Moxifloxacin - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate 187,500 mg, croscarmellose sodium 21,000 mg, povidone K-30 14,000 mg, talc 14,000 mg, microcrystalline cellulose-13,100 mg, silicon colloidal dioxide 7,000 mg, magnesium stearate 7,000 mg; film cover: [hypromellose - 10,500 mg, giprolose (hydroxypropylcellulose) -4.074 mg, talc - 4.044 mg, titanium dioxide - 2.283 mg, iron oxide yellow (iron oxide) - 0.099 mg] or [dry film coating mixture containing hypromellose 50%), giprolose (hydroxypropylcellulose) (19.4%), talc (19.26%), titanium dioxide (10.87%), iron oxide yellow (iron oxide) (0.47%)] - 21,000 mg.

Description:Round biconvex tablets, covered with a film coating of yellow color. On the cross-section the nucleus is from light yellow to yellow.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A.14 Moxifloxacin

Pharmacodynamics:Moxifloxacin - a bactericidal antibacterial broad-spectrum preparation, 8-methoxy fluoroquinolone. The bactericidal effect of the drug is due to the inhibition of bacterial topoisomerases II and IV,which leads to disruption of the processes of replication, repair and transcription of the biosynthesis of the DNA of a microbial cell and, as a result, to the death of microbial cells. The minimum bactericidal concentrations of moxifloxacin are generally comparable to its minimum inhibitory concentrations.

Mechanisms that lead to the development of resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines, do not affect the antibacterial activity of moxifloxacin. Cross-resistance between these groups of antibacterial drugs and moxifloxacin is not noted. So far, no cases of plasmid resistance have been observed.

The overall frequency of development of resistance is very low (10^-7-10^-10). Resistance to moxifloxacin develops slowly by multiple mutations. Multiple effects of moxifloxacin on microorganisms at concentrations below the minimum inhibitory concentration (MIC) are accompanied by only a slight increase in MIC. There are cases of cross-resistance to quinolones. Nevertheless, some gram-positive and anaerobic microorganisms resistant to other quinolones retain sensitivity to moxifloxacin.

It has been established that the addition of the methoxyfloxacin methoxy group in the C8 position to the molecule structure increases the activity of moxifloxacin and reduces the formation of resistant mutant strains of Gram-positive bacteria. The addition of a bicycloamine group at the C7 position prevents the development of an active efflux, a mechanism of resistance to fluoroquinolones.

Moxifloxacin in vitro is active against a wide range of gram-negative and gram-positive microorganisms, anaerobes, acid-fast bacteria and atypical bacteria such as Mycoplasma spp., Chlamydia spp., Legionella spp., And bacteria resistant to β-lactam and macrolide antibiotics.

Influence on human intestinal microflora

In two studies conducted on volunteers, the following changes in the intestinal microflora following oral administration of moxifloxacin were noted: a decrease in the concentrations of Escherichia coli, Bacillus spp., Bacteroides vulgatus, Enterococcus spp., Klebsiella spp., As well as anaerobes Bifidobacterium spp., Eubacterium spp., Peptostreptococcus spp. These changes were reversible within two weeks. There were no toxins of Clostridium difficile.

In Vitro Sensitivity Testing

The spectrum of antibacterial activity of moxifloxacin includes the following microorganisms (see Table No. 1).

Table 1

The spectrum of antibacterial activity of moxifloxacin

Sensitive

Moderately sensitive

Resistant

Gram-positive

Gardnerella vaginalis

treptococcus pneumoniae * (including strains resistant to penicillin and strains with multiple antibiotic resistance), as well as strains resistant to two or more antibiotics, such as penicillin (MIC ≥ 2 μg / ml), second-generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, trimethoprim / sulfamethoxazole

Streptococcus pyogenes (group A) *

Group Streptococcus milled (S. anginosus *, S. constellatus * and S. intermedius *)

Group Streptococcus viridans (S. viridans, S. mutans, S. mitis, S. sanguinis, S. salivarius,

S. thermophilus, S. constellatus)

Streptococcus agalactiae

Streptococcus dysgalactiae

Staphylococcus aureus (including methicillin-sensitive strains) *

Staphylococcus aureus (including methicillin-resistant / ofloxacin-resistant strains) **

