Avelox is an effective drug that successfully copes with bacterial infections. Avelox: instructions for use, indications and side effects Avelox instructions for use tablets 400 mg

Infectious and inflammatory diseases caused by microorganisms sensitive to moxifloxacin: acute sinusitis, exacerbation of chronic bronchitis, uncomplicated infections of the skin and subcutaneous structures, community-acquired pneumonia, including community-acquired pneumonia, the causative agents of which are 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).

Contraindications Avelox tablets 400mg

Hypersensitivity to moxifloxacin, other quinolones or any other component of the drug, age under 18 years, pregnancy and breastfeeding, a history of tendon pathology that has developed as a result of treatment with quinolone antibiotics. In preclinical and clinical studies, after the administration of moxifloxacin, a change in the electrophysiological parameters of the heart was observed, expressed in the prolongation of the QT interval. In this regard, the use of moxifloxacin is contraindicated in patients of the following categories: congenital or acquired documented prolongation of the QT interval, electrolyte disturbances, especially uncorrected hypokalemia; clinically significant bradycardia; clinically significant heart failure with reduced ejection fraction of the left ventricle; a history of arrhythmias accompanied by clinical symptoms. Moxifloxacin should not be used with other drugs that prolong the QT interval. Due to the presence of lactose in the preparation, its administration is contraindicated in case of congenital lactose intolerance, lactase deficiency, glucose-galactose malabsorption. Due to limited clinical data, the use of moxifloxacin is contraindicated in patients with hepatic impairment (Child-Pugh class C) and in patients with transaminase elevations greater than five times the upper limit of normal.

Method of application and dosage Avelox tablets 400mg

The recommended dosing regimen for moxifloxacin is 400 mg (1 tablet) once daily for the infections listed above. Do not exceed the recommended dose. Tablets should be swallowed whole, without chewing, with plenty of water, regardless of the meal. duration of treatment. The duration of treatment is determined by the location and severity of the infection, as well as the clinical effect: exacerbation of chronic bronchitis: 5-10 days, acute sinusitis: 7 days, uncomplicated infections of the skin and subcutaneous structures: 7 days ingestion) 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 (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. According to clinical studies, 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 impaired liver function do not need to change the dosing regimen. Renal failure. In patients with impaired renal function (including severe renal failure with creatinine clearance

Instructions for use

Active ingredients

Release form

Tablets

Compound

1 tablet contains: Active substance: moxifloxacin hydrochloride 436.8 mg (corresponds to moxifloxacin base - 400 mg)

Pharmacological effect

Broad-spectrum antibacterial bactericidal drug, 8-methoxyfluoroquinolone. The bactericidal effect of moxifloxacin is due to the inhibition of bacterial topoisomerases II and IV, which leads to disruption of the processes of replication, repair and transcription of microbial DNA biosynthesis and, as a result, to the death of microbial cells. The minimum bactericidal concentrations of the drug are generally comparable to its MIC. Mechanisms of resistance: Mechanisms leading 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 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 moxifloxacin to microorganisms at concentrations below the MIC is accompanied by only a slight increase. Cases of cross-resistance to quinolones have been reported. However, some Gram-positive and anaerobic organisms resistant to other quinolones remain susceptible to moxifloxacin. It has been established that the addition of a methoxy group at position C8 to the structure of the moxifloxacin molecule increases the activity of moxifloxacin and reduces the formation of resistant mutant strains of gram-positive bacteria. The addition of a bicycloamine group at position C7 prevents the development of active efflux, the mechanism of resistance to fluoroquinolones. Moxifloxacin is active in vitro against a wide range of gram-negative and gram-positive microorganisms, anaerobes, acid-fast bacteria and atypical bacteria such as Mycoplasma spp., Chlamydia spp., Legionella spp., as well as bacteria resistant to beta-lactam and macrolide antibiotics. Effects on the human intestinal microflora: In two studies conducted on volunteers, the following changes in the intestinal microflora after oral administration of moxifloxacin were noted: a decrease in the concentrations of Escherichia coli, Bacillus spp., Bacteroides vulgatus, Enterococcus spp., Klebsiella spp., and anaerobes Bifidobacterium spp. , Eubacterium spp., Peptostreptococcus spp. These changes were reversible within two weeks. No Clostridium difficile toxins were found.

Pharmacokinetics

Absorption: After oral administration, moxifloxacin is absorbed rapidly and almost completely. Absolute bioavailability is about 91%. The pharmacokinetics of moxifloxacin when taken at a dose of 50 to 1200 mg once, as well as 600 mg / day for 10 days, is linear. 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. After oral administration of moxifloxacin at a dose of 400 mg 1 time / day, Cssmax and Cssmin are 3.2 mg / l and 0.6 mg / l, respectively. 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. 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 moxifloxacin, exceeding those in plasma, are created in the lung tissue (including in the epithelial fluid, alveolar macrophages), in the nasal sinuses (maxillary and ethmoid sinuses), in nasal polyps, foci of inflammation (in the contents of blisters with skin lesions ). In the interstitial fluid and in saliva, moxifloxacin is determined in a free, non-protein-bound form, at a concentration higher than in plasma. In addition, high concentrations of moxifloxacin are determined in the tissues of the abdominal organs, peritoneal fluid, and also in the tissues of the female genital organs. Metabolism: Moxifloxacin undergoes phase 2 biotransformation and is excreted from the body by the kidneys, as well as through the intestines, both unchanged and in the form of inactive sulfo compounds (M1) and glucuronides (M2). Moxifloxacin is not biotransformed by the microsomal cytochrome P450 system. Metabolites M1 and M2 are present in 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 effect on the body in terms of safety and tolerability. Withdrawal: T1 / 2 is approximately 12 hours. The average total clearance after taking the drug orally at a dose of 400 mg is 179-246 ml / min. Renal clearance is 24-53 ml/min. This indicates partial tubular reabsorption of the drug. The mass balance of the parent compound and phase 2 metabolites is approximately 96-98%, indicating the absence of oxidative metabolism. About 22% of a single dose (400 mg) is excreted unchanged by the kidneys, about 26% - through the intestines. Pharmacokinetics in special groups of patients: In the study of the pharmacokinetics of moxifloxacin in men and women, differences of 33% were found in AUC and Cmax. Absorption of moxifloxacin was independent of gender. Differences in AUC and Cmax were due to differences in body weight rather than gender and are not considered clinically relevant. There were no clinically significant differences in the pharmacokinetics of moxifloxacin in patients of different ethnic groups and different ages. 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 those with CC less than 30 ml / min / 1.73 m2) and in patients on continuous hemodialysis and long-term outpatient peritoneal dialysis. There were no significant differences in the concentration of moxifloxacin in patients with impaired liver function (Child-Pugh classes A and B) compared with healthy volunteers and patients with normal liver function.

Indications

Infectious and inflammatory diseases in adults caused by microorganisms sensitive to the drug: Acute sinusitis Exacerbation of chronic bronchitis Community-acquired pneumonia (including those caused by strains of microorganisms with multiple antibiotic resistance*) 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 pelvic inflammatory disease (including salpingitis and endometritis). * Streptococcus pneumoniae with multiple antibiotic resistance includes penicillin-resistant strains and strains resistant to two or more antibiotics from groups such as penicillins ( at mic ≥2 mg/ml), 2nd 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

A history of tendon pathology developed as a result of treatment with quinolone antibiotics. In preclinical and clinical studies, after the administration of moxifloxacin, a change in the electrophysiological parameters of the heart was observed, expressed in the prolongation of the interval. In this regard, the use of moxifloxacin is contraindicated in patients of the following categories: congenital or acquired documented prolongation of the interval, electrolyte disturbances, especially uncorrected hypokalemia. Clinically significant bradycardia. Clinically significant heart failure with reduced left ventricular ejection fraction. A history of rhythm disturbances accompanied by clinical symptoms. Moxifloxacin cannot be used with other drugs that lengthen the interval. Due to the presence of lactose in the preparation, its administration is contraindicated in case of congenital lactose intolerance, lactase deficiency, glucose-galactose malabsorption (for tablets). Due to limited clinical data, the use of moxifloxacin is contraindicated in patients with hepatic impairment (Child-Pugh class C) and in patients with transaminase elevations greater than 5 times UL. Pregnancy. Lactation (breastfeeding). Age up to 18 years. Hypersensitivity to moxifloxacin, other quinolones or any other component of the drug. With caution, the drug should be prescribed for diseases of the central nervous system (including diseases suspected of involving the central nervous system), predisposing to the occurrence of seizures and reducing the threshold for convulsive readiness. In patients with psychosis and / or psychiatric diseases in history. In patients with potentially proarrhythmic conditions such as acute myocardial ischemia and cardiac arrest, especially in women and elderly patients. With myasthenia gravis. With cirrhosis of the liver. When taken simultaneously with drugs that reduce the content of potassium. In patients with a genetic predisposition or actual deficiency of glucose-6-phosphate dehydrogenase. Pregnancy and lactation The safety of moxifloxacin during pregnancy has not been established and its use is contraindicated. Cases of reversible joint damage have been described in children receiving certain quinolones, but this effect has not been reported in the fetus (when used by the mother during pregnancy). Reproductive toxicity has been shown in animal studies. 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 has been established that a small amount of moxifloxacin is excreted in breast milk. Data on its use in women during lactation are not available. Therefore, the appointment of moxifloxacin during breastfeeding is contraindicated.

