Flexin - instructions for use, doses, side effects, contraindications

* is used to bring the pH to the desired value (~ 4.8): about 0.006 ml of sodium hydroxide solution of 0.1 M and about 0.003 ml of 1 M hydrochloric acid solution.

Description:PA yellow liquid with a greenish tinge.

Pharmacotherapeutic group:antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A Fluoroquinolones

J.01.M.A.12 Levofloxacin

Pharmacodynamics:

Levofloxacin is a broad-spectrum antimicrobial bactericide that blocks DNA gyrase and topoisomerase IV, suppressing the synthesis of DNA.

Below are summarized data on the activity of levofloxacin based on studies in vitro and the results of clinical trials.

Sensitive microorganisms

Aerobic Gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus faecalis, Enterococcus spp., Listeria monocytogenes, Staphylococcus coagulase-negative methi-S (I) (methicillin-susceptible coagulase / -umerenno sensitive), Staphylococcus aureus methi-S (methicillin sensitive), Staphylococcus epidermidis methi-S ( methicillin-sensitive), Streptococci group C and G, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Viridans streptococci.

Aerobic Gram-negative microorganisms: Acinetobacter baumannii, Acinetobacter spp., Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp., Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae, Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp., Moraxella catarrhalis, Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurel la spp, Proteus mirabilis, Proteus vulgaris, Providencia spp., Pseudomonas aeruginosa (hospital infections caused by Pseudomonas aeruginosa may require combined treatment), Pseudomonas spp., Salmonella spp., Serratia marcescens, Serratia spp.

Anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Fusobacterium spp., Propionibacterium spp, Veillonella spp, Gardnerella vaginalis.

Other microorganisms: Bartonella spp., Chlamydophila pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp., Mycobacterium spp., Mycobacterium leprae, Mycobacterium tuberculosis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.

Moderately sensitive microorganisms

AehGram-positive microorganisms: Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis methi-R (methicillin-resistant), Staphylococcus haemolyticus methi-R.

Aehtimid gram-negative microorganisms: Burkholderia cepacia, Campylobacter jejuni / coli.

Anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovatus, Prevotella spp., Porphyromonas spp., Peptostreptococcus, Clostridium perfringens.

Resistant to levofloxacin microorganisms

Aerobic Gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus methi-R, Staphylococcus coagulase-negative methi-R.

Aerobic gram-negative microorganisms: Alcaligenes xylosoxidans, Burkholderia cepacia.

Anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides fragilis.

Other microorganisms: Mycobacterium avium, Mycoplasma hominis.

Resistance

Resistance to levofloxacin develops as a result of a phased mutation process of genes encoding both topoisomerases of type II: DNA-gyrase and topoisomerase IV (modification of the target of action).Other mechanisms of resistance, such as the effect on the penetration barriers of a microbial cell (a mechanism characteristic of Pseudomonas aeruginosa) and the mechanism of efflux (active removal of the antimicrobial from the microbial cell), can also reduce the sensitivity of microorganisms to levofloxacin.

There is cross-resistance between levofloxacin and other fluoroquinolones. In connection with the mechanism of action, there is usually no cross-resistance between levofloxacin and other groups of antibacterial drugs.

Pharmacokinetics:

After an intravenous 60-minute infusion of levofloxacin at a dose of 500 mg to healthy volunteers, the maximum plasma concentration (C_mOh) averaged 6.2 μg / ml.

The pharmacokinetics of levofloxacin is linear in the dosage range of 50 to 1000 mg. The equilibrium state of the concentration of levofloxacin in blood plasma when 500 mg of levofloxacin is administered 1 or 2 times a day is reached within 48 hours. On day 10 of intravenous administration levofloxacin 500 mg once a day C_mOh was 6.4 ± 0.8 μg / L, and the minimum concentration of levofloxacin (concentration before administration of the next dose) in blood plasma (C_min) was 0.6 ± 0.2 μg / ml.On the 10th day of intravenous Levofloxacin 2 times a day C_max was 7.9 ± 1.1 μg / ml, and C_minwas 2.3 ± 0.5 μg / ml.

Distribution

Communication with blood plasma proteins is 30-40%. The volume of distribution of levofloxacin is approximately 100 liters after a single and multiple intravenous injection, which indicates a good penetration of the drug into human organs and tissues. The equilibrium concentration is achieved within 48 hours after taking levofloxacin in a dose of 500 mg 1 or 2 times a day.

