What can replace avelox in gynecology. Avelox: instructions for use, analogues and reviews, prices in Russian pharmacies

In this article, you can read the instructions for use medicinal product Avelox. Reviews of site visitors - consumers are presented this medicine, as well as the opinions of specialist doctors on the use of Avelox in their practice. A big request to actively add your reviews about the drug: did the medicine help or not help get rid of the disease, what complications were observed and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Avelox in the presence of existing structural analogues. Use for the treatment of chlamydia, mycoplasmosis, chronic bronchitis and prostatitis in adults, children, as well as during pregnancy and lactation. The composition and interaction of the drug with alcohol.

Avelox- an antibacterial drug of the fluoroquinolone group. It has a bactericidal effect. The mechanism of action is due to the inhibition of bacterial topoisomerases 2 and 4, which leads to a disruption in the synthesis of DNA in a microbial cell and, as a result, to the death of a microbial cell. The minimum bactericidal concentrations of the drug are generally comparable to its MIC.

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. (mycoplasma), Chlamydia spp. (chlamydia), Legionella spp. (legionella), as well as bacteria resistant to beta-lactam and macrolide antibiotics.

Gram-positive and Gram-negative aerobic bacteria are sensitive to Avelox, anaerobic bacteria, atypical bacteria: Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila, Coxiella burnettii, Chlamydia trachomatis, Mycoplasma hominis, Mycoplasma genitalium.

Moxifloxacin ( active substance Avelox) is less active against Staphylococcus aureus (methicillin/ofloxacin resistant strains), Staphylococcus epidermidis (methicillin/ofloxacin resistant strains), Pseudomonas aeruginosa, Pseudomonas fluorescens, Burkholderia cepacia, Stenotrophomonas maltophilia, Neisseria gonorrhoea.

The mechanisms leading to the development of resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not impair the antibacterial activity of moxifloxacin. Cross stability between these groups antibacterial drugs and moxifloxacin is not noted. No cases of plasmid resistance have been observed so far either. The overall frequency of development of resistance is very low (10-7-10-10). Resistance to moxifloxacin develops slowly through multiple mutations. Repeated exposure of microorganisms to moxifloxacin at concentrations below the MIC is accompanied by only a slight increase in the MIC.

Cases of cross-resistance to quinolones have been reported. However, some Gram-positive and anaerobic organisms resistant to other quinolones are sensitive to moxifloxacin.

Compound

Moxifloxacin hydrochloride + excipients.

Pharmacokinetics

After oral administration, Avelox is absorbed quickly and almost completely. When taking moxifloxacin with food, the duration of absorption does not change. The drug can be used regardless of the meal. Absolute bioavailability is about 91%. Binding to blood proteins (mainly albumin) is about 45%. Moxifloxacin is rapidly distributed in organs and tissues. High concentrations of the drug, exceeding those in plasma, are created in the lung tissue (including in alveolar macrophages), in the bronchial mucosa, in the nasal sinuses, in soft tissues, skin and subcutaneous structures, foci of inflammation. In the interstitial fluid and in saliva, the drug is determined in a free, non-protein-bound form, at a concentration higher than in plasma. In addition, high concentrations of the drug are determined in the organs abdominal cavity and peritoneal fluid, as well as in the tissues of the female genital organs.

Biotransformed to inactive sulfo compounds and glucuronides. After passing through the 2nd phase of biotransformation, moxifloxacin is excreted from the body by the kidneys and through the intestines both unchanged and in the form of inactive sulfo compounds and glucuronides. It is excreted in the urine, as well as in the feces, both unchanged and in the form of inactive metabolites.

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

Pharmacokinetic studies of moxifloxacin in children have not been conducted.

Indications

Infectious and inflammatory diseases in adults caused by microorganisms sensitive to the drug:

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 soft tissues;
complicated infections of the skin and subcutaneous structures (including an infected diabetic foot);
complicated intra-abdominal infections, including polymicrobial infections, incl. intraperitoneal abscesses;
uncomplicated inflammatory diseases of the pelvic organs (including salpingitis and endometritis).

Release form

Film-coated tablets 400 mg.

Solution for infusion (injections in ampoules for injection).

Instructions for use and dosing regimen

The drug is prescribed orally and intravenously, 400 mg 1 time per day.

The duration of treatment with Avelox when administered orally and intravenously is determined by the severity of the infection and clinical effect and is: with exacerbation of chronic bronchitis - 5 days; with community-acquired pneumonia, the total duration of stepped therapy (in / in the introduction followed by oral administration) - 7-14 days, first in / in, then inside, or 10 days inside; with acute sinusitis and uncomplicated infections of the skin and soft tissues - 7 days; with complicated infections of the skin and subcutaneous tissues - the total duration of gradual therapy (in / in the introduction followed by oral administration) is 7-21 days; with complicated intra-abdominal infections - the total duration of gradual therapy (in / in the introduction of the drug, followed by oral administration) is 5-14 days; with uncomplicated inflammatory diseases pelvic organs -14 days.

The duration of treatment with Avelox intravenously can reach 14 days, orally - 21 days.

Elderly patients, patients with mild hepatic impairment (class A or B on the Child-Pugh scale), patients with impaired renal function (including those with CC<30 мл/мин/1.73 м2), а также пациентам, находящимся на непрерывном гемодиализе и длительном амбулаторном перитонеальном диализе, изменений режима дозирования не требуется.

Tablets should be taken without chewing, with a small amount of water, regardless of the meal.

