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

Excipients: potato starch - 110.00 mg, povidone low molecular weight - 22.00 mg, calcium stearate - 7.27 mg, hypromellose - to obtain a nucleus weighing 727.0 mg.

Sheath: hypromellose - 24.88 mg, titanium dioxide - 5.40 mg, macrogol 4000 - 2.68 mg, dye Krasnyj charming - 0.04 mg or ready mix Opadrai II pink 33.0 mg (polyvinyl alcohol partially hydrolyzed - 40%, titanium dioxide - 23.5%, macrogol - 20.2%, talc - 14.8%, dye red charming or aluminum varnish based on the dye red charming - 1.5%).

Weight of film coated tablet - 760.00 mg.

Description:

Tablets are round, biconcave with a risk, covered with a film membrane of pink color. On the fracture, a homogeneous mass of light yellow color.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A.14 Moxifloxacin

Pharmacodynamics:

Moxifloxacin is a bactericidal antibacterial preparation of a broad spectrum of action of the fluoroquinolone series.The bactericidal effect of the drug is due to the inhibition of bacterial topoisomerases II and IV, which leads to a disruption of the biosynthesis of the DNA of the microbial cell and, as a consequence, to the death of microbial cells. The minimum bactericidal concentrations of the preparation as a whole are comparable to its minimum inhibitory concentrations.

Mechanisms that lead to the development of resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines, do not interfere with 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 are sensitive to moxifloxacin.

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., Chlamidia spp., Legionella spp. Moxifloxacin is effective against bacteria resistant to β-lactam and macrolide antibiotics.

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

Table No. 1

Sensitive	Moderately sensitive	Resistant
Gram-positive
Gardnerella vaginalis
Streptococcus pneumoniae* (including strains resistant to penicillin and strains with multiple antibiotic resistance), and 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 staphylococciS. cohnii, S. epidermidis, S.haemolyticus, S. hominis, S. saprophyticus, S. simulans), methicillin-sensitive strains		Coagulase-negative staphylococciS. cohnii, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. simulans), methicillin-resistant strains
Corynebacterium diphtheriae
	Enterococcus faecalis (only strains sensitive to vancomycin and gentamicin)
	Enterococcus avium *
	Enterococcus faecium
Gram-negative
Haemophilus influenzae (including strains producing and non-producing β-lactamases) *
Haemophilus parainfluenzae *
Moraxella catarrhalis (including strains producing and non-producing β-lactamases) *
Bordetella pertussis
Acinetobacter baumannii
	Escherichia coli *
	Klebsiella pneumoniae *
	Klebsiella oxytoca
	Citrobacter freundii **
	Enterobacter spp. (E. aerogenes, E. intermedius, E. sakazakii)
	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. vulgaris )
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 burnetii

^* The sensitivity to moxifloxacin is confirmed by clinical data.

^** The use of the drug Moxifloxacin-Ferein® 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 patients undergoing inpatient treatment have a (AUC) / MBK₉₀ exceeds 125, and (C_m_Oh) / 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 / MIK₉₀ > 30-40 (see table 2).

Table 2. Values of pharmacodynamic parameters in outpatients

Parameter (average)	*AUIC (h)**	FROM_m_Oh / MIC₉₀**
MIC₉₀ 0,125 mg / l	279	23,6
MIC₉₀0,125 mg / l	140	11,8
MIC₉₀ 0.5 mg / l	70	5,9

*AUIC is the area under the inhibitory curve (ratio AUC *** / MIK₉₀).

** - 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 (FROM_mOh) in blood is reached 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_mOh (for 2 hours) and a slight decrease in C_mOh (approximately 16%), while the duration of absorption 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 (predominantly with 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 alveolar macrophages), in the bronchial mucosa, in the nasal sinuses, in the contents of the blisters in the defeat 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. Also high concentrations of moxifloxacin are created in the organs of the abdominal cavity and peritoneal fluid, as well as in the tissues of the female genital organs.

Metabolism

Moxifloxacin after passage of the 2nd phase of biotransformation is excreted from the body by the kidneys and the gastrointestinal tract, both in unmodified form and in the form of inactive sulfo compounds and glucuronides. Moxifloxacin does not undergo biotransformation by the microsomal system of cytochrome P450.

Excretion

The half-life of the drug is approximately 12 hours. The average total clearance after taking in a dose of 400 mg is from 179 to 246 ml / min. 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 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 those on continuous hemodialysis and long-term outpatient peritoneal dialysis.

