Avelox 400mg N5 coated pills
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Active ingredients
Moxifloxacin
Release form
Pills
Composition
1 tablet contains: Active ingredient: moxifloxacin hydrochloride 436.8 mg (corresponds to moxifloxacin base - 400 mg)
Pharmacological effect
Antibacterial bactericidal drug of a wide spectrum of activity, 8-methoxyfluoroquinolone. The bactericidal effect of moxifloxacin is due to inhibition of bacterial topoisomerases II and IV, which leads to disruption of the replication, repair and transcription of the biosynthesis of microbial cell DNA and, as a result, the death of microbial cells. The minimum bactericidal concentrations of the drug are generally comparable to its MIC. Mechanisms of resistance: The mechanisms that lead to the development of resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not affect the antibacterial activity of moxifloxacin. Cross-resistance between these groups of antibacterial drugs and moxifloxacin is not observed. So far, there have also been no cases of plasmid resistance. The overall incidence of resistance is very low (10–7–10–10). Resistance to moxifloxacin develops slowly through multiple mutations. Repeated exposure of moxifloxacin to microorganisms in concentrations below the MIC is accompanied only by its slight increase. There are cases of cross-resistance to quinolones. However, some gram-positive and anaerobic microorganisms that are resistant to other quinolones retain sensitivity to moxifloxacin. It has been established that the addition of the methoxy group to the moxifloxacin structure in the C8 position increases the activity of moxifloxacin and reduces the formation of resistant mutant strains of gram-positive bacteria. The addition of the bicycloamine group in position C7 prevents the development of active efflux, the mechanism of resistance to fluoroquinolones. In vitro moxifloxacin is active against a wide range of gram-negative and gram-positive microorganisms, anaerobes, acid-resistant bacteria, and atypical bacteria, such as Mycoplasma spp., Chlamydia spp., Legionella spp.Effects on human intestinal microflora: In two studies conducted on volunteers, the following changes in 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., As well as the Aaoba Ia Ia Ia Ia Ia Ia Ia Ia Ia Ia Ia Ia Ia I I I I I I is and is a Chafer, and I nominated Iaad Ia Ia Ia Ia Ia Ia Ia Ia Ia Ia Ia Ia Ia Ia Ia I I I I I is a object a sea a realtor. , Eubacterium spp., Peptostreptococcus spp. These changes were reversible within two weeks. Toxins Clostridium difficile was not detected.
Pharmacokinetics
Absorption: After oral administration, moxifloxacin is absorbed quickly and almost completely. Absolute bioavailability is about 91%. The pharmacokinetics of moxifloxacin when taken in a dose of from 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 amounts to 3.1 mg / l. After ingestion 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 by 16%), while the duration of absorption does not change. However, these data have no clinical significance, and the drug can be used regardless of the meal. 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 epithelial fluid, alveolar macrophages), in the nasal sinuses (maxillary and ethmoidal sinuses), in nasal polyps, inflammation foci (in the contents of the blistering skin lesions ). In interstitial fluid and in saliva, moxifloxacin is determined in a free, non-protein form, at a concentration higher than in plasma. In addition, high concentrations of moxifloxacin are determined in the tissues of the abdominal cavity organs, peritoneal fluid, as well as in the tissues of the female genital organs. Metabolism: Moxifloxacin undergoes biotransformation of the 2nd phase and is excreted from the body by the kidneys, as well as through the intestine, both unchanged and in the form of inactive sulfosulfur 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 from the point of view of safety and tolerability. Withdrawal: T1 / 2 is approximately 12 hours. The average total clearance after taking the drug inside the dose of 400 mg is 179-246 ml / min. Renal clearance is 24-53 ml / min. This indicates a partial tubular reabsorption of the drug. The mass balance of the parent compound and the metabolites of the 2nd phase is approximately 96-98%, which indicates the absence of oxidative metabolism. About 22% of a single dose (400 mg) is excreted unchanged by the kidneys, about 26% through the 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. Moxifloxacin absorption did not depend on sex. Differences in AUC and Cmax were due to differences in body weight rather than sex and are not considered clinically significant. There were no clinically significant differences in the pharmacokinetics of moxifloxacin in patients of different ethnic groups and different ages. Studies of the pharmacokinetics 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 KKmenhe 30 ml / min / 1.73 m2) and in patients on continuous hemodialysis and prolonged outpatient peritoneal dialysis. There were no significant differences in the concentration of moxifloxacin in patients with impaired liver function (grades A and B on the Child-Pugh scale) compared with healthy volunteers and patients with normal liver function.
