Alvelon-MF - instructions for use, dose, side effects, contraindications

cellulose microcrystalline - 101.80 mg, calcium hydrophosphate (calcium hydrophosphate anhydrous) - 73.09 mg, croscarmellose sodium - 33.94 mg, povidone - K30 - 27.17 mg, magnesium stearate - 6.00 mg.

Sheath: OUADRAY® 03F240015 Pink (OPADRY® 03F240015 Pink) [hypromellose (hydroxypropylmethylcellulose) -10,60 mg, titanium dioxide-3,24 mg, macrogol-4000 (polyethylene glycol-4000)-3.00 mg, iron-oxide red oxide-0.36 mg] -17.20 mg.

Description:

The tablets covered with a film cover of pink color, oblong, biconcave. On the cut from light yellow to yellow, a greenish shade is allowed.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A.14 Moxifloxacin

Pharmacodynamics:

Bactericidal antibacterial preparation of broad spectrum of action of fluoroquinolone series. The mechanism of action is due to the inhibition of bacterial topoisomerases II and IV, which leads to a disruption in the synthesis of microbial cell DNA and, as a consequence, to the death of microbial cells. The minimum bactericidal concentration of the drug as a whole is comparable to its minimal inhibitionsoup(MIC). 1n vitro the drug is active against a wide range of gram-negative and gram-positive microorganisms, anaerobes, acid-fast bacteria and atypical forms 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 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	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 cephalosporins (for example, 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. salivarius, S. thermophilus, S. constellatus)
Streptococcus agalactiae
Streptococcus dysgalactiac
Staphylococcus aureus (including methicillin-sensitive strains) *		Staphylococcus aureus (methicillin / mofloxacin resistant strains) +
Coagulase-negative staphylococciS. cohnii, S. epidermidis, S. hacmolyticus, S. hominis, S. saprophyticus, S. simulans), methicillin-sensitive strains		Coagulase-negative staphylococci (S. cohnii, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. simulans), methicillin-resistant strains
	Enterococcus laecalis * (strains sensitive to vancomycin and gentamicin only)
	Enterococcus avium *
	Enterococcus faecium *
Gram-negative
Haemophilus influenzae (including strains producing and non-producing β-lactamases) *
Haemophilus parainfluenzae *
Moraxclla catarrhalis (including strains producing and non-producing β-lactamases) *
Bordetella pertussis
Legionella pneumophila	Escherichia coli *
Acinetobactcr 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. unilormis * 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 bumettii

* sensitivity to moxifloxacin is confirmed by clinical data.

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

Mechanisms of resistance

Mechanisms that lead to the development of resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines, do not interfere with 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 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 are sensitive 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. Joining bicycloamine group in the C7 position prevents the development of active efflux, a mechanism of resistance to fluoroquinolones.

Pharmacokinetics:

Suction

After oral administration moxifloxacin absorbed quickly and almost completely. Absolute bioavailability is about 91%.

The pharmacokinetics of moxifloxacin when administered in single doses of 50 mg to 1200 mg, and also at a dose of 600 mg per day for 10 days is linear.

After a single dose of moxifloxacin at a dose of 400 mg, the maximum concentration (C_m_Oh) in the blood is reached within 0.5-4 hours and is 3.2 mg / l. When moxifloxacin is taken with food, there is a slight increase in the time to reach C_m_Oh (at 2 h) and a slight decrease in C_m_Oh (approximately 16%), while the duration of 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.

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

High concentrations of moxifloxacin, exceeding those in plasma, are created in the lung tissue (including alveolar macrophages), in the bronchial mucosa, in the nasal sinuses, in soft tissues, skin and subcutaneous structures, inflammation foci. In the interstitial fluid and in the saliva moxifloxacin is determined in a free, not protein-related form, at a concentration higher than in the plasma. In addition, high concentrations of moxifloxacin are determined in the organs of the abdominal cavity and peritoneal fluid, as well as in the tissues of the female genital organs.

Metabolism

Biotransformed to inactive sulfo compounds and glucuronides. Moxifloxacin does not undergo biotransformation with microsomal liver enzymes of the cytochrome P450 system.

