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

film coating: opadrai pink 02F540000 16 mg [hypromellose-2910 62.5%, titanium dioxide (E171) 25.26%, macrogol 10%, iron dye red oxide (E172) 2.2%, ferric oxide yellow oxide (E172) 0.04%].

Description:

Oval, biconvex tablets of pink color with a facet, covered with a film sheath, with engraving "MF"on one side of the pill.

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 a disruption in the processes of replication, repair and transcription of the biosynthesis of the microbial cell DIC and, as a consequence, to its death.

The minimum bactericidal concentrations of the preparation as a whole are comparable to its minimum inhibitory concentrations.

Mechanisms of resistance

Mechanisms that lead to the development of resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines, do not affect the antibacterial activity of moxifloxacin. Cross-resistance between these groups of antibacterial drugs and moxifloxacin is not noted. So far, no cases of plasmid resistance have been observed. The overall frequency of development of resistance is very low (10^-7- 10^-10). Resistance to moxifloxacin develops slowly by multiple mutations. Multiple effects of moxifloxacin on microorganisms at concentrations below the minimum inhibitory concentration (MIC) are accompanied by only a slight increase in MIC. There are cases of cross-resistance to quinolones. Nevertheless, some Gram-positive and anaerobic microorganisms resistant to other quinolones retain sensitivity to moxifloxacin.

It has been established that the addition of the methoxyfloxacin methoxy group in the C8 position to the molecule structure increases the activity of moxifloxacin and reduces the formation of resistant mutant strains of Gram-positive bacteria. The addition of the bicycloamine group in position C7 prevents the development of active efflux, - the mechanism of resistance to fluoroquinolones.

Moxifloxacin in vitro is active against a wide range of Gram-positive and Gram-negative microorganisms, anaerobes, acid-fast bacteria and atypical bacteria such as Mycoplasma spp., Chlamydia spp., Legionella spp., and also bacteria resistant to β-lactam and macrolide antibiotics.

Influence on human intestinal microflora

In two studies conducted on volunteers, the following changes in the intestinal microflora were observed after oral administration of moxifloxacin: a decrease in concentrations Escherichia coli, Bacillus spp., Bacteroides vulgatus, Enterococcus spp., Klebsiella spp., as well as anaerobes Bifidobacterium spp., Eubacterium spp., Peptostreptococcus spp. These changes were reversible within two weeks. Toxin Clostridium difficile Not found.

Sensitivity testing in vitro

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

Sensitive

- Gram-positive: Gardnerella vaginalis, Streptococcus pneumoniae* (including penicillin resistant strains and strains with multiple antibiotic resistance), as well as strains resistant to two or more antibiotics, such as penicillin (MIC> 2 μg / ml), cephalosporins of the second generation (for example, cefuroxime), macrolides, tetracyclines, trimethoprim / sulfamethoxazole), Streptococcus pyogenes (group A) *, group Streptococcus milleri (S. anginosus*, S. constellatus*, and S. intermedius*), Group Streptococcus viridians (S. viridians, S. mu tans, S. mitis, S. sanguinis, S. salivarius, S. thermophilus, S. constellatus), Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus aureus (including methicillin-sensitive strains) *, coagulase-negative staphylococci (S. cohnii, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. simulans, (including strains sensitive to methicillin).

- Gram-negative: Haemophilus influenzae (including strains, producing and non-producing β-lactamases) *, Haemophilus parainfluenzae*, Moraxella catarrhalis (including strains producing and not producing β-lactamases) *, Bordetella pertussis, Acinetobacter baumanii, Proteus vulgaris.

- anaerobes: Fusobacterium spp., Porphyromonas spp., Prevotella spp., Propionibacterium spp.

- atypical: Chlamydia pneumoniae *, Chlamydia trachomatis *, Mycoplasma pneumoniae *, Mycoplasma hominis, Mycoplasma genitalium, Legionella pneumophila *, Coxiella burnettii.

Moderately sensitive

- Gram-positive:

Enterococcus faecalis (only strains sensitive to vancomycin and gentamicin), Enterococcus avium*, Enterococcus faecium.

- gram-negativeьfollowing:

Escherichia coli *, Klebsiella pneumoniae *, Klebsiella oxytoca, Citrobacter freundii **, Enterobacter spp. (E. aerogenes, E. intermedins, E. sakazakii), Enterobacter cloacae *, Pantoea agglomerans, Neisseria gonorrhoeae, Pseudomonas fluorescens, Burkholderia cepacia, Stenotrophomonas maltophilia, Proteus mirabilis *, Morganella morganii, Providencia spp. (P. rettgeri, P. stuartii).