Indications
Infectious and inflammatory diseases in adults caused by susceptible microorganisms: Acute sinusitis. Exacerbation of chronic bronchitis. Community-acquired pneumonia (including caused by strains of microorganisms with multiple resistance to antibiotics *). Uncomplicated infections of the skin and soft tissues. Complicated skin infections subcutaneous structures (including an infected diabetic foot). Complicated intra-abdominal infections, including polymicrobial infections, includingIntraperitoneal abscesses. Uncomplicated inflammatory diseases of the pelvic organs (including Salpingitis and endometritis). * Streptococcus pneumoniae with multiple resistance to antibiotics include strains resistant to penicillin, and strains resistant to two or more antibiotics that are resistant to two or more antibiotics that are resistant to two or more antibiotics that are resistant to two or more antibiotics, groups that are resistant to two or more antibiotics, groups that are resistant to two or more antibiotics that are resistant to two or more antibiotics, are resistant to penicillin-resistant, and resistant to two or more antibiotics. with mic ≥2 mg / ml), second generation cephalosporins (cefuroxime), macrolides, tetracyclines and trimethoprim / sulfamethoxazole. It is necessary to take into account the existing official guidelines on the rules for the use of antibacterial agents STV.
Contraindications
A history of tendon pathology that developed as a result of quinolone treatment with 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 lengthening of the interval. In this regard, the use of moxifloxacin is contraindicated in patients of the following categories: congenital or acquired documented lengthening of the interval, electrolyte disturbances, especially uncorrected hypokalemia. Clinically significant bradycardia. Clinically significant heart failure with a reduced left ventricular ejection fraction. A history of rhythm disturbances accompanied by clinical symptoms. Moxifloxacin should not be used with other drugs that prolong the interval. Due to the presence of lactose in the preparation, its use is contraindicated in case of congenital lactose intolerance, lactase deficiency, glucose-galactose malabsorption (for pills). Due to the limited amount of clinical data, the use of moxifloxacin is contraindicated in patients with impaired liver function (class C according to child-drink classification) and in patients with increased transaminases more than 5 times higher in vgn. Pregnancy. Lactation (breastfeeding). Age up to 18 years. Hypersensitivity to moxifloxacin, other quinolones or any other component of the drug. With caution, you should prescribe the drug for diseases of the central nervous system (including diseases suspicious of involvement of the central nervous system), predisposing to the occurrence of convulsive seizures and reduce the threshold of convulsive readiness. In patients with psychoses 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. At the same time taken with drugs that reduce the content of potassium. In patients with a genetic predisposition or an actual deficiency of glucose-6-phosphate dehydrogenase. Use during pregnancy and breastfeeding The safety of using moxifloxacin during pregnancy has not been established and its use is contraindicated. Cases of reversible damage to the joints in children receiving certain quinolones have been described, however, this effect has not been reported in the fetus (when applied by the mother during pregnancy). Animal studies have shown reproductive toxicity. The potential risk to humans is unknown. Like other quinolones, moxifloxacin causes cartilage damage to large joints in premature animals. In preclinical studies found 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
Precautions should be prescribed the drug for diseases of the central nervous system (including diseases suspicious of involvement of the central nervous system), predisposing to the occurrence of convulsive seizures and reduce the threshold of convulsive readiness; in patients with psychoses 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, while taking it with drugs, potassium lowering; in patients with a genetic predisposition or an 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 damage to the joints in children receiving certain quinolones have been described, however, this effect has not been reported in the fetus (when applied by the mother during pregnancy).Animal studies have shown reproductive toxicity. The potential risk to humans is unknown. Like other quinolones, moxifloxacin causes cartilage damage to large joints in premature animals. In preclinical studies found 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 administered 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 by ingestion is determined by the severity of the infection and the clinical effect and is: for exacerbation of chronic bronchitis - 5-10 days; in community-acquired pneumonia, the total duration of the step therapy (in / in the introduction followed by ingestion) - 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 the step therapy (w / w introduction followed by ingestion) is 7-21 days; in case of complicated intra-abdominal infections, the total duration of the step therapy (intravenous administration of the drug with subsequent ingestion) is 5-14 days; with uncomplicated inflammatory diseases of the pelvic organs - 14 days. The duration of treatment with Avelox can be as long as 21 days. Changes in the dosage 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 changes in dosing regimen is not required. In patients with impaired renal function (including with severe renal failure with a CC of ≤ 30 ml / min / 1.73 m2), as well as in patients on continuous hemodialysis and long-term outpatient peritoneal dialysis, no change in dosage regimen is required. Patients of different ethnic groups do not need to change the dosage regimen.