Excretion

After passing the 2nd phase of biotransformation moxifloxacin is excreted from the body by the kidneys and the gastrointestinal tract (GIT), both in unmodified form and in the form of inactive sulfo compounds and glucuronides.

It is excreted in the urine, as well as with feces, as in unchanged form, both in the form of inactive metabolites. At a single dose of 400 mg, about 22% is excreted unchanged in the urine, about 26% - with feces. The half-life of the drug is approximately 12 hours.The average total clearance after taking in a dose of 400 mg is from 179 ml / min to 246 ml / min.

Pharmacokinetics in different patient groups

Age, gender and ethnicity

There are no differences in pharmacokinetic parameters of moxifloxacin depending on age, gender and race.

Children (<18 years old)

The pharmacokinetics of moxifloxacin in children have not been studied.

Patients with kidney failure

There were no significant changes in the pharmacokinetics of moxifloxacin in patients with impaired renal function (including creatinine clearance <30 mL / min / 1.73 m²) and in those on continuous hemodialysis and long-term outpatient peritoneal dialysis.

Patients with hepatic failure

In patients with minor and moderate hepatic impairment (class A or B on the Child-Pugh scale), the pharmacokinetics of moxifloxacin does not change. In patients with severe impairment of liver function (class C on the Child-Pugh scale), there is no data on the pharmacokinetics of moxifloxacin.

Indications:

Infectious-inflammatory diseases in adults caused by microorganisms sensitive to the preparation:

- acute sinusitis;

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

- exacerbation of chronic bronchitis;

- uncomplicated infections of the skin and subcutaneous structures;

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

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

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

* - Streptococcus pneumoniae with multiple antibiotic resistance include strains resistant to penicillin and strains resistant to two or more antibiotics from groups such as penicillins (with a minimum inhibitory concentration of ≥ 2 mg / ml), cephalosporins of the second generation (cefuroxime), macrolides, tetracyclines and trimethoprim / sulfamethoxazole.

Contraindications:

- Pregnancy;

- lactation period;

- age to 18 years;

- hypersensitivity to moxifloxacin (including other quinolones) and other components of the drug;

- the presence in the anamnesis of a pathology of tendons, developed as a result of antibiotic treatment of the quinolone series;

- due to the limited amount of clinical data, the use of moxifloxacin is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) and in patients with increased hepatic transaminase activity more than five times the upper limit of the norm;

- simultaneous reception of drugs that extend the interval QT;

- Congenital or acquired documented lengthening interval QT;

- electrolyte disorders, especially uncorrected hypokalemia;

- clinically significant bradycardia;

- clinically significant heart failure with a reduced fraction of the left ventricular ejection;

- presence in the anamnesis of rhythm disturbances, accompanied by clinical symptoms.

Carefully:

- In diseases of the central nervous system (CNS) (including in diseases suspected of involving the central nervous system), predisposing to the occurrence of convulsive seizures and reducing the threshold of convulsive readiness;

- in patients with potentially pro-arrhythmogenic conditions, such as acute myocardial ischemia, especially in women and elderly patients;

- with myasthenia gravis gravis;

- with simultaneous reception with drugs that reduce the content of potassium in the blood:

- with deficiency of glucose-6-phosphate dehydrogenase;

- patients with psychoses and patients with psychiatric illnesses in the anamnesis;

- in patients with cirrhosis of the liver.

Pregnancy and lactation:

Safety of moxifloxacin in pregnancy is not established and its use is contraindicated.

A small amount of moxifloxacin is excreted in breast milk. Data on the use of moxifloxacin in women during lactation are absent. Therefore, the use of moxifloxacin during breastfeeding is also contraindicated.

Dosing and Administration:

The drug is administered orally 400 mg once a day. Do not exceed the recommended dose. Tablets should be taken without chewing, washed down with a small amount of water, regardless of food intake.

The duration of treatment with oral administration is determined by the severity of the infection and the clinical effect and is:

- with exacerbation of chronic bronchitis-5-10 days;

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

- with acute sinusitis - 7 days;

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

- with complicated infections of the skin and subcutaneous structures - the total 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 (intravenous administration 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 Alvelon-MF can reach 21 days. Do not exceed the recommended duration of treatment.