Patients with hepatic impairment

There were no significant differences in the concentration of moxifloxacin in blood plasma in patients with impaired hepatic function. In patients with severe impairment of liver function (class C on the Child-Pugh scale), there is no data on the pharmacokinetics of moxifloxacin.

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 and complicated infections of the skin and soft tissues (including an infected diabetic foot);

- complicated intra-abdominal infections, including infections caused by several pathogens;

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

* Streptococcus pneumoniae with multiple antibiotic resistance include penicillin resistant strains and strains resistant to two or more antibiotics from groups such as penicillins (at a minimum inhibitory concentration ≥ 2 mg / ml), second-generation cephalosporins (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 (including other quinolones) and other components of the drug;

- children's age till 18 years;

- pregnancy and the period of breastfeeding;

- the defeat of the tendons during the previous treatment with quinolones;

- congenital or acquired lengthening syndrome QT;

- pronounced electrolyte imbalance (especially uncorrectable hypokalemia);

- clinically significant bradycardia;

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

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

- simultaneous reception of drugs that extend the interval QT;

- severe hepatic impairment (class FROM according to the Child-Pugh classification) and patients with increased transaminases more than 5 times higher than the upper limit of the norm.

Carefully:

In diseases of the central nervous system (CNS), including suspicious for involvement of the central nervous system, predisposing to the onset of seizures and reducing the threshold of convulsive activity; in patients with psychoses and / or with psychiatric illnesses in the anamnesis; in patients with potentially proarrhythmic conditions (especially in women and elderly patients),such as acute myocardial ischemia and cardiac arrest; with myasthenia gravis gravis; in patients with cirrhosis; with simultaneous administration with drugs that reduce the content of potassium; deficiency of glucose-6-phosphate dehydrogenase.

Pregnancy and lactation:

The use of moxifloxacin in pregnancy is contraindicated.

An insignificant amount of moxifloxacin is excreted in breast milk, therefore the use of moxifloxacin during breastfeeding is contraindicated.

Dosing and Administration:

The recommended dosage regimen for moxifloxacin is adult: one tablet (400 mg)

1 time per day at the same time, regardless of food intake.

The tablet should be swallowed whole, without chewing and washing down with a sufficient amount of water.

Duration of therapy. The duration of use is determined by the severity of the infection and the clinical effect:

acute sinusitis - 7 days; exacerbation of chronic bronchitis - 5-10 days; community-acquired pneumonia: the total duration of the stepwise therapy (intravenous administration of moxifloxacin followed by oral administration) is 7-14 days; uncomplicated skin and soft tissue infections - 7 days; complicated skin infections andsubcutaneous structures - the total duration of stepwise therapy with moxifloxacin (intravenous administration of the drug with subsequent ingestion) is 7-21 days; Complicated intra-abdominal infections - the total duration of the stepwise therapy (intravenous administration of the drug followed by oral administration) is 5-14 days; uncomplicated inflammatory diseases of the pelvic organs - 14 days.

The duration of treatment with moxifloxacin in tablets can reach 21 days.

There is no need to change the dosage regimen in elderly patients, patients with impaired liver function (classes A, B on the Child-Pugh scale), patients with impaired renal function (including renal insufficiency with creatinine clearance <30 mL / min / 1.73 m²), patients of different ethnic groups, as well as in patients on continuous hemodialysis and long-term outpatient peritoneal dialysis.

Do not exceed the recommended duration of treatment.

Side effects:

Data on adverse reactions recorded with the use of moxifloxacin 400 mg (by mouth, with stepwise therapy [intravenous administration of the drug followed by itsingestion] and only intravenously) were obtained from clinical studies and post-marketing messages (highlighted in italics).

Adverse reactions listed in the "frequently" group occurred with a frequency below 3%, except for nausea and diarrhea.

In each private group, adverse 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 ≥ 1/10000 to <1/1000); very rarely (<1/10000).

