized starch – 36 mg, colloidal silicon dioxide – 6 mg, sodium stearyl fumarate – 10 mg, magnesium hydrogen carbonate – 56 mg.

Coating: film coating – 14 mg.
Film coating composition hypromellose – 79.3 %, talc – 2.9 %, macrogol – 14.3 %, titanium dioxide E171 – 3.5 %.

Film-coated tablets from white to almost white in color, capsule-shaped, with a biconvex surface; the cross-section is white or almost white in color.

	1 tab.
Linezolid	600 mg

Excipients: betadex (beta-cyclodextrin) – 30 mg, copovidone – 27 mg, pregelatinized starch – 54 mg, colloidal silicon dioxide – 9 mg, sodium stearyl fumarate – 15 mg, magnesium hydrogen carbonate – 84 mg.

Coating: film coating – 21 mg.
Film coating composition hypromellose – 79.3 %, talc – 2.9 %, macrogol – 14.3 %, titanium dioxide E171 – 3.5 %.

Linezolid [Sintez PJSC (Russia)]
Film-coated tablets, 200 mg: 10, 14, 20, 24, 30, 50, 60, or 100 pcs.
Film-coated tablets 300 mg: 10, 14, 20, 24, 30, 50, 60 or 100 pcs.
Film-coated tablets, 600 mg: 10, 14, 20, 24, 30, 50, 60, or 100 pcs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Forms

	Linezolid	Film-coated tablets, 200 mg: 10, 14, 20, 24, 30, 50, 60, or 100 pcs.
		Film-coated tablets 300 mg: 10, 14, 20, 24, 30, 50, 60 or 100 pcs.
		Film-coated tablets, 600 mg: 10, 14, 20, 24, 30, 50, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light brown to dark brown in color, round, biconvex; surface roughness is allowed.

	1 tab.
Linezolid	200 mg

Excipients: microcrystalline cellulose (type 102) – 10 mg, copovidone – 9 mg, pregelatinized corn starch – 17.8 mg, sodium carboxymethyl starch type A (sodium starch glycolate type A) – 8.2 mg, colloidal silicon dioxide (aerosil) – 3 mg, sodium stearyl fumarate – 5 mg, magnesium carbonate (basic magnesium carbonate hydrate) – 18 mg, hypromellose 2910 (hydroxypropylmethylcellulose) – 2 mg.

Shell composition: ready-made film coating mixture – 7 mg (macrogol-4000 (polyethylene glycol-4000) – 1.414 mg, titanium dioxide – 0.497 mg, talc – 1.036 mg, polyvinyl alcohol – 2.8 mg, iron oxide yellow dye – 1.253 mg).

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
14 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
24 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Film-coated tablets from light brown to dark brown in color, round, biconvex; surface roughness is allowed.

	1 tab.
Linezolid	300 mg

Excipients: microcrystalline cellulose (type 102) – 15 mg, copovidone – 13.5 mg, pregelatinized corn starch – 26.7 mg, sodium carboxymethyl starch type A (sodium starch glycolate type A) – 12.3 mg, colloidal silicon dioxide (aerosil) – 4.5 mg, sodium stearyl fumarate – 7.5 mg, magnesium carbonate (basic magnesium carbonate hydrate) – 27 mg, hypromellose 2910 (hydroxypropylmethylcellulose) – 3 mg.

Shell composition: ready-made film coating mixture – 10.5 mg (macrogol-4000 (polyethylene glycol-4000) – 2.121 mg, titanium dioxide – 0.7455 mg, talc – 1.554 mg, polyvinyl alcohol – 4.2 mg, iron oxide yellow dye – 1.8795 mg).

Film-coated tablets from light brown to dark brown in color, oval, biconvex; surface roughness is allowed.

	1 tab.
Linezolid	600 mg

Excipients: microcrystalline cellulose (type 102) – 30 mg, copovidone – 27 mg, pregelatinized corn starch – 53.4 mg, sodium carboxymethyl starch type A (sodium starch glycolate type A) – 24.6 mg, colloidal silicon dioxide (aerosil) – 9 mg, sodium stearyl fumarate – 15 mg, magnesium carbonate (basic magnesium carbonate hydrate) – 54 mg, hypromellose 2910 (hydroxypropylmethylcellulose) – 6 mg.