Older patients, patients with minor hepatic impairment (class A or B on the Child-Pugh scale), patients with impaired renal function (including with creatinine clearance <30 mL / min / 1.73 m²), as well as patients on continuous hemodialysis and long-term outpatient peritoneal dialysis, changes in the dosing regimen ns are required. The efficacy and safety of moxifloxacin in children under 18 years of age is established.

Side effects:

The following undesirable phenomena noted with the use of moxifloxacin are distributed according to the frequency of occurrence according to the following gradation: often (≥ 1/100 to <1/10), infrequently (≥ 1/1000 to <1/100), rarely (≥ 1 / 10000 to <1/1000), very rarely (<1/10000).

Undesirable phenomena classified as "often" occurred with a frequency below 3%, except for nausea and diarrhea.

From the cardiovascular system: interval lengthening QT (often - in patients with concomitant hypokalemia, infrequently - in the remaining patients); infrequently - tachycardia and vasodilation ("tides" of blood to the face), a feeling of palpitations; rarely - lowering blood pressure, increasing blood pressure, fainting, ventricular tachyarrhythmias; very rarely - nonspecific arrhythmias (including extrasystole), polymorphic ventricular tachycardia ("torsade de pointes") or cardiac arrest, predominantly in persons with conditions predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia.

From the respiratory system: infrequently - shortness of breath (including asthmatic condition).

From the gastrointestinal tract: often - nausea, vomiting, abdominal pain, diarrhea; infrequently - anorexia, constipation, dyspepsia, flatulence,gastroenteritis (except erosive gastroenteritis), increased amylase activity, decreased appetite and reduced food intake; rarely - dysphagia, stomatitis, pseudomembranous colitis (in very rare cases associated with life-threatening complications).

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

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

Mental disorders: infrequently - feelings of anxiety, increased psychomotor activity, agitation, rarely - emotional lability, depression (possibly 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 side of the organ of vision: infrequent - a disorder of vision (blurred vision, reduced visual acuity, diplopia, especially in combination with dizziness and confusion); very rarely - transient loss of vision (especially against the background of reactions from the central nervous system).

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

On the part of the hematopoiesis system: infrequently - anemia, leukopenia (including neutropenia), thrombocytopenia, thrombocytosis, prolongation of prothrombin time and a decrease in the international normalized ratio (INR); rarely - change in the concentration of thromboplastin; very rarely - an increase in the concentration of prothrombin and a decrease in INR, a change in the concentration of prothrombin and INR.

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

From the side of 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 concomitant renal dysfunction).

From the genitals and the breast: often - candidiasis, vaginitis.

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

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

From the side of metabolism: infrequently hyperlipidemia; rarely hyperglycemia, hyperuricemia.

Infectious and parasitic diseases: often - fungal superinfections.

General disorders and disorders at the site of administration: infrequent - general malaise (including symptoms of poor health, nonspecific pain and sweating); rarely - swelling.

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

often - increased activity of gamma-glutamyltransferase; infrequently - ventricular tachyarrhythmias, lowering of arterial pressure, edema, pseudomembranous colitis (in very rare cases associated with life-threatening complications), seizures with various clinical manifestations (including "grand mal" seizures), hallucinations, impaired renal function, renal failure (as a result of dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing impaired renal function).

Overdose:

There are limited data on the overdose of moxifloxacin.

No side effects were observed with the use of moxifloxacin in a dose of up to 1200 mg once and 600 mg for 10 days or more.

Treatment: in case of an overdose, one should be guided by a clinical picture and carry out symptomatic maintenance therapy with ECG monitoring. The use of activated carbon at an early stage of suction prevents further systemic exposure of moxifloxacin, which should be considered in the event of an overdose of the drug.

Interaction:

When combined with atenolol, ranitidine, calcium-containing additives, with theophylline, cyclosporine, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid (no clinically significant interaction with moxifloxacin was confirmed), dose adjustment is not required.

