Авелокс®

General characteristics. Structure:

Active ingredient of a moksifloksatsin a hydrochloride of 0,436 g, is equivalent to 0,400 g of a moksifloksatsin.
Excipients: sodium chloride (2,00 g), Acidum hydrochloricum 1N (0 - 0,02 g), hydroxide 2N sodium solution (0 - 0,05 g), water for injections (248,659 - 248,664 g).
Description: transparent solution of color, yellow or yellow with a greenish shade, /

Pharmacological properties:

Pharmacokinetics.

Absorption and bioavailability. At oral administration it is soaked up quickly and almost completely. Absolute bioavailability makes about 91%.

The pharmacokinetics of a moksifloksatsin at reception in a dose from 50 to 1200 mg once, and also on 600 mg/days within 10 days is linear. The steady condition of parameters is reached within 3 days.

After single purpose of 400 mg of a moksifloksatsin of Cmax in blood it is reached during 0,5–4 h and makes 3,1 mg/l.

At reception together with food insignificant increase in time of achievement of Cmax is noted (on 2 h) and insignificant decrease in Cmax (approximately for 16%), at the same time duration of absorption does not change. However these data have no clinical value, and drug can be used irrespective of meal.

After single infusion in a dose of 400 mg during 1 h Cmax it is reached at the end of infusion and makes about 4,1 mg/l that corresponds to its increase approximately by 26% in comparison with the size of this indicator at administration of drug inside. The drug exposure determined by AUC indicator (the area under a curve concentration time), slightly exceeds that at administration of drug inside. After repeated in/in infusions of drug in a dose of 400 mg lasting 1 h of Cmax varies ranging from 4,1 to 5,9 mg/l. The average stable concentration equal to 4,4 mg/l are reached at the end of infusion.

Distribution. Moxifloxacin is quickly distributed in fabrics and bodies and contacts blood proteins (mainly with albumine) approximately for 45%. The volume of distribution makes about 2 l/kg. The high concentration of drug exceeding those in plasma are created in pulmonary fabric (including in alveolar macrophages), in mucous bronchial tubes, in nasal bosoms, in the inflammation centers (for solution for infusions — in contents of bubbles at damage of skin). In intersticial liquid and in saliva drug is defined in the free, not connected with proteins look, in concentration above, than in plasma. Besides, high concentration of drug are defined in abdominal fabrics and liquids.

Metabolism. Moxifloxacin is exposed to biotransformation of the 2nd phase and is removed from an organism by kidneys, and also with excrements both in not changed look, and in the form of inactive sulpho compounds and glucuronides. Moxifloxacin is not exposed to biotransformation microsomal system of P450 cytochrome.

Removal. T1/2 makes about 12 h. The average general clearance after intake or in/in introductions in a dose of 400 mg makes from 179 to 246 ml/min. About 19% of a single dose (400 mg) at intake (22% — at in introduction) are removed in not changed view with urine, about 25% (26% — at in introduction) — with excrements.

Pharmacokinetics at various groups of patients

Age, sex and ethnic origin. It is not established age, sexual and ethnic clinically significant distinctions in pharmacokinetics of a moksifloksatsin.

Children. The pharmacokinetics of a moksifloksatsin at children was not studied.

Renal failure. Essential changes of pharmacokinetics of a moksifloksatsin at patients with a renal failure (including patients with creatinine Cl <30 ml/min. / 1,73 sq.m) and being on a continuous hemodialysis and long out-patient peritoneal dialysis are not revealed.

Abnormal liver function. At patients with insignificant and moderate abnormal liver functions (a stage And yes In on classification of Chayld-Pyyu) the pharmacokinetics of a moksifloksatsin does not change. For patients with heavy abnormal liver functions (on Chayld-Pyyu a stage C) data on pharmacokinetics there is no moksifloksatsin.

Pharmacodynamics. Bactericidal effect of drug is caused by inhibition of bacterial topoisomerases II and IV which leads to disturbance of biosynthesis of DNA of a microbic cell and, as a result, to death of microbic cells. The minimum bactericidal concentration of drug in general are comparable to its minimum inhibiting concentration.