Shell composition: ready-made film coating mixture – 21 mg (macrogol-4000 (polyethylene glycol-4000) – 4.242 mg, titanium dioxide – 1.491 mg, talc -3.108 mg, polyvinyl alcohol – 8.4 mg, iron oxide yellow dye – 3.759 mg).

Linezolid [Pharmconcept, LLC (Russia)]
Film-coated tablets, 200 mg: 10, 14, 20 or 30 pcs.
Film-coated tablets, 300 mg: 10, 14, 20 or 30 pcs.
Film-coated tablets, 400 mg: 10, 14, 20, or 30 pcs.
Film-coated tablets, 600 mg: 10, 14, 20, or 30 pcs.

Marketing Authorization Holder

Pharmconcept, LLC (Russia)

Manufactured By

Pharmconcept, LLC (Russia)

Dosage Forms

	Linezolid	Film-coated tablets, 200 mg: 10, 14, 20 or 30 pcs.
		Film-coated tablets, 300 mg: 10, 14, 20 or 30 pcs.
		Film-coated tablets, 400 mg: 10, 14, 20, or 30 pcs.
		Film-coated tablets, 600 mg: 10, 14, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light brown to dark brown in color, round, biconvex; the cross-section is white or white with a yellowish tint.

	1 tab.
Linezolid	200 mg

Excipients: microcrystalline cellulose – 37.65 mg, corn starch – 19.21 mg, sodium carboxymethyl starch – 13.44 mg, magnesium stearate – 2.69 mg.

Shell composition hypromellose (hydroxypropylmethylcellulose) – 5.19 mg, macrogol 6000 (polyethylene glycol 6000) – 1.08 mg, titanium dioxide – 0.27 mg, talc – 0.017 mg, iron oxide red dye – 0.131 mg, iron oxide yellow dye – 0.302 mg.

10 pcs. – contour cell packs (1) – cardboard packs – group packaging.
10 pcs. – contour cell packs (2) – cardboard packs – group packaging.
10 pcs. – contour cell packs (3) – cardboard packs – group packaging.
14 pcs. – polymer jars (1) – cardboard packs – cardboard boxes (for hospitals).

Film-coated tablets from light brown to dark brown in color, round, biconvex; the cross-section is white or white with a yellowish tint.

	1 tab.
Linezolid	300 mg

Excipients: microcrystalline cellulose – 56.47 mg, corn starch – 28.81 mg, sodium carboxymethyl starch – 20.17 mg, magnesium stearate – 4.04 mg.

Shell composition hypromellose (hydroxypropylmethylcellulose) – 7.79 mg, macrogol 6000 (polyethylene glycol 6000) – 1.62 mg, titanium dioxide – 0.41 mg, talc – 0.026 mg, iron oxide red dye – 0.197 mg, iron oxide yellow dye 0.453 mg.

Film-coated tablets from light brown to dark brown in color, round, biconvex; the cross-section is white or white with a yellowish tint.

	1 tab.
Linezolid	400 mg

Excipients: microcrystalline cellulose – 75.3 mg, corn starch – 38.42 mg, sodium carboxymethyl starch – 26.89 mg, magnesium stearate – 5.38 mg.

Shell composition hypromellose (hydroxypropylmethylcellulose) – 10.38 mg, macrogol 6000 (polyethylene glycol 6000) – 2.16 mg, titanium dioxide – 0.55 mg, talc – 0.035 mg, iron oxide red dye – 0.263 mg, iron oxide yellow dye – 0.604 mg.

Film-coated tablets from light brown to dark brown in color, oval, biconvex; the cross-section is white or white with a yellowish tint.

	1 tab.
Linezolid	600 mg

Excipients: microcrystalline cellulose – 112.95 mg, corn starch – 57.63 mg, sodium carboxymethyl starch – 40.34 mg, magnesium stearate – 8.08 mg.

Shell composition hypromellose (hydroxypropylmethylcellulose) – 15.58 mg, macrogol 6000 (polyethylene glycol 6000) – 3.25 mg, titanium dioxide – 0.825 mg, talc – 0.053 mg, iron oxide red dye – 0.395 mg, iron oxide yellow dye – 0.906 mg.