- anaerobes:

Bacteroides spp. (B. distasonis *, B. fragilis *, B. ovatus *, B. thetaiotaomicron *, B. uniform is *, B. vulgatus *), Peptostreptococcus spp. *, Clostridium spp. *.

Resistant

- Gram-positive:

Staphylococcus aureus (methicillin / ofloxacin-resistant strains) **, coagulase-negative staphylococci (S. cohnii, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. simulans), resistant to methylpenicilliny strains).

Gram-negative:

Pseudomonas aeruginosa.

* - sensitivity to moxifloxacin is confirmed by clinical data.

** - use of the drug is not recommended for the treatment of infections caused by strains S. aureus, resistant to methicillin (MRSA). In the case of suspected or confirmed infections caused by MRSA, should be prescribed treatment with appropriate antibacterial drugs.

For certain strains, the 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 patients undergoing treatment in a hospital, the area under the pharmacokinetic curve "concentration-time" (AUC)/MANDK₉₀, exceeds 125, and the maximum concentration in the blood plasma (C_max) / MIC₉₀is within the range of 8-10, this implies a clinical improvement. In outpatients, the values of these surrogate parameters are usually less: AUC/MANDK₉₀ > 30-40.

Parameter (average value)	AUIC * (h)	FROM_m_Oh** / MIC₉₀
MIC₉₀ 0,125 mg / l	279	23,6
MIC₉₀ 0.25 mg / l	140	11,8
MIC₉₀ 0.5 mg / l	70	5,9

*AUIC - area under the inhibitory curve (ratio AUC***/MHK₉₀).

** - The maximum concentration of the drug in the blood plasma.

*** - area under the pharmacokinetic curve "concentration-time".

Pharmacokinetics:

Absorption and bioavailability

When taken orally moxifloxacin absorbed quickly and almost completely. Absolute bioavailability is about 91%. The pharmacokinetics of moxifloxacin when taken in a dose of 50 mg to 1200 mg once, and also 600 mg / day for 10 days, is linear. The equilibrium state is reached within 3 days.

After a single dose of 400 mg of moxifloxacin, the maximum concentration in the blood plasma (C_max) is achieved within 0.5-4 hours and is about 3.1 mg / l. After taking 400 mg of moxifloxacin once a day, the maximum equilibrium concentration in the blood plasma (Css_max) and the minimum equilibrium concentration in the blood plasma (Css_min) are 3.2 mg / l and 0.6 mg / l. respectively.

When taking moxifloxacin together with food, there is a slight increase in the time to reach the maximum concentration in the blood plasma (C_m_Oh) (for 2 hours) and a slight decrease in the maximum concentration in the blood plasma (C_m_Oh) (approximately 16%), while the suction duration does not change.However, these data have no clinical significance, and the drug can be used regardless of food intake.

Distribution

Moxifloxacin is rapidly distributed in tissues and organs and binds to plasma proteins (mainly albumins) by about 45%. The distribution volume is approximately 2 l / kg.

High concentrations of the drug, exceeding those in the blood plasma, are created in the lung tissue (including in the epithelial fluid, alveolar macrophages), in the bronchial mucosa, in the nasal sinuses (maxillary and etmoidal sinuses), in nasal polyps, in inflammation (in the contents of blisters in case of skin lesions). In the interstitial fluid and in saliva, the drug is determined in a free, non-protein-binding form at a concentration higher than in the blood plasma. In addition, high concentrations of the drug are determined in the tissues of the abdominal cavity, peritoneal fluid and female genital organs.

Metabolism

Moxifloxacin undergoes biotransformation of the 2nd phase and is excreted from the body by the kidneys, and also through the intestine both in unmodified form and in the form of inactive sulfo compounds (Ml) and glucuronides (M2). Moxifloxacin does not undergo biotransformation by the microsomal system of cytochrome P450. Metabolites M1 and M2 are present in blood plasma at concentrations lower than the parent compound. According to the results of preclinical studies, it was proved that these metabolites do not have a negative impact on the body in terms of safety and tolerability.

Excretion

The half-life (T_1/2) of the drug is approximately 12 hours. The average total clearance after taking 400 mg is 179-246 ml / min. Kidney clearance is 24-53 ml / min, which indicates partial tubular reabsorption of the drug.