The mechanisms leading to development of stability to penicillin, cephalosporins, aminoglycosides, macroleads and tetracyclines do not break antibacterial activity of a moksifloksatsin. Cross stability between these groups of antibacterial drugs and moksifloksatsiny is not noted. Still also cases of plasmid stability were not observed. The general frequency of development of stability is very insignificant (10-7–10-10). Resistance to a moksifloksatsin develops slowly, by multiple mutations. Repeated impact of a moksifloksatsin on microorganisms in concentration below the minimum inhibiting concentration (MIC) is followed only by insignificant increase in MIK. Cases of cross resistance to hinolona are noted. Nevertheless, some gram-positive and anaerobic microorganisms, steady against other hinolona, are sensitive to a moksifloksatsin.

In vitro moxifloxacin is active concerning a wide range of gram-negative and gram-positive microorganisms, anaerobe bacterias, acid resisting bacteria and such atypical forms as Mycoplasma, Chlamidia, Legionella. Moxifloxacin is effective concerning bacteria, resistant to β-laktamny and makrolidny antibiotics.

The range of antibacterial activity of a moksifloksatsin includes the following microorganisms:

Gram-positive — Streptococcus pneumoniae (including the strains steady against penicillin and macroleads and strains with multiple resistance to antibiotics) *; Streptococcus pyogenes (group A) *, Streptococcus milleri; Streptococcus mitis; Streptococcus agalactiae *, Streptococcus dysgalactiae, Streptococcus anginosus *, Streptococcus constellatus *, Staphylococcus aureus (including the strains sensitive to Methicillinum) *; Staphylococcus cohnii, Staphylococcus epidermidis (including the strains sensitive to Methicillinum); Staphylococcus haemolyticus; Staphylococcus hominis; Staphylococcus saprophyticus; Staphylococcus simulans; Corynebacterium diphtheriae; Enterococcus faecalis (only strains sensitive to Vancomycinum and gentamycin) *.

Gram-negative — Haemophillus influenzae (including the strains which are producing and not producing β-lactamelements) *, Haemophillus parainfluenzae *; Klebsiella pneumoniae *, Moraxella catarrhalis (including the strains which are producing and not producing β-lactamelements) *; Escherichia coli * Enterobacter cloacae *; Bordetella pertussis; Klebsiella oxytoca, Enterobacter aerogenes; Enterobacter agglomerans; Enterobacter intermedius; Enterobacter sakazaki; Proteus mirabilis *; Proteus vulgaris; Morganella morganii; Providencia rettgeri; Providencia stuartii.

Anaerobe bacterias — Bacteroides distasonis; Bacteroides eggerthii; Bacteroides fragilis *; Bacteroides ovatum; Bacteroides thetaiotaomicron *; Bacteroides uniformis; Fusobacterium spp.; Peptostreptococcus spp. *; Porphyromonas spp.; Porphyromonas anaerobius; Porphyromonas asaccharolyticus; Porphyromonas magnus; Prevotella spp.; Propionibacterium spp.; Clostridium perfringens *; Clostridium ramosum.

Atypical — Chlamydia pneumoniae *; Mycoplasma pneumoniae *; Legionella pneumophila *; Coxiella burnetti.

* — sensitivity to a moksifloksatsin is confirmed with clinical data.

Moxifloxacin is less active concerning Pseudomonas aeruginosa, Pseudomonas fluorescens, Burkholderia cepacia, Stenotrophomonas maltophilia.

Indications to use:

The infectious and inflammatory diseases caused by microorganisms, sensitive to a moksifloksatsin:
• Community-acquired pneumonia, including community-acquired pneumonia which activators are strains of microorganisms with multiple resistance to antibiotics *;
• the complicated infections of skin and soft tissues (including the infected diabetic foot).
• the complicated intraabdominal infections, including polymicrobial infections, including intraperitoneal abscesses.
• Streptococcus pneumoniae with multiple resistance to antibiotics include strains, resistant to penicillin and strains, resistant to two or more antibiotics from such groups as penicillin (at MIK> 2 mkg/ml), generation cephalosporins II (tsefuroksy), macroleads, tetracyclines and Trimethoprimum / sulfamethoxazole. It is necessary to take into account the acting official managements about rules of use of antibacterial agents.