10 pcs. – contour cell packaging (1) – cardboard packs – group packaging.
10 pcs. – contour cell packaging (2) – cardboard packs – group packaging.
10 pcs. – contour cell packaging (3) – cardboard packs – group packaging.
14 pcs. – polymer jars (1) – cardboard packs – cardboard boxes (for hospitals).

Linezolid [Mir Chemical and Pharmaceutical Concern, LLC (Russia)]
Solution for infusion 2 mg/1 ml: bottles, containers, or vials 100 ml, 150 ml, 200 ml, or 300 ml

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Manufactured By

Medpolymer Firm, JSC (Russia)

NPC Eskom, PJSC (Russia)

Dosage Form

Linezolid

Solution for infusion 2 mg/1 ml: bottles, containers, or vials 100 ml, 150 ml, 200 ml, or 300 ml

Dosage Form, Packaging, and Composition

Solution for infusion as a clear, colorless liquid or with a brownish tint.

	1 ml
Linezolid	2 mg

Excipients: dextrose monohydrate – 55.27 mg, citric acid monohydrate – 0.85 mg, sodium citrate dihydrate – 1.87 mg, water for injections – up to 1 ml.

Theoretical osmolarity: 314.9 mOsm/l.

100 ml – bottles (1) – cardboard packs.
100 ml – containers (1) – bags.
100 ml – containers (1) – film.
100 ml – vials (1) – cardboard packs.
100 ml – vials (1) – bags.
100 ml – vials (1) – film.
150 ml – bottles (1) – cardboard packs.
150 ml – containers (1) – bags.
150 ml – containers (1) – film.
150 ml – vials (1) – cardboard packs.
150 ml – vials (1) – bags.
150 ml – vials (1) – film.
200 ml – bottles (1) – cardboard packs.
200 ml – containers (1) – bags.
300 ml – containers (1) – film.
200 ml – vials (1) – cardboard packs.
200 ml – vials (1) – bags.
200 ml – vials (1) – film.
300 ml – bottles (1) – cardboard packs.
300 ml – containers (1) – bags.
300 ml – containers (1) – film.
300 ml – vials (1) – cardboard packs.
300 ml – vials (1) – bags.
300 ml – vials (1) – film.

Linezolid Canon [Canonpharma Production, CJS (Russia)]
Film-coated tablets, 200 mg: 10 or 30 pcs.
Film-coated tablets, 300 mg: 10 or 30 pcs.
Film-coated tablets, 400 mg: 10 or 30 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Forms

	Linezolid Canon	Film-coated tablets, 200 mg: 10 or 30 pcs.
		Film-coated tablets, 300 mg: 10 or 30 pcs.
		Film-coated tablets, 400 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; the cross-section is almost white.

	1 tab.
Linezolid	200 mg

Excipients: corn starch – 13.8 mg, croscarmellose sodium – 13.2 mg, mannitol – 18.7 mg, magnesium stearate – 2.8 mg, povidone K30 – 6.9 mg, microcrystalline cellulose – 34.6 mg.

Film coating composition Opadry white 9 mg, incl.: hypromellose (hydroxypropyl methylcellulose) – 3.0375 mg, hyprolose (hydroxypropyl cellulose) – 3.0375 mg, talc – 1.8 mg, titanium dioxide – 1.125 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex; the cross-section is almost white.

	1 tab.
Linezolid	300 mg

Excipients: corn starch – 20 mg, croscarmellose sodium – 19 mg, mannitol – 27 mg, magnesium stearate – 4 mg, povidone K30 – 10 mg, microcrystalline cellulose – 50 mg.

Film coating composition Opadry white 13 mg, incl.: hypromellose (hydroxypropyl methylcellulose) – 4.3875 mg, hyprolose (hydroxypropyl cellulose) – 4.3875 mg, talc – 2.6 mg, titanium dioxide – 1.625 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex; the cross-section is almost white.

	1 tab.
Linezolid	400 mg

Excipients: corn starch – 27.6 mg, croscarmellose sodium – 26.4 mg, mannitol – 37.4 mg, magnesium stearate – 5.6 mg, povidone K30 – 13.8 mg, microcrystalline cellulose – 69.2 mg.

Film coating composition Opadry white 18 mg, incl.: hypromellose (hydroxypropyl methylcellulose) – 6.075 mg, hyprolose (hydroxypropyl cellulose) – 6.075 mg, talc – 3.6 mg, titanium dioxide – 2.25 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.