Levofloxacin penetrates well into the bronchial mucosa, epithelial lining fluid, alveolar macrophages with penetration coefficients in the bronchial mucosa and epithelial lining fluid compared to the concentration in the blood plasma of 1.1-1.8 and 0.8-3, respectively.

Levofloxacin penetrates well into the lung tissue, the penetration factor is 2-5 compared to the concentration in the blood plasma. Well penetrates into the alveolar fluid with a coefficient of penetration of 1, compared with the concentrations in the blood plasma. When levofloxacin was administered 500 mg 1 or 2 times a day for 3 days, the maximum concentrations of levofloxacin in the alveolar fluid were achieved 2-4 hours after administration and were 4.0 and 6.7 μg / ml, respectively.

Levofloxacin well penetrates into the cortical and spongy bone tissue, both in the proximal and distal femur with a coefficient of penetration (bone tissue / blood plasma) of 0.1-3. Levofloxacin poorly penetrates into the cerebrospinal fluid. Levofloxacin well penetrates into the prostate tissue, the average ratio of prostatic / plasma concentrations is 1.84.

In the urine, high concentrations of levofloxacin are created, several times higher than plasma concentrations.

Metabolism

Levofloxacin in a small amount is metabolized with the formation of demethyl-levofloxacin and levofloxacin-Noxide. These metabolites account for less than 5% dose given through the kidneys.

Excretion

The half-life of levofloxacin (T_1/2) is 6-8 hours. Removal of the drug is mainly carried out by the kidneys (more than 85% of the administered dose). The total clearance of levofloxacin after a single administration of 500 mg is 175 ± 29.2 ml / min.

There are no significant differences in the pharmacokinetics of levofloxacin with its intravenous administration and ingestion, which confirms that oral and intravenous routes of administration are interchangeable.

In patients with renal insufficiency the pharmacokinetics of levofloxacin varies.As the kidney function worsens, excretion through the kidneys and kidney clearance (CIR) decrease, and T_1/2 increases.

The importance of pharmacokinetic parameters in renal failure:

Creatinine clearance (CK) (ml / min)	<20	20-49	50-80
CIR (ml / min)	13	26	57
T_1/2	35	27	9

In elderly patients (over 65 years of age) kinetics of levofloxacin does not differ from that in patients of other age groups, except for differences in pharmacokinetics associated with changes in creatinine clearance (CC).

The pharmacokinetics of levofloxacin in men and women do not differ.

Indications:

Infections caused by susceptible to levofloxacin strains of microorganisms:

- lower respiratory tract infection (community-acquired pneumonia);

- urinary tract infections;

- chronic bacterial prostatitis;

- infections of the skin and soft tissues;

- in the complex therapy of drug-resistant forms of tuberculosis;

- prevention and treatment of pulmonary form of anthrax.

Contraindications:

- Hypersensitivity to levofloxacin or other quinolones and / or other components of the drug;

- epilepsy;

- lesions of tendons that occurred with previous treatment with fluoroquinolones;

- children and adolescents under 18 years of age (due to incomplete growth of the skeleton, as the risk of damage to the cartilaginous growth points can not be completely excluded);

- pregnancy and the period of breastfeeding;

- pseudo-paralytic myasthenia gravis (myasthenia gravis gravis).

Carefully:

- Renal insufficiency, deficiency of glucose-6-phosphate dehydrogenase (increased risk of hemolysis), simultaneous administration of drugs that affect tubular secretion (eg, probenecid and cimetidine), diabetes, female sex;

- known risk factors for prolongation of the QT interval: congenital syndrome of the extended QT interval, simultaneous administration of drugs capable of prolonging the QT interval (eg, class I and III antiarrhythmics, tricyclic antidepressants, macrolides, neuroleptics, elderly patients and women may be more sensitive to drugs, prolonging QT interval), not corrected electrolyte disturbances (eg, hypomagnesemia, hypokalemia, hyponatremia);

- elderly age;

- heart disease (eg, heart failure, myocardial infarction, bradycardia);

- predisposition to convulsive reactions (atherosclerosis of vesselsbrain, cerebral circulation (history), organic diseases of the central nervous system);

- hepatic porphyria;

- simultaneous reception of drugs that reduce the threshold of convulsive readiness of the brain (fenbufen and other nonsteroidal anti-inflammatory drugs (NSAIDs) similar to it, theophylline);

- psychosis and other mental disorders in the history.