Side effects
Data on adverse reactions recorded with the use of moxifloxacin at a dose of 400 mg (orally, with incremental therapy [in / in the introduction of the drug, followed by ingestion] and only in / in), obtained from clinical studies and post-marketing messages (in italics). The adverse reactions listed in the group often occurred with a frequency below 3%, with the exception of nausea and diarrhea. In each frequency group, undesirable drug reactions are listed in decreasing order of importance. The frequency of adverse reactions is 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 side of the hematopoietic system, infrequently - anemia, leukopenia, neutropenia, thrombocytopenia, thrombocythemia, prolongation of the prothrombin time / increase in INR. rarely a change in thromboplastin concentration. very rarely - an increase in the concentration of prothrombin / a decrease in the INR. On the part of the immune system, it is not often - allergic reactions, urticaria, pruritus, rash, eosinophilia. rarely, anaphylactic / anaphylactoid reactions, angioedema, including laryngeal edema (potentially life-threatening). very rarely - anaphylactic / anaphylactoid shock (including potentially life-threatening). On 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, 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). On the nervous system, often - dizziness, headache. infrequently - paresthesia, dysesthesia, disturbances of taste sensitivity (including in very rare cases agevzii), confusion, disorientation, sleep disturbances, tremors, vertigo, drowsiness. rarely - hypoesthesia, olfactory disturbances (including anosmia), atypical dreams, impaired coordination (including gait disturbances due to dizziness or vertigo, in very rare cases leading to injuries due to a fall, especially in elderly patients), convulsions with various clinical manifestations (including . h.grand mal seizures), impaired attention, speech disorders, amnesia, peripheral neuropathy, polyneuropathy. very rarely - hyperesthesia. For the organ of vision infrequently - visual impairment (especially during reactions from the central nervous system). very rarely - transient loss of vision (especially in reactions from the CNS). On the part of the organ of hearing it is rare - tinnitus, hearing impairment, including deafness (usually reversible). On the side of the cardiovascular system, it is often a 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, syncope, ventricular tachyarrhythmias. very rarely, nonspecific arrhythmias, polymorphic ventricular tachycardia (such as pirouette), cardiac arrest (mainly in individuals with conditions that are predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia) 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). On the side of the liver and biliary tract often - an increase in the activity of hepatic transaminases. infrequently - abnormal liver function (including increased activity of LDH), increased concentration of bilirubin, increased activity of GGT and alkaline phosphatase. rarely - jaundice, hepatitis (mostly cholestatic). very rarely - fulminant hepatitis, potentially leading to life-threatening liver failure (including fatal cases). From 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 - tendonitis, 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. On the part of the urinary system it is not often - dehydration (caused by diarrhea or a decrease in fluid intake).rarely - impaired renal function, renal failure as a result of dehydration, which can cause kidney damage, especially in elderly patients with pre-existing impaired renal function). On the whole, the body often has reactions at the injection / infusion site. infrequently - general malaise, nonspecific pain, sweating. The frequency of the development of the following undesirable reactions was higher in the group that received step therapy, often the increase in GGT activity. infrequently - ventricular tachyarrhythmias, arterial hypotension, edema, pseudomembranous colitis (in very rare cases associated with life-threatening complications), seizures with various clinical manifestations (including grand mal seizures), hallucinations, impaired renal function, renal failure (in result of dehydration, which can lead to kidney damage, especially in older patients with pre-existing renal impairment).
