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

Composition:1 tablet contains: active substance - moxifloxacin hydrochloride 436.80 mg (in terms of moxifloxacin 400.00 mg); Excipients - cellulose microcrystalline 153.70 mg, povidone (povidone K 30) - 20.00 mg, croscarmellose sodium 36.30 mg, silicon dioxide colloid 6.60 mg, magnesium stearate 6.60 mg; shell - hypromellose 10.61 mg, propylene glycol 2.12 mg, titanium dioxide 3.40 mg, talc 3.54 mg, iron oxide red oxide 0.33 mg.

Description:Tablets are capsular biconvex, covered with a film membrane of pink color. 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 - a bactericidal antibacterial broad-spectrum preparation, 8-methoxy fluoroquinolone. The bactericidal effect of moxifloxacin 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 the 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 (MICs).

Mechanisms resistance

Mechanisms leading to the development of resistance to penicillin, 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, through multiple mutations. Multiple exposure of moxifloxacin to microorganisms at concentrations below the minimum inhibitory concentration (MIC) is 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„ and 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., Eubactcrium spp., Peptostreptococcus spp. These changes were reversible within two weeks. Toxins Clostridium difficile not detected.

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 resistance to antibiotics), as well as strains resistant to two or more antibiotics, such as penicillin (MIC ≥ 2 μg / ml), cephalosporins II generation (for example, cefuroxime), macrolides, tetracyclines, trimethoprim / sulfamethoxazole
Streptococcus pyogenes (Group A)*
Gruppa Streptococcus milleri (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 dysgalcictiae
Staphylococcus aureus (methicillin-sensitive strains) *		Staphylococcus aureus (methicillin / ofloxacin resistant strains)⁺
Coagulase-negative staphylococciS. 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
	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) *
Haemophillus parainfluenzae *
Moraxella catarrhalis (including strains producing and non-producing β-lactamases) *
Inrdetella pertussis
Legionella pneumophila	Escherichia coli *
Acinetobacter baumanii	Klebsiella pneumoniae *
	Klebsiella oxytoca
	Citrobacter freundii *
	Enterobacter spp. (E. aerogenes, E. intermedius, E. sakazakii)
	Enterobacter cloacae *
	Pantoca agglomerans
		Pseudomonas aeruginosa
	pseudomonas fluorcscens
	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 *)
fusobactcrium 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 burnettii

* sensitivity to moxifloxacin is confirmed by clinical data.

⁺ 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 distribution of acquired resistance may vary depending on the geographical region and over time. in this regard, when testing the sensitivity of the 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) / mik₉₀, exceeds 125, and the maximum concentration in blood plasma (s_max) / mic₉₀ is within the range of 8-10 - this implies a clinical improvement. in ambulatory patients, the values of these surrogate parameters are usually less: auc/ mik₉₀ > 30-40.

parameter (average value)	auic * (h)	from_max/ mik₉₀
mik₉₀0,125 mg / l	313	32,5
mik₉₀ 0.25 mg / l	156	16,2
mik₉₀ 0.5 mg / l	78	8,1

*auic- area under the inhibitory curve (ratio auc/ mik₉₀).

Pharmacokinetics:

Suction

When taken orally moxifloxacin absorbed quickly and almost completely. Absolute bioavailability is about 91%.

The pharmacokinetics of moxifloxacin when taken at doses 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 in the blood plasma (C_m_Oh) is achieved 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 together with the poor, there is an insignificant increase in the time to reach C_m_Oh (at 2 h) and a slight decrease in C_m_Oh (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 the blood plasma, are created in the lung tissue (including in the epithelial fluid, alveolar macrophages), in the nasal sinuses (maxillary and etmoidal 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, nc-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 (Ml) 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 ns 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 moxifloxacin.

The mass balance 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

When studying the pharmacokinetics of moxifloxacin in men and women, differences were found in 33% of the indicators AUC and C_max. Absorption of moxifloxacin did not depend on sex. Differences in indicators AUC and C_m_Oh 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 groups and 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,

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

- complicated skin and subcutaneous tissue infections, 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 include penicillin resistant strains and strains resistant to two or more antibiotics from groups such as penicillins (with MIC ≥ 2 μg / ml), cephalosporins II 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 drugs.