Pregnancy and lactation:

Studies in animals showed no reproductive toxicity of the drug. However, in the absence of similar data on the use of the drug in humans, given that the experimental data show the possibility of negative effects of fluoroquinolones on cartilage growth points of the skeleton, the use of levofloxacin during pregnancy is contraindicated.

It is not known whether the levofloxacin in breast milk. If you need to use the drug during breastfeeding, you should decide whether to stop it.

Dosing and Administration:

Dosing regimen is determined by the nature and severity of the infection, as well as the suspected pathogen susceptibility.

The drug should be administered slowly by intravenous drip infusion, once or twice a day. The recommended duration of infusion should be at least 30 minutes for the administration of 250 mg of levofloxacin, 60 minutes for the administration of 500 mg.

Preparation Fleksid® compatible with 0.9% sodium chloride solution, 5% glucose solution, 2.5% glucose solution in Ringer's solution, as well as with the combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).

The solution of the Flekside ® preparation should not be mixed with heparin or solutions that have an alkaline reaction!

Duration of treatment varies depending on the course of the disease. As with the use of other antibacterial drugs, treatment with Flexi ® is recommended to continue for at least 48-72 hours after the normalization of body temperature or reliable eradication of the pathogen. The course of treatment can not be interrupted or terminated prematurely without a doctor's instructions.

Dosing regimen of the drug adults with KK> 50 ml / min

Disease	Dosing regimen	Duration of treatment
Community-acquired pneumonia	500 mg 1-2 times a day	7-14 days
Complicated urinary tract infections	500 mg once a day	7-14 days
Pyelonephritis	500 mg once a day	7-10 days
Uncomplicated urinary tract infections	250 mg once a day	3 days
Chronic bacterial prostatitis	500 mg once a day	28 days
Infection of the skin and soft tissues	500 mg 1-2 times a day	7-14 days
As part of the complex treatment of drug-resistant forms of tuberculosis	500 mg 1-2 times a day	up to 3 months
Prevention and treatment of pulmonary form of anthrax	500 mg once a day	up to 8 weeks

After a few days of treatment, intravenous infusions of the drug can be replaced by the oral route of administration (bioavailability when taking the drug inside is 99-100%, dose adjustment is not required). The time to transition depends on the patient's condition and the clinical situation, but usually ranges from 2 to 4 days. This recommended duration of treatment includes the use of the Flexide® preparation in the form of a solution for infusion and a tablet form of the preparation.

Special categories of patients

Impaired renal function (CK <50 mL / min)

Creatinine clearance	Dosing regimen
Creatinine clearance	250 mg / day	500 mg / day	500 mg / 12 h
The first dose	250mg	500 mg	500 mg
50-20 ml / min	125 mg / day	250 mg / day	250 mg / 12 h
19-10 ml / min	125 mg / 48 h	125 mg / day	125 mg / 12 h
Less than 10 ml / min) *	125 mg / 48 h	125 mg / day	125 mg / day

* including peritoneal dialysis and hemodialysis. Patients on hemodialysis or peritoneal dialysis are not required to administer additional doses.

Impaired liver function

No dosage adjustment is required, since levofloxacin only slightly metabolized in the liver.

Elderly age

Correction of the dosing regimen is not required.

Side effects:

According to the World Health Organization (WHO), adverse reactions are classified according to their developmental frequency as follows: very often (≥1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, < 1/100), rarely (≥1 / 10000, <1/1000) and very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

Disturbances from the gastrointestinal tract (GIT)

often: nausea, diarrhea, vomiting;

infrequently: abdominal pain, indigestion, flatulence, constipation;

frequency is unknown: stomatitis, pancreatitis, diarrhea with an admixture of blood, which in very rare cases can be a sign of enterocolitis, including pseudomembranous colitis.

Disturbances from the liver and bile ducts

often: increased activity of "liver" transaminases, alkaline phosphatase (AP) and gamma-glutamyl transferase (G-HT);

infrequently: increased bilirubin concentration in blood plasma;

frequency is unknown: severe hepatic insufficiency, including cases of development of acute hepatic insufficiency, sometimes with fatal outcome, especially in patients with severe underlying disease (eg, in patients with sepsis), jaundice, hepatitis.

