Megaflox tabs 400mg #5

Megaflox instruction

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Composition

1 tablet contains:
active substance: moxifloxacin hydrochloride - 436.8 mg (in terms of moxifloxacin - 400 mg);
auxiliary substances: microcrystalline cellulose 161.2 mg, povidone K-30 18 mg, croscarmellose sodium 70 mg, silicon dioxide colloid (aerosil) 7 mg, magnesium stearate 7 mg;
Excipients for the shell: Opadry II (85 Series) [polyvinyl alcohol, 8.4 mg, 4.242 mg of macrogol, talc 3.108 mg, 4.916 mg of titanium dioxide, aluminum lake dye-based charming red 0.122 mg Aluminum Lake Dye azorubin 0.094 mg , aluminum lacquer based on the dye sunset sunset yellow 0.118 mg].

Description

The tablets covered with a film membrane of pink color, biconvex, oblong with rounded ends, with a risk. On the cross section, the core is light yellow in color.

Pharmacotherapeutic group

Antimicrobial agent - fluoroquinolone.
ATX Code:
J01MA14

Pharmacological properties

Pharmacodynamics

Mechanism of action.
Moxifloxacin is a bactericidal antibacterial broad-spectrum drug, 8-methoxy fluoroquinolone. The bactericidal action of moxifloxacin due to inhibition of bacterial topoisomerase II and IV, which leads to disruption of replication processes, repair and transcription of DNA biosynthesis of microbial cells and, consequently, to the death of the microbial cells. The minimum bactericidal concentrations of moxifloxacin are generally comparable to its minimum inhibitory concentrations.
Mechanisms of resistance.
Mechanisms that lead to the development of resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines, do not affect the antibacterial activity of moxifloxacin. Cross-resistance between these groups of antibacterial drugs and moxifloxacin is not noted. So far, no cases of plasmid resistance have been observed. The overall frequency of development of resistance is very low (10 -7-10-10). Resistance to moxifloxacin develops slowly by multiple mutations. Multiple effects of moxifloxacin on microorganisms at concentrations below the minimum inhibitory concentration (MIC) are accompanied by only a slight increase in MIC. There are cases of cross-resistance to quinolones. Nevertheless, some gram-positive and anaerobic microorganisms resistant to other quinolones retain sensitivity to moxifloxacin.
It has been established that the addition of the methoxyfloxacin methoxy group in the C8 position to the molecule structure increases the activity of moxifloxacin and reduces the formation of resistant mutant strains of Gram-positive bacteria. The addition of the bicycloamine group to the C7 position prevents the development of an active efflux, a mechanism of resistance to fluoroquinolones.
Moxifloxacin is active in vitro against a broad spectrum of gram-negative and gram-positive bacteria, anaerobes, and atypical acid-fast bacterial forms such as Mycoplasma spp., Chlamidia spp., Legionella spp., And bacteria resistant to beta-lactam antibiotics and macrolide.
Influence on human intestinal microflora.
In two studies conducted on volunteers, the following changes in the intestinal microflora were observed after oral administration of moxifloxacin. Escherichia coli, a decrease of concentrations, Bacillus spp., Bacteroides vulgates, Enterococcus spp., Klebsiella spp., As well as anaerobic Bifidobacterium spp., Eubacterium spp., Peptostreptococcus spp. These changes were reversible within two weeks. The toxin of Clostridium difficile was not detected.
The use of Megaflox is not recommended for the treatment of infections caused by S. aureus strains resistant to methicillin (MRSA). In the case of suspected or confirmed infections caused by MRSA, treatment should be prescribed with appropriate antibacterial drugs.
Possible development of acquired resistance.
For certain strains, the spread of acquired resistance may vary depending on the geographical region and over time. In this regard, when testing the sensitivity of a strain, it is desirable to have local information on resistance, especially when treating severe infections.

