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

Excipients: sodium croscarmellose - 30.0 mg, lactose monohydrate - 60.0 mg, giprolose - 7.2 mg, microcrystalline cellulose - 120.0 mg, magnesium stearate - 6.0 mg.

Film Sheath: hypromellose - 12.0 mg, macrogol 6000-4.0 mg, titanium dioxide - 3.46 mg, red iron oxide dye 0.54 mg.

Description:

The capsule-shaped, biconvex tablets covered with a film membrane of a red-pink color. On the cross section, the core is light yellow in color.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A.14 Moxifloxacin

Pharmacodynamics:

Mechanism of action

Moxifloxacin is a bactericidal antibacterial broad-spectrum drug, 8-methoxy fluoroquinolone.

The bactericidal effect of moxifloxacin is due to the inhibition of bacterial topoisomerases II and IV, which leads to violation of processes replication, repair and transcription of the biosynthesis of the DNA of a microbial cell and, as a consequence, to the death of microbial cells.

The minimum bactericidal concentrations of moxifloxacin are generally comparable to its minimum inhibitory concentrations.

Mechanisms of resistance

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 the 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., a also 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 were observed after oral administration of moxifloxacin. Decreased concentrations 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. Toxin Clostridium difficile Not found.

Sensitivity testing in vitro

The spectrum of antibacterial activity of moxifloxacin includes the following microorganisms:

Sensitive	Moderately sensitive	Resistant
Gram-positive
Gardnerella vaginalis
Streptococcus 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 milleri (S. anginosus , S. constellatus , u 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 (methicillin-sensitive strains) *		Staphylococcus aureus (methicillin / ofloxacin resistant strains) **
Coagulase-negative staphylococci (S. oohnii, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. simulans), methicillin-sensitive strains		Coagulase-negative staphylococci (S. cohnii, S. epider midis, S. haemolyticus, S. hominis, S. saprophyticus, S. simulans). methicillin-resistant strains
	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
Legionella pneumophila	Escherichia coli *
Acinetobacter baumannii	Klebsiella pneumoniae *
	Klebsiella oxytoca
	Citrobacter freundii *
	Enterobacter spp. (E aerogenes, E intermedius, E. sakazakii)
	Enterobacter cloacae *
	Pantoea agglomerans
		Pseudomonas aeruginosa
	Pseudomonas fluorescens
	Burkholderia cepacia
	Stenotrophomonas maltophilia
	Proteus mirabilis *
Proteus vulgaris
	Morganella morganii
	Neisseria gonorrhoeae *
	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

* Sensitivity to moxifloxacin is confirmed by clinical data

** The use of moxifloxacin is not recommended for the treatment of infections caused by S. 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.

For certain strains, the spread of acquired resistance may vary depending on the geographical region and over time. AT In connection with this, when testing the sensitivity of a strain, it is desirable to have local information on resistance, especially when treating severe infections. If patients undergoing treatment in a hospital, the area under the pharmacokinetic curve "concentration-time" (AUC/ MIC₉₀exceeds 125, and the maximum concentration in the blood plasma (FROM_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/ MIC₉₀>30-40.

Parameter (average value)	*AUIC (h)**	(FROM_m_Oh) / 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 is the area under the inhibitory curve (AUC / MIC ratio₉₀)

Pharmacokinetics:

Suction

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 C_mOh in blood is reached within 0.5-4 hours and is 3.1 mg / l. After taking 400 mg of moxifloxacin once a day Css^max and Css^min are 3.2 mg / L and 0.6 mg / L, respectively.

When moxifloxacin is taken with food, there is a slight increase in the time to reach C_mOh (at 2 h) and a slight decrease in C_mOh(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 the drug exceeding such in the blood plasma, are created in the lung tissue (including in the epithelial fluid, alveolar macrophages), in the nasal sinuses (maxillary and ethmoidal sinuses), in nasal polyps,in the foci of inflammation (in the contents of blisters in case of skin lesions). In the interstitial fluid and in the saliva moxifloxacin is determined in a free, not protein-related form, at a concentration higher than in the blood 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 (M1) and glucuronides (M2). Moxifloxacin does not undergo biotransformation by the microsomal system of cytochrome P450. Metabolites M1 and M2 are present in blood plasma at concentrations lower than the parent 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 of moxifloxacin is approximately 12 hours. The average total clearance after administration in a dose of 400 mg is 179-246 ml / min. Kidney clearance is 24-53 ml / min.This indicates a partial tubular reabsorption of the drug. The mass balance of the initial compound and the metabolites of the 2nd 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