Route of administration and doses:

The recommended mode of dosing of a moksifloksatsin: 400 mg (250 ml of solution for infusions) once a day at the infections stated above. It is not necessary to exceed the recommended dose.
Treatment duration
Duration of treatment is defined by localization and weight of an infection, and also clinical effect. At the initial stages of treatment the drug Aveloks®, solution for infusions, and then, in the presence of indications can be used, drug can be appointed for intake in the form of tablets, film coated.
• Community-acquired pneumonia: the general duration of step therapy (intravenous administration with the subsequent intake) makes 7-14 days;
• The complicated infections of skin and hypodermic structures: the general duration of step therapy moksifloksatsiny (intravenous administration with the subsequent intake) makes 7-21 days;
• The complicated intraabdominal infections: the general duration of step therapy (intravenous administration with the subsequent intake) makes 5-14 days.
It is not necessary to exceed the recommended treatment duration.
According to clinical trials treatment duration the drug Aveloks®, solution for infusions, can reach 21 days.

Patients of advanced age
Change of the mode of dosing is not required from elderly patients. Children
Efficiency and safety of use of a moksifloksatsin for children and teenagers is not established.
The abnormal liver function (a class A and B on classification of Chayld-Pyyu) is not required to Patients with abnormal liver functions of change of the mode of dosing (for use for patients with cirrhosis see the section "Special Instructions"). Renal failure
With a renal failure (including at heavy degree of a renal failure with clearance of creatinine <30 ml/min. / 1,73 sq.m), and also at the patients who are on a continuous hemodialysis and long out-patient peritoneal dialysis, change of the mode of dosing is not required from patients. Use for patsiyentov_razlichny ethnic groups of Change of the mode of dosing is not required. Route of administration
The drug is administered intravenously in the form of infusion lasting not less than 60 minutes both in an undiluted look, and in a combination to the following solutions, compatible to it (with use of the T-shaped adapter):
• water for injections;
• solution of sodium of chloride of 0,9%;
• chloride 1M sodium solution;
• solution of a dextrose of 5%;
• solution of a dextrose of 10%;
• solution of a dextrose of 40%;
• solution of xylitol of 20%;
• Ringer's solution;
• Ringer's solution lactate.
If the drug Aveloks®, solution for infusions, is appointed together with other drugs, then each drug should be administered separately.
Drug Aveloks® solution mix with the stated above infusion solutions remains stable within 24 hours at the room temperature. As solution cannot be frozen or cooled, it cannot be stored in the refrigerator. When cooling the deposit which is dissolved at the room temperature can drop out. Solution has to be stored in production packaging. It is necessary to apply only transparent solution /

Features of use:

In certain cases after the first use of drug hypersensitivity and allergic reactions can develop what it is necessary to inform the doctor immediately on. Very seldom even after the first use of drug anaphylactic reactions can progress to a life-threatening acute anaphylaxis. In these cases treatment by the drug Aveloks® should be stopped and to immediately begin to hold necessary medical events (including antishock).
At use of the drug Aveloks® for some patients lengthening of an interval of QT can be noted. As women in comparison with men have longer interval of QT, they can be more sensitive to the drugs extending QT interval. Elderly patients are also more subject to effect of the drugs exerting impact on QT interval.
Extent of lengthening of an interval of QT can accrue with increase in concentration of drug therefore it is not necessary to exceed the recommended dose and speed of infusion (400 mg within 60 min.). However patients with pneumonia have correlations between concentration of a moksifloksatsin in a blood plasma and lengthening of an interval of QT did not note. Lengthening of an interval of QT is accompanied by the increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. At one of 9000 patients receiving the drug Aveloks® the cardiovascular complications and lethal cases connected with lengthening of an interval of QT were not noted. At use of the drug Aveloks® the risk of development of ventricular arrhythmias in patients with the states contributing to arrhythmias can increase. In this regard drug is contraindicated at:
• changes of the electrophysiologic parameters of heart which are expressed in lengthening of an interval of QT: the inborn or acquired documentary lengthenings of an interval of QT, electrolytic disturbances, especially not adjusted hypopotassemia; clinically significant bradycardia; clinically significant heart failure with reduced fraction of emission of a left ventricle; in the presence in the anamnesis of the disturbances of a rhythm which were followed by clinical symptomatology;
• use with other drugs extending QT interval (see the section "Interaction with Other Medicines").

