Universal reference book for medicines
Product name: AVELOX ® (AVELOX ® )

Active substance: moxifloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: BAYER PHARMA (Germany)
Composition, form of production and packaging
The tablets covered with a film cover of
pink color, matte, oblong, biconcave, with a facet, with engraving "BAYER" on one side and "M400" on the other.

1 tab.

moxifloxacin hydrochloride 436.8 mg,

which corresponds to the content of moxifloxacin 400 mg

Excipients: microcrystalline cellulose - 136 mg, croscarmellose sodium - 32 mg, lactose monohydrate - 68 mg, magnesium stearate - 6 mg.

The composition of the film shell: hypromellose - 9-12.6 mg, iron dye red oxide - 300-420 mcg, macrogol 4000 - 3-4.2 mg, titanium dioxide - 2.7-3.78 mg.

5 pieces.
- blisters (1) - packs of cardboard.
5 pieces.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Antibacterial bactericide of a wide spectrum of action, 8-methoxyfluoroquinolone.
The bactericidal effect of moxifloxacin is due to 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 concentration of the drug as a whole is comparable to its MIC.

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 in concentrations below MIC are accompanied by only a slight increase. 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 bacteria resistant to beta-lactam and macrolide antibiotics.

Influence on human intestinal microflora

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

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

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 cefalosporins (eg cefuroxime) , macrolides, tetracyclines, trimethoprim / sulfamethoxazole

Streptococcus pyogenes (group A) *

The group 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 dysagalactiae

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

Coagulase-negative Staphylococcus spp.
(S. cohnii, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. simulans), methicillin-sensitive strains Coagulase-negative Staphylococcus spp. (S. cohnii, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. simulans), methicillin-resistant strains
Enterococcus faecalis * (strains sensitive to vancomycin and gentamicin only)

Enterococcus avium *

Enterococcus faecicum *

Gram-negative

Haemophilus influenzae (including strains producing and non-producing α-lactamases) *

Haemophillus parainfluenzae *

Moraxella catarrhalis (including strains producing and non-producing α-lactamases) *

Bordetella pertussis

Legionella pneumophila Escherichia coli *

Acinetobacter baumanii Klebsiella pneumoniae *

Klebsiella oxytoca

Citrobacter freundii *

Enterobacter spp.
(E. aerogenes, E. intermedius, 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. 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 burnettii

* sensitivity to moxifloxacin is confirmed by clinical data.

** Avelox ® is not recommended for the treatment of infections caused by methicillin-resistant Staphylococcus aureus strains (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.
In this regard, when testing the sensitivity of a strain, it is desirable to have local information on resistance, especially when treating severe infections.
If the AUC / MIK 90 value exceeds 125 in patients undergoing inpatient treatment and the C max / MIC 90 is within the range of 8-10, this implies a clinical improvement.
In outpatients, the values ​​of these surrogate parameters are usually less: AUC / MIC 90 > 30-40.
Parameter (average value) AUIC * (h) C max / MIC 90

MIC 90 0.125 mg / l 279 23.6

MIC 90 0.25 mg / l 140 11.8

MIC 90 0.5 mg / l 70 5.9

* AUIC is the area under the inhibitory curve (AUC / MIC ratio 90 ).

PHARMACOKINETICS

Suction

After oral administration, moxifloxacin is absorbed quickly and almost completely.
Absolute bioavailability is about 91%.
The pharmacokinetics of moxifloxacin when taken in a dose of 50 to 1200 mg once, and also at 600 mg / day for 10 days is linear.

After a single dose of moxifloxacin 400 mg C max in the blood is reached within 0.5-4 h and is 3.1 mg / l.
After oral administration of moxifloxacin at a dose of 400 mg 1 time / day, C ss max and C ss 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 (by 2 h) and a slight decrease in C max (by approximately 16%), while the duration of absorption does not change.
However, these data have no clinical significance, and the drug can be used regardless of food intake.
Distribution

The equilibrium state is reached within 3 days.
Binding to blood proteins (mainly with albumins) is about 45%. Moxifloxacin is rapidly distributed in organs and tissues. V d is approximately 2 l / kg.
High concentrations of moxifloxacin, exceeding those in plasma, are created in the lung tissue (including in the epithelial fluid, alveolar macrophages), in the nasal sinuses (maxillary and ethmoid sinuses), in nasal polyps, inflammation foci (in the contents of blisters in the lesions of the skin ).
In the interstitial fluid and saliva, moxifloxacin is determined in a free, non-protein-binding form at a concentration higher than in plasma. In addition, high concentrations of moxifloxacin are found in the tissues of the abdominal cavity, peritoneal fluid, and also in the tissues of the 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 is not biotransformed with the cytochrome P450 microsomal system. 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