The mass balance of the initial compound and the metabolites of the 2nd phase is approximately 96-98%, which indicates the absence of oxidative metabolism. About 22% of a single dose (400 mg) is excreted unchanged by the kidneys, about 26% - through the intestine.

Pharmacokinetics in different patient groups

Age, gender and ethnicity

When studying the pharmacokinetics of moxifloxacin in men and women, differences in 33% were observed for the area under the concentration-time curve (AUC) and the maximum concentration in the blood plasma (C_m_Oh). Absorption of moxifloxacin did not depend on sex.Differences in the area under the "concentration-time" curve (AUC) and the maximum concentration in the blood plasma (C_m_Oh) 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), and in patients on continuous hemodialysis and long-term ambulatory peritoneal dialysis.

Impaired liver function

There were no significant differences in the concentration moxifloxacin in patients with hepatic impairment (Child-Pugh classes A and B) compared with healthy volunteers and patients with normal liver function (for use in patients with cirrhosis of the liver, see also "Special instructions").

Indications:

Moxifloxacin is indicated for treatment in adults aged 18 years and older of infectious inflammatory diseases caused by moxifloxacin-sensitive microorganisms:

- 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 includes strains resistant to penicillin and strains resistant to two or more antibiotics from groups such as penicillins (with MIC> 2 μg / L), 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 quinolone drugs or to any 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;

- interval lengthening QT on a cardiogram (congenital or acquired);

- electrolyte imbalance, 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 (see the section "Interaction with other drugs");

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

- due to the limited amount of clinical data, the use of moxifloxacin is contraindicated in patients with impaired liver function (Child-Pugh class C) and in patients with elevated transaminases more than five times the upper limit of the norm.

Carefully:

In diseases of the central nervous system (CNS) (including suspicious for involvement of the central nervous system), predisposing to the onset of seizures and reducing the threshold of convulsive activity; patients with psychoses and patients 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 (see section "Special instructions"); with myasthenia gravis gravis; with cirrhosis of the liver; with simultaneous administration with drugs that reduce the content of potassium; with 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. There are no data on the use of moxifloxacin in women during breastfeeding. Therefore, the appointment of moxifloxacin during breastfeeding is contraindicated.

Dosing and Administration:

Inside. Recommended dosage regimen of moxifloxacin: one tablet (400 mg) once a day for the infections mentioned above. Do not exceed the recommended dose.

The tablet 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 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 stepwise therapy with moxifloxacin (intravenous administration followed by oral administration) is 7-14 days.

Complicated infections of the skin and subcutaneous structures - the total duration of stepwise therapy with moxifloxacin (intravenous administration followed by oral administration) is 7-21 days. Complicated intra-abdominal infections - the total duration of stepwise therapy with moxifloxacin (intravenous administration followed by oral administration) is 5-14 days.

Uncomplicated inflammatory diseases of the pelvic organs - 14 days. Do not exceed the recommended duration of treatment. The duration of treatment with the drug 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 hepatic impairment (class A, B by Child-Pugh), changes in the dosing regimen are not required (for use in patients with cirrhosis see the section "Special instructions").

Renal insufficiency

In patients with impaired renal function (including in severe cases renal failure with creatinine clearance ≤ 30 ml / min / 1.73 m²), as well as in patients on continuous hemodialysis and long-term outpatient peritoneal dialysis, changes in the dosing regimen are not required.

Use in patients of different ethnic groups

Dosage regimen changes are not required.

Side effects:

Adverse reactions listed in the "often" group occur with a frequency below 3%, with the exception of nausea and diarrhea.

The following undesirable phenomena noted with the use of the drug are distributed according to the frequency of occurrence in accordance with the following gradation: 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).

Infectious and parasitic diseases: often - fungal superinfections.

Violations of the blood and lymphatic system: infrequently - anemia, leukopenia, neutropenia, thrombocytopenia, thrombocythemia, lengthening of prothrombin time / increase in international normalized ratio (INR); rarely - change in the concentration of thromboplastin; very rarely - an increase in the concentration of prothrombin / decrease INR.

Immune system disorders: infrequently - allergic reactions,urticaria, pruritus, rash, eosinophilia; rarely anaphylactic / anaphylactoid reactions, angioedema, including laryngeal edema (potentially life-threatening); very rarely - anaphylactic / anaphylactoid shock (including potentially life-threatening).