At administration of drug of Aveloks® it was reported about cases of the fulminantny hepatitis which is potentially leading to development of a liver failure (including fatal cases) (see the section "Side effect"). The patient should be informed that in case of symptoms of a liver failure it is necessary to see a doctor before continuing treatment by the drug Aveloks®.
At administration of drug of Aveloks® it was reported about cases of development of violent damages of skin, such as Stephens-Johnson's syndrome or toxic epidermal necrolysis. The patient should be informed that in case of symptoms of damage of skin or mucous membranes it is necessary to see a doctor before continuing treatment by the drug Aveloks®.
Use of drugs of a hinolonovy row is accompanied by possible risk of development of spasms. The drug Aveloks® should be used with care at patients with diseases of TsNS and with the disturbances from TsNS contributing to developing of spasms or reducing a threshold of convulsive activity. Use of antibacterial drugs of a broad spectrum of activity, including the drug Aveloks®, is accompanied by risk of development of pseudomembranous colitis. This diagnosis should be meant at patients at whom against the background of treatment by the drug Aveloks® heavy diarrhea developed. In this case the corresponding therapy has to be immediately appointed. The drugs oppressing an intestines peristaltics are contraindicated at development of heavy diarrhea.
The drug Aveloks® should be used with care at patients with gravis myasthenia in connection with a possible exacerbation of a disease.
Against the background of therapy of a hinolonama, including moksifloksatsiny, development of a tendinitis and rupture of a sinew, especially at elderly and the patients receiving glucocorticosteroids is possible. Cases which arose within several months after completion of treatment are described. At the first symptoms of pain or an inflammation in the place of damage administration of drug it is necessary to stop and unload the affected extremity. At use of hinolon photosensitivity reactions are noted. However when performing preclinical and clinical trials, and also at drug Aveloks® use photosensitivity reactions in practice were not noted. Nevertheless, the patients receiving the drug Aveloks® have to avoid influence of direct sunshine and ultra-violet light.
It is not recommended to use moxifloxacin for treatment of the infections caused by Staphylococcus aureus strains, resistant to Methicillinum (MRSA). In case of the assumed or confirmed infections caused by MRSA it is necessary to appoint treatment the corresponding antibacterial drugs (see the section "Pharmacodynamics").
Ability of a moksifloksatsin suppress growth of mycobacteria can become the reason of interaction of in vitro of a moksifloksatsin with the test for Mycobacterium spp., resulting in false-negative results in the analysis of samples of patients which to this period carries out treatment by the drug Aveloks®.
At patients to whom treatment of a hinolonama was carried out including Aveloks®, cases of the touch or sensomotor polyneuropathy leading to paresthesias, gipoesteziya, dizesteziya or weakness are described. Patients to whom treatment is carried out by the drug Aveloks® should be warned about need of the immediate address to the doctor before continuation of treatment in case of the symptoms of neuropathy including pain, burning, a pricking, numbness or weakness (see the section "Side effect").
Reactions from mentality can arise even after the first purpose of ftorkhinolon, including moxifloxacin. Seldom or never the depression or psychotic reactions progress before emergence of suicide thoughts and behavior with a tendency to self-damage, including suicide attempts (see the section "Side effect"). In case of development in patients of such reactions it is necessary to cancel the drug Aveloks® and to take necessary measures. It is necessary to be careful at purpose of the drug Aveloks® the patient with psychoses and the patient with psychiatric diseases in the anamnesis.
Because of wide circulation and the growing incidence of the infections caused resistant to Neisseria gonorrhoeae ftorkhinolona at treatment of patients with inflammatory diseases of bodies of a small pelvis it is not necessary to carry out monotherapy moksifloksatsiny, except for cases when presence of N. gonorrhoeae, resistant to ftorkhinolona, is excluded. If there is no opportunity to exclude presence of N. gonorrhoeae, resistant to ftorkhinolona, it is necessary to resolve an issue of addition of empirical therapy moksifloksatsiny by the corresponding antibiotic which is active concerning N. gonorrhoeae (for example, cephalosporin).
The patients keeping to a diet with the lowered content of salt (at heart failure, a renal failure, at a nephrotic syndrome) have to consider that solution for infusions contains sodium chloride. The daily dose of sodium in drug makes 34 mmol.
Influence on ability to drive the car and moving mechanisms
Ftorkhinolona, including moxifloxacin, can break ability of patients to drive  the car  and  to be engaged  in other    potentially dangerous  types of activity requiring special attention and speed of psychomotor reactions owing to influence on TsNS and vision disorders.