T 1/2 is approximately 12 hours. The average total clearance after taking the drug inside at 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 specific patient groups

When studying the pharmacokinetics of moxifloxacin in men and women, differences in 33% were found for AUC and C max .
Absorption of moxifloxacin did not depend on sex. Differences in AUC and C max were due to differences in body 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.

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

There were no significant changes in the pharmacokinetics of moxifloxacin in patients with impaired renal function (including CC <30 mL / min / 1.73 m 2 ) and in patients undergoing continuous hemodialysis and long-term outpatient peritoneal dialysis.

There was no significant difference in moxifloxacin concentration 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 in adults caused by microorganisms sensitive to the preparation:

- Acute sinusitis;

- exacerbation of chronic bronchitis;

- community-acquired pneumonia (including caused by strains of microorganisms with multiple resistance to antibiotics *);

- uncomplicated skin and soft tissue infections;

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

- Complicated intra-abdominal infections, including polymicrobial infections, incl.
intraperitoneal abscesses;
- uncomplicated inflammatory diseases of the pelvic organs (including salpingitis and endometritis).

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

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

DOSING MODE

The drug is administered orally 400 mg 1 time / day.
Tablets should be taken without chewing, squeezed with enough water, regardless of food intake. Do not exceed the recommended dose.
The duration of treatment with Avelox at ingestion is determined by the severity of the infection and the clinical effect and is: with exacerbation of chronic bronchitis - 5-10 days;
with community-acquired pneumonia, the total duration of the stepwise therapy (intravenous administration followed by oral administration) is 7-14 days, first IV, then inside, or 10 days inside; with acute sinusitis and uncomplicated skin and soft tissue infections - 7 days; with complicated infections of the skin and subcutaneous tissues, thetotal duration of stepwise therapy (intravenous administration followed by oral administration) is 7-21 days; with complicated intra-abdominal infections, the total duration of the stepwise therapy (IV injection of the drug with subsequent ingestion) is 5-14 days; with uncomplicated inflammatory diseases of the pelvic organs - 14 days.
The duration of treatment with Avelox can reach 21 days.

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

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

Patients with impaired hepatic function are not required to change the dosage regimen.

In patients with impaired renal function (including severe renal insufficiency with QC-30 ml / min / 1.73 m 2 ), as well as in patients under continuous hemodialysis and long-term outpatient peritoneal dialysis, changes in the dosing regimen are not required .

Patients of different ethnic groups do not need to change the dosage regimen.

SIDE EFFECT

Data on adverse reactions recorded with the use of moxifloxacin at a dose of 400 mg (by mouth, with stepwise therapy [intravenous administration and subsequent oral administration] and only IV) are obtained from clinical studies and post-marketing reports ( italicized ).
Adverse reactions listed in the "often" group occurred at a frequency below 3%, with the exception of nausea and diarrhea.
In each frequency group, undesirable drug reactions are listed in order of decreasing significance.
Determination of the incidence of adverse reactions: 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).
Infections: often - fungal superinfections.

On the part of the hematopoiesis system: infrequently - anemia, leukopenia, neutropenia, thrombocytopenia, thrombocythemia, prothrombin time lengthening / increase INR;rarely - change in the concentration of thromboplastin;
very rarely - an increase in the concentration of prothrombin / decrease INR.
From the immune system: infrequently - allergic reactions, hives, itching, rash, eosinophilia;
rarely anaphylactic / anaphylactoid reactions, angioedema, including laryngeal edema (potentially life-threatening); very rarely - anaphylactic / anaphylactoid shock (including potentially life-threatening).
From the side of metabolism: infrequently - hyperlipidemia;
rarely hyperglycemia, hyperuricemia; very rarely - hypoglycemia.
Mental disorders: infrequent - anxiety, psychomotor hyperreactivity, agitation;
rarely - emotional lability, depression ( in very rare cases, behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts ), hallucinations; very rarely - depersonalization, psychotic reactions ( potentially manifested in behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts ).
From the nervous system: often - dizziness, headache;
infrequently - paresthesia, dysesthesia, a violation of taste sensitivity (including very rare cases of agevia), confusion, disorientation, sleep disorders, tremor, vertigo, drowsiness; rarely - hypoesthesia, impaired sense of smell (including anosmia), atypical dreams, impaired coordination (including gait disturbances due to dizziness or vertigo, very rarely leading to trauma from falling, especially in elderly patients ) , seizures with different clinical manifestations (in t "grand mal" seizures), attention disorders, speech disorders, amnesia, peripheral neuropathy, polyneuropathy; very rarely hyperesthesia.
From the side of the organ of vision: infrequently - visual impairment (especially with CNS reactions);
very rarely - a transient loss of vision (especially with reactions from the central nervous system).
From the side of the hearing organ: rarely - noise in the ears, hearing impairment, including deafness (usually reversible).