Disturbances from the nervous system

often: headache, dizziness, insomnia;

infrequently: drowsiness, increased excitability, confusion, anxiety, tremor, anxiety;

rarely: "nightmarish" dreams, paresthesia, convulsions, depression, agitation, disorientation, psychotic reactions (eg, hallucinations, paranoia);

frequency is unknown: extrapyramidal disorders and other disorders of coordination, dyskinesia, peripheral sensory neuropathy, peripheral sensory-motor neuropathy, disturbance of the psyche with violation of behavior with self-harm, suicidal ideation, suicide attempts, fainting, benign intracranial hypertension.

Impaired sensory organs

infrequently: vertigo, dysgeusia (a violation of taste sensitivity);

rarely: visual impairment (visual impairment), "ringing" in the ears;

frequency is unknown: transient loss of vision, hearing loss (including hearing loss), parosmia (impaired sense of smell), including anosmia (loss of smell), agevia (loss of taste sensitivity).

Disorders from the cardiovascular system

often: phlebitis;

rarely: sinus tachycardia, lowering blood pressure, palpitations, palpitations;

frequency is unknown: interval lengthening QT, ventricular arrhythmias and ventricular tachycardia, including the "pirouette" type (torsades de pointes) predominantly in patients with risk factors for lengthening the interval QT, which can lead to cardiac arrest.

Disturbances from the musculoskeletal system

infrequently: arthralgia, myalgia;

rarely: tendonitis, muscle weakness (is of particular importance for myasthenia patients);

frequency is unknown: rhabdomyolysis, tendon rupture (eg, Achilles tendon), ligament rupture, muscle rupture, arthritis.

Disorders from the urinary system

infrequently: increase in the concentration of creatinine in the blood plasma;

rarely: acute renal failure (eg, due to the development of interstitial nephritis).

Disturbances from the respiratory system

infrequently: dyspnea;

frequency unknown: bronchospasm, allergic pneumonitis.

Disturbances from the skin and soft tissues

infrequently: itching, skin rash, hives, hyperhidrosis;

frequency is unknown: toxic epidermal necrolysis (Lyell's syndrome), exudative erythema multiforme (including Stevens-Johnson syndrome), leukocytoplastic vasculitis, photosensitivity reactions.

Immune system disorders

rarely: angioedema, hypersensitivity reactions;

frequency unknown: anaphylactoid shock, anaphylactic shock (in some cases after the first administration).

Violations of the blood and lymphatic system

infrequently: eosinophilia, leukopenia;

rarely: neutropenia, thrombocytopenia;

frequency is unknown: hemolytic anemia, agranulocytosis, pancytopenia.

Disorders from the metabolism and nutrition

infrequently: anorexia;

rarely: hypoglycemia (decrease in the concentration of glucose in the blood, mainly in patients with diabetes mellitus);

rarely: Attacks of porphyria (a very rare metabolic disease) in patients already suffering from this disease, as evidenced by the experience of using other quinolones. A similar effect is not excluded when using levofloxacin.

frequency is unknown: hyperglycemia (increased blood glucose concentration), hypoglycemic coma.

Other

often: reactions at the injection site (redness, pain);

infrequently: asthenia, fungal infections, superinfection;

rarely: increased body temperature;

frequency is unknown: pain (including pain in the back, chest and extremities).

Overdose:

In case of drug overdose, the emergence and / or aggravation of symptoms from the side of the central nervous system is of major clinical importance: confusion, dizziness, convulsions, impaired consciousness, hallucinations, tremor, and lengthening QT interval. Similar data were obtained during the post-marketing tests of the drug.

Treatment: careful monitoring of the patient's condition, electrocardiographic monitoring,if necessary, symptomatic therapy. There is no specific antidote. Hemodialysis is ineffective.

Interaction:

There was no pharmacokinetic interaction between levofloxacin and theophylline. However, with the simultaneous use of quinolones with theophylline, with NSAIDs and other drugs that reduce the threshold of convulsive readiness, the risk of seizures may increase.

In the presence fenbufen The concentration of levofloxacin is increased by approximately 13%.