Coagulase-negative staphylococci (S. cohnii, S. epidermidis,

S. haemolyticus, S. hominis,

S. saprophyticus, S. simulans), methicillin-sensitive strains

Coagulase-negative staphylococci (S. cohnii, S. epidermidis,

S. haemolyticus,

S. hominis,

S. saprophyticus,

S. simulans), methicillin-resistant strains

Corynebacterium diphtheriae

Enterococcus faecalis (strains only, chuvart.to vancomycin and gentamicin)

Enterococcus avium *

Enterococcus faecium

Gram-negative

Haemophilus influenzae (including strains that produce and do not produce βlactamase) *

Haemophilus parainfluenzae *

Moraxella catarrhalis (including strains that produce and do not produce βlactamase) *

Bordetella pertussis

Acinetobacter baumanii

Escherichia coli *

Klebsiella pneumoniae *

Klebsiella oxytoca

Citrobacter freundii **

Enterobacter spp. (E. aerogenes,

E. intermedius,

E. sakazaki)

Enterobacter cloacae *

Pantoea agglomerans

Neisseria gonorrhoeae

Pseudomonas aeruginosa

Pseudomonas fluorescens

Burkholderia cepacia

Stenotrophomonas

maltophilia

Proteus mirabilis *

Proteus vulgaris

Morganella morganii

Providencia spp.

(P. rettgeri, P. stuartii)

Anaerobes

Bacteroides spp.

(B. fragilis *,

B. distasonis *,

B. thetaiotaomicron *, B. ovatus *,

B. uniformis *,

B. vulgarus *)

Fusobacterium spp.

Peptostreptococcus spp. *

Porphyromonas spp.

Prevotella spp.

Propionibacterium spp.

Clostridium spp. *

Atypical

Chlamydia pneumoniae *

Chlamydia trachomatis *

Mycoplasma pneumoniae *

Mycoplasma hominis

Mycoplasma genitalium

Legionella pneumophila *

Coxiella burnetti

*The sensitivity to moxifloxacin is confirmed by clinical data.

** Use of the drug Moxifloxacin is not recommended for the treatment of infections caused by strains S. aureus, resistant to methicillin (MRSA). In the case of suspected or confirmed infections caused by MRSA, should be prescribed treatment with appropriate antibacterial drugs.

For certain strains, the spread of acquired resistance may vary depending on the geographical region and over time. In this regard, when testing the sensitivity of a strain, it is desirable to have local information on resistance, especially when treating severe infections.

If the patients undergoing treatment in the hospital, the value (AUC) / MIC₉₀ exceeds 125, and (C_max)/ MIC₉₀ is within the range of 8-10, this implies a clinical improvement. In outpatients, the values of these surrogate parameters are usually less: AUC / MIC₉₀ > 30-40 (see table 2).

table 2

Values of pharmacodynamic parameters in outpatients

Parameter (average)	AUIC * (h)	C_max**/ MIC₉₀
MIC₉₀ 0,125 mg / l	279	23,6
MIC₉₀ 0.25 mg / l	140	11,8
MIC₉₀ 0.5 mg / l	70	5,9

* AUIC - the area under the inhibitory curve (ratio AUC *** / MIC₉₀).

** - the maximum concentration of the drug in the blood plasma.

*** - the area under the pharmacokinetic curve "concentration - time".

Pharmacokinetics:

Absorption and bioavailability

When taken orally moxifloxacin absorbed quickly and almost completely. Absolute bioavailability is about 91%. The pharmacokinetics of moxifloxacin when administered at a dose of 50 to 1200 mg once, and also at 600 mg / day for 10 days is linear. The equilibrium state is reached within 3 days. After a single application of 400 mg of moxifloxacin, the maximum concentration (C_max) in blood plasma is achieved within 0.5-4 hours and is 3.1 mg / l.

When moxifloxacin is taken with food, there is a slight increase in the time to reach C_max (for 2 hours) and a slight decrease in C_max (approximately 16%), while the duration of suction does not change. However, these data have no clinical significance, and the drug can be used regardless of food intake.

Distribution

Moxifloxacin is rapidly distributed in tissues and organs and binds to blood proteins (mainly albumins) by about 45%. The distribution volume is approximately 2 l / kg.