Overdose
There is limited evidence of an overdose of moxifloxacin. No adverse effects were noted with the use of Avelox at a dose of up to 1200 mg once and 600 mg for 10 days or more. Treatment: in case of overdose, in accordance with the clinical situation, symptomatic and supportive therapy is carried out with ECG monitoring. The use of activated carbon immediately after oral administration of the drug can help prevent excessive systemic exposure to moxifloxacin in cases of overdose.
Interaction with other drugs
Dose adjustment is not required when using the drug Avelox with atenolol, ranitidine, calcium supplements, theophylline, cyclosporine, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid (there is no clinically significant interaction with moxifloxacin). The possible additive effect of lengthening the QT interval of moxifloxacin and other drugs that affect the prolongation of the QT interval should be taken into account. 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 such as pirouette, increases.The combined use of moxifloxacin with the following drugs that affect the prolongation of the QT interval is contraindicated: class IA antiarrhythmic drugs (including quinidine, hydroquinidine, disopyramide); class III antiarrhythmic drugs (including amiodarone, sotalol, dofetilide, ibutilide); neuroleptics (including phenothiazine, pimozide, sertindol, haloperidol, sultoprid); tricyclic antidepressants; antimicrobial drugs (sparfloxacin, erythromycin IV, pentamidine, antimalarial drugs, especially halofantrine); antihistamines (terfenadine, astemizole, mizolastine); others (cisapride, Vincamine IV, bepridil, difemanil). Ingestion of the drug Avelox and antacids, multivitamins and minerals can interfere with the absorption of moxifloxacin due to the formation of chelate complexes with polyvalent cations contained in these preparations. As a result, plasma concentration of moxifloxacin may be significantly lower than therapeutic. In this regard, antacid, anti-retroviral (for example, didanosine) and other drugs containing magnesium, aluminum, sucralfate, iron, zinc should be taken at least 4 hours before or 4 hours after ingestion of moxifloxacin. With the combined use of Avelox with warfarin, the prothrombin time and other parameters of blood coagulation do not change. In patients who received anticoagulants in combination with antibiotics, incl. with moxifloxacin, there are cases of increased anticoagulant activity of anticoagulants. Risk factors are the presence of an infectious disease (and associated inflammatory process), age and general condition of the patient. Despite the fact that there is no interaction between moxifloxacin and warfarin, patients receiving combined treatment with these drugs need to monitor the INR and, if necessary, adjust the dose of indirect anticoagulants. Moxifloxacin and digoxin do not significantly affect the pharmacokinetic parameters of each other. With repeated administration of moxifloxacin, Cmax of digoxin increased by approximately 30%. The value of AUC and Cmin digoxin do not change. With simultaneous use of activated carbon and moxifloxacin orally at a dose of 400 mg, the systemic bioavailability of the drug is reduced by more than 80% as a result of slowing its absorption. In case of overdose, the use of activated carbon at an early stage of absorption prevents the further increase in systemic exposure.
