Lynozid
(Linezolid)




COMPOSITION

5 ml of suspension contain

Active ingredient: linezolid 100 mg.

Excipients: sucrose, mannitol, saccharin sodium, microcrystalline cellulose, carmellose sodium, xanthan gum, sodium citrate dehydrate, sodium chloride, sodium benzoate, citric acid anhydrous, orange flavor, cream flavor.

THERAPEUTIC INDICATIONS

Treatment of infectious inflammatory diseases caused by susceptible to linezolid anaerobic and aerobic gram-positive organisms (including infections accompanied by bacteremia):

- community-acquired pneumonia, caused by Streptococcus pneumoniae (poly-resistant strains as well), including cases accompanied by bacteremia, or by Staphylococcus aureus (only methicillin-susceptible strains);

- hospital-acquired pneumonia, caused by Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) or by Streptococcus pneumoniae (including poly-resistant strains);

- non-complicated and complicated infections of skin and soft tissues, 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.

CONTRAINDICATIONS

Hypersensitivity to linezolid or to any other component of the drug.

Do not administer the drug concomitantly or less than 2 weeks after administration of monoamine oxidase A or B inhibitors (phenelzine, isocarboxazid, selegiline, moclobemid).

Lynozid should not be prescribed to patients with the following clinical conditions (except for cases when close control and monitoring of arterial pressure is possible): uncontrolled arterial hypertension, pheochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder, acute dizziness episodes. Administration of Lynozid is also contraindicated in case of concomitant treatment with: serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5-НТ1-receptor agonists (triptans), sympathomimetic (including adrenergic bronchodilators, pseudoephedrine, phenylpropanolamine), vasopressors (epinephrine, norepinephrine), dopaminergic compounds (dopamine, dobutamin), petidine or buspirone.

ADVERSE EFFECTS

The used side effects frequency parameters presented below are classified in the following way:

frequently (from ≥ 1/100 to < 1/10), infrequently (from ≥ 1/1000 to < 1/100), unspecified frequency - frequency parameters can not be estimated from the available data.

Infections and invasions: frequently - candidiasis (oral and vaginal) or fungal infections; infrequently - vaginitis.

Blood and lymphatic system disorders: infrequently - leukopenia, thrombocytopenia; unspecified frequency – pancytopenia, transitory anemia.

Nervous system disorders: frequently - headache, metallic aftertaste; infrequently - dizziness, hypoesthesia, paresthesia; unspecified frequency - peripheral neuropathy, convulsions and serotonin syndrome.

Eye disorders: unspecified frequency - optic neuropathy.

Ear and labyrinth disorders: infrequently - tinnitus.

GIT disorders: frequently - diarrhea, nausea, vomiting; infrequently - local or generalized abdominal pain, constipation, mouth dryness, dyspepsia, gastritis, glossitis, pancreatitis, stomatitis, tongue discoloration.

Skin and subcutaneous tissue disorders: infrequently - rash, urticaria.

Psychiatric disorders: infrequently - insomnia.

DOSAGE AND ADMINISTRATION

Lynozid is administered orally in a recommended single dose 2 times daily. The suspension may be administered both during and between meals.

Instructions on administration: gently tap the bottle to loosen the cake, add water to the bottle label on the bottle in two steps (2 approximately equal portions) in order to obtain 150 ml of suspension. After addition of the first portion of water shake the bottle vigorously so as to moisten all the contents well; then add the rest of water and shake the bottle again until the homogeneous suspension is obtained. Reconstitute the suspension before administration by way of overturning the bottle 3–5 times (do not shake!).

Patients which were initially treated with the parenteral form of the drug may be switched to any other form for oral administration on clinical grounds. In such cases dose adjustment is not required, as oral bioavailability of linezolid practically equals 100%.

The dose is titrated individually depending on the location and severity of infection, as well as susceptibility of the organisms and the general state of the patient.

Doses recommended for adults and adolescents over 12 years old: hospital-acquired pneumonia (including forms accompanied by bacteraemia); community-acquired pneumonia (including forms accompanied by bacteraemia); infections of skin and soft tissues (including forms accompanied by bacteraemia) - 600 mg every 12 hours. Duration of therapy: 10-14 days.