Pharmacokinetics

Absorption and bioavailability.
After oral administration, moxifloxacin is absorbed rapidly and almost completely. Absolute bioavailability is about 91%.
The pharmacokinetics of moxifloxacin when administered at a dose of 50 to 1200 mg once, and also at 600 mg / day for 10 days is linear. The equilibrium state is reached within 3 days.
After a single application 400 mg of moxifloxacin C max in the blood is reached within 0.5-4 hours and is 3.1 mg / l. After taking 400 mg of moxifloxacin once a day, the average equilibrium maximum (Css max) and minimum (Cssmin) concentrations are 3.2 mg / L and 0.6 mg / L, respectively.
When moxifloxacin is taken with food, there is a slight increase in the time to reach C max (for 2 hours) and a slight decrease in C max (approximately 16%), while the duration of suction does not change. However, these data have no clinical significance, and the drug can be used regardless of food intake.
Distribution.
Moxifloxacin is rapidly distributed in tissues and organs and binds to blood proteins (mainly albumins) by about 45%. The distribution volume is approximately 2 l / kg.
High concentrations of moxifloxacin, exceeding those in blood 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, in the foci of inflammation (in the contents of blisters at damage to the skin). In the interstitial fluid and saliva, moxifloxacin is defined in a free, non-protein-binding form at a concentration higher than in the blood plasma. In addition, high concentrations of moxifloxacin are found in the tissues of the abdominal cavity, peritoneal fluid, and female genital organs.
Metabolism.
Moxifloxacin undergoes biotransformation of the 2nd phase and is excreted from the body by the kidneys, and also through the intestine, both in unmodified form and in the form of inactive sulfo compounds (M1) and glucuronides (M2). Moxifloxacin is not biotransformed with the cytochrome P450 microsomal system. Metabolites M1 and M2 are present in the blood plasma at concentrations lower than the original compound. According to the results of preclinical studies, it was proved that these metabolites do not have a negative impact on the body in terms of safety and tolerability.
Excretion.
The half-life (T1 / 2) of moxifloxacin is approximately 12 hours. The average total clearance after taking in a dose of 400 mg is from 179 to 246 ml / min. Kidney clearance is 24-53 ml / min. This indicates a partial tubular reabsorption of Megaflox. The mass balance of the initial compound and the metabolites of the 2nd phase is approximately 96-98%, which indicates the absence of oxidative metabolism. About 22% of a single dose (400 mg) is excreted unchanged by the kidneys, about 26% - through the intestine.
Pharmacokinetics in different patient groups
Age, gender and ethnicity.
When studying the pharmacokinetics of moxifloxacin in men and women, differences were found in 33% of AUC and C max. Absorption of moxifloxacin did not depend on sex. Differences in AUC and C max were due to differences in weight rather than sex and are not considered clinically significant. There were no clinically significant differences in the pharmacokinetics of moxifloxacin in patients of different ethnic groups and ages.
Children. The pharmacokinetics of moxifloxacin in children have not been studied.
Renal failure.
There were no significant changes in the pharmacokinetics of moxifloxacin in patients with impaired renal function (including patients with creatinine clearance <30 mL / min / 1.73 m 2) and in patients on continuous hemodialysis and long-term outpatient peritoneal dialysis.
Violation of the function of the liver.
There was no significant difference in moxifloxacin concentration in patients with hepatic impairment (Child-Pugh class A, B) compared with healthy volunteers and patients with normal liver function.

Indications for use of Megaflox

Infectious-inflammatory diseases caused by micro-organisms sensitive to moxifloxacin:
- Acute sinusitis.
- Exacerbation of chronic bronchitis.
- Uncomplicated infections of the skin and subcutaneous structures.
- Community-acquired pneumonia, including CAP which pathogens are microbial strains with multiple resistance to antibiotics ⃰.
- Complicated infections of the skin and subcutaneous structures (including an infected diabetic foot).
- Complicated intra-abdominal infections, including polymicrobial infections, including intraperitoneal abscesses.
- Uncomplicated inflammatory diseases of the pelvic organs (including salpingitis and endometritis).
⃰Streptococcus pneumoniae with multiple antibiotic resistance includes penicillin resistant strains and strains resistant to two or more antibiotics from such groups as penicillins (with MIC ≥ 2 μg / ml), cephalosporins of the second generation (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 for Megaflox

- Hypersensitivity to moxifloxacin, other quinolones and any other component of the drug;
- Age to 18 years;
- Pregnancy, the period of breastfeeding;
- Presence in the anamnesis of a pathology of tendons, developed as a result of treatment with antibiotics of the quinolone series;
- Congenital or acquired QT interval prolongations on a cardiogram;
- Violations of electrolyte balance, especially uncorrected hypokalemia;
- Acute myocardial ischemia;
- Clinically significant bradycardia;
- Clinically significant heart failure with a reduced fraction of the ejection of the left ventricle;
- The presence in the anamnesis of rhythm disturbances, accompanied by clinical symptoms;
- Simultaneous use with other drugs that extend the QT interval;
- Due to the limited number of clinical data, moxifloxacin is contraindicated in patients with impaired liver function (Child-Pugh class C) and in patients with elevated transaminases more than five times the upper limit of the norm.