High concentrations of moxifloxacin, exceeding those in plasma, are created in the lung tissue (including in the epithelial fluid, alveolar macrophages), in the nasal sinuses (maxillary and ethmoid sinuses), in nasal polyps, in inflammation foci (in the contents of blisters in the lesion of the skin) . In the interstitial fluid and in saliva, the drug is determined in a free, non-protein-binding form at a concentration higher than in the plasma. In addition, high concentrations of moxifloxacin are determined in the tissues of the abdominal cavity, peritoneal fluid and female genital organs.

Metabolism

Moxifloxacin undergoes biotransformation of the 2nd phase and is excreted from the body by the kidneys, and also through the intestine, both in unmodified form and in the form of inactive sulfo compounds (Ml) and glucuronides (M2). Moxifloxacin does not undergo biotransformation by the microsomal system of cytochrome P450. Metabolites Ml and M2 are present in blood plasma at concentrations lower than the original compound.According to the results of preclinical studies, it was proved that these metabolites do not have a negative impact on the body in terms of safety and tolerability.

Excretion

The half-life (T_1/2) of moxifloxacin is approximately 12 hours. The average total clearance after taking in a dose of 400 mg is from 179 ml / min to 246 ml / min. Kidney clearance is 24-53 ml / min. This indicates a partial tubular reabsorption of the drug.

The ratio of the initial compound and the metabolites of the second phase is approximately 96-98%, which indicates the absence of oxidative metabolism. About 22% of a single dose (400 mg) is excreted unchanged by the kidneys, about 26% - through the intestine.

Pharmacokinetics in different patient groups

Age, gender and ethnicity

There were no clinically significant differences in the pharmacokinetics of moxifloxacin in patients of different ethnic groups, of different age and sex.

Children

Studies of the pharmacokinetics of moxifloxacin in children have not been conducted.

Patients with renal insufficiency

There were no significant changes in the pharmacokinetics of moxifloxacin in patients with impaired renal function (including patients with creatinine clearance <30 mL / min / 1.73 m²) and in patients on continuous hemodialysis and long-term outpatient peritoneal dialysis.

Patients with hepatic impairment

There was no significant difference in the concentration of moxifloxacin in blood plasma in patients with hepatic impairment (Child-Pugh class A and B) compared with healthy volunteers and patients with normal liver function.

Indications:

Infectious-inflammatory diseases in adults caused by microflora-susceptible microflora:

- Acute sinusitis;

- Community-acquired pneumonia, including community-acquired pneumonia, caused by strains of microorganisms with multiple antibiotic resistance *;

- exacerbation of chronic bronchitis;

- uncomplicated infections of the skin and subcutaneous structures;

- complicated infections of the skin and subcutaneous structures (including an infected diabetic foot);

- Complicated intra-abdominal infections, including polymicrobial infections, including intraperitoneal abscesses;

- uncomplicated inflammatory diseases of the pelvic organs (including salpingitis and endometritis).

* Streptococcus pneumoniae with multiple antibiotic resistance includes strains resistant to penicillin and strains resistant to two or more antibiotics from groups such as penicillins (with a minimum inhibitory concentration of ≥ 2 mg / ml), cephalosporins of the second generation (cefuroxime), macrolides, tetracyclines and trimethoprim / sulfamethoxazole.

It is necessary to take into account the current official guidelines on the rules for the use of antibacterial agents.

Contraindications:

- Hypersensitivity to moxifloxacin, other quinolones or any other component of the drug;

- pregnancy and the period of breastfeeding;

- age up to 18 years;

- the presence in the anamnesis of a pathology of tendons, developed as a result of treatment with antibiotics of the quinolone series;

- prolongation of the QT interval on a cardiogram (congenital or acquired);

- Violations of electrolyte balance, especially uncorrected hypokalemia;

- acute myocardial ischemia,

- clinically significant bradycardia;

- Clinically significant heart failure with a reduced fraction of the left ventricular ejection;

- the presence in the anamnesis of cardiac rhythm disorders, accompanied by clinical symptoms;

- simultaneous use with other drugs that extend the QT interval (see Fig.section "Interaction with other drugs");

- Because of the limited amount of clinical data, the use of moxifloxacin is contraindicated in patients with impaired liver function (Child-Pugh class C) and in patients with increased transaminase concentrations more than five times the upper limit of the norm;

- cirrhosis of the liver;

lactose intolerance; deficiency of lactase; glucose-galactose malabsorption.