When studying the pharmacokinetics of moxifloxacin in men and women, differences were found in 33% of the indicators AUC and C_mOh. Absorption of moxifloxacin did not depend on sex. Differences in indicators AUC and C_mOh were due to the difference in weight rather than sex and are not clinically significant. There were no clinically significant differences in the pharmacokinetics of moxifloxacin in patients of different ethnic trunks and different ages.

Children

The pharmacokinetics of moxifloxacin in children have not been studied.

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.

Impaired liver function

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

Indications:

Infectious-inflammatory diseases caused by micro-organisms sensitive to moxifloxacin:

- acute sinusitis;

- 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);

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

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

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

*Streptococcus pneumoniae c multiple resistance to antibiotics include penicillin resistant strains and strains resistant to two or more antibiotics from groups such as penicillins (at MICs of 2 μg / 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, other quinolones or any other component of the drug;

- age to 18 years;

- pregnancy and the period of breastfeeding;

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

- in preclinical and clinical studies after administration of moxifloxacin, a change in the electrophysiological parameters of the heart was observed, expressed in the lengthening of the interval QT. In this regard, the use of moxifloxacin is contraindicated in patients of the following categories: congenital or acquired documentary lengthening interval QT, electrolyte disorders, especially uncorrected 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;

- moxifloxacin can not be used with other drugs that extend the interval QT (cm.section "Interaction with other medicinal products");

- due to the presence of lactose drug, its reception is contraindicated in congenital lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

- Due to the limited amount of clinical data, the use of moxifloxacin is contraindicated in patients with impaired hepatic function (class C according to the Child-Pugh classification) and patients with increased transaminases more It is five times higher than the upper limit of the norm.

Carefully:

In diseases of the central nervous system (in t. h suspicious regarding CNS involvement) predisposing to seizures, and reducing the threshold for seizure 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; in patients with a genetic predisposition, or actual presence of glucose-6-phosphate dehydrogenase deficiency.

Pregnancy and lactation:

Safety of moxifloxacin during pregnancy is not established and its use is contraindicated. Cases of reversible joint damage in children receiving certain quinolones are described, but no evidence of this effect was 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 its use in women during lactation are absent. Therefore, the appointment of moxifloxacin during breastfeeding is contraindicated.

Dosing and Administration:

The recommended dosage regimen for moxifloxacin is 400 mg (1 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.

Duration of treatment

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

- with exacerbation of chronic bronchitis - 5-10 days;

- in acute sinusitis and uncomplicated infections of the skin and subcutaneous structures - 7 days;

- in community-acquired pneumonia the total duration of stepwise therapy with moxifloxacin (intravenous administration followed by oral administration) is 7-14 days;

- with complicated infections of the skin and subcutaneous structures the total duration of stepwise therapy with moxifloxacin (intravenous administration followed by oral administration) is 7-21 days;

- with complicated intra-abdominal infections the total duration of stepwise therapy with moxifloxacin (intravenous administration followed by oral administration) is 5-14 days;

- with uncomplicated pelvic inflammatory disease - 14 days.

Do not exceed the recommended duration of treatment. The duration of treatment with moxifloxacin in tablets can reach 21 days.

Special patient groups

Changes in the dosing regimen in elderly patients not required.

Efficacy and safety of moxifloxacin in children and adolescents (under 18 years of age) not installed.

Patients with impaired hepatic function (class A and B on the Child-Pugh scale), a change in the dosing regimen is not required.

Patients with impaired renal function (including those with 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, a change in the dosage regimen is not required.

In patients of different ethnic groups a change in the dosage regimen is not required.

Side effects:

Data on adverse reactions recorded with the use of moxifloxacin 400 mg (by mouth, with stepwise therapy [intravenous administration and subsequent oral administration] and only intravenously) are obtained from clinical studies and post-marketing reports (italicized).

