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

Sheath: Opadry II orange 85F23452 (polyvinyl alcohol 40.0%, titanium dioxide 24.0%, macrogol 20.2%, talc 14.8%, dye sunset yellow with aluminum lacquer (E110) 0.8%, iron dye oxide red (E172) 0.2%) 20.0 mg.

Description:

The tablets covered with a film cover, light orange color, biconcave capsular shaped with a facet. On the cross section, the core of the tablet 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 the drug is due to the inhibition of bacterial topoisomerases II and IV, which leads to disruption of the processes of replication, repair and transcription of the biosynthesis of the DNA of a microbial cell and, as a 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 is established that the addition to the structuremolecule moxifloxacin methoxy group in the C8 position 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., as well as 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.

In Vitro Sensitivity Testing

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

Sensitive	Moderately-sensitive	Resistant
Gram-positive
Gardnerella vaginalis
Streptococcus pneumonia * (including strains resistant to penicillin and strains with multiple antibiotic resistance), as well as strains resistant to two or more antibiotics, such as penicillin (MIC2 μg / ml), second-generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, trimethoprim / sulfamethoxazole	-
Streptococcus pyogenes (group A) *
Group Streptococcus milleri (S. anginosus , S. constellatus , and S. intermedins *)
Group Streptococcus viridians (S. viridians, S. mutans, S. mitis, S. sanguinis, S. salivarius, S. thermophilus, S. constellatus)
Streptococcus agalactiae
Streptococcus dysgalactiae
Staphylococcus aureus (methicillin-sensitive strains) *		Staphylococcus aureus (methicillin / moxifloxacin resistant strains)⁺
Coagulase-negative staphylococci (S. cohnii, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus.S. simulcins), 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) *
Haemophilus parainfluenzae *
Moraxella catarrhalis (including strains producing and non-producing β-lactamases) *
Bordetella pertussis
Legionella pneumophila	Escherichia coli *
Acinetobacter baumanii	Klebsiella pneumoniae*
	Klebsiella oxytoca
	Citrobacter freundii *
	Enterobacter spp. (E. aerogenes, S. intermedins, E. sakazaki)
	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. distasoni* b. thetaiotaomicron * b. ovatus * b. uniform is . 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.

- moxifloxacin is not recommended for the treatment of infections caused by strains s. aureus, resistant to methicillin (mrsa). at cases of suspected infections 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.

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, the maximum concentration (C_mOh) in the 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_max(at 2 h) and a slight decrease in C_mOh (approximately 16%), while the duration of suction does not change. However, these data are not clinically relevant, and moxifloxacin can be used regardless of the intake of food.

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 blood plasma, are created in the lung tissue (including in the epithelial fluid, alveolar macrophages), in the nasal sinuses (maxillary and ethmoid sinuses), in nasal polyps, in the foci of inflammation (in the contents of blisters at damage to the skin). 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 taking 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 2nd phase is approximately 96-98%, which indicates the absence of oxidative metabolism. About 22% 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_max were due to the difference in weight rather than sex and are not considered 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), who are 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 infections of the skin and subcutaneous structures (including an infected diabetic foot);

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

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

* - Streptococcus pneumoniae with multiple antibiotic resistance include penicillin resistant strains and strains resistant to two or more antibiotics from groups such as penicillins (with MIC> 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 and 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;

- in connection with the limited number of clinical data, the use of moxifloxacin is contraindicated in patients with impaired liver function (Child-Pugh class C) andpatients with increased transaminases more than five times higher than the upper limit of the norm.

Carefully:

- In diseases of the central nervous system (including suspicious for involvement of the central nervous system), predisposing to the occurrence of seizures and reducing 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;

- in patients with a genetic predisposition or an actual deficiency of glucose-6-phosphate dehydrogenase.

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 of moxifloxacin: 400 mg (1 tablet) 1 time per 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:

- exacerbation of chronic bronchitis: 5-10 days;

- acute sinusitis: 7 days;

- uncomplicated infections of the skin and subcutaneous structures: 7 days;

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

- complicated infections of the skin and subcutaneous structures: 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 the stepwise therapy (intravenous administration of the drug with subsequent ingestion) is 5-14 days;

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

Do not exceed the recommended duration of treatment.

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

Elderly patients

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

Children

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

Impaired liver function

Patients with impaired hepatic function, changes in the dosing regimen are not required (for use in patients with cirrhosis of the liver, see section "Special instructions").

Renal insufficiency

In patients with impaired renal function (including those with severe renal insufficiency with CC <30 mL / min / 1.73 m²), as well as in patients on continuous hemodialysis and long-term outpatient peritoneal dialysis, changes in the dosing regimen are not required.