Carefully:

It should be used with caution:

- with diseases of the central nervous system (including suspicious of involvement of the central nervous system), predisposing to the onset of seizures and reducing the threshold of convulsive activity;

- in women and elderly patients (see section "Special instructions");

- with myasthenia gravis;

- with simultaneous reception with drugs that reduce the content of potassium;

- with deficiency of glucose-6-phosphate dehydrogenase;

- in patients with psychoses and patients with mental illnesses in the anamnesis (see section "Side effect").

Pregnancy and lactation:

Safety of moxifloxacin during pregnancy is not established, therefore its use is contraindicated.Cases of reversible joint damage in children receiving certain quinolones have been described, but this effect has not been reported in the fetus (if the mother used it during pregnancy).

In animal studies, reproductive toxicity has been demonstrated. The potential risk to humans is unknown.

Like other quinolones, moxifloxacin causes damage to the cartilage of large joints in preterm animals. In preclinical studies, it was found that a small amount of moxifloxacin is excreted into breast milk. Data on the use of moxifloxacin in women during breastfeeding are not available, so its use during breastfeeding is also contraindicated.

Dosing and Administration:

The recommended dosage regimen for moxifloxacin is 400 mg (one tablet) once a day for the infections mentioned above. Do not exceed the recommended dose.

Tablets should be swallowed whole, not liquid, squeezed with enough water, regardless of food intake.

The duration of treatment is determined by the localization and severity of the infection, as well as clinical effect.

With an exacerbation of chronic bronchitis: 5-10 days.

With extrapulmonary pneumonia: 7-14 days.

In acute sinusitis: 7 days.

With uncomplicated infections of the skin and subcutaneous structures: 7 days.

With complicated infections of the rut and subcutaneous structures: 7-21 days.

With complicated intra-abdominal infections: 5-14 days.

With uncomplicated inflammatory diseases of the pelvic organs: 14 days.

Do not exceed the recommended duration of treatment. Duration of drug treatment Moxifloxacin can reach 21 days. Elderly patients

Changes in the dosing regimen in elderly patients are not required.

Children

The efficacy and safety of moxifloxacin in children and adolescents has not been established.

Patients with hepatic impairment

Patients with hepatic impairment (class A and B according to the Child-Pugh classification), changes in the dosing regimen are not required.

Patients with renal insufficiency

In patients with impaired renal function (including severe renal failure with creatinine clearance ≤ 30 ml / min / 1.73 m²), as well as in patients on continuous hemodialysis and long-term outpatient peritoneal dialysis, changes in the dosing regimen are not required.

Use in patients of different ethnic groups Changes in the dosing regimen are not required.

Side effects:

Adverse reactions listed in the "frequently" group occurred with a frequency below 3%, except for nausea and diarrhea. In each frequency group, undesirable drug reactions are listed in order of decreasing significance. The side effects listed below (see Table 3) are distributed according to the frequency of occurrence according to the following gradation: often (from ≥ 1/100 to <1/10), infrequently (from≥1 / 1000 to <1/100), rarely (from ≥ 1/10 000 to <1/1000), very rarely (<1/10 000).

Table 3

Side effect, which can be caused by the use of moxifloxacin

Systems of organs classes (MedDRA)

Often

Infrequently

Rarely

Infectious and parasitic diseases

Fungal superinfections

Violations of the blood and lymphatic system

Anemia

Leukopenia

Hettropenia

ThrombocytoPthe

Prothrombol extensioninThe increase in the international standardized ratio (INR)

Change in the concentration of thromboplastin

Increase

concentrations

prothrombin /

decrease

INR

Immune system disorders

Allergic reactions

Itching

Rash

Hives

EosiMr.officilia

Anaphylactic reactions / aMr.affilactoid reactions

Angioedema, including laryngeal edema (potentially life-threatening)

Anaphylactic / anaphylactoid shock (including potentially life-threatening).