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 frequency is defined as follows: 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).

System-organ classes (MedDRA)	Often	Infrequently	Rarely	Rarely
Infection and parasitic diseases	Fungal superinfection
Disorders from the hematopoietic system		Anemia Leukopenia Neutropenia Thrombocytopenia Thrombocythemia Elongation prothrombin time / enlargement of international normalized relations (INR)	Change in the concentration of thromboplastin	Increase in prothrombin concentration / decrease in INR
Immune system disorders		Allergic reactions Itching Rash Hives Eosinophilia	Anaphylactic / anaphylactoid reactions Angioedema, including laryngeal edema (potentially life-threatening)	Anaphylactic / anaphylactoid shock (including potentially life-threatening)
Metabolic disorders		Hyperlipidemia	Hyperglycemia Hyperuricemia	Hypoglycaemia
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 / Dysaesthesia Violations gustatory sensitivity (including in very rare cases agevziyu) Confusion and disorientation Sleep Disorders Tremor Vertigo Drowsiness	Hypesesia Abnormalities of smell (including anosmia) Atypical dreams Violation coordination (including gait violations 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)
Violations from the organ of hearing and labyrinthine violations			Wmind in the ears Deterioration of hearing, including deafness (usually reversible)
Disorders from the cardiovascular system	Interval lengthening QT in patients with concomitant hypokalemia	Elongation interval QT Feeling palpitation Tachycardia Vasodilation	Ventricular tachyarrhythmias Fainting Increase arterial pressures Decrease arterial pressures	Nonspecific arrhythmias Polymorphic ventricular tachycardia (Torsade de Pointes) Heart failure, (mainly in Persons with predisposing to arrhythmias, such as clinically significant bradycardia. acute myocardial ischemia)
Disturbances from the respiratory system, chest and mediastinal organs		Dyspnea (including asthmatic condition)
Disorders from the gastrointestinal tract	Nausea Vomiting Pain in abdomen Diarrhea	Reduced appetite and reduced food intake Constipation Dyspepsia Flatulence Gastroenteritis (except erosive gastroenteritis) Increase activity amylase	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"	Violations liver function (including rise lactate dehydrogenase activityShl) Increase concentrations bilirubin Increase activity gamma glutamyl transferase The increase in blood activity alkaline phosphatases	Jaundice Hepatitis (mainly cholestatic)	Fulminant hepatitis, potentially leading to life-threatening liver failure (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 disturbance due to damage to the musculoskeletal system Increased myasthenia gravis symptoms gravis
Disorders from the kidneys and urinary tract		Dehydration (caused by diarrhea or decreased fluid intake)	Function violation kidneys Renal insufficiency dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing impairments in kidney function)
General disorders and disorders at the injection site	Reactions in place injections / infusions	General information malaise Nonspecific pain Sweating Phlebitis / thrombophlebitis in place introduction of	Edema

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

Often: Increase in activity of gamma-glutamyl transferase

Infrequently: Ventricular tachyarrhythmias, lowering blood pressure, swelling, 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:

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, cyclosporine, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid (no clinically significant interaction with moxifloxacin was confirmed), dose adjustment is not required.

Drugs that extend the QT interval

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 and etc.);

- antiarrhythmic drugs of class III (amiodarone, sotalol, dofetilide, ibutilide, etc.);

- neuroleptics (phenothiazine, iimozide, sertindole, haloperidol, sultopride and other);

- tricyclic antidepressants;

- antimicrobials (sparfloxacin, erythromycin for intravenous administration, pentamidine, antimalarial drugs, especially halofantrine);

- antihistamines (terfenadine, astemizole, misolastine);

- others (cisapride, wincamine for intravenous administration, bepridil, difemanyl).

Antacids, multivitamins and minerals

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, antacids, antiretroviral drugs (for example, didanosine) and other preparations containing magnesium and 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.

Changing the value of INR. In patients who received anticoagulants in combination with antibacterial drugs, 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. Although the interaction between moxifloxacin and warfarin has not been revealed, 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 the simultaneous use of activated carbon and moxifloxacin inside at a dose of 400 mg, the 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 immediately begin the necessary treatment activities (includinganti-shock).