Antacids, multivitamins and minerals

The use of moxifloxacin concomitantly with antacid agents, multivitamins and minerals can lead to impaired absorption of moxifloxacin after ingestion, due to the formation of chelate complexes with polyvalent cations contained in these preparations. As a result, the concentration of moxifloxacin in plasma can be significantly lower than desired. Consequently, antacids, antiretroviral drugs (for example: didanosine) and other preparations containing magnesium or aluminum, sucralfate and other preparations containing iron and zinc, should be prescribed at least 4 hours before or 4 hours after ingestion of moxifloxacin.

Warfarin

With the combined use of moxifloxacin with warfarin, prothrombin time and other coagulation parameters do not change.

Change in the value of INR (the international normalized relationship).

In patients who received anticoagulants in combination with antibiotics, including moxifloxacin, there are cases of increased anticoagulant activity of anticoagulants.Risk factors are the presence of an infectious disease (and concomitant inflammatory process), the age and general condition of the patient. Despite the fact that there is no interaction between moxifloxacin and warfarin, in patients receiving concomitant treatment with these drugs, it is necessary to monitor the INR and, if necessary, adjust the dose of oral anticoagulants.

Digoxin

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

Drugs that extend the interval QT

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

Contraindicated joint use of moxifloxacin with the following drugs that affect the lengthening of the interval QT:

- antiarrhythmic drugs class IA (quinidine, hydroquinidine, disopyramide and etc.);

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

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

- tricyclic antidepressants;

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

- antihistamines (terfenadine, astemizole, misolastine);

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

Activated carbon

With the simultaneous use of activated charcoal 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 a slowing of its absorption. In case of an overdose, the use of activated charcoal at an early stage of absorption prevents further increase in the systemic effect.

Food and Dairy Products

Absorption of moxifloxacin does not change with simultaneous intake of food (including dairy products). Moxifloxacin can be taken regardless of food intake.

Special instructions:

In some cases, after the first use of the drug may develop hypersensitivity and allergic reactions, which should immediately inform the doctor.

Very rarely anaphylactic reactions can progress to a life-threatening anaphylactic shock even after the first use of the drug. In such cases moxifloxacin it is necessary to cancel and conduct the necessary medical measures (including anti-shock).

With the use of moxifloxacin in some patients, lengthening of the interval QT. Moxifloxacin should be taken with caution in women and elderly patients. Because women have a longer interval than men QT, they may be more sensitive to drugs that extend the interval QT. Elderly patients are also more prone to the effects of drugs that have an effect on the interval QT. Interval lengthening QT is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. Degree of lengthening interval QT may increase with increasing drug concentration, therefore, do not exceed the recommended dose.However, in patients with pneumonia, the correlation between the concentration of moxifloxacin in the blood plasma and the lengthening of the interval QT was not noted. None of the 9,000 patients who received moxifloxacin, there were no cardiovascular complications and lethal cases associated with lengthening the interval QT. When moxifloxacin is used, the risk of developing ventricular arrhythmias in patients with predisposing arrhythmias may increase.

Concerning moxifloxacin contraindicated in:

- changes in the electrophysiological parameters of the heart, expressed in the lengthening of the interval QT: congenital or acquired documented lengthening interval QT, Electrolyte disorders, especially uncorrected hypokalemia; clinically significant bradycardia; clinically significant heart failure with a reduced fraction of the left ventricular ejection; presence in the anamnesis of rhythm disturbances, accompanied by clinical symptoms;

- use with other drugs that extend the interval QT (see the section "Interaction with other medicinal products"). Moxifloxacin should be used with caution:

- in patients with potentially proarrhythmic conditions, such as acute myocardial ischemia and cardiac arrest;

- in patients with cirrhosis of the liver (since this category of patients can not exclude the risk of developing an extension of the interval QT.

In patients with predisposing to arrhythmias, moxifloxacin may increase the risk of developing ventricular arrhythmias.

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 about that. that in case of symptoms of hepatic insufficiency it is necessary to consult a doctor before continuing treatment with the drug.

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

It is not recommended to use the drug in patients with severe impairment of liver function (class C on the Child-Pugh scale) due to the lack of sufficient clinical data.