Violations from sides of metabolism

Hyperlipidemia

Hyperglycaemia

Hyperuricemia

Mental disorders

Anxiety

Psychomotor hyperreactivityMr.awn / agitationandI

Emotional lability

Depression (in very rare cases, behavior with a tendency to self-extinguisherailwayesuch as suicidal ideation or suicide attempts)

Hallucinations

Depersonalizedand I

Psychotic reactions (potentially manifested in behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts)

Violations from the sides of the nervous system

Headache Dizzinesse

Paresthesia

Dysaesthesia

Disturbance of taste is sensitiveart.and (including in very rare cases, agevia)

Confusion and disorientation

Sleep Disorders

Tremor

Vertigo

Drowsiness

Hypesesia

Abnormalities of smell (including anosmia)

Atypical dreams

Disturbance of coordination (including gait disturbance due to dizziness or vertigo, in very rare cases leading to trauma from falling, especially in elderly patients)

Seizures with various clinical manifestations (including "grand mal" seizures)

Violations of attention

Violations of speech

Amnesia

Peripheral neuropathy and polyneuropathy

Diperesthesia

Violations from side of the organ of vision

Visual impairment (especially with CNS central nervous system reactions)

Transient loss of vision (especially with CNS reactions)

Violations from the sides of the hearing organ and labyrinthine disorders

Noise in ears

Deterioration of hearing, including deafness (usually reversible)

Violations from cardiovascular system

Elongation of the QT interval in patients with concomitant hypokalemiamission

QT interval extension

Heart palpitations

Tachycardia

Vasodilation

Ventricular tachyarrhythmias

Fainting

Increase blood pressure

Reduction of arterial pressures

Nonspecific arrhythmias

Polymorphic ventricular tachycardia (Torsade de pointes)

Heart failure (mainly in people with predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia)

Violations from side of the respiratory system, chest and mediastinal organs

Shortness of breath (including asthmatic condition)

Violations from side of the gastrointestinal tract

Nausea

Vomiting

Stomach ache

Diarrhea

Reduced appetite and reduced food intake

Constipation

Dyspepsia

Flatulence

Gastroenteritis (other than erosive gastroenteritis)

Increase activity

amylase

Dysphagia

Stomatitis

Pseudomembranous colitis (in very rare cases associated with life-threatening complications)

Violations from sides of the liver and bile ducts

Increased activity of "liver" transaminases

Dysfunction of the liver (including increased levels of lactate dehydrogenase)

Increased bilirubin concentration

Increase in activity of gamma glutamyl transferase

Increase in blood activity of alkaline phosphatase

Jaundice

Hepatitis (predominantly cholestatic)

Fulminant hepatitis, potentially leading to life-threatening hepatic insufficiency (including fatal cases)

Violations from skin and soft tissue

Bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal nerveerabies (potentially life-threatening).

Violations from side of skeletal-muscular and connective tissue

Arthralgia

Myalgia

Tendonitis

Increased muscle tone and cramps

Muscle weakness

Tendon tendons

Arthritis

Violation of the gait due to damage to thePOrno-engineTheth system

Increased myasthenia gravis symptoms gravis

Violations from the side of the urinary tract

Dehydration (caused by diarrhea or decreased fluid intake)

Impaired renal function

Renal failure due to dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing impaired renal function)

Common violations

General malaise

Nonspecific bol

Sweating

Edema

Overdose:

There are limited data on the overdose of moxifloxacin.

No side effects were observed with the use of moxifloxacin in a dose of up to 1200 mg once and 600 mg for 10 days or more. In case of an overdose, one should be guided by the clinical picture and carry out symptomatic maintenance therapy with ECG monitoring.

The use of activated carbon immediately after oral administration of the drug can help prevent excessive systemic exposure to moxifloxacin in cases of overdose.

Interaction:

When combined with atenolol, ranitidine, calcium-containing additives, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid (no clinically significant interaction with moxifloxacin was confirmed), dose adjustment is not required.

Antacids, multivitamins and other preparations containing salts of magnesium, aluminum, iron and zinc

Taking moxifloxacin concomitantly with antacid agents, multivitamins and minerals can lead to a moxifloxacin absorption, due to the formation of chelate complexes with polyvalent cations contained in these preparations. As a result, the concentration of moxifloxacin in the blood plasma may be significantly lower than desired. In this regard, antacid preparations, antiretroviral drugs (for example, didanosine) and other preparations containing magnesium or aluminum, sucralfate and other preparations containing iron or zinc should be used at least 4 hours before or 4 hours after ingestion of moxifloxacin.