Linezolid Canon [Canonpharma Production, CJS (Russia)]
Film-coated tablets, 600 mg: 10, 20, or 30 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Manufactured By

Canonpharma Production, CJS (Russia)

Dosage Form

Linezolid Canon

Film-coated tablets, 600 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oval, biconvex; the cross-section is almost white.

	1 tab.
Linezolid	600 mg

Excipients: corn starch – 40 mg, croscarmellose sodium – 38 mg, mannitol – 54 mg, magnesium stearate – 8 mg, povidone K30 – 20 mg, microcrystalline cellulose – 100 mg.

Film coating composition opadry white – 26 mg (incl. hypromellose (hydroxypropyl methylcellulose) – 8.775 mg, hyprolose (hydroxypropyl cellulose) – 8.775 mg, talc – 5.2 mg, titanium dioxide – 3.25 mg).

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.

Linezolid Canon [Canonpharma Production, CJS (Russia)]
Solution for infusion 2 mg/ml: cont. 100 ml, 200 ml, or 300 ml, 1 or 10 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Manufactured By

Belarusian-Dutch Joint Venture “FARMLAND”, LLC (Republic of Belarus)

Dosage Form

Linezolid Canon

Solution for infusion 2 mg/ml: cont. 100 ml, 200 ml, or 300 ml, 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion clear, from colorless to yellow.

	1 ml
Linezolid	2 mg

Excipients: dextrose monohydrate 50.24 mg, anhydrous citric acid – 0.85 mg, sodium citrate – 1.64 mg, 50% citric acid solution to pH 4.4-5.2, water for injections – up to 1 ml.

100 ml – polymer container (1) – bag.
100 ml – polymer container (1) – bag (10) – cardboard packs.
200 ml – polymer container (1) – bag.
200 ml – polymer container (1) – bag (10) – cardboard packs.
300 ml – polymer container (1) – bag.
300 ml – polymer container (1) – bag (10) – cardboard packs.

Linezolid-Advanced [Advanced Pharma, LLC (Russia)]
Solution for infusion 2 mg/1 ml: bottles 100 ml, 200 ml, 250 ml, or 300 ml

Marketing Authorization Holder

Advanced Pharma, LLC (Russia)

Manufactured By

Advanced Perm, LLC (Russia)

Dosage Form

Linezolid-Advanced

Solution for infusion 2 mg/1 ml: bottles 100 ml, 200 ml, 250 ml, or 300 ml

Dosage Form, Packaging, and Composition

Solution for infusion as a clear liquid from colorless to yellow with a brownish tint.

	1 ml
Linezolid	2 mg

Excipients: dextrose monohydrate – 55.26 mg, citric acid – 0.83 mg, sodium citrate dihydrate – 1.9 mg, 1M sodium hydroxide solution or 1M hydrochloric acid solution – to pH 4.0-5.0, water for injections – up to 1 ml.

100 ml – glass bottles (1) – cardboard packs.
200 ml – glass bottles (1) – cardboard packs.
250 ml – glass bottles (1) – cardboard packs.
300 ml – glass bottles (1) – cardboard packs.

Linezolid-Akri^® [Polpharma Pharmaceutical Works, Sa (Poland)]
Film-coated tablets, 600 mg: 10, 20, 30, 50, or 60 pcs.

Marketing Authorization Holder

Polpharma Pharmaceutical Works, Sa (Poland)

Dosage Form

Linezolid-Akri^®

Film-coated tablets, 600 mg: 10, 20, 30, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oblong, biconvex; the fracture is from white to almost white.

	1 tab.
Linezolid	600 mg

Excipients: sodium carboxymethyl starch – 25.2 mg, microcrystalline cellulose PH101 – 24 mg, povidone K30 – 15.2 mg, sodium dihydrogen citrate powder F0100 – 47.54 mg, microcrystalline cellulose PH102 – 129.66 mg, magnesium stearate – 8.4 mg.

Coating composition Sepifilm^® 752 white (hypromellose (40%) – 6.8 mg, microcrystalline cellulose (32%) – 5.44 mg, macrogol 40 stearate (8%) – 1.36 mg, titanium dioxide (E171) (20%) – 3.4 mg) – 17 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.