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 history of the pathology of tendons, developed as a result of treatment with antibiotics of the quinolone series; changes in the electrophysiological parameters of the heart, expressed in the lengthening of the interval QT: Congenital or acquired documented lengthening interval QT, electrolyte disorders, especially uncorrelated 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; use with other drugs that extend the interval QT (see the section "Interaction with other medicinal products"); violations of liver function (class C according to Child-Pugh classification) and increaseTransaminase is more than five times higher than the upper limit of the norm, due to the limited amount of clinical data.

Carefully:

In diseases of the central nervous system (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 reception with drugs that reduce the content of potassium: in patients with genetic predisposition or the 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 use of moxifloxacin during breastfeeding is contraindicated.

Dosing and Administration:

Inside, regardless of food intake, 400 mg (1 tablet) per day, observing equal intervals between doses - every 24 hours. Do not exceed the recommended dose.

Swallow the tablet without chewing, drink plenty of water. The duration of therapy is established by the attending physician, taking into account the features of the pathogen, the localization and severity of the infection, and the effect of the therapy.

The recommended course of treatment with moxifloxacin

- acute sinusitis - 7 days;

- exacerbation of chronic bronchitis - 5 - 10 days;

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

- uncomplicated inflammatory diseases of the pelvic organs - 14 days;

- uncomplicated infections of skin and soft tissues - 7 days;

- complicated infections of the skin and soft tissues - the total duration of the stepwise therapy (intravenous administration followed by oral administration) is 7-21 days;

- Complicated intra-abdominal infections - the total duration of stepwise therapy (intravenous administration followed by oral administration) is 5-14 days.

Do not exceed the recommended duration of treatment.

According to clinical studies, the duration of treatment with moxifloxacin in tablets can reach 21 days.

Patients of elderly increase

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

Children

The efficacy and safety of moxifloxacin in children and adolescents under the age of 18 years has not been established.

Impaired liver function

Patients with hepatic dysfunction are not required to change the dosage regimen (for use in patients with cirrhosis see the section "Special instructions").

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.

Application the patients of different ethnic groups

Dosage regimen changes are not required.

Important! If the drug is missed, you should take the pill as soon as possible without waiting for the next time. Further, to observe equal intervals of time between doses - 24 hours.

Never take a double dose to compensate for missed medication!

Moxifloxacin STADA Tablet can not divide and / or pound.

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 oral administration] and only intravenously) are obtained from clinical studies and post-registration reports (in italics).

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 importance.The frequency is determined as follows:

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).

Systems bodies	Often	Infrequently	Rarely	Rarely
Infectious and parasitic diseases	Fungal superinfection
From the side hematopoiesis systems		Anemia Leukopenia Neutropenia Thrombocytopenia Thrombocytosis Elongation prothrombin time / increase international normalized relationship (INR)	Change Thromboplastin concentration	Increase prothrombin concentration / decrease INR
From the side immune system		Allergic reactions Itching Rash Hives Eosinophilia	Anaphylactic /anaphylactoid reactions Angioedema, including laryngeal edema (potentially life-threatening)	Anaphylactic/ anaphylactoid shock (including potentially life-threatening)
From the side metabolism		Hyperlipidemia	Hyperglycaemia Hyperuricemia	Hypoglycaemia
Mental disorders		Anxiety Psychomotor hyperreactivity / agitation	Emotional lability Depression (in very rare cases, possibly 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)
From the nervous side systems	Headache Dizziness	Paresthesia / Dysaesthesia Violation taste sensitivity (including in very rare cases, agevia) Confusion consciousness and disorientation Sleep Disorders Tremor Vertigo Drowsiness	Hypesesia Violations smell (including anosmia) Atypical dreaming Violation coordination (including gait disturbances due to dizziness or vertigo, in very rare cases leading to injury from falling, especially in elderly patients) Seizures with various clinical manifestations (including "grand mal" seizures) Violations attention Violations speech Amnesia Peripheral neuropathy and polyneuropathy	Hypersthesia
From the side of the organ of vision		Violations (especially in reactions from the central nervous system (CNS))		Transient loss of vision (especially against the background of reactions from the central nervous system)
From the side of the hearing organ and labyrinthine disorders			Noise in ears Deterioration hearing, including deafness (usually reversible)
From the side of the cardiovascular system	Elongation of the QT interval in patients with concomitant hypokalemia	Elongation of the QT interval Feeling palpitation Tachycardia Vasodilation	Ventricular tachyarrhythmias Fainting Increase blood pressure Decrease blood pressure	Nonspecific arrhythmias Polymorphic ventricular tachycardia (Torsade de pointes) Stop heart (mainly in persons with predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia)
On the part of the respiratory system, the organs of the thorax and the mediastinum		Dyspnea (including asthmatic condition)
From the gastrointestinal side tract	Nausea Vomiting Stomach ache Diarrhea	Reduced appetite and reduced food intake Constipation Dyspepsia Flatulence Gastroenteritis (except erosive gastroenteritis) Increase activity of amylase	Dysphagia Stomatitis Pseudomembranous colitis (in very rare cases associated with life-threatening complications)
From the liver and biliary tract	Increase activity of "liver" transaminases	Violations liver function (including increased lactate dehydrogenase activity) Increase bilirubin concentration Increase activity of gamma-glutamyl transferase The increase in blood activity of alkaline phosphatase	Jaundice Hepatitis (predominantly cholestatic)	Fulminant hepatitis, potentially leading to life-threatening hepatic insufficiency (including fatal cases)
From the skin and soft tissues				Bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).
From the musculoskeletal and connective tissue		Arthralgia Myalgia	Tendonitis Increase muscle tone and cramps Muscular weakness	Tendon tendons Arthritis Violation of the gait due to damage to the musculoskeletal system Increased symptoms of myasthenia gravis
From the side of the kidneys and 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)
General disorders and injuries at the site of administration	Reactions at the injection / infusion site	General malaise Nonspecific pain Sweating Phlebitis / thrombophlebitis at the site of administration	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, hypotension, edema, pseudomembranous colitis (in very rare cases associated with life-threatening complications), convulsions with various clinical manifestations (incl. "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 moxifloxacin at a dosage 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 and supportive 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 ethenolol, ranitidine, calcium-containing additives, theophylline, cyclosporin, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid (no clinical interaction with moxifloxacin was 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 developing 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 of class 1A (quinidine, hydroquinidine, disopyramide and other);