The solution for infusion should be administered intravenously slowly over 60 minutes. The drug can be administered both diluted and undiluted. Avelox solution is compatible with the following solutions: water for injection, sodium chloride solution 0.9%, sodium chloride solution 1M, dextrose solution 5%, dextrose solution 10%, dextrose solution 40%, xylitol solution 20%, Ringer's solution, Ringer's lactate solution, aminofusin solution 10%, ionosteril solution. Only clear solution should be used.

Side effect

prolongation of the QT interval (often in patients with concomitant hypokalemia, sometimes in other patients);
tachycardia and vasodilation (flushing of the face);
arterial hypotension;
arterial hypertension;
fainting;
ventricular tachyarrhythmias;
nonspecific arrhythmias (including extrasystole);
polymorphic ventricular tachycardia (ventricular arrhythmia of the "pirouette" type) or cardiac arrest, mainly in individuals with conditions predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia;
shortness of breath, including an asthmatic condition;
nausea, vomiting;
stomach ache;
diarrhea;
anorexia;
constipation;
dyspepsia;
flatulence;
gastroenteritis (other than erosive gastroenteritis);
stomatitis;
pseudomembranous colitis (in very rare cases, associated with life-threatening complications);
jaundice;
hepatitis (mainly cholestatic);
dizziness;
headache;
confusion;
disorientation;
drowsiness;
tremor;
sleep disorders;
sense of anxiety;
increased psychomotor activity;
impaired coordination (including gait disturbance due to dizziness, in very rare cases leading to injuries due to falls, especially in elderly patients);
convulsive seizures with various clinical manifestations (including grand mal seizures);
attention disorders;
speech disorders;
amnesia;
depression (in very rare cases, behavior with a tendency to self-harm is possible);
hallucinations;
psychotic reactions (potentially manifested in behavior with a tendency to self-harm);
taste disorders;
visual disturbances (blurring, decreased visual acuity, diplopia, especially in combination with dizziness and confusion);
noise in ears;
impaired sense of smell, including anosmia;
loss of taste sensitivity;
anemia, leukopenia (including neutropenia), thrombocytopenia, thrombocytosis, prolongation of prothrombin time and decrease in INR;
arthralgia;
myalgia;
tendinitis;
increased muscle tone and cramps;
tendon ruptures;
candida superinfection;
vaginitis;
dehydration (caused by diarrhea or decreased fluid intake);
impaired renal function;
renal failure as a result of dehydration, which can lead to kidney damage (especially in elderly patients with concomitant impaired renal function);
bullous skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening);
hives;
rash;
eosinophilia;
anaphylactic / anaphylactoid reactions;
angioedema, including laryngeal edema (potentially life-threatening);
anaphylactic shock (including life-threatening);
general malaise (including symptoms of feeling unwell, non-specific pain and sweating);
swelling.

Contraindications

pregnancy;
lactation (breastfeeding);
children and adolescents up to 18 years of age;
hypersensitivity to moxifloxacin and other components of the drug.

Use during pregnancy and lactation

The safety of Avelox during pregnancy has not been established, so 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 not available. Therefore, the use of Avelox during breastfeeding is also contraindicated.

In experimental studies, when studying the effect of moxifloxacin on reproductive function in rats, rabbits and monkeys, it was proved that moxifloxacin crosses the placental barrier. Studies conducted in rats (with the introduction of moxifloxacin orally and / in) and monkeys (with the introduction of moxifloxacin orally) did not reveal the teratogenic effect of moxifloxacin and its effect on fertility. With intravenous administration of moxifloxacin to rabbits at a dose of 20 mg/kg, skeletal malformations were observed. An increase in the number of miscarriages in monkeys and rabbits was found with the use of moxifloxacin at a therapeutic dose. In rats, a decrease in fetal weight, an increase in miscarriages, a slight increase in the duration of pregnancy, and an increase in spontaneous activity of the offspring of both sexes were observed with the use of moxifloxacin, the dose of which was 63 times higher than the recommended one.

Use in elderly patients

Elderly patients do not need to change the dosing regimen.

Use in children

The drug is contraindicated in children and adolescents under 18 years of age.

special instructions

It should be borne in mind that when prescribing Avelox, the risk of convulsive seizures increases, therefore, the drug is prescribed with caution to patients with CNS diseases accompanied by convulsions or predisposing to their development or a decrease in the threshold of convulsive readiness, as well as if such diseases and conditions are suspected.

When using Avelox, some patients may experience a prolongation of the QT interval. In this regard, the drug should be avoided in patients with prolongation of the QT interval, hypokalemia, as well as on the background of treatment with class 1 A antiarrhythmic drugs (quinidine, procainamide) or class 3 (amiodarone, sotalol) antiarrhythmic drugs, since the experience of using moxifloxacin in these patients is limited. Avelox should be administered with caution along with drugs that prolong the QT interval (cisapride, erythromycin, antipsychotics, tricyclic antidepressants), as well as in patients with conditions predisposing to arrhythmias, such as bradycardia, acute myocardial ischemia. The degree of prolongation of the QT interval may increase with increasing concentration of the drug, so do not exceed the recommended dose. Prolongation of the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. In patients with pneumonia, there was no correlation between plasma concentrations of moxifloxacin and prolongation of the QT interval. None of the 9000 patients treated with moxifloxacin experienced QT-related cardiovascular complications and deaths. However, in patients with predisposing conditions to arrhythmias, the use of moxifloxacin may increase the risk of developing ventricular arrhythmias.

Against the background of therapy with fluoroquinolones, incl. moxifloxacin, especially in the elderly and patients receiving glucocorticosteroids (GCS), tendinitis and tendon rupture may develop. If pain or signs of inflammation of the tendon appear, stop taking Avelox and unload the affected limb.