Linezolid-AMEDART [Amedart LLC (Russia)]
Solution for infusion 2 mg/ml: infusion bags 50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, or 400 ml

Marketing Authorization Holder

Amedart LLC (Russia)

Dosage Form

Linezolid-AMEDART

Solution for infusion 2 mg/ml: infusion bags 50 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, or 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion clear from colorless to yellow.

	1 ml
Linezolid	2 mg

Excipients: sodium citrate dihydrate, citric acid, dextrose monohydrate, water for injections.

50 ml – infusion bags (1) – cardboard boxes.
50 ml – infusion bags (5) – cardboard boxes.
50 ml – infusion bags (10) – cardboard boxes.
50 ml – infusion bags (25) – cardboard boxes.
100 ml – infusion bags (1) – cardboard boxes.
100 ml – infusion bags (5) – cardboard boxes.
100 ml – infusion bags (10) – cardboard boxes.
100 ml – infusion bags (25) – cardboard boxes.
150 ml – infusion bags (1) – cardboard boxes.
150 ml – infusion bags (5) – cardboard boxes.
150 ml – infusion bags (10) – cardboard boxes.
150 ml – infusion bags (25) – cardboard boxes.
200 ml – infusion bags (1) – cardboard boxes.
200 ml – infusion bags (5) – cardboard boxes.
200 ml – infusion bags (10) – cardboard boxes.
200 ml – infusion bags (25) – cardboard boxes.
250 ml – infusion bags (1) – cardboard boxes.
250 ml – infusion bags (5) – cardboard boxes.
250 ml – infusion bags (10) – cardboard boxes.
250 ml – infusion bags (25) – cardboard boxes.
300 ml – infusion bags (1) – cardboard boxes.
300 ml – infusion bags (5) – cardboard boxes.
300 ml – infusion bags (10) – cardboard boxes.
300 ml – infusion bags (25) – cardboard boxes.
400 ml – infusion bags (1) – cardboard boxes.
400 ml – infusion bags (5) – cardboard boxes.
400 ml – infusion bags (10) – cardboard boxes.
400 ml – infusion bags (25) – cardboard boxes.

Linezolid-Edvansd [Advanced Pharma, LLC (Russia)]
Film-coated tablets, 200 mg: 10 pcs.
Film-coated tablets, 300 mg: 10 pcs.
Film-coated tablets, 400 mg: 10 pcs.
Film-coated tablets, 600 mg: 10 pcs.

Marketing Authorization Holder

Advanced Pharma, LLC (Russia)

Dosage Forms

	Linezolid-Advanced	Film-coated tablets, 200 mg: 10 pcs.
		Film-coated tablets, 300 mg: 10 pcs.
		Film-coated tablets, 400 mg: 10 pcs.
		Film-coated tablets, 600 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex; the cross-section of the core is from white to almost white.

	1 tab.
Linezolid	200 mg

Excipients: microcrystalline cellulose type 102 – 26.67 mg, corn starch – 26.67 mg, hyprolose – 10 mg, sodium carboxymethyl starch – 23.33 mg, croscarmellose sodium – 8.33 mg, colloidal silicon dioxide – 3.33 mg, magnesium stearate – 1.67 mg.

Film coating composition hypromellose – 3.7 mg, macrogol 400 – 0.7 mg, titanium dioxide – 1.57 mg, macrogol 6000 – 0.7 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – plastic jars (1) – cardboard packs.

Film-coated tablets white, oval, biconvex, with a score; the cross-section of the core is from white to almost white.

	1 tab.
Linezolid	300 mg

Excipients: microcrystalline cellulose type 102 – 40 mg, corn starch – 40 mg, hyprolose – 15 mg, sodium carboxymethyl starch – 35 mg, croscarmellose sodium – 12.5 mg, colloidal silicon dioxide – 5 mg, magnesium stearate – 2.5 mg.

Film coating composition hypromellose – 5.55 mg, macrogol 400 – 1.05 mg, titanium dioxide – 2.35 mg, macrogol 6000 – 1.05 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – plastic jars (1) – cardboard packs.

Film-coated tablets white, round, biconvex; the cross-section of the core is from white to almost white.

	1 tab.
Linezolid	400 mg

Excipients: microcrystalline cellulose type 102 – 53.33 mg, corn starch – 53.33 mg, hyprolose – 20 mg, sodium carboxymethyl starch – 46.67 mg, croscarmellose sodium – 16.67 mg, colloidal silicon dioxide – 6.67 mg, magnesium stearate – 3.33 mg.