Warfarin

When combined with warfarin prothrombin time and other parameters of blood coagulation do not change.

Change the value of INR. In patients who received anticoagulants in combination with antibiotics, including moxifloxacin, there are cases of increased anticoagulant activity of anticoagulants. Risk factors are the presence of an infectious disease (and concomitant inflammatory process), the age and general condition of the patient. Despite the fact that the interaction between moxifloxacin and warfarin is not detected, in patients receiving concomitant treatment with these drugs, it is necessary to monitor the INR and, if necessary, adjust the dose of indirect anticoagulants.

Digoxin

Moxifloxacin and digoxin do not significantly affect the pharmacokinetic parameters of each other. With the repeated use of moxifloxacin C_max digoxin increased by approximately 30%, while the area under the pharmacokinetic concentration-time curve (AUC) and the minimum digoxin concentration did not change.

Activated carbon

With the simultaneous use of activated carbon and moxifloxacin inside at a dose of 400 mg, the systemic bioavailability of the drug is reduced by more than 80% as a result of inhibition of its absorption. In the case of an overdose, the use of activated carbon at an early stage of absorption inhibits further increase in systemic exposure.

Drugs that extend the QT interval

Contraindicated the combined use of moxifloxacin with the following drugs that affect the prolongation of the QT interval: antiarrhythmic drugs class IA (quinidine, hydroquinidine, disopyramide, etc.); antiarrhythmic drugs of class III (amiodarone, sotalol, dofetilide, ibutilide, etc.); neuroleptics (phenothiazine, pimozide, sertindole, haloperidol, sultopride, etc.); tricyclic antidepressants; antimicrobials (sparfloxacin, erythromycin (intravenously), pentamidine, antimalarial drugs, especially halofantrine); antihistamines (terfenadine, astemizole, misolastine); others (cisapride, wincamine (intravenously), bepridil, difemanyl).

Special instructions:

In some cases, after the first use of the drug may develop hypersensitivity and allergic reactions, which should immediately inform the doctor.Very rarely even after the first use of the drug, anaphylactic reactions can progress to a life-threatening anaphylactic shock. In these cases, treatment with moxifloxacin should be discontinued and necessary medical measures (including anti-shock) should be carried out.

When moxifloxacin is used, prolongation of the QT interval may be noted in some patients.

A drug moxifloxacin should be used with caution in women and elderly patients. Since women have a longer QT interval than men, they may be more sensitive to drugs that extend the QT interval. Elderly patients are also more prone to drugs that affect the QT interval.

The degree of elongation of the QT interval may increase with increasing drug concentration, therefore, do not exceed the recommended dose. However, in patients with pneumonia, there was no correlation between the concentration of moxifloxacin in the blood plasma and the prolongation of the QT interval. The prolongation of the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. None of the 9,000 patients who received moxifloxacin, there were no cardiovascular complications and lethal cases associated with prolongation of the QT interval. However, in patients with predisposing arrhythmias, the risk of developing ventricular arrhythmias may increase with moxifloxacin.

Concerning moxifloxacin contraindicated in patients with established QT interval elongation, patients with uncorrected hypokalemia, patients taking drugs, prolonging the QT interval (see section "Interaction with other drugs").

Because of the risk of additive action on the QT interval moxifloxacin is contraindicated in patients with conditions predisposing to arrhythmias, such as clinically significant bradycardia, clinically significant heart failure, rhythm disturbances, accompanied by clinical symptoms, acute myocardial ischemia; patients with cirrhosis of the liver (since this category of patients can not exclude the risk of developing an extension of the QT interval).

When moxifloxacin was taken, cases of fulminant hepatitis, potentially leading to liver failure (including fatal cases), were reported (see p.section "Side effect"). The patient should be informed that if symptoms of hepatic insufficiency occur, the doctor should be consulted before continuing with moxifloxacin.

When moxifloxacin was taken, cases of development of bullous skin lesions (Stevens-Johnson syndrome, toxic epidermal necrolysis) were reported. The patient should be informed that in case of symptoms of skin or mucous membrane damage, the doctor should be consulted before continuing with moxifloxacin.