The use of broad-spectrum antibacterial drugs is associated with the risk of developing pseudomembranous colitis. This should be borne in mind if severe diarrhea occurs during treatment with Avelox. In this case, the drug should be discontinued and appropriate therapy should be prescribed immediately.

Do not use Avelox together with ethanol (alcohol).

There is a risk of developing hypersensitivity reactions and anaphylactic reactions during the initial use of the drug. Very rarely, an anaphylactic reaction can progress to anaphylactic shock. In such cases, you should immediately stop the administration of the drug and take appropriate resuscitation measures (including anti-shock).

When using quinolones, photosensitivity reactions are noted. However, when conducting preclinical, clinical studies, as well as when using Avelox in clinical practice, no photosensitivity reactions were noted. However, patients during the period of taking the drug should avoid direct sunlight and UV radiation.

Patients of different ethnic groups do not require dose adjustment.

Influence on the ability to drive vehicles and control mechanisms

Despite the fact that moxifloxacin rarely causes adverse reactions from the central nervous system, the question of the possibility of driving a car or moving machinery is decided individually after assessing the patient's response to taking the drug.

drug interaction

No dose adjustment is required when Avelox is co-administered with atenolol, ranitidine, calcium-containing supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid (no clinically significant interaction with moxifloxacin has been confirmed).

The combined use of Avelox and antacids, minerals and vitamin-mineral complexes inside can disrupt the absorption of moxifloxacin due to the formation of chelate complexes with the polyvalent cations contained in these preparations, and therefore reduce the concentration of moxifloxacin in the blood plasma. In this regard, antacids, antiretroviral and other drugs containing calcium, magnesium, aluminum, iron, sucralfate should be taken at least 4 hours before or 2 hours after ingestion of Avelox.

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

In patients receiving anticoagulants in combination with antibiotics, incl. with moxifloxacin, there have been 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 the interaction between moxifloxacin and warfarin is not detected, in patients receiving concomitant treatment with these drugs, it is necessary to monitor the INR and, if necessary, adjust the dose of oral anticoagulants.

Moxifloxacin and digoxin do not significantly affect each other's pharmacokinetic parameters.

With the simultaneous use of activated charcoal and oral moxifloxacin at a dose of 400 mg, the systemic bioavailability of the drug is reduced by more than 80% as a result of slowing down its absorption. In case of an overdose, the use of activated charcoal at an early stage of absorption prevents a further increase in systemic exposure.

The absorption of moxifloxacin does not change with the simultaneous ingestion of food (including dairy products). Moxifloxacin can be taken with or without food.

Analogues of the drug Avelox

Structural analogues for the active substance:

Vigamox;
Moximac;
Moxin;
Moxifloxacin;
Moxifur;
Plevilox.

Analogues by pharmacological group (antibiotics quinolones and fluoroquinolones):

Abaktal;
Alcipro;
Vigamox;
Gatispan;
Glevo;
Zanocin;
Zoflox;
Quipro;
Levolet R;
Levofloxacin;
Lomefloxacin;
Microflox;
Nevigramon;
Negroes;
Nolicin;
Norbactin;
Norfloxacin;
Ofloks;
Ofloxacin;
Oflocid;
Oflocid forte;
Palin;
Pefloxacin;
Recipro;
Sifloks;
Tavanic;
Uniflox;
Factive;
Floracid;
Hyleflox;
Ciprobay;
Tsiprolet;
Ciprofloxacin;
Cifran;
Elefloks;
Unikpef;
Youtibid.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

Instruction:

Clinical and pharmacological group

06.038 (Antibacterial drug of the fluoroquinolone group)

Release form, composition and packaging

Solution for infusion transparent, greenish-yellow color.

Excipients: sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.

250 ml - polyolefin bags (1) - polyethylene bags laminated with foil (12) - cardboard boxes.

pharmachologic effect

Antibacterial drug of the fluoroquinolone group. It has a bactericidal effect. The mechanism of action is due to the inhibition of bacterial topoisomerases II and IV, which leads to a disruption in the synthesis of DNA in a microbial cell and, as a result, to the death of a microbial cell. The minimum bactericidal concentrations of the drug are generally comparable to its MIC.

In vitro, the drug is active against a wide range of gram-negative and gram-positive microorganisms, anaerobes, acid-resistant bacteria and atypical forms, such as Mycoplasma spp., Chlamydia spp., Legionella spp., as well as bacteria resistant to β-lactam and macrolide antibiotics.

Gram-positive aerobic bacteria are sensitive to Avelox: Streptococcus pneumoniae (including strains resistant to penicillin and macrolides), Streptococcus pyogenes (group A) *, Streptococcus milleri, Streptococcus mitis, Streptococcus agalactiae *, Streptococcus dysgalactiae, Streptococcus anginosus *, Streptococcus constellatus *, Staphylococcus aureus (including methicillin-susceptible strains)*, Staphylococcus cohnii, Staphylococcus epidermidis (including methicillin-susceptible strains), Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus simulans, Corynebacterium diphtheriae, Enterococcus faecalis (vancomycin and gentamicin-susceptible strains only) *; Gram-negative aerobic bacteria: Haemophilus influenzae (including β-lactamase and non-β-lactamase producing strains)*, Haemophilus parainfluenzae*, Klebsiella pneumoniae*, Moraxella catarrhalis (including β-lactamase producing and non-β-lactamase producing strains)*, 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, Gardnerella vaginalis; anaerobic bacteria: Bacteroides distasonis, Bacteroides eggerthii, Bacteroides fragilis*, Bacteroides ovatus, Bacteroides thetaiotaomicron*, Bacteroides uniformis, Fusobacterium spp., Peptostreptococcus spp.*, Porphyromonas spp. (including Porphyromonas anaerobius, Porphyromonas asaccharolyticus, Porphyromonas magnus), Prevotella spp., Propionibacterium spp., Clostridium perfringens*, Clostridium ramosum; atypical bacteria: Chlamydia pneumoniae*, Mycoplasma pneumoniae*, Legionella pneumophila*, Coxiella burnettii, Chlamydia trachomatis, Mycoplasma hominis, Mycoplasma genitalium.