Carefully

- with diseases of the central nervous system (including diseases suspected of involving the central nervous system), predisposing to the onset of seizures and reducing the threshold of seizure activity;
- Patients with psychoses and patients with psychiatric illnesses in the anamnesis;
- in patients with potentially proarrhythmic conditions (especially in women and elderly patients), such as acute myocardial ischemia;
- with myasthenia gravis;
- in patients with cirrhosis of the liver;
- with simultaneous use with drugs that reduce the content of potassium.

Application in pregnancy and during breastfeeding

Pregnancy. Safety of moxifloxacin during pregnancy is not established, therefore its use is contraindicated. Cases of reversible joint damage in children receiving certain quinolones are described, but no evidence of this effect was reported in the fetus (if the mother used it during pregnancy).
In animal studies, reproductive toxicity has been demonstrated. The potential risk to humans is unknown. Like other quinolones, moxifloxacin causes damage to cartilaginous large joints in preterm animals.
Breastfeeding period. In preclinical studies, it was found that a small amount of moxifloxacin is excreted into breast milk. Data on the use of moxifloxacin in women during lactation are absent. Therefore, the use of moxifloxacin during breastfeeding is contraindicated.

Dosing and Administration

Inside, not liquid, squeezed enough water, regardless of food intake.
The recommended dosage regimen for moxifloxacin is one tablet (400 mg) once a day for the infections mentioned above. Do not exceed the recommended dose.
The duration of treatment is determined by the localization 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;
- Community-acquired pneumonia: the total duration of the stepwise therapy (intravenous administration followed by oral administration) is 7-14 days;
- Complicated infections of the skin and subcutaneous structures: the total duration of stepwise therapy (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 pelvic inflammatory disease: 14 days.
Do not exceed the recommended duration of treatment.
The duration of treatment with Megaflox can be up to 21 days.
Children. The efficacy and safety of moxifloxacin in children and adolescents has not been established.
Patients of advanced age. Changes in the dosing regimen in elderly patients are not required.
Violation of the function of the liver. Patients with hepatic dysfunction are not required to change the dosage regimen (for use in patients with cirrhosis see the section "Special instructions").
Renal failure. In patients with impaired renal function (including severe renal failure with creatinine clearance ≤30 ml / min / 1.73 m 2), as well as in patients undergoing continuous hemodialysis and long-term outpatient peritoneal dialysis, changes in the dosing regimen it takes.
Use in patients of different ethnic groups. Dosage regimen changes are not required.