Precautionary measures

With caution, the drug should be prescribed for diseases of the central nervous system (including diseases suspected of involving the central nervous system) that predispose to the occurrence of seizures and reduce the threshold for convulsive readiness; in patients with a history of psychosis and / or psychiatric diseases, in patients with potentially proarrhythmic conditions such as acute myocardial ischemia and cardiac arrest, especially in women and elderly patients, with myasthenia gravis, with cirrhosis of the liver, while taking with drugs, reducing the content of potassium; in patients with a genetic predisposition or actual deficiency of glucose-6-phosphate dehydrogenase.

Use during pregnancy and lactation

The safety of moxifloxacin during pregnancy has not been established and its use is contraindicated. Cases of reversible joint damage have been described in children receiving certain quinolones, but this effect has not been reported in the fetus (when used by the mother during pregnancy). Reproductive toxicity has been shown in animal studies. 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 has been established that a small amount of moxifloxacin is excreted in breast milk. Data on its use in women during lactation are not available. Therefore, the appointment of moxifloxacin during breastfeeding is contraindicated.

Dosage and administration

The drug is prescribed orally 400 mg 1 time / day. Tablets should be taken without chewing, drinking plenty of water, regardless of the meal. Do not exceed the recommended dose. The duration of treatment with Avelox when taken orally is determined by the severity of the infection and the clinical effect and is: with exacerbation of chronic bronchitis - 5-10 days; with community-acquired pneumonia, the total duration of 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 stepwise 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 can reach 21 days. Changes in the dosing regimen in elderly patients are not required. The efficacy and safety of moxifloxacin in children and adolescents has not been established. Patients with impaired liver function do not need to change the dosage regimen. In patients with impaired renal function (including those with severe renal failure with CC ≤30 ml / min / 1.73 m2), as well as in patients on continuous hemodialysis and long-term ambulatory peritoneal dialysis, a change in dosing regimen is not required. In patients of different ethnic groups, a change in dosing regimen is not required.

Side effects

Data on adverse reactions reported with the use of moxifloxacin at a dose of 400 mg (by mouth, with stepwise therapy [in / in the introduction of the drug followed by oral administration] and only in / in) are obtained from clinical studies and post-marketing reports (highlighted in italics). Adverse reactions listed in the group often occurred with a frequency below 3%, with the exception of nausea and diarrhea. In each frequency group, adverse drug reactions are listed in descending order of significance. Determination of the frequency of adverse reactions often (from ≥1/100 to less than 1/10), infrequently (from ≥1/1000 to less than 1/100), rarely (from ≥1/10,000 to less than 1/1000), very rarely (less than 1/10 000). Infections are often fungal superinfections. On the part of the hematopoietic system, infrequently - anemia, leukopenia, neutropenia, thrombocytopenia, thrombocythemia, prolongation of prothrombin time / increase in INR. rarely - a change in the concentration of thromboplastin. very rarely - an increase in the concentration of prothrombin / a decrease in INR. From the immune system infrequently - allergic reactions, urticaria, itching, rash, eosinophilia. rarely - anaphylactic / anaphylactoid reactions, angioedema, including laryngeal edema (potentially life-threatening). very rarely - anaphylactic / anaphylactoid shock (including potentially life-threatening). From the side of metabolism infrequently - hyperlipidemia. rarely - hyperglycemia, hyperuricemia. very rarely - hypoglycemia. Mental disorders infrequently - anxiety, psychomotor hyperreactivity, agitation. rarely - emotional lability, depression (in very rare cases, behavior with a tendency to self-harm is possible, such as suicidal thoughts or suicidal attempts), hallucinations. very rarely - depersonalization, psychotic reactions (potentially manifested in behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts). From the nervous system often - dizziness, headache. infrequently - paresthesia, dysesthesia, taste disturbances (including in very rare cases ageusia), confusion, disorientation, sleep disturbances, tremor, vertigo, drowsiness. rarely - hypoesthesia, impaired sense of smell (including anosmia), atypical dreams, impaired coordination (including gait disturbance due to dizziness or vertigo, in very rare cases leading to injuries due to falls, especially in elderly patients), convulsions with various clinical manifestations (including .h. grand mal seizures), attention disorders, speech disorders, amnesia, peripheral neuropathy, polyneuropathy. very rarely - hyperesthesia. On the part of the organ of vision infrequently - visual disturbances (especially with reactions from the central nervous system). very rarely - transient loss of vision (especially with reactions from the central nervous system). On the part of the hearing organ, rarely - tinnitus, hearing loss, including deafness (usually reversible). From the cardiovascular system, often - prolongation of the QT interval in patients with concomitant hypokalemia. infrequently - prolongation of the QT interval, palpitations, tachycardia, vasodilation. rarely - increased blood pressure, decreased blood pressure, fainting, ventricular tachyarrhythmias. very rarely - nonspecific arrhythmias, polymorphic ventricular tachycardia (pirouette type), cardiac arrest (mainly in persons with conditions predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia). From the respiratory system infrequently - shortness of breath, including an asthmatic condition. side of the digestive system often - nausea, vomiting, abdominal pain, diarrhea. infrequently - reduced appetite and reduced food intake, constipation, dyspepsia, flatulence, gastroenteritis (except erosive gastroenteritis), increased amylase activity. rarely - dysphagia, stomatitis, pseudomembranous colitis (in very rare cases, associated with life-threatening complications). From the side of the liver and biliary tract, often - increased activity of hepatic transaminases. infrequently - abnormal liver function (including an increase in LDH activity), an increase in the concentration of bilirubin, an increase in the activity of GGT and alkaline phosphatase. rarely - jaundice, hepatitis (mainly cholestatic). very rarely - fulminant hepatitis, potentially leading to life-threatening liver failure (including fatal cases). On the part of the skin, very rarely - bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening). muscular system infrequently - arthralgia, myalgia. rarely - tendinitis, increased muscle tone and cramps, muscle weakness. very rarely - arthritis, tendon ruptures, gait disturbance due to damage to the musculoskeletal system, increased symptoms of myasthenia gravis. From the urinary system infrequently - dehydration (caused by diarrhea or reduced fluid intake). rarely - 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). On the part of the body as a whole, often - reactions at the injection / infusion site. infrequently - general malaise, nonspecific pain, sweating. The frequency of development of the following adverse reactions was higher in the group receiving stepwise therapy; often - an increase in GGT activity. infrequently - ventricular tachyarrhythmias, arterial hypotension, edema, pseudomembranous colitis (in very rare cases associated with life-threatening complications), convulsions with various clinical manifestations (including grand mal seizures), hallucinations, impaired renal function, renal failure (in dehydration, which can lead to kidney damage, especially in older patients with pre-existing kidney dysfunction).

Overdose

There are limited data on overdose of moxifloxacin. No side effects were noted when using Avelox at a dose of up to 1200 mg once and 600 mg for 10 days or more. Treatment: in case of overdose, according to the clinical situation, symptomatic and supportive therapy with ECG monitoring is carried out. The use of activated charcoal immediately after oral administration of the drug may help prevent excessive systemic exposure to moxifloxacin in cases of overdose.