Moxifloxacin is less active against Staphylococcus aureus (methicillin/ofloxacin resistant strains)*, Staphylococcus epidermidis (methicillin/ofloxacin resistant strains)*, Pseudomonas aeruginosa, Pseudomonas fluorescens, Burkholderia cepacia, Stenotrophomonas maltophilia, Neisseria gonorrhoea.

The mechanisms leading to the development of resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not impair the antibacterial activity of moxifloxacin. Cross-resistance between these groups of antibacterial drugs and moxifloxacin is not observed. No cases of plasmid resistance have been observed so far either. The overall frequency of development of resistance is very low (10-7-10-10). Resistance to moxifloxacin develops slowly through multiple mutations. Repeated exposure of microorganisms to moxifloxacin at concentrations below the MIC is accompanied by only a slight increase in the MIC.

Cases of cross-resistance to quinolones have been reported. However, some Gram-positive and anaerobic organisms resistant to other quinolones are sensitive to moxifloxacin.

* Susceptibility to moxifloxacin is confirmed by clinical data.

Pharmacokinetics

Suction

After oral administration, moxifloxacin is absorbed rapidly and almost completely. After a single dose of moxifloxacin at a dose of 400 mg, Cmax in the blood is reached within 0.5-4 hours and is 3.1 mg / l. When taking moxifloxacin with food, there is a slight increase in the time to reach Cmax (by 2 hours) and a slight decrease in Cmax (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.

After a single infusion of Avelox at a dose of 400 mg for 1 hour, Cmax is reached at the end of the infusion and is 4.1 mg / l, which corresponds to an increase of approximately 26% compared with the value of this indicator when taken orally. With repeated intravenous infusions at a dose of 400 mg lasting 1 hour, Cmax varies from 4.1 mg / l to 5.9 mg / l. Average Css equal to 4.4 mg/l are reached at the end of the infusion.

Absolute bioavailability is about 91%.

The pharmacokinetics of moxifloxacin when taken in single doses from 50 mg to 1200 mg, as well as at a dose of 600 mg / day for 10 days, is linear.

Distribution

The equilibrium state is reached within 3 days.

Binding to blood proteins (mainly albumin) is about 45%.

Moxifloxacin is rapidly distributed in organs and tissues. Vd is approximately 2 l/kg.

High concentrations of the drug, exceeding those in plasma, are created in the lung tissue (including in alveolar macrophages), in the bronchial mucosa, in the nasal sinuses, in soft tissues, skin and subcutaneous structures, and foci of inflammation. In the interstitial fluid and in saliva, the drug is determined in a free, non-protein-bound form, at a concentration higher than in plasma. In addition, high concentrations of the drug 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 is not biotransformed by microsomal liver enzymes of the cytochrome P450 system.

breeding

After passing through the 2nd phase of biotransformation, moxifloxacin is excreted from the body by the kidneys and through the intestines both unchanged and in the form of inactive sulfo compounds and glucuronides.

It is excreted in the urine, as well as in the feces, both unchanged and in the form of inactive metabolites. With a single dose of 400 mg, about 19% is excreted unchanged in the urine, about 25% in the feces. T1 / 2 is approximately 12 hours. The average total clearance after taking a dose of 400 mg is from 179 ml / min to 246 ml / min.

Pharmacokinetics in special clinical situations

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

Pharmacokinetic studies of moxifloxacin in children have not been conducted.

There were no significant changes in the pharmacokinetics of moxifloxacin in patients with impaired renal function (including with CC<30 мл/мин/1.73 м2) и у находящихся на непрерывном гемодиализе и длительном амбулаторном перитонеальном диализе.

In patients with mild to moderate hepatic impairment (Child-Pugh class A or B), the pharmacokinetics of moxifloxacin does not change. In patients with severely impaired liver function (Child-Pugh class C), there are no data on the pharmacokinetics of moxifloxacin.

Dosage

The drug is prescribed orally and intravenously, 400 mg 1 time / day.

The duration of treatment with Avelox when administered orally and intravenously is determined by the severity of the infection and the clinical effect and is: with exacerbation of chronic bronchitis - 5 days; with community-acquired pneumonia, the total duration of stepped therapy (in / in the introduction followed by oral administration) - 7-14 days, first in / in, then inside, or 10 days inside; with acute sinusitis and uncomplicated infections of the skin and soft tissues - 7 days; with complicated infections of the skin and subcutaneous tissues - the total duration of gradual therapy (in / in the introduction followed by oral administration) is 7-21 days; with complicated intra-abdominal infections - the total duration of gradual therapy (in / in the introduction of the drug, followed by oral administration) is 5-14 days; with uncomplicated inflammatory diseases of the pelvic organs -14 days.

The duration of treatment with Avelox IV can reach 14 days, inside - 21 days.

Tablets should be taken without chewing, with a small amount of water, regardless of the meal.