Table 3. Side effect, which can be caused by the use of moxifloxacin

System-Organ classes (MedDRA)	Often	Infrequently	Rarely	Rarely
Infectious and parasitic diseases	Fungal superinfections
Violations of the blood and lymphatic system		Anemia Leukopenia Neutropenia Thrombocytopenia Thrombocythemia Prothrombin time extension / increase in the international normalized ratio (INR)	Change in the concentration of thromboplastin	Increased concentration of prothrombin / decrease in INR
Immune system disorders		Allergic reactions Itching Rash Hives Eosinophilia	Anaphylactic reactions / anaphylactoid reactions Angioedema, including laryngeal edema (potentially life-threatening)	Anaphylactic / anaphylactoid shock (including potentially life-threatening)
Metabolic disorders		Hyperlipidemia	Hyperglycaemia Hyperuricemia
Mental disorders		Anxiety Psychomotor hyperactivity / agitation	Emotional lability Depression (in very rare cases, behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts) Hallucinations	Depersonalization Psychotic reactions (potentially manifested in behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts)
Disturbances from the nervous system	Headache Dizziness	Paresthesia Dysaestia Disturbances in taste sensitivity (including in very rare cases, agevia) Confusion and disorientation Sleep Disorders Tremor Vertigo Drowsiness	Hypesesia Abnormalities of smell (including anosmia) Atypical dreams Violation 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	Hyperesthesia
Disturbances on the part of the organ of sight		Visual impairment (especially with CNS reactions)		Transient loss of vision (especially against the background of reactions from the central nervous system)
Hearing disorders and labyrinthine disorders			Noise in ears Deterioration of hearing, including deafness (usually reversible)
Disorders from the cardiovascular system	Interval lengthening QT in patients with concomitant hypokalemia	Interval lengthening QT Heart palpitations Tachycardia Vasodilation	Ventricular tachyarrhythmias Fainting Increased blood pressure Reduction of blood pressure	Nonspecific arrhythmias Polymorphic ventricular tachycardia (of the type "feasting") Heart failure (mainly in people with predisposing to arrhythmias,such as clinically significant bradycardia, acute myocardial ischemia)
Disturbances from the respiratory system, chest and mediastinal organs		Shortness of breath (including asthmatic conditions)
Disorders from the gastrointestinal tract	Nausea Vomiting Stomach ache Diarrhea	Reduced appetite and reduced food intake Constipation Dyspepsia Flatulence Gastroenteritis (other than erosive gastroenteritis) Increase of amylase activity	Dysphagia Stomatitis Pseudomembranous colitis (in very rare cases associated with life-threatening complications)
Disturbances from 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)
Disturbances from the skin and soft tissues				Bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening)
Disturbances from musculoskeletal and connective tissue		Arthralgia Myalgia	Tendonitis Increased muscle tone and cramps Muscle weakness	Tendon tendons Arthritis Gait disorders due to damage to the musculoskeletal system increased myasthenia gravis symptoms gravis
disorders of the kidneys and urinary tract		dehydration (caused by diarrhea or decreased fluid intake)	impaired renal function renal failure (as a result of dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing impairment of kidney function)
common violations		general malaise nonspecific pain sweating	edema

the frequency of development of the following adverse reactions was higher in the group receiving the stepwise therapy:

often:

increased activity of gamma-glutamyltransferase.

infrequently:

ventricular tachyarrhythmias, lowering of arterial pressure, edema, pseudomembranous colitis (in very rare cases associated with life-threatening complications), seizures with various clinical manifestations (including "grand mal" seizures), hallucinations, impaired renal function, renal failure (as a result of dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing impaired renal function).

Overdose:

Overdose can manifest itself in the form of various dose-dependent adverse side effects (see section "Side effect").

Treatment: adequate hydration, reception of activated charcoal, symptomatic therapy with ECG monitoring due to possible lengthening of the interval Q-T. It should be borne in mind that the reception of activated carbon at an early stage of absorption prevents further systemic effects of moxifloxacin. In case of acute overdosage, it is necessary to rinse the stomach.

Interaction:

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

Drugs that extend the interval QT

It should be taken into account the possible additive effect of lengthening the interval QT moxifloxacin and other drugs that affect the lengthening of the interval QT.

Due to the combined use of moxifloxacin and drugs that affect the lengthening of the interval QT, the risk of ventricular arrhythmia increases, including polymorphic ventricular tachycardia (torsade de pointes).

Contraindicated joint use of moxifloxacin with the following drugs that affect the lengthening of the interval QT:

- 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).

Antacids, multivitamins and minerals

The use of moxifloxacin concomitantly with antacids, multivitamins and minerals can lead to impaired absorption of moxifloxacin,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, antacids, 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 there is no interaction between moxifloxacin and warfarin, 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. When repeated doses of moxifloxacin were used, the maximum digoxin concentration increased by approximately 30%, while the area under the concentration-time curve (AUC) and minimal digoxin concentration did not change.