Side effects:

Data on side effects of drug moxifloxacin at a dose of 400 mg (at intake and step therapy) are received from clinical trials (n=11,464, including n=2,239 — at step therapy moksifloksatsiny, as of December, 2004). Side effects, according to post-marketing messages (as of December, 2004), are italicized.

With a frequency of development of 1% <10% (frequency of development of all side effects in this subgroup, except nausea and diarrhea — <3 %).

Cardiovascular system: lengthening of an interval of QT at patients with the accompanying hypopotassemia.

Alimentary system: abdominal pains, nausea, diarrhea, vomiting, dyspepsia symptoms, passing increase in level of transaminases.

Nervous system: dizziness, headache.

Infectious complications: candidosis superinfection, including stomatitis, a vaginitis.

Local symptoms (for infusion solution): reactions in the field of an injection (hypostasis, an inflammation, pain, allergic symptoms).

With a frequency of development of ≥0,1% <1%

Organism in general: an adynamy, a febricula, a hyperhidrosis, dehydration (caused by diarrhea or reduction of reception of liquid).

Allergic reactions: urticaria, itch, rash.

Cardiovascular system: cardiopalmus, lengthening of an interval of QT, nonspecific arrhythmias.

Alimentary system: a meteorism, a lock, lack of appetite, dyspepsia, a gastroenteritis, increase in GGTP (gamma глутамил - transpeptidases), amylases, bilirubin, a tranzitorny abnormal liver function with increase in LDG (lactate dehydrogenase), tranzitorny increase in ShchF serum.

Blood and lymphatic system: anemia, leukopenia, thrombocytosis, eosinophilia, thrombocytopenia.

Musculoskeletal system: arthralgia, mialgiya.

Nervous system: disorder of consciousness (confusion, disorientation), sleeplessness, dizziness, drowsiness, feeling of alarm, tremor, paresthesias / дизестезии, increase in psychomotor activity.

Sense bodys: disorder of taste, a visual disturbance — an illegibility, decrease in visual acuity, a diplopia (especially in combination with dizziness and confusion).

Respiratory system: an asthma (including an asthmatic state).

Metabolism: lipidemia.

Local symptoms (for infusion solution): phlebitis/thrombophlebitis.

With a frequency of development of ≥0,01% <0,1%

Organism in general: pains in the field of a basin, puffiness of the person, a dorsodynia, change of laboratory tests, onychalgias.

Allergic/anaphylactic reactions: anaphylactic/anaphylactoid reactions, Quincke's diseases, including a face edema, throats (potentially life-threatening).

Cardiovascular system: ventricular tachyarrhythmias, hypotension, hypertensia, a faint, a vazodilatation (rushes of blood to the person).

Alimentary system: a dysphagy, pseudomembranous colitis (in rare instances associated with life-threatening complications), jaundice, hepatitis (preferential cholestatic).