Cimetidine and probenecid due to blocking tubular secretion, the renal clearance of levofloxacin is reduced by 24% and 34%, respectively, therefore levofloxacin should be used with caution at the same time with drugs that affect tubular secretion, especially in patients with impaired renal function.

Joint application calcium carbonate, glibenclamide, ranitidine, digoxin had no clinically significant effect on the pharmacokinetics of levofloxacin.

With the concomitant use of levofloxacin T_1/2 cyclosporine increases by 33%.

When used simultaneously with indirect anticoagulants, coumarin derivatives (warfarin), there is an increase in the coagulability of blood (prothrombin time / international normalized ratio (INR)), possibly the development of bleeding (including severe bleeding). In this regard, patients receiving vitamin K antagonists should closely monitor blood coagulability during treatment with levofloxacin.

Levofloxacin can prolong the QT interval, so caution should be used when combined with antiarrhythmic drugs IA and III classes, tricyclic antidepressants, macrolides and antipsychotics.

Joint reception with glucocorticosteroids increases the risk of rupture of tendons.

Special instructions:

Fluoroquinolones can reduce the threshold of convulsive readiness. Levofloxacin is contraindicated in a patient with epileptic seizures in history and, like other fluoroquinolones, should be used with extreme caution in patients predisposed to developing seizures that have an anamnesis of brain damage (cerebral blood flow, trauma), including those receiving other drugs that lower the threshold of convulsive readiness.In the case of a development of levofloxacin in a seizure disorder, the drug should be immediately withdrawn.

In patients with a deficiency of glucose-6-phosphate dehydrogenase against the background of levofloxacin therapy, hemolysis may develop. If it is necessary to prescribe the drug to such patients, their condition should be carefully monitored for the development of hemolytic reactions.

Special care should be taken when treating levofloxacin in patients with an elongated QT interval (congenital or acquired, developed against the background of antiarrhythmics IA and III classes, tricyclic antidepressants, macrolides, electrolyte disorders, diseases of the cardiovascular system). It was reported on the lengthening of the interval QT in patients who received fluoroquinolones, including levofloxacin.

Caution should be exercised in patients with known risk factors for the development of lengthening the interval QT: uncorrected violation of water-electrolyte balance (hypokalemia, hypomagnesemia); syndrome of congenital extension of the QT interval; heart disease (heart failure, myocardial infarction, bradycardia); simultaneous administration of drugs that can extend the QT interval.

Older patients and female patients may be more sensitive to the effects of drugs extending the QT interval. Therefore, care should be taken to use fluoroquinolones, including levofloxacin.

The prevalence of acquired resistance of the sown strains of microorganisms can vary depending on the geographic region and over time. In this regard, information is required on the resistance of microorganisms to the drug in a particular country. For the treatment of severe infections or in the ineffectiveness of treatment, a microbiological diagnosis should be made, isolating the pathogen and determining its sensitivity to levofloxacin.

There is a high probability that methicillin-resistant Staphylococcus aureus will be resistant to fluoroquinolones, including levofloxacin. therefore levofloxacin is not recommended for the treatment of established or suspected infections caused by methicillin-resistant Staphylococcus aureus in the event that the results of laboratory tests did not confirm the susceptibility of this microorganism to levofloxacin.

The recommended duration of infusion of the drug is 30 to 60 minutes depending on the dose (see "Method of administration and dose"). During the infusion of the drug, it is possible to develop tachycardia and a marked decrease in blood pressure (BP). If infusion of the drug shows a decrease in blood pressure, the infusion should be stopped immediately. The drug Flexin^® the infusion solution contains about 354 mg (15.4 mmol) of table salt per 100 ml of solution. This information should be taken into account when treating patients who follow a diet that restricts the intake of table salt.

Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (angioedema, anaphylactic shock) even with the use of initial doses (see section "Side effect"). If hypersensitivity reaction develops, immediately discontinue the drug.

When taking levofloxacin, there were cases of severe bullous skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (see section "Side effect"). In case of any reactions from the skin and mucous membranes, the patient should immediately notify the attending physician.

There have been reports of hepatic necrosis, including the development of fatal liver failure with levofloxacin, mainly in patients with severe underlying diseases, for example, with sepsis (see section "Side effect"). Patients should be warned about the need for discontinuation of treatment and urgent medical attention in case of signs and symptoms of liver damage such as anorexia, jaundice, darkening of urine, pruritus and abdominal pain.