Overdose

No side effects were noted when using Avelox at a dose of up to 1200 mg once and 600 mg for more than 10 days.

Treatment: in case of overdose, according to the clinical situation, symptomatic therapy with ECG monitoring is carried out. The use of activated charcoal is advisable only in case of an overdose of moxifloxacin in the form of tablets.

drug interaction

No dose adjustment is required when Avelox® is co-administered with atenolol, ranitidine, calcium-containing supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid (no clinically significant interaction with moxifloxacin has been confirmed).

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

Moxifloxacin and digoxin do not significantly affect each other's pharmacokinetic parameters. With repeated administration of moxifloxacin, Cmax of digoxin increased by approximately 30%. At the same time, the ratio of AUC and Cmix of digoxin does not change.

The absorption of moxifloxacin does not change with the simultaneous ingestion of food (including dairy products). Moxifloxacin can be taken with or without food.

Use during pregnancy and lactation

The safety of Avelox during pregnancy has not been established, so its use is contraindicated.

Side effects

Data on the side effects of the drug moxifloxacin 400 mg (oral and step therapy) are obtained from clinical studies and post-marketing reports.

Determining the frequency of adverse reactions: often (> 1%,< 10%), иногда (> 0.1%, <1%), редко (> 0.01%, <0.1%), очень редко (< 0.01%).

Adverse events classified as "common" were observed in less than 3% of patients, except for nausea and diarrhea.

From the side of the cardiovascular system: prolongation of the QT interval (often in patients with concomitant hypokalemia, sometimes in other patients); sometimes - tachycardia and vasodilation (flushing of blood to the face); rarely - arterial hypotension, arterial hypertension, syncope, ventricular tachyarrhythmias; very rarely - nonspecific arrhythmias (including extrasystole), polymorphic ventricular tachycardia (pirouette-type ventricular arrhythmia) or cardiac arrest, mainly in individuals with conditions predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia.

From the respiratory system: sometimes - shortness of breath, including an asthmatic condition.

From the digestive system: often - nausea, vomiting, abdominal pain, diarrhea, transient increase in transaminase levels; sometimes - anorexia, constipation, dyspepsia, flatulence, gastroenteritis (except erosive gastroenteritis), increased levels of amylase, bilirubin, abnormal liver function (including increased levels of LDH), increased activity of GGT and alkaline phosphatase; rarely - dysphagia, stomatitis, pseudomembranous colitis (in very rare cases associated with life-threatening complications), jaundice, hepatitis (mainly cholestatic); very rarely - fulminant hepatitis, potentially leading to life-threatening liver failure.

From the side of the central nervous system and peripheral nervous system: often - dizziness, headache; sometimes - confusion, consciousness, disorientation, vertigo, drowsiness, tremor, paresthesia, dysesthesia, sleep disturbances, anxiety, increased psychomotor activity, agitation; rarely - hypesthesia, pathological dreams, impaired coordination (including gait disturbance due to dizziness, in very rare cases leading to injuries as a result of a fall, especially in elderly patients), convulsive seizures with various clinical manifestations (including grand mal seizures), attention disturbances, speech disorders, amnesia, emotional lability, depression (in very rare cases, behavior with a tendency to self-harm is possible), hallucinations; very rarely - hyperesthesia, depersonalization, psychotic reactions (potentially manifested in behavior with a tendency to self-harm).

From the senses: sometimes - taste disorders, visual disturbances (blurring, decreased visual acuity, diplopia, especially in combination with dizziness and confusion); rarely - tinnitus, impaired sense of smell, including anosmia; very rarely - loss of taste sensitivity.

From the hematopoietic system: sometimes - anemia, leukopenia (including neutropenia), thrombocytopenia, thrombocytosis, prolongation of prothrombin time and decrease in INR; rarely - a 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: sometimes - arthralgia, myalgia; rarely - tendinitis, increased muscle tone and convulsions; very rarely - tendon ruptures, arthritis, gait disturbance due to damage to the musculoskeletal system.

From the reproductive system: often - candidal superinfection, vaginitis.

From the urinary system: sometimes - dehydration (caused by diarrhea or decreased fluid intake); rarely - impaired renal function, renal failure as a result of dehydration, which can lead to kidney damage (especially in elderly patients with concomitant impaired renal function).

Dermatological reactions: very rarely - bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).

Allergic reactions: sometimes - urticaria, itching, 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: hyperlipidemia, hyperglycemia, hyperuricemia.

On the part of the body as a whole: sometimes - general malaise (including symptoms of poor health, nonspecific pain and sweating); rarely - swelling.

Terms and conditions of storage

List B. Tablets should be stored out of the reach of children, in a dry place at a temperature not exceeding 25 ° C. Shelf life - 5 years.

List B. The solution for infusion should be stored in a dry, dark place and out of the reach of children at a temperature of 8 ° to 25 ° C; do not freeze. Shelf life - 5 years.

After dilution with compatible solvents, the Avelox solution remains stable for 24 hours at room temperature. Since the solution cannot be frozen or refrigerated, it must not be stored in a refrigerator. The solution may precipitate on cooling, but the precipitate usually dissolves at room temperature. The solution should only be stored in the original container.

Indications

Infectious and inflammatory diseases in adults caused by microorganisms sensitive to the drug:

- acute sinusitis;

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

- exacerbation of chronic bronchitis;

- uncomplicated infections of the skin and soft tissues;

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

- complicated intra-abdominal infections, including polymicrobial infections, incl. intraperitoneal abscesses;

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

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

Contraindications

- pregnancy;

- lactation (breastfeeding);

- children and adolescents up to 18 years of age;

- hypersensitivity to moxifloxacin and other components of the drug.