Interaction with other drugs

No dose adjustment is required when Avelox is co-administered with atenolol, ranitidine, calcium-containing supplements, theophylline, cyclosporine, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid (no clinically significant interaction with moxifloxacin has been confirmed). The possible additive effect of QT prolongation of moxifloxacin and other drugs that affect QT interval prolongation should be considered. Due to the combined use of moxifloxacin and drugs that affect the prolongation of the QT interval, the risk of developing ventricular arrhythmias, including polymorphic ventricular tachycardia of the torsade de pointes, increases. The combined use of moxifloxacin with the following drugs that affect the lengthening of the QT interval is contraindicated: class IA antiarrhythmic drugs (including quinidine, hydroquinidine, disopyramide); class III antiarrhythmic drugs (including amiodarone, sotalol, dofetilide, ibutilide); antipsychotics (including phenothiazine, pimozide, sertindole, haloperidol, sultopride); tricyclic antidepressants; antimicrobials (sparfloxacin, IV erythromycin, pentamidine, antimalarials, especially halofantrine); antihistamines (terfenadine, astemizole, mizolastine); others (cisapride, IV vincamine, bepridil, diphemanil). Ingestion of the drug Avelox and antacids, multivitamins and minerals can disrupt the absorption of moxifloxacin due to the formation of chelate complexes with the polyvalent cations contained in these preparations. As a result, the concentration of moxifloxacin in plasma can be significantly lower than therapeutic. In this regard, antacids, antiretrovirals (eg, didanosine) and other drugs containing magnesium, aluminum, sucralfate, iron, zinc should be taken at least 4 hours before or 4 hours after oral administration of moxifloxacin. 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 combined treatment with these drugs, it is necessary to monitor INR and, if necessary, adjust the dose of indirect anticoagulants. 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 AUC value and Cmin of digoxin do not change. 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.

special instructions

In some cases, after the first use of the drug, hypersensitivity and allergic reactions may develop, which should be immediately reported to the doctor. Very rarely, even after the first use of the drug, anaphylactic reactions can progress to life-threatening anaphylactic shock. In these cases, treatment with Avelox should be discontinued and the necessary therapeutic measures (including anti-shock) should be started immediately. When using the drug Avelox, some patients may experience a prolongation of the QT interval. Avelox should be used with caution in women and elderly patients. Because women have a longer QT interval than men, they may be more sensitive to drugs that prolong the QT interval. Elderly patients are also more susceptible to drugs that affect the QT interval. 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. However, in patients with pneumonia, correlations between plasma concentrations of moxifloxacin and prolongation of the QT interval have been noted. None of the 9000 patients treated with Avelox experienced cardiovascular complications and deaths associated with prolongation of the QT interval. When using the drug Avelox, the risk of developing ventricular arrhythmias in patients with conditions predisposing to arrhythmias may increase. In this regard, Avelox is contraindicated in: changes in the electrophysiological parameters of the heart, expressed in prolongation of the QT interval (congenital or acquired documented prolongation of the QT interval, electrolyte disorders, especially uncorrected hypokalemia, clinically significant bradycardia, clinically significant heart failure with a reduced ejection fraction of the left ventricle, the presence a history of indications of rhythm disturbances accompanied by clinical symptoms), use with other drugs that prolong the QT interval. Avelox should be used with caution: in patients with potentially proarrhythmic conditions, such as acute myocardial ischemia, in patients with cirrhosis of the liver (because in this category of patients the risk of QT prolongation cannot be excluded). When taking the drug Avelox, cases of fulminant hepatitis have been reported, potentially leading to the development of liver failure (including fatal cases). The patient should be informed that in case of symptoms of liver failure, it is necessary to consult a doctor before continuing treatment with Avelox. Bullous skin lesions (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) have been reported while taking Avelox. The patient should be informed that in the event of symptoms of skin or mucous membrane lesions, it is necessary to consult a doctor before continuing treatment with Avelox. The use of quinolone drugs is associated with a possible risk of seizures. Avelox should be used with caution in patients with CNS disease and CNS disorders that predispose to seizures or lower the seizure threshold. The use of broad-spectrum antibacterial drugs, including Avelox, is associated with a risk of developing pseudomembranous colitis. This diagnosis should be considered in patients who develop severe diarrhea during treatment with Avelox. In this case, appropriate therapy should be prescribed immediately. Drugs that inhibit intestinal motility are contraindicated in the development of severe diarrhea. Avelox should be used with caution in patients with myasthenia gravis due to possible exacerbation of the disease. Against the background of quinolone therapy, incl. moxifloxacin, tendinitis and tendon rupture may develop, especially in the elderly and patients receiving corticosteroids. Cases that arose within a few months after completion of treatment are described. At the first symptoms of pain or inflammation at the site of injury, the drug should be stopped and the affected limb unloaded. When using quinolones, photosensitivity reactions are noted. However, when conducting preclinical and clinical studies, as well as when using Avelox, no photosensitivity reactions were observed in practice. However, patients receiving Avelox should avoid exposure to direct sunlight and ultraviolet radiation. 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). Moxifloxacin is not recommended for the treatment of infections caused by methicillin-resistant strains of Staphylococcus aureus (MRSA). In the case of suspected or confirmed infections caused by MRSA, treatment with appropriate antibacterial drugs should be initiated. The ability of Avelox to inhibit the growth of mycobacteria may cause an in vitro interaction of moxifloxacin with a test for Mycobacterium spp., leading to false negative results when analyzing samples from patients who are treated with Avelox during this period. In patients treated with quinolones, including Avelox, cases of sensory or sensorimotor polyneuropathy have been described, leading to paresthesias, hypoesthesias, dysesthesias, or weakness. Patients who are being treated with Avelox should be warned about the need to immediately consult a doctor before continuing treatment in case of symptoms of neuropathy, including pain, burning, tingling, numbness or weakness. Psychiatric reactions may occur even after the first administration of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions progress to suicidal thoughts and behaviors with a tendency to self-harm, including suicidal attempts. If such reactions develop in patients, Avelox should be discontinued and the necessary measures taken. Caution should be exercised when prescribing Avelox to patients with a history of psychosis and / or psychiatric illness. Due to the widespread and increasing incidence of infections caused by fluoroquinolone-resistant Neisseria gonorrhoeae, moxifloxacin monotherapy should not be used in patients with pelvic inflammatory disease, unless the presence of fluoroquinolone-resistant N. gonorrhoeae is excluded. If the presence of fluoroquinolone-resistant N. gonorrhoeae cannot be ruled out, consideration should be given to supplementing empiric moxifloxacin therapy with an appropriate antibiotic that is active against N. gonorrhoeae (eg, a cephalosporin). As with other fluoroquinolones, changes in blood glucose concentration, including hypo- and hyperglycemia, have been observed with the use of Avelox. During therapy with Avelox, dysglycemia occurred mainly in elderly patients with diabetes mellitus receiving concomitant therapy with oral hypoglycemic drugs (for example, sulfonylurea drugs) or insulin. When treating patients with diabetes mellitus, careful monitoring of blood glucose concentrations is recommended. Influence on the ability to drive vehicles and control mechanisms Fluoroquinolones, including moxifloxacin, can interfere with the ability of patients to drive a car and engage in other potentially hazardous activities that require increased attention and speed of psychomotor reactions, due to effects on the central nervous system and visual impairment.

Antibiotics are medicines that help fight bacterial infections. They are constantly being improved, because the pharmaceutical industry is trying to rid such drugs of their many side effects. One of the latest antibiotics is Avelox. Reviews about him and doctors and patients leave quite positive.

Pharmaceutical group of the drug

Medicines, which then formed the pharmaceutical group of antibiotics, began their history back in 1928 with the world-famous discovery of the unique ability of green mold (penicillum fungus) to destroy staphylococcus bacteria. From that moment on, pharmacology was replenished with antibiotics - drugs that help fight microorganisms - bacteria that cause various diseases. These substances are divided into several groups according to their chemical structure:

• aminoglycosides;
• beta-lactam, which includes penicillins, cephalosporins, carbapenems;
• glycopeptide antibiotics;
• chloramphenicol;
• lincosamides;
• macrolides;
• thyrothricins;
• tetracyclines;
• quinolones.

The drug "Avelox" is an antibiotic of the quinolone group, since its active ingredient, moxifloxacin, belongs to the 4th generation of drugs of this pharmaceutical group.

In what dosage form is the drug produced?

The drug "Avelox" receives reviews in most advisory. Both doctors and patients note two dosage forms as a plus - tablets and injection solution, because in various situations one or another type of medicine should be used in the treatment.

The tablets of the drug are round, elongated, biconvex, have a pink color. The original tablets are not shiny, glossy, but matte. On one side there is an embossed inscription of the name of the manufacturing company - Bayer, while the other is provided with the inscription M400, indicating the amount of the active ingredient in one tablet. There are chamfers along the edge of the tablet. Tablets of 5 or 7 pieces are placed in a transparent plastic blister with an aluminum protective film. One carton pack may contain 1 or 2 blisters.

The solution for infusion of this drug is available as a clear liquid with a yellowish-light color. It is packaged in 400 mg in 250 ml glass or polyethylene bottles.

What works in a drug?

The composition of the drug "Avelox" depends on the dosage form. The active substance in it is one - moxifloxacin hydrochloride. One tablet contains 436.8 mg, which is enough for the therapeutic use of the drug. Also included in the tablets: hypromellose, titanium dioxide, croscarmellose sodium, macrogol 4000, lactose monohydrate, iron oxide yellow, iron oxide red, magnesium stearate, microcrystalline cellulose. These components carry only a formative function and do not play a healing role.

If the drug is prescribed as a solution for infusion, then 1 ml contains 1.6 mg of the active substance, in addition, forming components are used: water, sodium chloride, hydrochloric acid, sodium hydroxide solution.

How does the active component work?

The antibacterial agent "Avelox" receives quite positive reviews. Its active substance moxifloxacin belongs to the group of trifluoroquinolones, being a representative of the 4th generation. The range of his work is very wide. It suppresses enzymes important for the DNA of abnormal cells, thereby violating the integrity of the cells and leading them to death. This process occurs very quickly, the bacteria do not have time to release a significant amount of toxins, which means that the patient's body does not receive severe intoxication.