From the cardiovascular system: often - prolongation of the QT interval in patients with concomitant hypokalemia;
infrequent - prolongation of QT interval, palpitation, tachycardia, vasodilation; rarely - increased blood pressure, lower blood pressure, fainting, ventricular tachyarrhythmias; very rarely - nonspecific arrhythmias, polymorphic ventricular tachycardia (such as pirouettes), cardiac arrest (mainly in persons with predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia).
From the respiratory system: infrequently - shortness of breath, including asthmatic condition.

On the part of the digestive system: often - nausea, vomiting, abdominal pain, diarrhea;
infrequent - reduced appetite and reduced food intake, constipation, dyspepsia, flatulence, gastroenteritis (other than erosive gastroenteritis), increased amylase activity; rarely - dysphagia, stomatitis, pseudomembranous colitis (in very rare cases associated with life-threatening complications).
From the liver and biliary tract: often - increased activity of liver transaminases;
infrequently - violations of liver function (including increased LDH activity), increased bilirubin concentration, increased activity of GGT and APF; rarely - jaundice, hepatitis (mostly cholestatic); very rarely - fulminant hepatitis, potentially leading to life-threatening liver failure (including fatal cases).
For the skin: very rarely - bullous cutaneous reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).
On the part of the musculoskeletal system: rarely - arthralgia, myalgia; rarely - tendinitis, increased muscle tone and seizures, muscle weakness; very rarely - arthritis, tendon rupture, gait disturbance due to deterioration of the musculoskeletal system, enhancing the symptoms of myasthenia gravis.
From the urinary system: infrequently - dehydration (caused by a decrease in diarrhea or fluid receiving); rarely - renal dysfunction, renal failure due to dehydration, which may lead to kidney damage, especially in elderly patients with preexisting renal dysfunction).
From the body as a whole: often - the reaction at the injection / infusion; infrequently - malaise, non-specific pain, sweating.
The frequency of these adverse events was higher in the group receiving treatment step:often - increasing the activity of GGT; infrequently - ventricular tachyarrhythmias, hypotension, edema, pseudomembranous colitis (very rarely associated with life-threatening complications), seizures with different clinical manifestations (including "grand mal" seizure), hallucinations, impaired renal function, renal failure (due to dehydration, which may lead to kidney damage, especially in elderly patients with preexisting renal dysfunction).
CONTRAINDICATIONS

- a history of tendon pathology, which developed as a result of treatment with antibiotics of the quinolone series;
- in pre-clinical and clinical studies were observed after administration of moxifloxacin change of electrophysiological parameters of the heart, expressed in the extension of the QT interval. In this regard, the use of moxifloxacin contraindicated in patients following categories: acquired or congenital documented elongation interval QT, electrolyte abnormalities, particularly hypokalemia uncorrected; clinically significant bradycardia; clinically significant heart failure with reduced left ventricular ejection fraction; a history of arrhythmias, accompanied by clinical symptoms;
- Moxifloxacin should not be used with other drugs that prolong the QT interval;
- due to the presence of lactose preparation, its reception is contraindicated in congenital lactose intolerance, lactase deficiency, glucose-galactose malabsorption (for tablets);
- due to the limited amount of clinical data moxifloxacin use is contraindicated in patients with impaired liver function (class C Child-Pugh classification) and patients with elevated transaminase more than 5 times the ULN;
- Pregnancy;

- lactation (breastfeeding);

- age up to 18 years;