Side effects of Megaflox

The incidence of adverse reactions is as follows: very often (≥1 / 10 cases), often (≥1 / 100 and <1/10 cases) infrequently (≥1 / 1000 and <1/100 cases), rarely (≥1 / 10000 and <1/1000 cases) and very rarely (<1/10000 cases).
Adverse reactions listed in the "frequently" group occurred with a frequency below 3%, with the exception of nausea and diarrhea. In each frequency group, undesirable drug reactions are listed in order of decreasing significance.
Infectious and parasitic diseases: often - fungal superinfections.
On the part of the hematopoiesis system: infrequently - anemia, leukopenia, neutropenia, thrombocytopenia, thrombocythemia, lengthening of the porphbin time / increase in the international normalized ratio (INR); rarely - a change in the concentration of tromboplastin; very rarely - an increase in the concentration of the protozoa / decrease in INR.
From the immune system: infrequently - allergic reactions, itching, rashes, urticaria, 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.
Mental disorders: infrequent - anxiety, psychomotor hyperactivity / agitation; rarely - emotional lability, depression (in very rare cases, behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts), hallucinations; very rarely - depersonalization, psychotic reactions (potentially manifested in behavior with a tendency to self-harm, such as suicidal thoughts and suicidal attempts).
From the nervous system: often - headache, dizziness; infrequently paresthesia / dysesthesia, disorders of taste sensitivity (including very rare cases of agevia), confusion and disorientation, sleep disorders, tremor, vertigo, drowsiness; rarely - hypoesthesia, olfactory impairment (including anosmia), atypical dreams, impaired coordination (including dizziness or vertigo gait disturbance, very rarely leading to trauma from falling, especially in elderly patients), seizures with different clinical manifestations (including including "grand mal" seizures), attention disorders, speech disorders, amnesia, peripheral neuropathy and polyneuropathy; very rarely hyperesthesia.
From the side of the organ of vision: infrequently - visual impairment (especially with CNS reactions); very rarely - transient loss of vision (especially against the background of reactions from the central nervous system).
From the side of the organ of hearing and labyrinthine disturbances: rarely - noise in the ears, hearing impairment, including deafness (usually reversible).
From the cardiovascular system: often - prolongation of the QT interval in patients with concomitant hypokalemia, infrequent - prolongation of the QT interval, palpitation, tachycardia, vasodilation; rarely - ventricular tachyarrhythmias, fainting, increased blood pressure, lower blood pressure; very rarely - nonspecific arrhythmias, polymorphic ventricular tachycardia (Torsade de Pointes), cardiac arrest (mainly in persons with predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia).
From the respiratory system, chest and mediastinum: infrequently - shortness of breath (including asthmatic condition).
From the gastrointestinal tract: often - nausea, vomiting, abdominal pain, diarrhea; infrequent - reduced appetite and reduced food intake, constipation, dyspepsia, flatulence, gastroenteritis (other than erosive gastroenteritis), increased amylase activity; rarely - dysphagia, stomatitis, pseudomembranous colitis (in very rare cases associated with life-threatening complications).
Disorders from the liver and bile ducts: often - increased activity of "liver" transaminases, infrequently - violations of liver function (including increased lactate dehydrogenase activity), increased bilirubin concentration, increased activity of gamma-glutamyl transferase, increased alkaline phosphatase activity in blood; rarely - jaundice, hepatitis (mostly cholestatic); very rarely - fulminant hepatitis, potentially leading to life-threatening liver failure (including fatal cases).
From the skin and soft tissues: very rarely - bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).
From the musculoskeletal and connective tissue: infrequently - arthralgia, myalgia; rarely - tendonitis, increased muscle tone and cramps, muscle weakness; very rarely - tendon ruptures, arthritis, gait disturbance due to damage to the musculoskeletal system, increased symptoms of myasthenia gravis.
From the side of the kidneys and urinary tracts: infrequently - dehydration (caused by diarrhea or decreased fluid intake); rarely - renal dysfunction, renal failure (as a result of dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing impairment of kidney function.
The frequency of development of the following adverse reactions was higher in the group receiving stepwise therapy: often - increased activity of gamma-glutamyltransferase; infrequently, ventricular tachyarrhythmias, lowering of arterial pressure, edema, pseudomembranous colitis (in very rare cases associated with life-threatening complications), seizures with various clinical manifestations (including "grand mal" seizures), hallucinations, impaired renal function, renal failure as a result of dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing impaired renal function).

Overdose

Symptoms. There are limited data on the overdose of moxifloxacin. No side effects were observed with the use of moxifloxacin in a dose of up to 1200 mg once and 600 mg for 10 days or more.
Treatment. In case of an overdose, one should be guided by the clinical picture and carry out symptomatic maintenance therapy with ECG monitoring. The use of activated carbon immediately after taking Megaflox can help prevent excessive systemic exposure to moxifloxacin in cases of overdose.