A feature of moxifloxacin is its ability to act on bacteria that are resistant to most other antibiotics, such as aminoglycosides, macrolides, penicillins, tetracyclines, cephalosporins. During the work of this substance, plasmid resistance to it, as well as cross-resistance was not revealed, which makes it active against many pathogenic species of representatives of this microworld.

Another practical feature of moxifloxacin is the presence of a methoxy group on the eighth carbon atom. It makes the agent more active against a large number of pathogenic bacteria. This also reduces the potential incidence of resistant bacterial strains.

This substance works against many types of anaerobic, gram-positive, gram-negative, acid-fast bacteria. It is also active against such atypical agents as legionella, mycoplasma and chlamydia.

A huge advantage of using the drug "Avelox" reviews of doctors and patients note the ability to restore the natural microflora of the gastrointestinal tract in a natural way after the end of the course of treatment. Yes, disruption of the gastrointestinal tract due to the suppression of bacteria cannot be avoided, but the qualitative result of the treatment compensates for this problem, which, moreover, can be solved independently or with the help of special medications.

Pathway of a drug in the human body

The medicine "Avelox" is a sought-after antibiotic, produced in two forms: tablets and solution for infusion. In any form, the medicinal substance is quickly and almost completely absorbed into the systemic circulation, binding to blood proteins (mostly albumin) by 40-50%. Its bioavailability is almost 90%, and the maximum concentration corresponds to 3.1 mg of the substance per 1 liter of blood when taken orally and up to 4.5 mg/l when administered through infusion.

The concentration of the drug is reduced by half after 12 hours. That is why it is recommended to take it 2 times a day with an equal interval. The drug substance is excreted by the kidneys, and most of it is unchanged, the rest is in the form of inactive metabolites.

Taking the drug does not depend on food intake, since the tests revealed a minimal decrease in the concentration of the active substance when taken together with food.

Moxifloxacin crosses the placental barrier. This fact was revealed during research. Such penetration can increase the risk of miscarriage, abnormal development of the fetal skeleton, a decrease in its weight, as well as premature birth.

In what cases is the use of the drug indicated?

For the drug "Avelox" indications for use are determined by its activity against many pathogenic bacteria. Prescribe medication for diagnoses:

• abscess of the intraperitoneal space;
• chronic bronchitis;
• skin and soft tissue infections;
• infections of the pelvic organs;
• pneumonia;
• polymicrobial infections;
• salpingitis;
• sinusitis in acute and chronic forms;
• endometritis.

Contraindications

For the antibacterial drug "Avelox", the instructions for use indicate strict adherence to contraindications for use. It:

• allergy to the components of the drug;
• arrhythmias;
• pregnancy;
• bradycardia;
• hypokalemia;
• children's age (up to 18 years), since the drug has not been tested on patients of this age;
• severe diarrhea;
• heart disease with prolongation of the QT interval;
• liver disease;
• lactation;
• lactose intolerance;
• heart failure associated with disorders of the right ventricle;
• epilepsy.

The use of an antibiotic is possible with extreme caution, if necessary, in conditions and diseases such as:

• diseases of the central nervous system;
• acute myocardial ischemia;
• psychosis;
• cirrhosis of the liver.

If the patient is taking medications that affect the functioning of the heart, it is necessary to inform the attending physician about this. The same applies to those who are forced to take hemodialysis.

If there's something wrong

The drug with antibiotic action - "Avelox". Side effects of it on the body during treatment are most often manifested in the form of diarrhea, vomiting or nausea. Conducted studies and observations of patients taking this medicine have revealed possible deviations in the state of health:

• cardiac arrhythmia;
• soreness at the injection site;
• epigastric pain;
• headache;
• dizziness;
• fungal infections;
• increased levels and activity of transaminases (liver enzymes);
• with the introduction of the drug intramuscularly, pain and reactions at the site of infusion were observed.

Very rarely (less than 2% of cases) manifested

• allergy;
• anaphylactic or anaphylactoid shock;
• angioedema;
• anemia;
• vertigo;
• hyperglycemia;
• hyperlipidemia;
• hyperuricemia;
• depersonalization;
• depression;
• dyskenesia;
• constipation;
• changes in blood pressure;
• ischemia;
• hives;
• leukopenia;
• flatulence;
• impairment and loss of vision and hearing;
• dyspnea;
• paresthesia;
• psychomotor agitation;
• tachycardia;
• anxiety;
• tremor;
• thrombocytopenia;
• stomatitis;
• drowsiness;
• convulsions;
• emotional lability;
• eosinophilia.

How to take medicine?

If the drug "Avelox" for injection is prescribed for use, then the following rules should be observed:

• the solution must be absolutely transparent, without turbidity and sediment;
• the introduction of the drug in the form of an infusion is carried out for at least 60 minutes;
• the finished product can be mixed during the procedure with water for injection, dextrose solution, xylitol solution, Ringer's solution, sodium chloride solution;
• Do not mix the drug and other medicines in the same syringe or dropper.

It should be remembered that the prepared solution in a printed vial can be stored only for a day.

"Avelox" in tablets is taken orally without chewing, drinking plenty of clean water. Reception can be carried out at any convenient time, without reference to food intake.

The daily dose for patients over 18 years of age in the treatment of any indicated diseases is 400 mg - 1 tablet. The drug is taken in a course, the duration of which is determined by the attending physician, but basically its duration is from 5 to 14 days.

Severe forms of the disease require initial therapy with injections, and when the patient's condition stabilizes, he can be prescribed Avelox tablets. It should be borne in mind that advanced age, impaired renal or hepatic function, not specifically indicated, does not require adjustment of the dosage of the drug.

Antibiotic overdose

The drug "Avelox" is an antibiotic, so some patients may decide that a larger dose than the doctor prescribes and the instructions recommend will help solve the problem of the disease faster and better. But this is absolutely not true! If the doctor's prescriptions are not followed, you can only get an overdose of the drug. In this case, symptomatic therapy is carried out, based on the patient's condition. Activated charcoal will only help reduce systemic exposure if the medicine has been taken orally some time ago.

"Avelox" and other drugs

The drug "Avelox" reviews is positive, as it helps in the treatment of many fairly severe forms of infectious diseases. The use of enterosorbents reduces the bioavailability of the active substance. Antacids, as well as vitamin-mineral complexes, lower the concentration of moxifloxacin in the blood plasma, which affects drug therapy. Therefore, it is recommended to separate the intake of antibiotics and other drugs by an interval of at least 4 hours.

Are there similar drugs?

Antibiotics are commonly used drugs for the treatment of various diseases. "Avelox" belongs to the group of quinolone antibacterial agents. Absolute analogues of this drug must contain the same active substance. This, for example, is the generic Moxifloxacin, produced by various pharmaceutical companies. The same substance works in the preparations "Moxifluor", "Moksin".

Medicines belonging to the same pharmaceutical group, but containing another active substance of the fluoroquinolone group: Ofloxin, Hailefloks, Lefoktsin. Which drug is needed to treat the disease, decides only the doctor leading the patient.

How to buy and store?

For the Avelox antibiotic, the instructions for use mention that the drug is dispensed from the pharmacy network by prescription. Its cost is quite high for the drugs of this pharmaceutical group - a package with 5 tablets costs, on average, about 850 rubles. But this is offset by its activity, minor side effects, a single daily use. The medicine is stored only during the expiration date - 5 years from the date of production. Then the tablets and solution are disposed of.

Some features of the application

The drug "Avelox" reviews from patients are grateful. Many note its ability to cope even with advanced forms of infectious diseases. As a plus, they note convenient use - 1 time per day. The only thing that causes complaints from patients is the price. It is quite high compared to analogues.

For many patients, it has become a problem that treatment with this drug requires the refusal to drive a car for the entire course, since moxifloxacin, like other fluoroquinolones, affects the central nervous and visual systems.

Experts note that the drug "Avelox" is an active antibiotic that helps in the treatment of diseases caused by strains of bacteria resistant to many antibiotics. The practice of its use is mostly positive with a rare manifestation of side effects.

So we can conclude that the antibiotic "Avelox" reviews are mainly advisory from specialists and grateful from patients.

INN: Moxifloxacin

Manufacturer: Bayer Pharma AG

Anatomical-therapeutic-chemical classification: Moxifloxacin

Registration number in the Republic of Kazakhstan: No. RK-LS-5 No. 003599

Registration period: 30.10.2015 - 30.10.2020

KNF (drug is included in the Kazakhstan National Formulary of Medicines)

ALO (Included in the Free Outpatient Drug Supply List)

ED (Included in the List of drugs in the framework of the guaranteed volume of medical care, subject to purchase from a single distributor)

Limit purchase price in the Republic of Kazakhstan: 464.14 KZT

Instruction

Tradename

Avelox®

International non-proprietary name

Moxifloxacin

Dosage form

Coated tablets, 400 mg

Compound

One tablet contains

akactive substance - moxifloxacin hydrochloride 436.8 mg,

(equivalent to moxifloxacin 400.0 mg),

Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate,

shell composition: iron oxide red, hypromellose, macrogol 4000, titanium dioxide.