- Hypersensitivity to moxifloxacin, other quinolones or to any other component of the drug.
With caution should be prescribed for diseases of the central nervous system (including for diseases that are suspicious regarding CNS involvement) predisposing to seizures and lowering seizure threshold; in patients with psychosis and / or a history of psychiatric disease; in patients with potentially proarrhythmic conditions, such as acute myocardial ischemia and heart failure, particularly in women and elderly patients; with myasthenia gravis; liver cirrhosis; while reception with drugs to lower the potassium content; in patients with a genetic predisposition or actual deficiency of glucose-6-phosphate dehydrogenase.
PREGNANCY AND LACTATION

Safety of application of moxifloxacin during pregnancy has not been established and its use is contraindicated. Cases of reversible damage to the joints in children receiving some quinolones, however, no reports of the manifestation of this effect in the fetus (when using the mother during pregnancy).
In animal studies, reproductive toxicity was shown. The potential risk for humans is unknown.
As with other quinolones, moxifloxacin causes damage to the cartilage of large joints in premature animals. Preclinical studies have shown that small amounts of moxifloxacin is excreted in breast milk. Data on its use in women during lactation are not available. Therefore, the appointment of moxifloxacin during breast feeding is contraindicated.
APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with impaired renal function (including the clearance <30 mL / min / 1.73 m 2 ), as well as patients undergoing hemodialysis and continuous ambulatory peritoneal dialysis prolonged, the dosing regime changes are needed.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Patients with impaired liver function changes in dosage regimen is required.
With caution should be used drug in liver cirrhosis.
APPLICATION FOR CHILDREN

Contraindicated: children and teens under 18 years old .
APPLICATION IN ELDERLY PATIENTS