special instructions
In some cases, after the first use of the drug may develop hypersensitivity and allergic reactions, which should immediately inform the doctor. Very rarely, even after the first use of the drug, anaphylactic reactions can progress to life-threatening anaphylactic shock. In these cases, treatment with the drug Aveloks should be stopped and immediately begin to carry out the necessary therapeutic measures (including antishock). When using the drug Avelox in some patients, a prolongation of the QT interval may be noted. Avelox should be used with caution in women and elderly patients. Since 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 an increase in the concentration of the drug; therefore, the recommended dose should not be exceeded. Lengthening the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. However, in patients with pneumonia, a correlation between plasma concentration of moxifloxacin and prolongation of the QT interval was noted. None of the 9000 patients who received Avelox had any cardiovascular complications or deaths associated with prolongation of the QT interval. The use of the drug Avelox may increase the risk of ventricular arrhythmias in patients with conditions predisposing to arrhythmias. In this regard, Avelox is contraindicated in: changes in the cardiac electrophysiological parameters, expressed in prolongation of the QT interval (congenital or acquired documented lengthenings of the QT interval, electrolyte disorders, especially uncorrected hypokalemia, clinically significant bradycardia, clinically significant heart failure with a reduced left ventricular ejection, in the history of indications of rhythm disturbances, accompanied by clinical symptoms), use with other drugs, extending of the interval QT. Avelox should be used with caution: in patients with potentially proarrhythmic conditions, such as acute myocardial ischemia, in patients with cirrhosis of the liver (since in this category of patients the risk of developing a prolonged QT interval 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 if symptoms of liver failure appear, it is necessary to consult a doctor before continuing treatment with Avelox. When taking the drug Avelox, cases of bullous skin lesions have been reported (such as Stevens-Johnson syndrome or toxic epidermal necrolysis). The patient should be informed that if symptoms of lesions of the skin or mucous membranes appear, 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 diseases of the central nervous system and disorders of the central nervous system, predisposing to the occurrence of seizures or lowering the threshold of seizure activity. The use of broad-spectrum antibacterial drugs, including Avelox, is associated with the risk of developing pseudomembranous colitis. This diagnosis should be kept in mind in patients who developed severe diarrhea during treatment with Aveloks. In this case, you should immediately assign the appropriate therapy. Drugs that suppress intestinal motility are contraindicated in the development of severe diarrhea. Avelox should be used with caution in patients with myasthenia syndrome due to the possible exacerbation of the disease. Against the background of quinolone therapy, incl. moxifloxacin, may develop tendonitis and tendon rupture, especially in the elderly and patients receiving SCS. Cases that occurred 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 quinolones are used, photosensitivity reactions are noted. However, during preclinical and clinical studies, as well as with the use of the drug Avelox in practice, photosensitivity reactions were not observed. However, patients receiving Avelox should avoid exposure to direct sunlight and ultraviolet radiation.The use of the drug in the form of pills for oral administration is not recommended in patients with complicated inflammatory diseases of the pelvic organs (for example, associated with tubo-ovarian or pelvic abscesses). It is not recommended to use moxifloxacin for the treatment of infections caused by Methicillin-resistant Staphylococcus aureus (MRSA) strains. In the case of suspected or confirmed infections caused by MRSA, treatment with appropriate antibacterial drugs should be prescribed. The ability of Avelox to suppress the growth of mycobacteria can cause in vitro interaction of moxifloxacin with the test for Mycobacterium spp., Which leads to false-negative results when analyzing samples of patients who are being treated with Aveloks during this period. Patients who were treated with quinolones, including the drug Avelox, described cases of sensory or sensorimotor polyneuropathy, leading to paresthesia, hypesthesia, dysesthesia, or weakness. Patients who are treated with Avelox should be warned of the need to immediately see a doctor before continuing treatment if symptoms of neuropathy occur, including pain, burning, tingling, numbness or weakness. Reactions from the psyche can occur even after the first appointment of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions progress to the occurrence of suicidal thoughts and behaviors with a tendency to self-harm, including suicidal attempts. If such reactions develop in patients, Avelox should be discontinued and the necessary measures should be taken. Caution should be exercised in the appointment of the drug Avelox patients with psychosis and / or psychiatric diseases in history. Due to the widespread and increasing incidence of infections caused by fluoroquinolone-resistant Neisseria gonorrhoeae in the treatment of patients with pelvic inflammatory diseases, moxifloxacin monotherapy should not be performed unless the presence of fluoroquinolone-resistant N. gonorrhoeae is excluded. If it is not possible to exclude the presence of a fluoroquinolone-resistant N.gonorrhoeae, it is necessary to resolve the issue of supplementing empiric therapy with moxifloxacin with an appropriate antibiotic that is active against N. gonorrhoeae (eg, cephalosporin). As in the case of other fluoroquinolones, when using the drug Avelox, a change in glucose concentration in the blood, including hypo- and hyperglycemia, was noted. During therapy with Avelox, dysglycemia occurred mainly in elderly patients with diabetes who received concomitant therapy with oral hypoglycemic drugs (for example, sulfonylureas) or insulin. When treating patients with diabetes mellitus, careful monitoring of blood glucose concentration is recommended. Influencing the ability to drive vehicles and control mechanisms Fluoroquinolones, including moxifloxacin, can impair the ability of patients to drive and engage in other potentially dangerous activities that require increased attention and speed of psychomotor reactions