Film coating composition hypromellose – 7.4 mg, macrogol 400 – 1.4 mg, titanium dioxide – 3.13 mg, macrogol 6000 – 1.4 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – plastic jars (1) – cardboard packs.

Film-coated tablets white, oval, biconvex; the cross-section of the core is from white to almost white.

	1 tab.
Linezolid	600 mg

Excipients: microcrystalline cellulose type 102 – 80 mg, corn starch – 80 mg, hyprolose – 30 mg, sodium carboxymethyl starch – 70 mg, croscarmellose sodium – 25 mg, colloidal silicon dioxide – 10 mg, magnesium stearate – 5 mg.

Film coating composition hypromellose – 11.1 mg, macrogol 400 – 2.1 mg, titanium dioxide – 4.7 mg, macrogol 6000 – 2.1 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – plastic jars (1) – cardboard packs.

Linezolid-KRKA [Krka d.d., Novo mesto (Slovenia)]
Film-coated tablets, 600 mg: 10, 20, or 30 pcs.

Marketing Authorization Holder

Krka d.d., Novo mesto (Slovenia)

Dosage Form

Linezolid-KRKA

Film-coated tablets, 600 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oval, slightly biconvex; the appearance of the fracture is a rough mass of white or almost white color.

	1 tab.
Linezolid	600 mg

Excipients: microcrystalline cellulose, corn starch, sodium starch glycolate (type A), hypromellose, magnesium stearate.

Film coating composition film-forming mixture (hypromellose, titanium dioxide (E171), macrogol, talc).

10 pcs. – blisters (1) – carton packs.
10 pcs. – blisters (2) – carton packs.
10 pcs. – blisters (3) – carton packs.

Linezolid-Teva [Teva Pharmaceutical Industries, Ltd. (Israel)]
Solution for infusion 2 mg/1 ml: bag 300 ml 10 or 30 pcs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Pharmaceutical Works, Private Limited Company (Hungary)

Dosage Form

Linezolid-Teva

Solution for infusion 2 mg/1 ml: bag 300 ml 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion	1 ml
Linezolid	2 mg

300 ml – bags (10) for infusion – carton boxes.
300 ml – bags (30) for infusion – carton boxes.

Linezolid-Vial [Vial, LLC (Russia)]
Film-coated tablets, 600 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Marketing Authorization Holder

Vial, LLC (Russia)

Manufactured By

Protech Biosystems, Pvt. Ltd. (India)

Dosage Form

Linezolid-Vial

Film-coated tablets, 600 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, biconvex, oblong in shape, with a score on one side; the core on the cross-section is white or almost white.

	1 tab.
Linezolid	600 mg

Excipients: corn starch – 136.8 mg, microcrystalline cellulose – 110 mg, sodium carboxymethyl starch (type A) – 16.8 mg, croscarmellose sodium – 11 mg, magnesium stearate – 8.8 mg, talc – 8.52 mg, colloidal silicon dioxide – 7 mg, methylparaben – 0.9 mg, propylparaben – 0.18 mg.

Film coating composition film coating Color Coat FH4S-H, white color (hypromellose 15 cP – 9.45 mg, dibutyl sebacate – 2.65 mg, hypromellose 5 cP – 1.89 mg, colloidal silicon dioxide – 1.14 mg, titanium dioxide – 2.14 mg, talc – 2.73 mg) – 20 mg.

10 pcs. – blisters made of aluminum foil (1) – carton packs.
10 pcs. – blisters made of aluminum foil (2) – carton packs.
10 pcs. – blisters made of aluminum foil (3) – carton packs.
10 pcs. – blisters made of aluminum foil (4) – carton packs.
10 pcs. – blisters made of aluminum foil (5) – carton packs.
10 pcs. – blisters made of aluminum foil (6) – carton packs.
10 pcs. – blisters made of aluminum foil (7) – carton packs.
10 pcs. – blisters made of aluminum foil (8) – carton packs.
10 pcs. – blisters made of aluminum foil (9) – carton packs.
10 pcs. – blisters made of aluminum foil (10) – carton packs.
50 pcs. – polymer containers (1) – carton packs.

Medixlife (Author)

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