It is not recommended to use the drug in patients with complicated inflammatory diseases of small organs (for example, associated with tubo-ovarian or gas abscesses).

Against the background of therapy with fluoroquinolones, including moxifloxacin, especially in the elderly and patients receiving glucocorticosteroids, tendonitis and tendon rupture may develop. When pain or signs of inflammation occur at the site of damage to the tendon, moxifloxacin should be stopped and the affected limb unloaded.

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, the drug should be withdrawn and immediate therapy should be prescribed. Do not use drugs that inhibit the intestinal motility.

Moxifloxacin should be used with caution in patients with myasthenia gravis in connection with a possible exacerbation of the disease.

When moxifloxacin was taken, cases of development of bullous skin lesions (Stevens-Johnson syndrome, toxic epidermal necrolysis) were reported. The patient follows inform that if skin or mucous membrane symptoms appear, you should consult a doctor before proceeding with the drug. When applying quinolones, photosensitization reactions are noted. However, when moxifloxacin was used, no photosensitivity reactions were observed in clinical practice. Nevertheless, patients receiving moxifloxacin, should avoid direct sunlight and ultraviolet irradiation.

It is not recommended to use moxifloxacin for the treatment of infections caused by strains Staphylococcus aureus resistant to methicillin (MRSA). In the case of suspected or confirmed infections caused by MRSA, should be prescribed treatment with appropriate antibacterial drugs (see the section "Pharmacodynamics").

The ability of moxifloxacin to inhibit the growth of mycobacteria can cause interaction in vitro moxifloxacin with a Mycobacterium spp., leading to false-negative results in the analysis of samples of patients treated with moxifloxacin during this period.

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

Reactions from the psyche may occur even after the first use of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions progress to the occurrence of suicidal thoughts and behavior with a tendency to self-harm, including suicidal attempts (see "Side effect" section). In case of development of such reactions in patients it is necessary to cancel moxifloxacin and take the necessary measures.Caution should be exercised when using moxifloxacin in patients with psychoses and / or psychiatric illnesses in an anamnesis.

Because of the wide spread and growing incidence of infections caused by fluoroquinolone-resistant Neisseria gonorrhoeae in the treatment of patients with inflammatory diseases of the pelvic organs, monotherapy with moxifloxacin should not be carried out, except when the presence of a resistant to fluoroquinolones N. gonorrhoeae, 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).

Effect on the ability to drive transp. cf. and fur:

Moxifloxacin may interfere with the ability of patients to drive a car and engage in other potentially dangerous activities requiring increased attention and speed of psychomotor reactions, due to the effect on the central nervous system.

Form release / dosage:

Tablets, film-coated, 400 mg.

Packaging:

When manufacturing at OJSC "Pharmstandard-Tomskkhimpharm":

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

1 a contour pack of 5, 7 or 10 tablets together with the instruction for use is placed in a pack of cardboard.

2 contour packs of 5 or 7 tablets together with the instructions for use are placed in a pack of cardboard.

3 contour packs of 7 tablets together with instructions for use are placed in a pack of cardboard.

For hospitals with 30 or 50 tablets per jar of polymeric or polymer jars with control of the first opening and a shock absorber.

100-200 cans, together with an equal number of instructions for use, are placed in a box of corrugated cardboard with dividing partitions.

When produced at OJSC Pharmstandard-Leksredstva:

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

1 a contour pack of 5, 7 or 10 tablets together with the instruction for use is placed in a pack of cardboard.

2 contour packs of 5 or 7 tablets together with the instructions for use are placed in a pack of cardboard.

3 contour packs of 7 tablets together with instructions for use are placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

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

Terms of leave from pharmacies:On prescription

Registration number:LP-003360

Date of registration:09.12.2015

The owner of the registration certificate:PHARMSTANDART-TOMSKHIMFARM, OJSC PHARMSTANDART-TOMSKHIMFARM, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-TOMSKHIMFARM, OJSC Russia

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp25.06.2017

Illustrated instructions

Instructions

Alvelon-MF (Alvelon-MF)