Enterococci infections (including those caused by vancomycin-resistant strains and the forms accompanied by bacteraemia) - 600 mg every 12 hours. Duration of therapy: 14-28 days.

Doses recommended for children (from birth to 11 years old inclusively): hospital-acquired pneumonia (including forms accompanied by bacteraemia); community-acquired pneumonia (including forms accompanied by bacteraemia); infections of skin and soft tissues - 10 mg/kg of body weight every 8 hours. Duration of therapy: 10-14 days.

Non-complicated infections of skin and soft tissues: children under 5 years old - 10 mg/kg of body weight every 8 hours; children from 5 to 11 years old - 10 mg/kg of body weight every 12 hours. Duration of therapy: 10-14 days.

Enterococci infections (including those caused by vancomycin-resistant strains and the forms accompanied by bacteraemia) - 10 mg/kg of body weight every 8 hours. Duration of therapy: 14-28 days.

Elderly patients: no dose adjustment is required.

Patients with renal failure: no dose adjustment is required.

Patients with hepatic failure: no dose adjustment is required.

SPECIAL INDICATIONS

In diagnosed infection (or suspected infection), caused by associated gram-negative organisms, concomitant administration of drugs acting against gram-negative flora is indicated.

Reversible myelosuppression (anemia, thrombocytopenia, leukopenia and pancytopenia) was reported to appear in some patients receiving linezolid; severity of myelosuppression may depend on the dosage and duration of treatment. Thrombocytopenia may more often appear in patients with severe renal failure regardless of dialysis. Thus, control of extensive complete blood analysis should be established in patients with existing anemia, granulocytopenia, thrombocytopenia; in patients receiving drugs reducing hemoglobin or thrombocyte count in peripheral blood or suppressing their function; in patients with severe renal failure; in patients with increased hemorrhage risk; in patients with previously diagnosed myelosuppression or those receiving linezolid for more than 2 weeks.

Risk of development of pseudomembranous colitis of various degrees of severity should be considered in patients receiving antibacterial drugs, including linezolid. Cases of diarrhea, associated with Clostridium difficile, were reported in administration of almost all antimicrobial drugs, including linezolid; the severity may vary from insignificant diarrhea to colitis with lethal outcome. Diarrhea, associated with C. difficile, should be suspected in all patients with diarrhea developing after administration of antibiotics.

In case of symptoms of eye function deterioration, such as alteration of visual acuity, alteration of color perception, blurred vision, and visual field defects, urgent ophthalmic examination is recommended. Visual function should be controlled in all patients administering linezolid over a long period of time (3 months or more) and in all patients with complaints of eye symptoms, irrespective of duration of treatment with linezolid. In case of development of peripheral or optic neuropathy advisability of further linezolid treatment should be considered, as well as the associated potential risk.

Cases of lactate acidosis during treatment with linezolid were reported. Patients administering linezolid and experiencing recurrent nausea or vomiting, acidosis with undefined reasons or decreased blood bicarbonate levels should be immediately subjected to medical examination.

Emergence of seizures was rarely reported in patients administering linezolid, mainly in cases of history of seizures or risk factors of development of these.

If administration of selective serotonin reuptake inhibitors concomitantly with Lynozid treatment is necessary, continuous monitoring of such patients should be established in order to reveal the signs and symptoms of serotonin syndrome: impairment of cognitive function, hyperpyrexia, hyperreflexia and motor dysfunction. In case of emergence of such signs and symptoms the doctor should consider the necessity to discontinue one of the two or both drugs. After withdrawal of serotoninergic drug the symptoms may disappear.

PREGNANCY AND LACTATION

Administration of Lynozid during pregnancy is possible only in cases when the expected benefit for the mother outweighs the potential risk for the fetus.

Breast feeding during treatment should be terminated.

MANUFACTURED FORM AND PACKAGE

Powder for oral suspension 100 mg/5 ml in a 250 ml amber glass bottle with plastic closure with white coloured polyethylene seal.

1 bottle with a measuring spoon together with the enclosed leaflet in a carton box.

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