Disorders from the metabolism and nutrition: infrequently - hyperlipidemia; rarely hyperglycemia, hyperuricemia; very rarely - hypoglycemia.

Disorders of the psyche: infrequent - anxiety, psychomotor hyperactivity / 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).

Disturbances from the nervous system: often - dizziness, headache; infrequently - confusion and disorientation, vertigo, drowsiness, tremor, paresthesia / dysesthesia, sleep disorders, taste disorders (including very rare cases of agevia); rarely - hypoesthesia,atypical dreams, impaired sense of smell (including anosmia), impaired coordination (including gait disturbance due to dizziness or vertigo, in very rare cases leading to trauma from falling, especially in elderly patients), seizures with various clinical manifestations (including "grand mal "seizures), attention disorders, speech disorders, amnesia, peripheral neuropathy and polyneuropathy, very rarely hyperesthesia.

Disturbances on the part of the organ of sight: infrequently - visual impairment (especially with CNS reactions); very rarely - transient loss of vision (especially against the background of reactions from the central nervous system).

Hearing disorders and labyrinthine disorders: rarely - noise in the ears, hearing impairment, including deafness (usually reversible).

Disorders from the cardiovascular system: interval lengthening QT (often - in patients with concomitant hypokalemia, infrequently - in the remaining patients); infrequently - tachycardia, palpitation and vasodilation; rarely - hypotension, hypertension, syncope, ventricular tachyarrhythmias; very rarely - nonspecific arrhythmias, polymorphic ventricular tachycardia (torsades de pointes), cardiac arrest (mainly in persons with predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia).

Disturbances from the respiratory system, chest and mediastinal organs: infrequently - shortness of breath (including asthmatic conditions).

Disorders from the gastrointestinal tract: 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).

Disturbances from the liver and bile ducts: often - increased activity of "liver" transaminases; infrequently - violations of the liver (including increased levels of lactate dehydrogenase), increased levels of bilirubin, increased activity of gamma-glutamyl transferase, increased blood alkaline phosphatase activity; rarely - jaundice, hepatitis (mostly cholestatic); very rarely - fulminant hepatitis, potentially leading to life-threatening liver failure (including fatal cases).

Disturbances from the skin and subcutaneous tissues: very rarely - bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).

Disturbances from musculoskeletal and connective tissue: infrequently - arthralgia, myalgia; rarely - tendonitis, increased muscle tone and cramps, muscle weakness; very rarely - tendon ruptures, arthritis, gait disturbance due to damage to the musculoskeletal system, increased myasthenia gravis symptoms gravis.

Disorders from the kidneys and urinary tract: infrequently - dehydration (caused by diarrhea or decreased fluid intake); rarely - renal dysfunction, kidney failure (as a result of dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing impaired renal function).

General disorders: infrequently - general malaise, nonspecific pain, sweating.

If any of the side effects listed in the manual are aggravated or you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

There are limited data on the overdose of moxifloxacin.There were no side effects when taking moxifloxacin at a dose of up to 1200 mg once and 600 mg for 10 days or more. In case of an overdose, one should be guided by the clinical picture and carry out symptomatic maintenance therapy with ECG monitoring.

Acceptance of activated carbon at an early stage of absorption prevents further systemic exposure of moxifloxacin, which should be considered in the event of an overdose of the drug.

Interaction:

Dose correction is not required when moxifloxacin is used together with atenolol, ranitidine, calcium-containing additives, theophylline, cyclosporine, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid (no clinically significant interaction with moxifloxacin).

Drugs that extend the range of OT

It should be taken into account the possible additive effect of lengthening the interval QT moxifloxacin and other drugs that affect the lengthening of the interval QT. Due to the combined use of moxifloxacin and drugs that affect the lengthening of the interval QT, the risk of developing ventricular arrhythmia increases, including polymorphic ventricular tachycardia (torsades 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);

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

- Neuroleptics (phenothiazine, pimozide, sertindole, haloperidol, sultopride);

- Tricyclic antidepressants;

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

- antihistamines (terfenadine, astemizole, misolastine);

- others (cisapride, wincamine (intravenously), bepridil, difemanyl).