Blood and lymphatic system: change of level of thromboplastin, lengthening PV/increase in MNO.

Metabolism: hyperglycemia, hyperuricemia.

Musculoskeletal system: tendinitis, myotonia.

Nervous system: pathological dreams, a lack of coordination (including the disorder of walking as a result of dizziness seldom or never leading to injuries as a result of falling, especially at elderly patients), convulsive attacks with various clinical manifestations (including "grand mal" attacks), disturbance of attention, an alalia, amnesia, emotional lability, hallucinations, a depression (the behavior with a tendency to self-damage is seldom or never possible), a hypesthesia.

Sense bodys: a sonitus, disturbance of sense of smell, including an anosmia.

Urinogenital system: a renal failure as a result of dehydration that can lead to injury of kidneys, especially at elderly patients with the accompanying renal failures.

With a development frequency <0,01%

Allergic reactions: acute/anaphylactoid anaphylaxis (including life-threatening).

Musculoskeletal system: ruptures of sinews, arthritises, disorder of gait owing to damage of a musculoskeletal system.

Integuments: Stephens-Johnson's syndrome.

Nervous system: the hyperesthesia, depersonalization, psychotic reactions (which are potentially shown in behavior with a tendency to self-damage).

Cardiovascular system: polymorphic ventricular tachycardia (Torsade de Pointes), a cardiac standstill, it is preferential at persons with such states as clinically significant bradycardia, acute ischemia of a myocardium contributing to arrhythmias.

Blood and lymphatic system: change of level of a prothrombin and MNO.

Frequency of development of the following side effects at use of step therapy moksifloksatsiny (at in administration of drug with the subsequent intake) is higher, than at administration of drug inside: increase in level gamma глютамил - transpeptidases, a ventricular tachyarrhythmia, hypotension, a vazodilatation, pseudomembranous colitis (in rare instances associated with the complications menacing for life), convulsive attacks with various clinical manifestations (including "grand mal" attacks), hallucinations, a renal failure as a result of dehydration that can lead to injury of kidneys, especially at elderly patients with the accompanying renal failures.

Interaction with other medicines:

At combined use with atenololy, ranitidine, kaltsiysoderzhashchy additives, theophylline, peroral contraceptive means, Glibenclamidum, itrakonazoly, digoxin, morphine, probenetsidy (lack of clinically significant interaction with moksifloksatsiny is confirmed) correction of a dose is not required.
The drugs extending QT interval
It is necessary to consider possible additive effect of lengthening of an interval of QT of a moksifloksatsin and other drugs which influence lengthening of an interval of QT. Owing to the combined use of a moksifloksatsin and drugs influencing lengthening of an interval of QT the risk of development of ventricular arrhythmia, including polymorphic ventricular tachycardia (torsade de pointes) increases.
Contraindicated combined use of a moksifloksatsin with the following drugs influencing lengthening of an interval of QT:
• antiarrhytmic drugs of the class IA (quinidine, hydroquinidine, Disopyramidum, etc.);
• antiarrhytmic drugs of a class III (Amiodaronum, соталол, дофетилид, ибутилид and
other);
• neuroleptics (фенотиазин, Pimozidum, сертиндол, haloperidol, сультоприд, etc.);
• tricyclic antidepressants;
•    germicides   (спарфлоксацин,   erythromycin IV,    pentamidine, antimalarial drugs, especially галофантрин);
• antihistaminic drugs (терфенадин, астемизол, мизоластин);
• others (цизаприд, Vincaminum of IV, bepridit, difemanit). Warfarin
At the combined use with warfarin the prothrombin time and other parameters of a blood coagulation do not change.
MNO value change. At the patients receiving anticoagulants in combination with antibiotics including with moksifloksatsiny, cases of increase in anti-coagulative activity of anticoagulative drugs are noted. Risk factors are existence of an infectious disease (and the accompanying inflammatory process), the age and the general condition of the patient. In spite of the fact that interaction between moksifloksatsiny and warfarin is not revealed, at the patients receiving the combined treatment by these drugs it is necessary to carry out monitoring of MNO and if necessary to adjust a dose of indirect anticoagulants. Digoxin
Moxifloxacin and digoxin has no significant effect on pharmacokinetic parameters of each other. At purpose of repeated doses of a moksifloksatsin the maximum concentration of digoxin increased approximately by 30%, at the same time value of the area under a curve "concentration - time" (AUC) and the minimum concentration of digoxin did not change. Absorbent carbon
At intravenous administration of a moksifloksatsin with concomitant oral administration of absorbent carbon system bioavailability of drug slightly decreases (approximately by 20%) owing to adsorption of a moksifloksatsin in a digestive tract gleam in the course of enterogepatichesky recirculation. Dairy products and meal
Absorption of a moksifloksatsin does not change at a concomitant use of food (including dairy products). Moxifloxacin can be accepted irrespective of meal. Incompatibility
It is impossible to enter infusion solution of a moksifloksatsin along with others solutions, incompatible with it, which treat:
• Solution of sodium of chloride of 10%;
• Solution of sodium of chloride of 20%;
• Solution of Natrii hydrocarbonas of 4,2%;
• Solution of Natrii hydrocarbonas of 8,4%.