Use with caution in diseases of the central nervous system (including diseases suspected of involving the central nervous system), predisposing to the occurrence of convulsive seizures and lowering the threshold for convulsive readiness, with prolongation of the QT interval, hypokalemia, bradycardia, acute myocardial ischemia, while taking drugs that prolong the QT interval, and antiarrhythmic drugs of classes IA and III, with severe liver failure.

special instructions

It should be borne in mind that when prescribing Avelox®, the risk of convulsive seizures increases, therefore, the drug is prescribed with caution to patients with CNS diseases accompanied by convulsions or predisposing to their development or a decrease in the threshold of convulsive readiness, as well as when such diseases and conditions are suspected.

When using Avelox, some patients may experience a prolongation of the QT interval. In this regard, the drug should be avoided in patients with prolongation of the QT interval, hypokalemia, as well as against the background of treatment with antiarrhythmic drugs of class I A (quinidine, procainamide) or class III (amiodarone, sotalol), since the experience of using moxifloxacin in these patients is limited. Avelox® should be administered with caution along with drugs that prolong the QT interval (cisapride, erythromycin, antipsychotics, tricyclic antidepressants), as well as in patients with conditions predisposing to arrhythmias, such as bradycardia, acute myocardial ischemia. The degree of prolongation of the QT interval may increase with increasing concentration of the drug, so do not exceed the recommended dose. Prolongation of the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. In patients with pneumonia, there was no correlation between plasma concentrations of moxifloxacin and prolongation of the QT interval. None of the 9000 patients treated with moxifloxacin experienced QT-related cardiovascular complications and deaths. However, in patients with predisposing conditions to arrhythmias, the use of moxifloxacin may increase the risk of developing ventricular arrhythmias.

Against the background of therapy with fluoroquinolones, incl. moxifloxacin, especially in the elderly and patients receiving corticosteroids, tendinitis and tendon rupture may develop. If pain or signs of inflammation of the tendon appear, stop taking Avelox and unload the affected limb.

Patients of different ethnic groups do not require dose adjustment.

Pediatric use

The efficacy and safety of Avelox® in children and adolescents have not been established.

Influence on the ability to drive vehicles and control mechanisms

Results of experimental studies

The following pathological changes are manifestations of the toxic effects of moxifloxacin, as well as other fluoroquinolones: the hematopoietic system (hypoplasia of the bone marrow in dogs and monkeys), the central nervous system (convulsions in monkeys) and the liver (increased activity of liver enzymes, single necrosis of hepatocytes in rats, dogs and monkeys) . These disturbances occur, as a rule, after a long period of administration of moxifloxacin in high doses.

Use for impaired renal function

Patients with impaired renal function (including with CC<30 мл/мин/1.73 м2), а также пациентам, находящимся на непрерывном гемодиализе и длительном амбулаторном перитонеальном диализе, изменений режима дозирования не требуется

Use in violation of liver function

Patients with mild hepatic impairment (Child-Pugh class A or B) do not need to change the dosing regimen.

Use with caution in severe liver failure.

This page contains detailed instructions for use. Avelox. The available dosage forms of the drug are listed (400 mg tablets, injections in ampoules for injection in an antibiotic solution), as well as its analogues. Information is provided on the side effects that Avelox can cause, on interactions with other drugs. In addition to information about the diseases for the treatment and prevention of which the drug is prescribed (sinusitis, prostatitis, pyelonephritis, chlamydia and other infectious diseases), the algorithms for admission, possible dosages for adults and children are described in detail, the possibility of using during pregnancy and breastfeeding is specified. The annotation to Avelox is supplemented by reviews of patients and doctors. The composition of the drug.

Instructions for use and dosing regimen

The drug is prescribed orally and intravenously, 400 mg 1 time per day.

The duration of treatment with Avelox when taken orally and intravenously is determined by the severity of the infection and the clinical effect and is: with exacerbation of chronic bronchitis - 5 days; with community-acquired pneumonia, the total duration of stepped therapy (in / in the introduction followed by oral administration) - 7-14 days, first in / in, then inside, or 10 days inside; with acute sinusitis and uncomplicated infections of the skin and soft tissues - 7 days; with complicated infections of the skin and subcutaneous tissues - the total duration of gradual therapy (in / in the introduction followed by oral administration) is 7-21 days; with complicated intra-abdominal infections - the total duration of gradual therapy (in / in the introduction of the drug, followed by oral administration) is 5-14 days; with uncomplicated inflammatory diseases of the pelvic organs -14 days.

The duration of treatment with Avelox intravenously can reach 14 days, orally - 21 days.

Elderly patients, patients with mild hepatic impairment (class A or B on the Child-Pugh scale), patients with impaired renal function (including those with CC less than 30 ml / min / 1.73 m2), as well as patients who are on continuous hemodialysis and long-term ambulatory peritoneal dialysis, changes in dosing regimen are not required.

Tablets should be taken without chewing, with a small amount of water, regardless of the meal.

Compound

Moxifloxacin hydrochloride + excipients.

Release form

Film-coated tablets 400 mg.

Solution for infusion (injections in ampoules for injection).

Gram-positive and gram-negative aerobic bacteria, anaerobic bacteria, atypical bacteria are sensitive to Avelox: Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila, Coxiella burnettii, Chlamydia trachomatis, Mycoplasma hominis, Mycoplasma genitalium.