The use of drugs quinolone series is associated with a possible risk of seizures. Moxifloxacin Caution should be used with caution in patients with CNS diseases and with conditions suspicious of CNS involvement predisposing to seizures or reducing the threshold of seizure activity. The use of broad-spectrum antibacterial drugs, including moxifloxacin, is associated with a risk of developing pseudomembranous colitis associated with taking antibiotics. This diagnosis should be borne in mind in patients with moxifloxacin onset of severe diarrhea.In this case, the drug should be withdrawn and immediate therapy should be prescribed. Preparations that inhibit the intestinal peristalsis are contraindicated in the development of severe diarrhea. Moxifloxacin should be used with caution in patients with myasthenia gravis in connection with possible exacerbation of the disease.

Against the background of quinolone therapy, including moxifloxacin, especially in the elderly and patients receiving glucocorticosteroids, tendonitis and tendon rupture may develop. Cases which have arisen within several months after the end of treatment are described. At the first symptoms of pain or inflammation at the site of damage, stop taking the medication and unload the affected limb.

When applying quinolones, photosensitivity reactions are noted. However, in the conduct of preclinical, clinical studies, as well as with the use of moxifloxacin, no photosensitivity reactions were observed in practice. Nevertheless, patients receiving moxifloxacin, should avoid direct sunlight and ultraviolet light.

It is not recommended to use the drug in patients with complicated inflammatory diseases of the pelvic organs(for example, associated with tubo-ovarian or pelvic abscesses).

It is not recommended to use moxifloxacin for the treatment of infections caused by Staphylococcus aureus strains resistant to methicillin (MRSA). In the case of suspected or confirmed infections caused by MRSA, treatment should be prescribed with appropriate antibacterial drugs (see the section "Pharmacodynamics").

Ability of the drug Moxifloxacin suppress the growth of mycobacteria can cause in vitro interaction of moxifloxacin with a test for Mycobacterium spp., leading to false-negative results in the analysis of samples of patients treated with moxifloxacin during this period.

In patients treated with quinolones, including moxifloxacin, cases of sensory or sensorimotor polyneuropathy, leading to paresthesia, hypoesthesia, dysesthesia or weakness are described. Patients undergoing treatment with moxifloxacin should be warned of the need to seek immediate medical attention before continuing treatment in the event of symptoms of neuropathy, including pain, burning, tingling, numbness, or weakness (see "Side effect" section).

Reactions from the psyche may occur even after the first appointment of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions progress to the occurrence of suicidal thoughts and behavior with a tendency to self-harm, including suicidal attempts (see "Side effect" section). If the patient develops such reactions, it is necessary to cancel the drug and take the necessary measures. Caution should be exercised when administering moxifloxacin to patients with psychoses and patients with a history of mental illness.

Because of widespread and increasing incidence of infections caused by fluoroquinolone-resistant Neisseria gonorrhoeae, in the treatment of patients with inflammatory diseases of the pelvic organs should not be spending moxifloxacin monotherapy. Except in cases where the presence of N. gonorrhoeae resistant to fluoroquinolones is excluded. If you can not exclude the presence of fluoroquinolone-resistant N. gonorrhoeae, it is necessary to solve the question of supplementing the empirical treatment with an appropriate antibiotic moxifloxacin, which is active against N. gonorrhoeae (eg a cephalosporin).

Effect on the ability to drive transp. cf. and fur:Fluoroquinolones, including moxifloxacin, can disrupt the ability of patients to drive a car and engage in other potentially dangerous activities requiring increased attention and speed of psychomotor reactions, due to the effect on the central nervous system.

Form release / dosage:

Tablets, film-coated, 400 mg.

Packaging:

5 or 7 tablets in a planar cell packaging made of a polyvinylchloride film and aluminum foil.

10 tablets in a can of high-density polyethylene.

1, 2 or 3 contourcell packs of 5 tablets, 1 or 2 contour packs of 7 tablets or one pot together with instructions for use in a pack of cardboard.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002476

Date of registration:26.05.2014 / 20.04.2017

Expiration Date:26.05.2019

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VERTEKS, AO Russia

Information update date: & nbsp12.06.2018

Illustrated instructions

Instructions

Moxifloxacin (Moxifloxacine)