Activated carbon

With simultaneous use of activated carbon and moxifloxacin inside at a dose of 400 mg, the system 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.

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.

With the use of moxifloxacin in some patients, lengthening of the interval QT.

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

Degree of lengthening interval QT may increase with increasing drug concentration, therefore, do not exceed the recommended dose. However, in patients with pneumonia, the correlation between the concentration of moxifloxacin in the blood plasma and the lengthening of the interval QT was not noted. Interval lengthening QT 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 lengthening the interval QT. However, in patients with predisposing arrhythmias, the risk of developing ventricular arrhythmias may increase with moxifloxacin.

Concerning moxifloxacin contraindicated in: changes in the electrophysiological parameters of the heart, expressed in the lengthening of the interval QT: congenital or acquired; documented lengthening interval QT, electrolyte disturbances, especially uncorrectable hypokalemia; clinically significant bradycardia; clinically significant heart failure with a reduced fraction of the left ventricular ejection; presence in the anamnesis of rhythm disturbances, accompanied by clinical symptoms; application with other drugs that extend the interval QT (see the section "Interaction with other medicinal products").

Moxiflocacin should be used with caution: in patients with potentially proarrhythmic conditions, such as acute myocardial ischemia and cardiac arrest; in patients with cirrhosis of the liver (since this category of patients can not exclude the risk of developing an extension of the interval QT).

Disglycemia. As in the case of other fluoroquinolones, when the drug is used moxifloxacin there was a change in the concentration of glucose in the blood, including hypo- and hyperglycemia. Against the background of drug therapy moxifloxacin dysglycemia occurred predominantly in elderly patients with diabetes mellitus receiving concomitant therapy with oral hypoglycemic drugs (eg, sulfonylureas) or insulin. When performing treatment in patients with diabetes, careful monitoring of the concentration of glucose in the blood is recommended.

When moxifloxacin was taken, cases of fulminant hepatitis, potentially leading to the development of hepatic insufficiency (including fatal cases) were reported (see 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 should be used with caution in patients with diseases of the central nervous system (CNS) and with conditions suspicious of CNS involvement predisposing to the occurrence of 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 gravis in connection with a 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 strains Staphylococcus aureus, resistant to methicillin (MRSA). In the case of suspected or confirmed infections caused by MRSA, should be prescribed treatment with appropriate antibacterial drugs (see the section "Pharmacodynamics"). Ability of the drug Moxifloxacin To 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, described cases of sensory or sensorimotor polyneuropathy, leading to paresthesia, hypoesthesia, dysesthesia or weakness. 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 the wide spread and growing incidence of infections caused by fluoroquinolone-resistant Neisseria gonorrhoeae, in the treatment of patients with inflammatory diseases of the pelvic organs, monotherapy with moxifloxacin should not be carried out. Except where the presence of a resistant to fluoroquinolones N. gonorrhoeae excluded. If there is no way to exclude the presence of fluoroquinolones resistant N. gonorrhoeae, it is necessary to resolve the issue of supplementing empirical therapy with moxifloxacin with an appropriate antibiotic that is active against N. gonorrhoeae (e.g., cephalosporin).

Effect on the ability to drive transp. cf. and fur:The drug may cause dizziness and dizziness. Do not engage in potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 400 mg.

Packaging:

By 5, 7, 10 tablets into the contour cell packaging of a polyvinyl chloride film and flexible packaging on the basis of aluminum foil fordrugs.

10, 20, 50, 100 tablets in cans of polymeric with screw caps.

To the bank or 1, 2 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Packing for hospitals

For 50, 100, 200, 300, 500 contour mesh packages together with an equal number of instructions for use are placed in a box of cardboard.

10, 20, 50, 100 tablets in cans of polymeric with screw caps. 4, 6, 8, 10, 12, 24, 50, 100 cans, together with an equal number of instructions for use, are placed in a cardboard box.

For 500, 1000 tablets in cans of polymeric with screw caps. 4, 6, 8, 10, 12 cans, together with an equal number of instructions for use, are placed in a cardboard box.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-004145

Date of registration:14.02.2017

Expiration Date:14.02.2022

The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia

Manufacturer: & nbsp

BRYNTSALOV-A, CJSC Russia

Representation: & nbspBRYNTSALOV-A, CJSCBRYNTSALOV-A, CJSC

Information update date: & nbsp29.03.2017

Illustrated instructions

Instructions

Moxifloxacin-Ferein® (Moxifloxacin-Ferein®)