Contraindications:

• Hypersensitivity to a moksifloksatsin, other hinolona or any other component of drug;
• age up to 18 years;
• pregnancy and period of breastfeeding;
• existence in the anamnesis of the pathology of sinews which developed owing to treatment by antibiotics of a hinolonovy row;
• the changes of electrophysiologic parameters of heart which are expressed in lengthening of an interval of QT: the inborn or acquired documentary lengthenings of an interval of QT, electrolytic disturbances, especially not adjusted hypopotassemia; clinically significant bradycardia; clinically significant heart failure with reduced fraction of emission of a left ventricle; existence in the anamnesis of the disturbances of a rhythm which were followed by clinical symptomatology;
• use with other drugs extending QT interval (see the section "Interaction with Other Medicines");
• abnormal liver functions (a class C on classification of Chayld-Pyyu) and increase in content of transaminases more, than are five times higher than the upper bound of norm, in connection with the limited number of clinical data.
WITH CARE
At TsNS diseases (including suspicious concerning involvement of TsNS) contributing to developing of spasms and reducing a threshold of convulsive activity, at patients with potentially pro-arhythmic states, such as acute ischemia of a myocardium at women and patients of advanced age; at gravis myasthenia; at cirrhosis; at a concomitant use with the drugs reducing the content of potassium.
Patients with genetic predisposition or the actual existence of deficit glyukozo-6-fosfatdegidrogenazy are inclined to hemolitic reactions at therapy of a hinolonama. Thereof at such patients moxifloxacin has to be applied with care.
Use at pregnancy and during breastfeeding
Safety of use of a moksifloksatsin during pregnancy is not established and its use is contraindicated. Cases of reversible injuries of joints at the children receiving some hinolona are described, however it was not reported about manifestation of this effect at a fruit (at use by mother during pregnancy).
In researches on animals reproductive toxicity was shown. The potential risk for the person is unknown.
As well as other hinolona, moxifloxacin causes injuries of cartilages of large joints in premature animals. In preclinical trials it is established that a small amount of a moksifloksatsin is allocated in breast milk. Data on its use for women in the period of a lactation are absent. Therefore purpose of a moksifloksatsin during breastfeeding is contraindicated.

Overdose:

There are limited data on overdose of a moksifloksatsin. Any side effects at use of a moksifloksatsin in a dose to 1200 mg are noted once and on 600 mg within 10 days and more. In case of overdose it is necessary to be guided by a clinical picture and to carry out a symptomatic maintenance therapy with ECG monitoring.

Storage conditions:

Period of validity of 5 years. Not to use after the expiry date specified on packaging. To store at a temperature from 15 to 30 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Solution for infusions of 1,6 mg/ml. On 250 ml in the bottle from colourless glass corked by a stopper chlorbutyl or brombutilovy gray color, an aluminum blooming ring and a plastic cap. On 1 bottle together with the application instruction in a cardboard pack.