Description

Tablets are opaque red, oblong, film-coated, about 17 mm long and about 7 mm wide, marked "M 400" on one side and "BAYER" on the other.

Pharmacotherapeutic group

Antibacterial drugs for systemic use. Antimicrobials are quinolone derivatives. Fluoroquinolones. Moxifloxacin.

Code ATXJ01MA14

Pharmacological properties

Pharmacokinetics

Absorption and bioavailability

When taken orally, moxifloxacin is absorbed rapidly and almost completely. Absolute bioavailability is about 91%.

The pharmacokinetics of moxifloxacin when taken at a dose of 50 to 1200 mg once, as well as 600 mg / day for 10 days, is linear. The equilibrium state is reached within 3 days.

After a single appointment of 400 mg of moxifloxacin, the maximum concentration (C max) in the blood is reached within 0.5-4 hours and is 3.1 mg / l. Peak and trough plasma concentrations at steady state (400 mg once daily) were 3.2 and 0.6 mg/L, respectively.

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 are of no clinical significance because the AUC/MIC ratio is more predictive of the antimicrobial activity of quinolones. Therefore, the drug can be used regardless of food intake.

Distribution

Moxifloxacin is very rapidly distributed in the extravascular bed. There is a large area under the pharmacokinetic curve AUC (AUCnorm = 6 kg * hours / l) with an equilibrium volume of distribution (Vss) of moxifloxacin of approximately 2 l / kg. The peak concentration of moxifloxacin in saliva is higher than in plasma. In in vitro and in vivo studies in the concentration range from 0.02 to 2 ml / l, the binding of moxifloxacin to proteins was approximately 45%, regardless of the concentration of the drug.

Moxifloxacin is mainly bound to plasma albumin.

There is a high peak free concentration > 10xMIC due to the low volume.

High concentrations of the drug, exceeding those in plasma, are created in the lung tissue (epithelial fluid, alveolar macrophages, biological tissue), in the nasal sinuses and polyps, in the foci of inflammation. In saliva, interstitial fluid (intermuscular and subcutaneous), a high concentration of the drug in the free state is determined.

In addition, high concentrations of the drug are determined in the organs of the abdominal cavity and peritoneal fluid, as well as in the female genital organs.

After a single dose of moxifloxacin 400 mg, comparable maximum concentrations were observed in both routes of administration compared to plasma concentrations in various target tissues.

Metabolism

After passing through the 2nd phase of biotransformation, moxifloxacin is excreted from the body by the kidneys and the gastrointestinal tract (GIT) both unchanged and in the form of inactive sulfo compounds (M1) and glucuronides (M2). These metabolites are applicable only in relation to the human body and do not have antimicrobial activity. The study of metabolic pharmacokinetic interactions with other drugs showed that moxifloxacin is not biotransformed by the microsomal cytochrome P450 system.

Regardless of the method of administration, the metabolites M1 and M2 are found in plasma at a concentration lower than the concentration of unchanged moxifloxacin.

breeding

The half-life of the drug from plasma is approximately 12 hours. The average total clearance after taking a dose of 400 mg is from 179 to 246 ml / min. Renal clearance of approximately 24-53 ml / min occurs by partial tubular reabsorption of the drug in the kidneys. The combined use of ranitidine and probenecid does not affect the renal clearance of the drug. Regardless of the route of administration, the parent substance moxifloxacin is almost completely 96-98% metabolized to stage II metabolites without signs of oxidative metabolism.

Pharmacokinetics in different groups of patients

Elderly patients

No differences in the pharmacokinetics of moxifloxacin have been established.

Floor. There were differences (33%) in pharmacokinetics (AUC, Cmax) between males and females. The observed differences in AUC and Cmax were explained by differences in body weight rather than gender. Thus, they are not clinically significant.

ethnic differences

Possible interethnic differences have been studied in Caucasian, Japanese, Negroid and other ethnic groups. Clinically significant differences in the pharmacokinetics of moxifloxacin have not been established.

Children

The pharmacokinetics of moxifloxacin have not been studied in children.

kidney failure

There were no significant changes in the pharmacokinetics of moxifloxacin in patients with impaired renal function (including patients with creatinine clearance< 30 мл/мин/1,73 кв.м) и у находящихся на непрерывном гемодиализе и длительном амбулаторном перитонеальном диализе.

Impaired liver function

Plasma concentrations of moxifloxacin in patients with mild to severe hepatic impairment (Child-Pugh stage A to C) showed no clinically significant difference compared with healthy volunteers or patients with normal hepatic function, respectively (see also section "Special instructions" use in patients with cirrhosis of the liver).

Pharmacodynamics

Avelox® is an 8-methoxy-fluoroquinolone antibiotic with a wide spectrum of activity and bacterial activity. Avelox® has "in vitro" activity against a wide range of gram-positive and gram-negative organisms, anaerobic organisms, acid-fast bacteria and atypical forms, such as Chlamydia spp., Mycoplasma spp. and Legionella spp.

The bactericidal effect of the drug is due to the inhibition of bacterial topoisomerases II and IV - important enzymes that control the topology of DNA (responsible for replication, repair and transcription of microbial DNA).

The bactericidal effect of moxifloxacin depends on its concentration. The minimum bactericidal concentrations of the drug are generally close to the minimum inhibitory concentrations.

Avelox® has a bactericidal effect on bacteria resistant to β-lactams and macrolides.

resistance

The mechanisms leading to the development of resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not violate the antibacterial activity of the drug. Cross-resistance between these groups of antibacterial drugs and Avelox® is not observed. Plasmid-mediated resistance has not yet been observed.

It has been established that the C8-methoxy group in the structure of the drug increases activity against gram-positive microorganisms and helps to reduce the development of mutants for the selection of resistant gram-positive bacteria compared to the C8-H group. The presence of an azabicyclostructure at the C7 position in the structure prevents active efflux (i.e. active ejection of a fluoroquinolone from the cell), a mechanism underlying the development of microbial resistance to fluoroquinolones.

Resistance to Avelox® develops slowly through multiple mutations. The overall frequency of development of resistance is very low (10-7 - 10-10). Repeated exposure of the drug to microorganisms at concentrations below the minimum inhibitory concentration (MIC) is accompanied by only a slight increase in MIC.

Cases of cross-resistance to quinolones have been reported. However, some Gram-positive and anaerobic microorganisms resistant to other quinolones remain sensitive to Avelox®.

Impact on human intestinal flora

The following changes in the intestinal flora were observed after oral administration of Avelox®: a decrease in E.Coli, Bacillus spp., Bacteroides vulgatus, Enterococci and Klebsiella spp., as well as anaerobic Bifidobacterium, Eubacterium and Peptostreptococcus. These changes took place within two weeks. Clostridium difficile toxin was not detected.

Susceptibility data in vitro

Susceptible microorganisms:

Gram-positive bacteria:

Gardnerella vaginalis

Streptococcus pneumoniae (including multidrug-resistant strains of Streptococcus pneumoniae (MDRSP), including strains known as PRSP (penicillin-resistant St. Pneumoniae) and strains resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2 µg/mL), second-generation cephalosporins (eg, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole

Streptococcus pyogenes (group A)*

Streptococcus milleri group (S. anginosus*, S. constellatus* and S. intermedius*)

Streptococcus viridans group (S. viridans, S. mutans, S. mitis, S. sanguinis, S. salivarius, S. thermophilus, S. constellatus)

Streptococcus agalactiae

Streptococcus dysgalactiae

Staphylococcus aureus (methicillin-susceptible strains)*

Coagulase-negative staphylococci (S. cohnii, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. simulans) strains susceptible to methicillin

Gram-negative bacteria

- Haemophillus influenzae (including β-lactamase and non-β-lactamase producing strains) *

Haemophillus parainfluenzae*

Moraxella catarrhalis (including β-lactamase producing and non-β-lactamase producing strains) *

Bordetella pertussis

Legionella pneumophilia 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 burnetti

Intermediate microorganisms:

Gram-positive bacteria:

Enterococcus faecalis* (vancomycin and gentamicin susceptible strains only)

Enterococcus avium*

Enterococcus faecium*

Gram-negative bacteria:

Escherichia coli*

Klebsiella pneumoniae*

Klebsiella oxytoca

Citrobacter freundii*

Enterobacter species (E. aerogenes, E. intermedius, E. sakazaki)

Enterobacter cloacae*

Pantoea agglomerans

Pseudomonas fluorescens

Burkholderia cepacia

Stenotrophomonas maltophilia

Proteus mirabilis*

Morganella morganii

Neisseria gonorrhoea **

Providencia species (P. rettgeri, P. stuartii)

Anaerobes:

Bacteroides sp (B. fragilis*, B. distasoni*, B. thetaiotaomicron*, B. ovatus*, B. uniformis*, B. vulgaris*)

Peptostreptococcus spp. *

Clostridium sp*

resistive

Gram positive:

Staphylococcus aureus - methicillin / ofloxacin resistant strains.