Interaction Megaflox with other drugs

When combined with atenolol, ranitidine, calcium-containing additives, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenicide (no clinically significant interaction with moxifloxacin was confirmed), dose adjustment is not required.
Drugs that extend the QT interval.
Consider the possible additive effect of prolonging the QT interval of moxifloxacin and other drugs that affect the prolongation of the QT interval. Due to the combined use of moxifloxacin and drugs that affect the prolongation of the QT interval, the risk of ventricular arrhythmia increases, including polymorphic torsade de pointes.
Contraindicated the combined use of moxifloxacin with the following drugs that affect the prolongation of the QT interval:
- antiarrhythmic drugs of class IA (quinidine, hydroquinidine, disopyramide, etc.);
- antiarrhythmic drugs of class III (amiodarone, sotalol, dofetilide, ibutilide, etc.);
- Neuroleptics (phenothiazine, pimozide, sertindole, haloperidol, sultopride, etc.);
- tricyclic antidepressants;
- antimicrobial drugs (sparfloxacin, erythromycin (intravenously), pentamidine, antimalarial drugs, especially halofantrine);
- antihistamines (terfenadine, astemizole, misolastine);
- Others (cisapride, vincomamine (intravenously), bepridil, difemanyl).
Antacids, multivitamins and minerals.
Taking moxifloxacin concomitantly with antacid agents, multivitamins and minerals can lead to a violation of absorption of moxifloxacin after ingestion, due to the formation of chelate complexes with polyvalent cations contained in these preparations. As a result, the concentration of moxifloxacin in the blood plasma may be significantly lower than desired. In this regard, antacid preparations, antiretroviral drugs (for example, didanosine) and other preparations containing magnesium or aluminum, sucralfate and other preparations containing iron or zinc should be used at least 4 hours before or 4 hours after ingestion moxifloxacin.
Warfarin.
When combined with warfarin prothrombin time and other parameters of blood coagulation do not change.
Change the value of INR. In patients who received anticoagulants in combination with antibiotics, including moxifloxacin, there are cases of increased anticoagulant activity of anticoagulants. Risk factors are the presence of an infectious disease (and concomitant inflammatory process), the age and general condition of the patient. Despite the fact that there is no interaction between moxifloxacin and warfarin, in patients receiving concomitant treatment with these drugs, it is necessary to monitor the INR and, if necessary, adjust the dose of indirect anticoagulants.
Digoxin.
Moxifloxacin and digoxin do not significantly affect the pharmacokinetic parameters of each other. With the appointment of repeated doses of moxifloxacin, the maximum digoxin concentration increased by approximately 30%, while the area under the pharmacokinetic curve "concentration-time" (AUC) and minimum digoxin concentration did not change.
Activated carbon.
With the simultaneous use of activated carbon and moxifloxacin inside at a dose of 400 mg, the systemic bioavailability of Megaflox is reduced by more than 80% as a result of inhibition of its absorption. In the case of an overdose, the use of activated carbon at an early stage of absorption inhibits further increase in systemic exposure.