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

Interval lengthening QT is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia.

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. None of the 9,000 patients who received moxifloxacin, there were no cardiovascular complications and lethal cases associated with lengthening the interval QT. With the use of moxifloxacin, the risk of developing ventricular arrhythmias in patients with predisposing arrhythmias may increase.

Concerning moxifloxacin contraindicated in:

- changes in the electrophysiological parameters of the heart, expressed in elongation of the QT interval: congenital or acquired documented lengthening of the QT interval, electrolyte disturbances, especially uncorrected 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"),

Moxifloxacin 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).

When applying moxifloxacin reported cases of fulminant hepatitis, potentially leading to the development of hepatic insufficiency (including fatal cases) (see section "Side effect"). The patient should be informed that if symptoms of hepatic insufficiency occur, the doctor should be consulted before continuing moxifloxacin treatment.

When moxifloxacin was used, cases of developing bullous skin lesions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, were reported (see "Side effect" section). 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 CNS diseases and CNS disorders, predisposing to the onset 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. This diagnosis should be borne in mind in patients who have developed severe diarrhea with moxifloxacin. In this case, immediate therapy should be prescribed. Drugs that inhibit the peristalsis of the intestine 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, tendonitis and tendon rupture are possible, especially in the elderly and patients receiving glucocorticosteroids. 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, taking the drug should stop and unload the affected limb.

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

The use of moxifloxacin in the form of oral tablets is not recommended 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").

The ability of moxifloxacin to inhibit the growth of mycobacteria can cause interaction in vitro moxifloxacin with a Mycobacterium spp., leading to false negative results in the analysis of samples of patients who undergo drug treatment 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 use 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). In case of development of such reactions in patients it is necessary to cancel moxifloxacin and take the necessary measures.

Caution should be exercised when using moxifloxacin in patients with psychoses and / or psychiatric illnesses in the anamnesis.

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. with the exception of cases when the presence of resistant to fluoroquinolones Neisseria gonorrhoeae excluded. If there is no way to exclude the presence of fluoroquinolones resistant Neisseria gonorrhoeae, it is necessary to resolve the issue of supplementing empirical therapy with moxifloxacin with an appropriate antibacterial drug that is active against Neisseria gonorrhoeae (e.g., cephalosporin).

Disglycemia

As in the case of other fluoroquinolones, the use of moxifloxacin showed a change in the concentration of glucose in the blood, including hypo- and hyperglycemia. Against the background of drug therapy moxifloxacin dysglycemia occurred mainly 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.

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

Fluoroquinolones, including moxifloxacin, may impair the ability of patients to drive and engage in other potentially dangerous species activities that require increased attention and speed of psychomotor reactions, due to influence on the central nervous system and visual impairment.

Form release / dosage:

Tablets, film-coated, 400 mg.

Packaging:

Primary packaging

By 5, 7 or 10 tablets in a contour cell pack of film polyvinylchloride and aluminum foil printed lacquered.

For 30 or 60 tablets in a can of polymeric polyethylene with a lid pulled with the control of the first opening. Free space is filled with cotton wool. Labels are applied to cans from paper label or writing, or from polymer materials, self-adhesive.

Secondary packaging

By 1, 2, 3 or 6 contour cell packs of 5 tablets together with instructions for use are placed in a cardboard pack.

On 1 circuit cell pack of 7 tablets together with the instruction for use are placed in a cardboard pack.

For 1, 3 or 6 contour cell packs of 10 tablets together with the instructions for use are placed in a pack of cardboard.

One bank of 30 or 60 tablets together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

In the original packaging of the manufacturer, 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 expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-004130

Date of registration:08.02.2017

Expiration Date:08.02.2022

The owner of the registration certificate:FARMASINTEZ, JSC (Irkutsk) FARMASINTEZ, JSC (Irkutsk) Russia

Manufacturer: & nbsp

FARMASINTEZ, JSC (Irkutsk) Russia

Representation: & nbspPharmasynthesis, JSCPharmasynthesis, JSC

Information update date: & nbsp05.03.2017

Illustrated instructions

Instructions

Moxiflo (Moxiflo)