(The use of Avelox® is not recommended in the treatment of infections caused by methicillin-resistant Staphylococcus aureus (MRSA). If an infection is suspected or confirmed to be caused by these strains (MRSA), treatment with an appropriate antibiotic should be started).

Coagulase-negative staphylococci (S. cohnii, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. simulans) methicillin-resistant strains

Gram negative

Pseudomonas aeruginosa

*/** Sensitivity to Avelox® confirmed by clinical data.

The frequency of acquired resistance in some strains of microorganisms may vary over time depending on the geographical area.

It is desirable to have information on local resistance of microorganisms, especially in the treatment of severe infections.

Indications for use

Avelox® tablets are indicated for the treatment of the following bacterial infections caused by susceptible organisms:

Respiratory tract infections, incl. exacerbation of chronic bronchitis, community-acquired pneumonia, including those caused by multidrug-resistant strains*

Acute sinusitis

Uncomplicated skin and soft tissue infections

Complicated infections of the skin and soft tissues, including infected

"diabetic foot"

Uncomplicated pelvic inflammatory disease (upper female genital tract infections, including salpingitis and endometritis)

Complicated intra-abdominal infections, including polymicrobial infections

infections, including intraperitoneal abscesses

* Multidrug-resistant Streptococcus pneumoniae (MDRSP) includes isolates known as PRSP (penicillin-resistant S. pneumoniae) and strains resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2 µg/mL), second-generation cephalosporins (eg, cefuroxime) , macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

Official recommendations on the appropriate use of antibacterial drugs should be taken into account.

Dosage and administration

The tablet should be swallowed whole with a sufficient amount of liquid. May be taken with or without food.

Duration of therapy

The duration of treatment is determined by the severity of the indications or clinical effect.

Exacerbation of chronic bronchitis- 5 days.

community-acquired pneumonia- 10 days.

Acute sinusitis- 7 days.

Uncomplicated skin and soft tissue infections- 7 days.

Uncomplicated pelvic inflammatory disease- 14 days.

Complicated skin and soft tissue infections- the total duration of stepwise therapy with Avelox® (intravenous administration of the drug followed by oral administration) is 7-21 days.

Complicated intra-abdominal infections- the total duration of stepwise therapy (intravenous administration of the drug followed by oral administration) is 5-14 days.

Additional information on special categories of patients

Children and teenagers

The efficacy and safety of Avelox® in children and adolescents under 18 years of age has not been established.

Elderly patients

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

ethnic differences

Changes in dosing regimen in ethnic groups are not required

Patients with impaired liver function

Dosing regimen changes are not required in patients with hepatic impairment.

Patients with impaired functionpoints

In patients with impaired renal function (including creatinine clearance< 30 мл/мин/1,73 кв.м), а также у пациентов, находящихся на хроническом диализе, например гемодиализе и длительном амбулаторном перитонеальном диализе, изменения режима дозирования не требуется.

Side effects

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

Often (> 1/100 and 1/< 10 %)

Candida superinfections

Dizziness, headache

- prolongation of the QT interval on the ECG in patients with hypokalemia

Nausea, vomiting, abdominal pain, diarrhea

An increase in the level of transaminases in the blood

Injection and infusion site reactions

Infrequently(> /1 000 and<1/10 %)

Anemia, leukopenia, neutropenia, thrombocytopenia,

thrombocytosis, prolongation of prothrombin time and increase in

international normalized ratio

Allergic reactions, urticaria, pruritus, rash, eosinophilia

Hyperlipidemia

Feeling of anxiety, increased psychomotor activity, agitation

- paresthesia/dysesthesia

Taste disorders, including ageusia (loss of taste sensation) in very rare cases

Confusion, disorientation, sleep disturbances, dizziness, tremors, somnolence

Visual disturbances, especially in combination with reactions from the central nervous system

Prolongation of the QT interval on the ECG in patients, palpitations, tachycardia, vasodilation

Shortness of breath, including asthma

Decreased appetite, constipation, dyspepsia, flatulence, gastroenteritis (except erosive gastroenteritis)

Increased levels of amylase, bilirubin, abnormal liver function, including increased levels of lactate dehydrogenase, increased levels of gamma-glutamyl transferase and alkaline phosphatase

Arthralgia, myalgia

Dehydration (caused by diarrhea or decreased fluid intake)

General malaise, non-specific pain, sweating

Thrombophlebitis at the site of infusion

Rarely (> 1/10 0000 and 1/1 000)

Change in thromboplastin concentration

Anaphylactic / anaphylactoid reactions, allergic / angioedema, including laryngeal edema (potentially life-threatening)

Hyperglycemia, hyperuricemia

- emotional lability, depression (on very rare occasions potentially manifesting in self-injurious behavior such as suicidal thoughts or attempts), hallucinations

Hypothesia, impaired sense of smell, including anosmia

Pathological dreams, impaired coordination (including gait disturbances mainly due to dizziness or vertigo (leading to injuries due to falling, especially in elderly patients in very rare cases), convulsive seizures with various clinical manifestations (including generalized), attention disturbances, disorders speech, amnesia

Peripheral neuropathy and polyneuropathy

Tinnitus, hearing impairment, including deafness (usually reversible)

Syncope, hypotension, hypertension, ventricular tachyarrhythmias

Dysphagia, stomatitis, pseudomembranous colitis (associated with life-threatening complications in very rare cases), jaundice, hepatitis (predominantly cholestatic)

Tendenitis, increased muscle tone and muscle cramps, muscle weakness

Impaired renal function, renal failure (due to dehydration, especially in elderly patients with concomitant impaired renal function)

Very rarely (<1/10 000)

An increase in the concentration of prothrombin and a decrease in the indicator of international

native normalized ratio or change in concentration

prothrombin and an indicator of international normalized ratio.

Anaphylactic / anaphylactoid shock (including potentially threatening

greedy for life)

hypoglycemia

Depersonalization, psychotic reactions, potentially manifesting

in behavior with a tendency to self-harm

Hyperesthesia

Transient visual impairment, especially in combination with reactions from the central nervous system

Nonspecific arrhythmias, torsades de pointes, cardiac arrest, predominantly in individuals with conditions predisposing to arrhythmias such as clinically significant bradycardia, acute myocardial ischemia

Fulminant hepatitis, potentially leading to life-threatening

liver failure, including fatal

Bullous skin reactions, such as Stevens-Johnson syndrome or

toxic epidermal necrolysis (potentially life-threatening)

Tendon ruptures, arthritis, gait disorders due to muscle

injuries, tendon or joint injuries, exacerbation of symptoms

myasthenia gravis

The following adverse events were observed in a subgroup of patients who were on stepwise Avelox therapy.® solution/Avelox® tablets:

Often

Increased gamma-glutamyltransferase levels

Infrequently

Ventricular tachyarrhythmias, hypotension, edema, antibiotic-induced pseudomembranous colitis (in very rare cases associated with life-threatening complications), convulsive seizures with various clinical manifestations (including generalized), hallucinations, impaired renal function and renal failure (as a result of dehydration, especially in elderly patients with concomitant impaired renal function)

Contraindications

Known hypersensitivity to moxifloxacin or other quinolones, or to any of the ingredients of the formulation

Children and adolescents up to 18 years of age

Pregnancy and lactation

Drug Interactions

Dosage adjustment is not required when combined with atenolol, ranitidine, calcium-containing supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenicide (no clinically significant interaction with Avelox® has been confirmed).

Antacids, multivitamins and minerals

Taking Avelox® simultaneously with antacids, multivitamins and minerals can lead to impaired absorption of moxifloxacin after oral administration, due to the formation of chelate complexes with the multivalent cations contained in these preparations. As a result, the plasma concentration of moxifloxacin may be significantly lower than desired. Therefore, antacids, antiretroviral drugs (eg, didanosine) and other drugs containing magnesium or aluminum, sucralfate and other drugs containing iron or zinc should be given at least 4 hours before or 2 hours after Avelox® is taken orally.

warfarin

When combined with warfarin, the pharmacokinetics, prothrombin time and other parameters of blood coagulation do not change.

Changing the value of the INR (international normalized ratio)

In patients receiving anticoagulants in combination with antibiotics, including Avelox®, 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 Avelox® and warfarin is not detected, in patients receiving combined treatment with these drugs, it is necessary to monitor the INR and, if necessary, adjust the dose of oral anticoagulants.

Digoxin

Avelox® and digoxin do not have a significant effect on the pharmacokinetic parameters of each other. With the appointment of repeated doses of Avelox® in healthy individuals, the maximum concentration of digoxin increased by approximately 30%, while the ratio of the area under the concentration-time curve (AUC) and the minimum concentration of digoxin did not change.