In patients who simultaneously take indirect anticoagulants, coumarin derivatives, it is necessary to monitor the parameters of clotting of blood (see "Interaction with other drugs").

In rare cases, developed along with fluoroquinolone treatment, tendinitis can lead to the rupture of tendons, especially the Achilles tendon. This side effect manifests itself within 48 hours after initiation of therapy. For elderly people and patients taking glucocorticosteroids, the risk of developing tendonitis is higher. Therefore, during the treatment with levofloxacin, careful monitoring of the condition of such patients is necessary.If there is a suspicion of tendonitis (it is necessary to inform patients about its symptoms), the drug Flexin^® it is necessary to immediately cancel and begin the appropriate treatment (for example, immobilization).

Diarrhea (especially in cases of severe, persistent and / or appearance of blood impurities) during or after treatment with Flexid® may be a symptom of the disease caused by Clostridium difficile, the most severe form of which is pseudomembranous colitis. If there is a suspicion of pseudomembranous colitis, the Flexide® drug should be immediately withdrawn and symptomatic treatment (eg, vancomycin orally). In this condition, drugs that inhibit intestinal peristalsis are contraindicated.

For the treatment of hospital infections caused by R. aeruginosa, requires combination therapy.

During treatment with Flexid® and for at least 48 hours after its completion, direct sunlight and artificial ultraviolet radiation (solarium) should be avoided in order to avoid the development of photosensitization reactions.

As levofloxacin excreted mainly by the kidneys, patients with renal insufficiency are required to monitor kidney function; The dosage regimen may also need to be adjusted.

In patients with diabetes mellitus, receiving oral hypoglycemic agents (for example, glibenclamide) or insulin, the use of levofloxacin increases the risk of hypo- / hyperglycemia. If it is necessary to prescribe the drug to a patient with diabetes mellitus, the concentration of glucose in the blood plasma should be carefully monitored.

In patients receiving fluoroquinolones, including levofloxacin, sensory and sensory-motor peripheral neuropathy was noted, the onset of which can be rapid. When a patient develops symptoms of neuropathy, the use of Flexid® should be stopped (minimizes the possible risk of irreversible changes).

The drug Fleksid® should not be used in patients with pseudo-paralytic myasthenia (myasthenia gravis) due to the possible development of neuromuscular blockade. In the postmarketing period, adverse reactions were observed, including respiratory failure, requiring artificial ventilation, and death that were associated with the use of fluoroquinolones in patients with myasthenia gravis. The use of the drug in patients with established diagnosis of myasthenia gravis is contraindicated.

When using quinolones, including levofloxacin, reported the development of psychotic reactions, which in very rare cases progressed to the development of suicidal thoughts and behavioral disorders with self-harm (sometimes after taking a single dose of levofloxacin). With the development of such reactions, treatment with Fleksid® should be stopped and appropriate therapy prescribed. Caution should be used to prescribe the drug to patients with psychoses or patients who have a history of mental illness.

With the development of any visual impairment, an immediate consultation of the ophthalmologist is necessary.

On the background of levofloxacin therapy, especially prolonged, the growth of insensitive microorganisms is possible. In case of development of superinfection, appropriate measures should be taken.

Levofloxacin can inhibit growth Mycobacterium tuberculosis, so a false-negative result of bacteriological examination for tuberculosis is possible.

In patients receiving treatment with the drug Fleksid®, false-positive results of the determination of opiates in the urine are possible. In this case, more specific methods should be used.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, it is possible to reduce the speed of mental and motor reactions, so it is necessary to refrain from driving motor vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for infusion, 5 mg / ml

Packaging:

For 50 ml and 100 ml in disposable bags of low-density polyethylene with a hanging loop that meet the requirements of the European Pharmacopoeia for infusion solutions. A label is attached to the packages.

For 1, 5 or 20 packs together with instructions for use in a cardboard box.

Storage conditions:

In the original packaging in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Ready-to-use infusion solution in 5% glucose solution, 0.9% solution of sodium chloride or 2.5% glucose solution in Ringer's solution: no more than 8 hours at a temperature of 22 to 25 ° C.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003436

Date of registration:02.02.2016

Expiration Date:02.02.2021

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

SALUTAS PHARMA, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp03.08.2016

Illustrated instructions

Instructions

Flexible® (Flexid®)