Moxifloxacin (the active ingredient of Avelox) is less active against Staphylococcus aureus (methicillin/ofloxacin resistant strains), Staphylococcus epidermidis (methicillin/ofloxacin resistant strains), Pseudomonas aeruginosa, Pseudomonas fluorescens, Burkholderia cepacia, Stenotrophomonas maltophilia, gorhoeis.

The mechanisms leading to the development of resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not impair the antibacterial activity of moxifloxacin. Cross-resistance between these groups of antibacterial drugs and moxifloxacin is not observed. No cases of plasmid resistance have been observed so far either. The overall frequency of development of resistance is very low (10-7-10-10). Resistance to moxifloxacin develops slowly through multiple mutations. Repeated exposure of microorganisms to moxifloxacin at concentrations below the MIC is accompanied by only a slight increase in the MIC.

Cases of cross-resistance to quinolones have been reported. However, some Gram-positive and anaerobic organisms resistant to other quinolones are sensitive to moxifloxacin.

Pharmacokinetics

After oral administration, Avelox is absorbed quickly and almost completely. When taking moxifloxacin with food, the duration of absorption does not change. The drug can be used regardless of the meal. Absolute bioavailability is about 91%. Binding to blood proteins (mainly albumin) is about 45%. Moxifloxacin is rapidly distributed in organs and tissues. High concentrations of the drug, exceeding those in plasma, are created in the lung tissue (including in alveolar macrophages), in the bronchial mucosa, in the nasal sinuses, in soft tissues, skin and subcutaneous structures, and foci of inflammation. In the interstitial fluid and in saliva, the drug is determined in a free, non-protein-bound form, at a concentration higher than in plasma. In addition, high concentrations of the drug are determined in the organs of the abdominal cavity and peritoneal fluid, as well as in the tissues of the female genital organs.

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

Pharmacokinetic studies of moxifloxacin in children have not been conducted.

Indications

Infectious and inflammatory diseases in adults caused by microorganisms sensitive to the drug:

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 soft tissues;
complicated infections of the skin and subcutaneous structures (including an infected diabetic foot);
complicated intra-abdominal infections, including polymicrobial infections, incl. intraperitoneal abscesses;
uncomplicated inflammatory diseases of the pelvic organs (including salpingitis and endometritis).

Contraindications

pregnancy;
lactation (breastfeeding);
children and adolescents up to 18 years of age;
hypersensitivity to moxifloxacin and other components of the drug.

special instructions

Do not use Avelox together with ethanol (alcohol).

Patients of different ethnic groups do not require dose adjustment.

Influence on the ability to drive vehicles and control mechanisms

Side effect

prolongation of the QT interval (often in patients with concomitant hypokalemia, sometimes in other patients);
tachycardia and vasodilation (flushing of the face);
arterial hypotension;
arterial hypertension;
fainting;
ventricular tachyarrhythmias;
nonspecific arrhythmias (including extrasystole);
polymorphic ventricular tachycardia (ventricular arrhythmia of the "pirouette" type) or cardiac arrest, mainly in individuals with conditions predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia;
shortness of breath, including an asthmatic condition;
nausea, vomiting;
stomach ache;
diarrhea;
anorexia;
constipation;
dyspepsia;
flatulence;
gastroenteritis (other than erosive gastroenteritis);
stomatitis;
pseudomembranous colitis (in very rare cases, associated with life-threatening complications);
jaundice;
hepatitis (mainly cholestatic);
dizziness;
headache;
confusion;
disorientation;
drowsiness;
tremor;
sleep disorders;
sense of anxiety;
increased psychomotor activity;
impaired coordination (including gait disturbance due to dizziness, in very rare cases leading to injuries due to falls, especially in elderly patients);
convulsive seizures with various clinical manifestations (including grand mal seizures);
attention disorders;
speech disorders;
amnesia;
depression (in very rare cases, behavior with a tendency to self-harm is possible);
hallucinations;
psychotic reactions (potentially manifested in behavior with a tendency to self-harm);
taste disorders;
visual disturbances (blurring, decreased visual acuity, diplopia, especially in combination with dizziness and confusion);
noise in ears;
impaired sense of smell, including anosmia;
loss of taste sensitivity;
anemia, leukopenia (including neutropenia), thrombocytopenia, thrombocytosis, prolongation of prothrombin time and decrease in INR;
arthralgia;
myalgia;
tendinitis;
increased muscle tone and cramps;
tendon ruptures;
candida superinfection;
vaginitis;
dehydration (caused by diarrhea or decreased fluid intake);
impaired renal function;
renal failure as a result of dehydration, which can lead to kidney damage (especially in elderly patients with concomitant impaired renal function);
bullous skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening);
hives;
rash;
eosinophilia;
anaphylactic / anaphylactoid reactions;
angioedema, including laryngeal edema (potentially life-threatening);
anaphylactic shock (including life-threatening);
general malaise (including symptoms of feeling unwell, non-specific pain and sweating);
swelling.

drug interaction

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

Moxifloxacin and digoxin do not significantly affect each other's pharmacokinetic parameters.

The absorption of moxifloxacin does not change with the simultaneous ingestion of food (including dairy products). Moxifloxacin can be taken with or without food.

Analogues of the drug Avelox

Structural analogues for the active substance:

Vigamox;
Moximac;
Moxin;
Moxifloxacin;
Moxifur;
Plevilox.