Activated carbon

With the simultaneous use of activated charcoal and Avelox® orally 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 case of an overdose, the use of activated charcoal at an early stage of absorption prevents a further increase in systemic exposure.

Food and dairy products

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

special instructions

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

Very rarely, anaphylactic reactions can progress to life-threatening anaphylactic shock, in some cases after the first use of the drug. In these cases, Avelox® should be canceled and the necessary therapeutic measures (including anti-shock) should be carried out.

The use of quinolone drugs is associated with a possible risk of developing a seizure. Avelox ® should be used with caution in patients with CNS disease and in conditions suspected of CNS involvement, predisposing to seizures, or lowering the seizure threshold.

When using Avelox®, some patients may experience a prolongation of the QT interval on the electrocardiogram.

Given that women tend to prolong the QT interval compared to men, they may be more sensitive to drugs that prolong the QT interval. Elderly patients may also be more sensitive to such drugs.

The degree of prolongation of the QT interval may increase with increasing concentration of the drug, so do not exceed the recommended dose and infusion rate (400 mg in 60 minutes). However, in patients with pneumonia, there was no correlation between the concentration of the drug in blood plasma and prolongation of the QT interval. Prolongation of the QT interval is associated with an increased risk of ventricular arrhythmias, including torsades de pointes. When taking the drug, there were no cardiovascular complications and deaths associated with prolongation of the QT interval. However, in patients with certain conditions predisposing to arrhythmias, the use of Avelox® may increase the risk of developing ventricular arrhythmias.

In this regard, the appointment of the drug in the following patients should be avoided, since the experience of using Avelox® in these patients is limited:

With prolongation of the QT interval

With untreated hypokalemia

Who are receiving class IA (quinidine, procainamide) or class III (amiodarone, sotalol) antiarrhythmic drugs

Avelox® should be administered with caution, since the additive effect of moxifloxacin cannot be excluded under the following conditions:

In patients receiving concomitant treatment with drugs that prolong the QT interval (cisapride, erythromycin, antipsychotics, tricyclic antidepressants)

In patients with conditions predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia

In patients with cirrhosis of the liver, since the presence of prolongation of the QT interval cannot be excluded

In women or older patients who may be more sensitive to drugs that prolong the QT interval

Cases of fulminant hepatitis have been reported with the use of Avelox®, potentially leading to life-threatening liver failure, including death. If signs of liver failure appear, patients should immediately consult a doctor before continuing treatment.

Bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening) have been reported. In the event of reactions from the skin and / or mucous membranes, you should also immediately consult a doctor before continuing treatment.

Since the use of broad-spectrum antibacterial drugs, including Avelox®, is associated with a risk of developing antibiotic-associated pseudomembranous colitis, this diagnosis should be considered in patients who develop severe diarrhea during treatment with the drug. In this case, appropriate therapy should be prescribed immediately. In patients with severe diarrhea, drugs that inhibit intestinal motility are contraindicated.

Avelox® should be used with caution in patients with myasthenia gravis, as the drug may exacerbate the symptoms of this disease.

Against the background of therapy with fluoroquinolones, including Avelox®, especially in the elderly and patients receiving glucocorticosteroids, tendinitis and tendon rupture may develop; there have been isolated cases of development within a few months after completion of therapy. At the first symptoms of pain or inflammation at the site of injury, the drug should be stopped and the affected limb unloaded.

When using quinolones, photosensitivity reactions are noted. However, no photosensitivity reactions have been reported with Avelox, either in specially designed clinical studies or in routine clinical practice. However, patients receiving the drug should avoid direct sunlight and ultraviolet radiation.

For patients with complicated inflammatory diseases of the pelvic organs (for example, associated with tubo-ovarian or pelvic abscesses), for whom intravenous treatment is indicated, taking Avelox® 400 mg tablets is not recommended.

Avelox® is not recommended for the treatment of infection caused by methicillin-resistant Staphylococcus aureus (MRSA). In case of suspicion or confirmation of the specified infection, you should start with the use of the appropriate antibacterial drug (see section "Pharmacodynamic properties").

The study of the activity of moxifloxacin "in vitro" showed that interaction with culture is possible Mycobacterium due to suppression of mycobacterial growth, which can lead to a false negative result in samples obtained from patients receiving Avelox®.

With the use of quinolones, including Avelox®, cases of sensory and sensorimotor polyneuropathy have been reported, leading to paresthesia, hypoesthesia, dysesthesia, or weakness. With the development of symptoms of neuropathy, such as pain, burning, tingling, numbness or weakness in patients treated with Avelox®, you should immediately consult a doctor before continuing treatment.

Mental reactions may occur even after the first use of fluoroquinolone drugs, including Avelox®.

In very rare cases, depression or psychotic reactions have progressed to the development of suicidal thoughts or behavior with a tendency to self-harm (see section "Side Effects").

If the patient develops these reactions, it is necessary to stop treatment with Avelox® and take appropriate measures. Caution is advised when using the drug in psychotic patients or in patients who have a history of psychiatric illness.

Given the widespread and increasing frequency of fluoroquinolone-resistant forms of infection Neisseria gonorrhoeae, it is recommended to prescribe monotherapy with Avelox® in patients with inflammatory diseases of the pelvic organs after exclusion of resistance N. gonorrhoeae to fluoroquinolones.

If infection resistance Neisseria gonorrhoeae to fluoroquinolones cannot be ruled out, in addition to therapy with Avelox®, consideration should be given to prescribing an appropriate antibiotic that acts against N. gonorrhoeae(eg cephalosporins).

For patients on a low sodium diet (with congestive heart failure, renal failure, nephrotic syndrome, etc.), additional sodium intake with infusion solution should be taken into account.

Dysglycemia

Taking Avelox®, like other fluoroquinolones, can cause fluctuations in blood sugar levels: cases of hypoglycemia and hyperglycemia have been reported. In the treatment of Avelox®, dysglycemia mainly occurs in elderly patients with diabetes mellitus and receiving therapy with oral hypoglycemic drugs (for example, sulfonylureas) or insulin.

Pregnancy and lactation

The safety of Avelox during pregnancy has not been established. Reversible joint damage has been described in children treated with some quinolone antibiotics, but no similar effect has been reported on the fetus. The potential risk to humans is not known.

Therefore, the use of Avelox® during pregnancy is contraindicated.

Data on the use of Avelox® in women during lactation and feeding are not available. Therefore, the use of Avelox® in lactating women is contraindicated.

Features of the effect of the drug on the ability to drive vehicles and potentially dangerous mechanisms.

Fluoroquinolones, including Avelox®, may impair the ability to drive or use machines due to CNS reactions.

Overdose

Symptoms- there is limited information on 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 in healthy people.

Treatment- in case of overdose, one should focus on the clinical picture and carry out symptomatic supportive therapy with ECG monitoring. Taking activated charcoal immediately after taking the tablets helps prevent an excessive increase in systemic exposure to moxifloxacin.

Release form and packaging

5 tablets in a blister of colorless or white PP or PVC film and aluminum foil.

1 blister, together with instructions for medical use in the state and Russian languages, in a cardboard box.

Storage conditions

Store in a dry place at a temperature not exceeding 25°C.

Store in original packaging.

Keep out of the reach of children!

Shelf life

Do not use after the expiry date stated on the packaging.

Terms of dispensing from pharmacies

On prescription

Manufacturer

Bayer Pharma AG,

D-51368 Leverkusen, Germany.

Registration certificate holder

Bayer Pharma AG, Berlin, Germany.

Address of the organization that accepts claims from consumers on the quality of the product (goods) on the territory of the Republic of Kazakhstan

Bayer KAZ LLP

st. Timiryazeva, 42, business center "Expo City", pav. fifteen

050057 Almaty, Republic of Kazakhstan,

tel. +7 727 258 80 40,

fax: +7 727 258 80 39,

e-mail: [email protected]

Attached files

187316541477976368_en.doc	118 kb
012625381477977572_kz.doc	169 kb

One tablet contains moxifloxacin hydrochloride – 436.8 mg + excipients (microcrystalline cellulose, magnesium stearate, iron oxide yellow, titanium dioxide, iron oxide red, lactose monohydrate, croscarmellose sodium, hypromellose, macrogol 4000).

One milliliter solution the drug contains the active substance moxifloxacin - 1.6 mg + auxiliary elements (hydrochloric acid, water, sodium chloride, 2N sodium hydroxide solution).

Release form

• Avelox (Avelox) is produced in the form of convex pink matte tablets, oblong shape. The tablet has a chamfer and the inscription Bayer on one side, M400 on the other. In blisters of 5 or 7 pieces, in cardboard packs of 1 or 2 blisters.
• The drug also has the form of a yellow-green clear liquid. In bottles of 250 ml, one bottle in a pack or in plastic bags of the same capacity, 12 in a pack.

pharmachologic effect

Antibacterial action.