Use in patients of different ethnic groups

Changing the dosing 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 with 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 determined 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).

Systems bodies	Often	Infrequently	Rarely	Rarely
Infectious and parasitic diseases	Fungal superinfections
On the part of the hematopoiesis system		Anemia Leukopenia Neutropenia Thrombocytopenia Thrombocythemia Prothrombin time extension / increase in the international normalized ratio (INR)	Change in the concentration of thromboplastin	Increase in prothrombin concentration / decrease in INR
From the side immune system		Allergic reactions Itching Rash Hives Eosinophilia	Anaphylactic / anaphylactoid reactions Angioedema, including laryngeal edema (potentially life-threatening)	Anaphylacticcue / anaphylactoid shock (including potentially life-threatening)
From the side of metabolism		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 suicide attempts)
From the side nervous system	Headache Vertigo	Paresthesia / Dysaesthesia Violations 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 innimania Violations of speech Amnesia Peripheral neuropathy and polyneuropathy	Hyperesthesia
From the side of the organ of vision		Violations vision (especially with CNS reactions)		Transient loss of vision (especially against the background of reactions from the central nervous system)
From the side of the organ of hearing and labyrinthine disorders			Noise in the ears Impairment of 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) Heart failure (mainly in people with predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia)
From the side respiratory system, chest and mediastinal organs		Dyspnea (including asthmatic conditions)
From the gastrointestinal tract	Nausea Vomiting Abdominal pain 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	Dysfunction of the liver (including increased levels lactate dehydrogenase) Increase 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)
From the skin and soft tissues				Bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).
From the side of skeletal-muscular and connective tissue		Arthralgia Myalgia	Tendonitis Increased muscle tone and cramps Muscle weakness	Breaks tendons Arthritis Violation gait due to damage to the musculoskeletal system Gain 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 (as a result of dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing impairment of kidney function)
General disorders and disorders at the injection site	Reactions at the injection / infusion site	General malaise Nonspecific pain Sweating Phlebitis / thrombophlebitis at the site of infusion.	Edema

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

- often - increased activity of gamma-glutamyl transferase;

- 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:

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, it is necessary to focus on the clinical picture to 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 supplements, 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 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 joint 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 and other);

- tricyclic antidepressants;

- antimicrobials (sparfloxacin, erythromycin (intravenously), pentamidine, antimalarial drugs, especially halofantrine);

- antihistamines (terfenadine, astemizole, misolastine);

- neuroleptics (phenothiazine, pimozide, sertindole, haloperidol, sultopride, etc.);

- others (cisapride, wincamine (intravenously), 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 plasma can be significantly lower than desired. In this regard, antacid, antiretroviral drugs (for example, didanosine) and other preparations containing magnesium and aluminum, sucralfate and other preparations containing iron and 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 MNO and, if necessary, adjust the dose of indirect anticoagulants.

Digoxin

Moxifloxacin and digoxin do not have a significant impact on pharmacokinetic parameters of each other. When repeated doses of moxifloxacin were used, 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 systemic bioavailability of the drug is reduced by more than 80% as a result of inhibition of its absorption. In the case of an overdose, the use of activated carbon at an early stage of absorption inhibits further increase in systemic exposure.

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, drug treatment Moxifloxacin should stop 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 an increase in the concentration of moxifloxacin, 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 the lengthening of the 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").

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 taking the drug 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 with moxifloxacin.

When moxifloxacin was administered, 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 It should be used with caution in patients with CNS diseases and with CNS disorders that predispose to seizures or reduce 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 kept in mind in patients who have 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 the drug in the form of tablets for oral administration 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 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 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 an 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, except when 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).

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 moxifloxin therapy, disglycemia 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 mellitus, careful monitoring of the concentration of glucose in the blood is recommended (see section "Side effect").

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:

Film coated tablets 400 mg.

Packaging:

5, 7, 10 tablets into a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

5, 7, 10, 14, 21, 30, 50 tablets in a polymer can of polypropylene, low pressure polyethylene. Each jar, 1, 2, 3, 4, 5 contour squares with instruction for use is placed in a pack of cardboard.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003564

Date of registration:13.04.2016 / 06.02.2018

Expiration Date:13.04.2021

The owner of the registration certificate:VELFARM, LLC VELFARM, LLC Republic of San Marino

Manufacturer: & nbsp

VELFARM, LLC Russia

Information update date: & nbsp12.06.2018

Illustrated instructions

Instructions

Moxifloxacin (Moxifloxacine)