Elderly patients dosing regimen change is required.
SPECIAL INSTRUCTIONS

In some cases, after the first use of the drug may develop hypersensitivity and allergic reactions, as should inform your doctor immediately. Very rarely, even after the first use of the drug anaphylactic reactions may progress to life-threatening anaphylactic shock. In these cases, treatment with Avelox ® should be discontinued immediately and begin to carry out the necessary remedial measures (including anti-shock).
In applying the drug Aveloks ® some patients may experience an elongation interval QT.
Avelox ®should be used with caution in women and elderly patients. Since women than men have the QT interval is longer, they may be more sensitive to the drug, prolongs the QT interval. Elderly patients are also more exposed to drugs affecting the QT interval.
The degree of lengthening QT interval may increase with increasing concentration of the drug, however, do not exceed the recommended dose. QT prolongation is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. However, in patients with pneumonia correlation between plasma concentrations of moxifloxacin and QT prolongation have been reported. None of the 9000 patients treated Aveloks ®, There was no cardiovascular complications and deaths associated with prolongation of the QT interval.
In applying the drug Aveloks ® may increase the risk of ventricular arrhythmias in patients with predisposing conditions to arrhythmias. Therefore Aveloks ® is contraindicated in:
- changes in the electrophysiological parameters of the heart, expressed in lengthening QT interval (congenital or acquired documented elongations QT interval, electrolyte disturbances, particularly uncorrected hypokalemia, clinically significant bradycardia, clinically significant heart failure with left ventricular ejection fraction lowering , a history indication rhythm disturbances, accompanied by clinical symptoms);
- use of other drugs that prolong the QT interval.
Avelox ® should be used with caution:
- in patients with potentially proarrhythmic conditions, such as acute myocardial ischemia;
- in patients with liver cirrhosis (since it is impossible to eliminate the risk of QT interval prolongation in these patients).
Before the drug Aveloks ® reported cases of fulminant hepatitis, potentially leading to the development of liver failure (including fatal cases). Patients should be informed that in case of the onset of symptoms of liver failure should consult a doctor before continuing treatment with Avelox ® .
When receiving the preparation Aveloks ® reported cases of bullous lesions of the skin (such as Stevens-Johnson syndrome or toxic epidermal necrolysis). Patients should be informed that in case of the onset of symptoms of skin lesions or mucous membranes, seek medical advice before continuing treatment with Avelox ® .
The use of drugs of the quinolone series associated with a possible risk of seizures. Aveloks ® should be used with caution in patients with CNS diseases and disorders of the CNS, predisposing to occurrence of seizures or lowering the threshold for seizure activity.
Application of antibacterial drugs broad-spectrum, including Aveloks ®, Carries a risk of pseudomembranous colitis. This diagnosis should be borne in mind in patients on background treatment with Avelox ® developed severe diarrhea. In this case immediately to assign appropriate therapy. Drugs that inhibit peristalsis are contraindicated in the development of severe diarrhea.
Aveloks ® should be used with caution in patients with myasthenia the possible exacerbation of disease.
Against the background of quinolone therapy including moxifloxacin, may develop tendinitis and tendon rupture, particularly in elderly and in patients receiving corticosteroids. There are cases that occurred within a few months after completing treatment. At the first sign of pain or inflammation at the site of injury should stop taking the drug and to relieve the affected limb.
In applying quinolones marked photosensitivity reactions. However, during the pre-clinical and clinical studies and also in applying Aveloks preparation ® in practice not observed photosensitivity reactions. However, patients taking Avelox ® , should avoid direct sunlight and UV radiation.
Use of the drug in tablet form for oral administration is not recommended for patients with complicated inflammatory diseases of the pelvic organs (e.g., associated with or pelvic tubo-ovarian abscess).
Moxifloxacin is not recommended for the treatment of infections caused by strains of Staphylococcus aureus, methicillin-resistant (MRSA). In case of suspected or confirmed infections caused by MRSA, treatment should assign appropriate antibacterial agents.
The ability of drug Aveloks ®inhibit mycobacterial growth may cause interaction in vitro test of moxifloxacin with Mycobacterium spp., leading to false negative results when analyzing patient samples, which in this period is the treatment drug Aveloks ® .
In patients who underwent treatment quinolones, including drug Aveloks ® , described cases sensory or sensorimotor polyneuropathy resulting in paresthesia, hypoesthesia, dysesthesia or weakness. Patients undergoing treatment with Avelox ® , should be warned about the need for immediate treatment to the doctor before continuing treatment in the event of symptoms of neuropathy, including pain, burning, tingling, numbness or weakness.
Reaction from the psyche may occur even after the first administration of quinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions to progress of suicidal thoughts and behavior with a tendency to self-harm, including suicide attempts. In the case of patients of such reactions should be discontinued medication Avelox® and take necessary measures. Caution must be exercised when administering the drug Aveloks ® patients with psychosis and / or psychiatric diseases in history.
Because of widespread and increasing incidence of infections caused by fluoroquinolone-resistant Neisseria gonorrhoeae in the treatment of patients with inflammatory diseases of the pelvic organs should not be spending moxifloxacin monotherapy, except in cases where the presence of fluoroquinolone-resistant N. gonorrhoeae is possible. If you can not exclude the presence of fluoroquinolone-resistant N. gonorrhoeae, it is necessary to solve the question of supplementing the empirical treatment with an appropriate antibiotic moxifloxacin, which is active against N. gonorrhoeae (eg a cephalosporin).
As is the case with other fluoroquinolones, when applying Aveloks preparation ®mentioned change in the concentration of glucose in the blood, including hypo- and hyperglycemia. The therapy drug Aveloks ® dysglycemia occurred predominantly in elderly diabetic patients receiving concomitant therapy with oral hypoglycemic agents (e.g., sulfonylureas) or with insulin. In conducting the treatment in patients with diabetes mellitus recommended careful monitoring of blood glucose concentration.
Impact on the ability to drive vehicles and manage mechanisms

Fluoroquinolones, including moxifloxacin, can disrupt the ability of patients to drive and engage in other potentially hazardous activities that require increased attention and psychomotor speed reactions, because of the effect on the central nervous system and vision disturbances.
OVERDOSE

There are limited data on overdose of moxifloxacin. Not observed any side effects when applied Aveloks at a dose of 1200 mg once and 600 mg for 10 days or more.
Treatment: In case of overdose according to the clinical situation, symptomatic and supportive therapy with ECG monitoring.
The use of activated charcoal immediately after oral administration of the drug can help prevent excessive systemic exposure of moxifloxacin in cases of overdose.
DRUG INTERACTION

No dose adjustment is required in the combined use of the drug Aveloks ® atenolol, ranitidine, calcium-containing additives, theophylline, cyclosporin, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid (Confirmed the absence of clinically significant interactions with moxifloxacin).
It will be appreciated the possible additive effect of QT interval elongation of moxifloxacin and other preparations, which influence the lengthening of the interval QT. Due to the joint application of moxifloxacin and drugs affecting the lengthening of the interval QT, it increases the risk of ventricular arrhythmias, including ventricular tachycardia, a polymorphic type "pirouette". contraindicated joint

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