Pharmacodynamics and pharmacokinetics

Active substance - moxifloxacin – 4th generation antibacterial agent quinolones , groups trifluoroquinolones . It has broad antibacterial activity. The substance penetrates directly into the cell, disrupts replication processes DNA hydrases , this leads to the death of the bacterium due to the violation of the integrity of the cell. It should be noted that pathogenic agents do not have time to release a significant amount, severe does not occur.

A number of mechanisms that lead to resistance to cephalosporins, macrolides, penicillins, aminoglycosides, tetracyclines , do not apply in case moxifloxacin . Not visible cross and plasmid sustainability. If resistance does occur, it does not happen immediately, after many mutations in harmful organisms. Rarely occurred cross stability to quinolones .

Thanks to the molecule added to the structure methoxy group , on the eighth carbon atom, the activity increases, the formation of resistant .

Moxifloxacin is active against a wide range of acid-fast, gram-positive and - negative bacteria , anaerobes , atypical agents (Xlamydia, mycoplasma and llegionelle ).

When using oral forms of the drug, changes in the intestines are observed, the concentration of bacteria necessary for normal functioning decreases gastrointestinal tract . However, already two weeks after the end of the antibiotic course, the microflora is restored.

According to the results of studies conducted in the laboratory in vitro , sensitive to Moxifloxacin: Gardnerella vaginalis, Streptococcus pyogenes, Streptococcus anginosus, Streptococcus intermedius, Streptococcus agalactiae, Staphylococcus aureus, S. cohnii, S. haemolyticus, S. saprophyticus, Streptococcus pneumoniae, Streptococcus constellatus, Streptococcus viridans group, S. epidermidis, S. hominis. Also show sensitivity: Haemophillus influenzae, Moraxella catarrhalis, Legionella pneumophila, Proteus vulgaris, Fusobacterium spp., Prevotela spp., Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycoplasma enitalium, Coxiella burnetii, Chlamydia trachomatis, Mycoplasma hominis, Legionella pneumophila, Propionibacterium spp. spp., Haemophillus parainfluenzue, Bordetella pertussis, Acinetobacter baumanii.

Moderate sensitivity have: sensitive to vancomycin and gentamicin strains of Enterococcus faecalis; Enterococcus faecium; Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Enterobacter cloacae, Enterobacter cloacae, Pseudomonas fluorescens, Stenotrophomonas maltophilia, Morganella morganii, Bacteroides spp., Clostridium spp. and others.

Moxifloxacin has the ability to cross the placenta. This has been proven through studies on rats and monkeys. There have been cases of increased frequency, abnormal skeletal formation, premature and reduced fetal weight, even when using doses slightly higher than therapeutic.

When taken orally, the antibiotic is quickly and almost completely absorbed and enters the bloodstream. About 90% of the drug is found in the blood plasma after half an hour, and after 4 it reaches its maximum. If the drug is taken with food, the Cmax and absorption time change, but to a small extent.

With infusor input, by the end of the injection, the maximum concentration is reached, it is 25% more than when taking tablets. The antibiotic quickly binds to (50%) and other plasma proteins, spreads throughout the body, reaching many target organs. The antibiotic is easy to detect unchanged in the abdominal cavity, interstitial fluid , peritoneal fluid and genitals.

Part of the drug in the body undergoes biotransformation and is excreted through the kidneys and gastrointestinal tract. Formed do not have a negative effect on tissues and organs.

12 hours after taking the antibiotic, its plasma concentration is reduced by half, so it is advisable to take the next dose of the drug. Partial tubular reabsorption in the kidneys. A quarter of unchanged moxifloxacin is excreted through the kidneys and another 22% with feces.

There were no significant changes in pharmacokinetic parameters in patients with kidney and liver diseases depending on age and race.

Indications for use

The drug is prescribed for the treatment of infections and inflammations caused by agents sensitive to its action:

• for the treatment of acute and chronic;
• skin and soft tissue infections;
• chronic;
• intra-abdominal abscesses , polymicrobial infections ;
• , salpingitis , other inflammatory diseases of the pelvic organs.

Contraindications

The drug is not prescribed:

• children under 18 , due to insufficient research;
• when on the components of the remedy, antibiotics of this series;
• for and ;
• with congenital or acquired heart diseases, accompanied by prolongation of the QT interval ;
• at hypokalemia ;
• at bradycardia ;
• heart failure (violation of the right ventricle);
• at lactose intolerance ;
• in the presence of serious liver diseases .

Care must be taken:

• at psychoses , other mental illnesses, illnesses CNS ;
• with acute;
• when combined with drugs that affect the activity of the heart.

Side effects

The drug has been well researched. From the results of post-marketing studies and clinical trials, a conclusion can be drawn about the frequency and nature of adverse reactions that occur.

The most common and common of the effects are nausea, and vomit .

With a frequency of less than 3% met:

• fungal infections;
• occurrence cardiac ;
• pain in epigastric areas;
• increased levels and activity of liver enzymes ( transmiasis );
• with the introduction of the drug intramuscularly, pain and reactions at the site of infusion were observed.

Rarely and very rarely observed:

• leukopenia, thrombocytopenia, anemia , concentration change prothrombin or thromboplastin ;
• hyperuricemia , hyperlipidemia and hyperglycemia ;
• condition anxiety , emotional lability, suicidal tendencies and actions, depersonalization , psychomotor agitation ;
• impairment and loss of vision and hearing;
• , , eosinophilia , or ;
• dyskenesia and sleep disturbances vertigo , violations in taste and olfactory sensations, convulsions , hyperesthesia ;
• , heartbeat, increase or decrease , ;
• Withsteven johnson syndrome (occurs very rarely);
• and decline , stomatitis , ;
• liver problems, increased bilirubin , jaundice , ;
• disorders in the work of the kidneys.

Instructions for use (Method and dosage)

Tablets are taken without chewing and without dividing, regardless of the meal.

According to the instructions for Avelox 400 mg, for adults, the daily dosage is one tablet or 400 mg of antibiotic.

The duration and mode of administration should be determined by the attending physician, depending on the severity of the infection, its effectiveness and the sensitivity of the patient.

As a rule, at the beginning of treatment, the drug is prescribed in injections, then, after the onset of improvements, tablets can be prescribed.

With an exacerbation chronic the course of treatment with the drug is 5 days. When - from 7 (injections) to 10 days.

At acute sinusitis and uncomplicated infections of the skin and tissues, the duration of the antibiotic is one week.

For uncomplicated infections of the pelvic organs, the course of treatment is two weeks.

With complicated infections of the skin and structures under the skin, therapy is carried out in stages and lasts from 5 days to two weeks.

In persons with impaired renal and hepatic function, the elderly, and for different ethnic groups, dose adjustment is not performed.

Application instruction of Aveloks for injections

Use only a clear solution, without sediment or turbidity.

Intravenously, the drug is administered for a long time, for 60 minutes, at least without diluting. Also, often the antibiotic is mixed with T-piece with water for injection, sodium chloride solution (0.9% or 1M), solution dextrose (5%, 10%, 40%), solution xylitol 20%, Ringer's solution . The prepared mixture can be stored at room temperature for 24 hours.

Do not mix other drugs in one syringe or dropper.

Overdose

There is not much data on overdose with the drug.

When used up to 1200 mg at a time or 600 mg in 10 days, no side effects were recorded.
If an overdose of the agent nevertheless occurred, symptomatic therapy should be performed with careful monitoring of the heart rhythm.

Immediately after taking extra-large doses of the tablet form, the drug can be taken enterosorbents this will reduce the likelihood of adverse reactions.

Interaction

The product works well with atenolol, theophylline, calcium preparations, oral contraceptives, itraconazole, morphine, digoxin, warfarin,.

However, when combined with indirect anticoagulants should be taken into account and checked periodically. INR adjust the antibiotic dose correctly.

When combined with antacids, multivitamins and minerals are formed chelated complexes with polyvalent cations, the concentration of the antibiotic in the blood decreases. In this regard, an interval of 4 hours between taking drugs should be observed.

If you combine the medicine with activated charcoal or other enterosorbents , then the bioavailability of the drug is greatly reduced (approximately 80%). With intravenous administration, this figure reaches 20%.

The solution for infusion should not be administered with 10% and 20% sodium chloride solution, sodium bicarbonate solution 4.2% and 8.4%.

Terms of sale

To purchase Avelox, you must have a prescription with you.

Storage conditions

Tablets are stored in a dry, cool place out of the reach of children.

Solution for infusion - at a temperature of 15-25 degrees.

Best before date

Tablets, glass vials - 5 years.

Polymer containers - 3 years.

Avelox's analogs

Coincidence in the ATX code of the 4th level:

The closest analogues of Avelox: -Farmex , Moxifloxacin , Moxifluor , Moflox , Moxifloxacin-Credopharm , Maksitsin , Moxifluor 400 , Moxin , Tevalox , Mofloxin Lupine .