special instructions

In some cases, after the first use of Megaflox may develop hypersensitivity and allergic reactions, which should immediately inform the doctor. Very rarely, even after the first use of the drug, anaphylactic reactions can progress to a life-threatening anaphylactic shock. In these cases, treatment with Megaflox should be stopped and immediately begin to take the necessary medical measures (including anti-shock).
When moxifloxacin is used, prolongation of the QT interval may be noted in some patients. Megaflox 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 extend the QT interval. Elderly patients are also more prone to drugs that affect the QT interval.
The degree of elongation of the QT interval may increase with increasing drug concentration, therefore, do not exceed the recommended dose. The prolongation of the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. However, in patients with pneumonia, there was no correlation between the concentration of moxifloxacin in the blood plasma and the prolongation of the QT interval. None of the 9,000 patients receiving moxifloxacin had cardiovascular complications and lethal cases associated with prolongation of the QT interval. With the use of moxifloxacin, the risk of developing ventricular arrhythmias in patients with predisposing arrhythmias may increase.
In this regard, the drug Megaflox is contraindicated:
- patients with an established QT interval elongation;
- patients with unadjusted hypokalemia;
- patients with predisposing to arrhythmias, such as clinically significant bradycardia.
Megaflox should be used with caution:
- in patients with potentially proarrhythmic conditions, such as acute myocardial ischemia;
- in patients with cirrhosis of the liver (because this category of patients can not exclude the risk of developing an extension of the QT interval).
When moxifloxacin was taken, cases of fulminant hepatitis, potentially leading to liver failure (including fatal cases) were reported (see "Side effect" section). The patient should be informed that if symptoms of hepatic insufficiency occur, you should consult a doctor before continuing with Megaflox.
When moxifloxacin was taken, cases of developing bullous skin lesions, such as Stephen-Johnson syndrome or toxic epidermal necrolysis, were reported (see "Side effect" section). The patient should be informed that in case of symptoms of skin or mucous membrane damage, the doctor should be consulted before continuing treatment with Megaflox.
The use of drugs quinolone series is associated with a possible risk of seizures. Megaflox should be used with caution in patients with CNS diseases and with CNS disorders that predispose to seizures or reduce the threshold of seizure activity.
The use of broad-spectrum antibacterial drugs, including Megaflox, is associated with a risk of developing pseudomembranous colitis. This diagnosis should be kept in mind when developing patients with severe diarrhea in the background of treatment with Megaflox. In this case, immediate therapy should be prescribed. Drugs that inhibit the peristalsis of the intestine are contraindicated in the development of severe diarrhea.
Megaflox should be used with caution in patients with myasthenia gravis in connection with possible exacerbation of the disease.
Against the background of quinolone therapy, including moxifloxacin, tendonitis and tendon rupture are possible especially in elderly patients receiving glucocorticosteroids. Cases which have arisen within several months after the end of treatment are described. At the first symptoms of pain or inflammation at the site of damage, stop taking the medication and unload the affected limb.
When applying quinolones, photosensitivity reactions are noted. However, in pre-clinical and clinical studies, as well as with the use of moxifloxacin, no photosensitivity reactions were observed in practice. However, patients receiving moxifloxacin should avoid exposure to direct sunlight and ultraviolet light.
It is not recommended to use Megaflox in patients with complicated inflammatory diseases of the pelvic organs (for example, associated with tubo-ovarian or pelvic abscesses).
It is not recommended to use moxifloxacin for the treatment of infections caused by strains of Staphylococcus aureus resistant to methicillin (MRSA). In the case of suspected or confirmed infections caused by MRSA, treatment should be prescribed with appropriate antibacterial drugs (see the section "Pharmacodynamics").
The ability of Megaflox to inhibit the growth of mycobacteria can cause in vitro interaction of moxifloxacin with the test for Mycobacterium spp., Leading to false negative results in the analysis of samples of patients treated with moxifloxacin during this period.
Patients treated with quinolones, including moxifloxacin, described cases of sensory or sensorimotor polyneuropathy, leading to paresthesia, hypoesthesia, dysesthesia, or weakness. Patients undergoing treatment with moxifloxacin should be warned of the need to seek immediate medical attention before continuing treatment in case of symptoms of neuropathy, including pain, burning, tingling, numbness or weakness (see "Side effect" section)
Reactions from the psyche may occur even after the first appointment of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions progress to the occurrence of suicidal thoughts and behavior with a tendency to self-harm, including suicidal attempts (see the "Side effect" section). If the patient develops such reactions, it is necessary to cancel the drug and take the necessary measures. Caution should be exercised in prescribing moxifloxacin to patients with psychoses and patients with psychiatric illnesses in the anamnesis.
Because of the wide spread and growing incidence of infections caused by Neuriseria resistant to fluoroquinolones, gonorrhoeae, in the treatment of patients with inflammatory diseases of the pelvic organs, monotherapy with moxifloxacin should not be carried out. Except in cases where the presence of N. Gonorrhoeae resistant to fluoroquinolones is excluded. If there is no way to exclude the presence of N. Gonorrhoeae resistant to fluoroquinolones, the question of supplementing empirical therapy with moxifloxacin with an appropriate antibiotic that is active against N. Gonorrhoeae (eg, cephalosporin) should be addressed.
Impact on the ability to manage vehicles and mechanisms
Fluoroquinolones, including moxifloxacin, can disrupt the ability of patients to drive and engage in other potentially dangerous activities requiring increased attention and speed of psychomotor reactions, due to the effects on the central nervous system and visual impairment.

Form of issue

Tablets, film-coated, 400 mg.
For 5, 7, 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.
For 1, 2, 3, 5 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions

In dry, dark place at a temperature of no higher than 25 оС.
Keep out of the reach of children.
Shelf life - 2 years.
Do not use after the expiry date printed on the package.

Leave conditions

To buy Megaflox the prescription is not required.