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

- Neuroleptics (phenothiazine, pimozide, sertindole, haloperidol, sultopride, etc.):

- Tricyclic antidepressants;

- Antimicrobials (sparfloxacin, erythromycin for intravenous administration, pentamidine, antimalarial drugs, especially halofantrine):

- Antihistamines (terfenadine, astemizole, misolastine):

- Others (cisapride, wincamine for intravenous administration, beprideal. 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, antacid drugs, antiretroviral preparations (e.g., 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 8 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 antibacterial drugs, including moxifloxacin, there are cases of increased anti-coagulation 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 does not have a significant impact on pharmacokinetic parameters\ each other. When repeated doses are used moxifloxacin, the maximum digoxin concentration increased by approximately 30%, with the area under the 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 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.

Dairy products and food intake

Absorption of moxifloxacin ns varies with simultaneous intake of food (including dairy products). Moxifloxacin can be used regardless of food intake.

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 stopped and immediately begin to carry out the necessary medical measures (including anti-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 lengthening interval QT: congenital or acquired documented 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:

- application with other drugs that extend the interval QT (see the section "Interaction with other medicinal products").

The drug 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 moxifloxacin was used, cases of fulminant hepatitis, potentially leading to hepatic insufficiency (including fatal cases) were reported (see "Side effect"). The patient should be informed that If symptoms of liver failure appear, you should consult your doctor before continuing with moxifloxacin.

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 appointed treatment appropriate antibacterial preparations (see 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 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 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 suicide attempts (the section "Adverse Effects"). 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 e other fluoroquinolones, when moxifloxacin was used, there was a change in the concentration of glucose in the blood, including hypo- and hyperglycemia. Against the background of drug therapy moxifloxacin Disglycemia occurred mainly in elderly patients with diabetes mellitus receiving concomitant therapy oral hypoglycemic agents (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, 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 effects on the central nervous system and visual impairment.

Form release / dosage:

Tablets, film-coated, 400 mg.

Packaging:

5 tablets in a blister of polyvinylchloride / polyvinylidene chloride film and aluminum foil printed lacquer. 1 blister together with instructions for use in a pack of cardboard.

Storage conditions:

In a place protected from moisture, at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-003297

Date of registration:06.11.2015

Expiration Date:06.11.2020

The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Information update date: & nbsp12.06.2018

Illustrated instructions

Instructions

Moxifloxacin STADA (Moxifloxacine STADA)