Analogues by pharmacological group (antibiotics quinolones and fluoroquinolones):

Abaktal;
Alcipro;
Vigamox;
Gatispan;
Glevo;
Zanocin;
Zoflox;
Quipro;
Levolet R;
Levofloxacin;
Lomefloxacin;
Microflox;
Nevigramon;
Negroes;
Nolicin;
Norbactin;
Norfloxacin;
Ofloks;
Ofloxacin;
Oflocid;
Oflocid forte;
Palin;
Pefloxacin;
Recipro;
Sifloks;
Tavanic;
Uniflox;
Factive;
Floracid;
Hyleflox;
Ciprobay;
Tsiprolet;
Ciprofloxacin;
Cifran;
Elefloks;
Unikpef;
Youtibid.

Use in elderly patients

Elderly patients do not need to change the dosing regimen.

Use in children

The drug is contraindicated in children and adolescents under 18 years of age.

Use during pregnancy and lactation

The safety of Avelox during pregnancy has not been established, so its use is contraindicated.

Which successfully copes with bacteria and is characterized by a fast and long-lasting effect. The substance is well tolerated by patients, and therefore is often prescribed by doctors. In any case, experts categorically do not advise self-medication.

Composition, release form, packaging

The drug is produced in 2 main forms:

Tablets that are pink in color and oblong in shape. There are 5 or 7 pieces in blisters. Each pack contains 1-2 blisters.
Yellow-green liquid for injection. The medicine is in 250 ml bottles or polyethylene bags of the same volume.

1 tablet contains 436.8 mg of moxifloxacin hydrochloride. It also contains additional components - titanium dioxide, magnesium stearate, iron oxide, cellulose.

In 1 ml of the solution, 1.6 mg of the main component, moxifloxacin, is present. Additional ingredients include sodium chloride, water.

Manufacturer

The tool is produced by the German company Bayer Weimar GmbH.

Indications

The substance is used in the event of infectious and inflammatory pathologies that provoke microorganisms that are sensitive to the main ingredient. These include the following:

acute form of sinusitis, sinusitis;
recurrence of chronic bronchitis,;
infectious pathologies of the dermis and soft tissues;
community-acquired pneumonia;
intra-abdominal pathologies of an infectious nature, including polymicrobial pathologies;
pelvic inflammatory disease, prostatitis.

Contraindications

age less than 18 years - this is due to the lack of the required number of studies;
on the ingredients of the substance and antibacterial agents of this series;
, which are accompanied by an increase in the QT interval;
lactation;
hypokalemia;
lactose intolerance;
serious liver pathology.

You should be very careful in such situations:

cirrhosis of the liver;
acute form;
pathology of the nervous system;
mental illness;
the use of other drugs that affect the functioning of the heart.

Mechanism of action

Avelox belongs to the category of fluoroquinolones. The medicine successfully copes with most harmful microorganisms. After the active ingredient enters the body, the DNA of abnormal cells is disrupted, which leads to their death.

With the help of the drug, you can cope with many bacteria, ureaplasma, mycoplasma, chlamydia, anaerobic infections. The drug successfully eliminates bacteria that are resistant to penicillins.

The antibacterial action of the drug is not affected by the mechanisms that provoke resistance to cephalosporins, tetracyclines, macrolides. Resistance to the basic substance avelox is developed gradually. Usually long-term mutations lead to it.

Instructions for use

Tablets should be taken orally with water. The drug does not need to be chewed. Its intake does not depend on food. For 1 time, the use of 400 mg of the substance is shown - this is the dose contained in 1 tablet.

The drug in the form of a solution is used intravenously. 400 mg of the substance is shown per day. Intravenous use of the drug is indicated for 14 days. Tablets can be taken up to 21 days.

For minor problems in the functioning of the liver or kidneys, the dosage is not adjusted. The same is true for patients who are on from toxic substances.

An intravenous solution is used by drip for an hour. It can be used alone or combined with other substances - water for injection or sodium chloride. In any case, only clear liquids may be used.

With great care, the remedy is prescribed for complex forms. In such a situation, strict medical supervision is required.

Side effects

Negative effects are extremely rare. They are usually associated with a violation of the rules of use or dosage. In such a situation, the following reactions may appear:

, abdominal pain, disorders of the taste buds, diarrhea.
, and heart rate.
feeling of anxiety, insomnia, depression.
Pain in muscle tissue, back,. There is a risk of tendon ruptures and the development of tendovaginitis.
The appearance of , and .
Hyperglycemia. There is also a risk of hyperlipidemia and hyperuricemia.
in various zones.

Instructions for use Avelox:

Overdose

There are few data on drug overdose. Side effects with a single dose of 1200 ml or 600 mg for 10 days did not occur.

If negative consequences nevertheless appeared, symptomatic treatment is carried out. It is also necessary to use ECG monitoring.

To reduce the effect of moxifloxacin on the body, activated charcoal is used immediately after using the drug.

special instructions

The harmlessness of the use of the substance during pregnancy has not been proven, therefore doctors prefer not to prescribe the drug. The same applies to lactation.

If pain occurs in the tendons or joints, the use of the drug is canceled. This helps prevent tendon rupture.

People suffering from, there is a risk of occurrence. Also, the remedy should be discontinued if severe diarrhea occurs. The drug is not used to treat children.

drug interaction

The drug goes well with atenolol, morphine, calcium-based drugs, theophylline. It can be combined with ranitidine, digoxin. Combination with indirect coagulants should be the basis for INR control. If necessary, the dosage of the antibacterial drug is adjusted.

With simultaneous use with antacids, minerals and vitamins, chelate complexes can form, which include polyvalent cations. As a result, the level of the antibiotic in the blood decreases. To avoid this, the interval between the use of funds should be 4 hours.

When a substance is combined with enterosorbents, the bioavailability of the agent is markedly reduced - by about 80%. If the antibiotic is administered intravenously, this figure is 20%.