Antacid agents, multivitamins and other preparations containing salts of magnesium, aluminum, iron and zinc

Taking moxifloxacin concomitantly with antacid agents, multivitamins and minerals can lead to a moxifloxacin absorption, due to the formation of chelate complexes with polyvalent cations contained in these preparations.As a result, the concentration of moxifloxacin in the blood plasma may be significantly lower than desired. Consequently, antacids, antiretroviral drugs (eg, didanosine) and other preparations containing magnesium or aluminum, sucralfate and other preparations containing iron or zinc should be taken 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), age and general condition patient. Despite the fact that no interaction was found between moxifloxacin and warfarin, in patients receiving concomitant treatment with these drugs, it is necessary to monitor the INR and, if necessary, adjust the dose of indirect anticoagulants.

Digoxin

Moxifloxacin and digoxin do not significantly affect the pharmacokinetic parameters of each other. In appointing repeated doses of moxifloxacin, the maximum digoxin concentration increased by approximately 30%, with the area under the concentration-time curve (AUC) and the minimum digoxin concentration did not change.

Activated carbon

With the simultaneous use of activated carbon and moxifloxacin inside at a dose of 400 mg, the 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, treatment with the drug should be discontinued and necessary medical measures (including anti-shock) should be carried out.

With the use of moxifloxacin in some patients, lengthening of the interval QT. 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. Degree of lengthening interval QT may increase with increasing drug concentration, therefore, do not exceed the recommended dose. However, in patients with pneumonia, the correlation between the concentration of moxifloxacin in the blood plasma and the lengthening of the interval QT was not noted. Interval lengthening QT is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. None of the 9,000 patients who received moxifloxacin, there were no cardiovascular complications and lethal cases associated with lengthening the interval QT. However, in patients with predisposing arrhythmias, the risk of developing ventricular arrhythmias may increase with moxifloxacin.

Concerning moxifloxacin contraindicated in patients with an established interval lengthening QT, patients with uncorrected hypokalemia, patients with predisposing conditions (congenital or acquired), such as clinically significant bradycardia, with clinically significant heart failure with reduced left ventricular ejection fraction, history of rhythm disorders accompanied by clinical symptoms, use with other drugs, extending the interval QT.

Moxifloxacin should be used with caution in patients with potentially antiarrhythmic conditions such as acute myocardial ischemia, cardiac arrest, patients with cirrhosis (since this category of patients can not exclude the risk of lengthening the interval QT).

When moxifloxacin was taken, cases of fulminant hepatitis, potentially leading to the development of hepatic insufficiency (including fatal cases) were reported (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 therapy.

When moxifloxacin was taken, 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 therapy.

The use of drugs quinolone series is associated with a possible risk of seizures. Moxifloxacin Caution should be used with caution in patients with CNS diseases and with conditions suspicious of CNS involvement predisposing to seizures or reducing the threshold of seizure activity.

The use of broad-spectrum antibacterial drugs, including moxifloxacin, is associated with a risk of developing pseudomembranous colitis associated with taking antibiotics. This diagnosis should be kept in mind in patients who have severe diarrhea with moxifloxacin. In this case, appropriate therapy should be immediately given.Preparations that inhibit the intestinal peristalsis 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, especially in the elderly and patients receiving glucocorticosteroids, tendonitis and tendon rupture may develop. 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 the pre-clinical and clinical studies, as well as with the use of moxifloxacin, no reactions were observed in practice photosensitivity. Nevertheless, patients receiving moxifloxacin, should avoid 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 who undergo drug treatment during this period.

In patients treated with quinolones, including moxifloxacin, cases of sensory or sensorimotor polyneuropathy, leading to paresthesia, hypoesthesia, dysesthesia or weakness are described. Patients undergoing treatment with the drug should be warned about the need to seek immediate medical attention before continuing treatment in case of symptoms of neuropathy, including pain, burning, tingling, numbness or weakness (see section "Side effect").

Reactions from the psyche may occur even after the first appointment 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). If the patient develops such reactions, it is necessary to cancel the drug and take the necessary measures. Care should be taken when prescribing the drug to patients with psychoses and patients with psychiatric illnesses in history.

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 where 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 moxifloxacin 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 vehicles and engage in other potentially hazardous 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:

For 5 tablets in a blister of PVC film and aluminum foil. For 3 blisters together with instructions for use in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002998

Date of registration:19.05.2015 / 01.12.2015

Expiration Date:19.05.2020

The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India

Manufacturer: & nbsp

MICRO LABS, Limited India

Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India

Information update date: & nbsp11.06.2018

Illustrated instructions

Instructions

Moxigram (Moxigram)