Description
Release form
Tablets, film-coated, dark pink, biconvex, capsule-shaped. Cross-sectional view: bright yellow rough mass with a film shell of dark pink color.
Pharmacological action of
Antimicrobial agent – fluoroquinolone
Indications
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 microorganisms with multiple antibiotic resistance *
infection and skin complications )
– complicated intra-abdominal infections, including polymicrobial infections, including intraperitoneal abscesses
– uncomplicated inflammatory disease pelvic tions (including salpingitis and endometritis).
* Streptococcus pneumoniae with multiple antibiotic resistance include penicillin resistant strains and strains resistant to two or more antibiotics from groups such as penicillins (with a MIC of 2 μg / ml), II generation cephalosporins, 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
– Hypersensitivity to moxifloxacin, other quinolones, or any other component of the
preparation – age under 18 years old
– pregnancy and lactation period of
– the presence of a history of tendinous disease and convalescent disease, after the administration of moxifloxacin, a change in the electrophysiological parameters of the heart was observed, expressed in lengthening of the QT interval. Concerning, 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 chronic heart failure with a reduced left ventricular ejection fraction, the presence of a history of rhythm disturbances accompanied by clinical moxifloxacin can not be used with other drugs that extend the QT interval
– in connection with ogre a bounded amount of clinical data moxifloxacin use is contraindicated in patients with impaired liver function (class C Child-Pugh classification) and patients with elevated transaminase activity of greater than five times the upper limit of normal.
Caution:
– For diseases of the central nervous system (CNS) (including suspected involvement of the central nervous system), predisposing to seizures and lowering the threshold of convulsive activity
– use in patients with psychosis and / or with psychiatric diseases with a history of
– use in patients with potentially proarrhythmic conditions (especially in women and elderly patients), such as acute myocardial ischemia and cardiac arrest
– use in patients with cirrhosis of the liver
– myasthenia gravis
– concomitant use m with drugs that reduce potassium
– use in patients with a genetic predisposition or the actual presence of a deficiency of glucose-6-phosphate dehydrogenase.
Use during pregnancy and lactation
Pregnancy
The safety of using moxifloxacin during pregnancy has not been established, therefore its use is contraindicated. Cases of reversible joint damage in children receiving some quinolones are described, however, the manifestation of this effect in the fetus (when used by the mother during pregnancy) was not reported.
Reproductive toxicity has been identified in animal studies. The potential risk to humans is unknown.
Like other quinolones, moxifloxacin causes damage to the cartilage of large joints in premature animals.
Breastfeeding period
Preclinical studies have 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 use of moxifloxacin during breastfeeding is contraindicated.
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 Moflaxia should be discontinued and the necessary therapeutic measures (including anti-shock) should be started immediately.
With the use of the drug Moflaxia, prolongation of the QT interval may be noted in some patients. Moflaxia should be used with caution in women and elderly patients. Because women have a longer QT interval compared to men, they may be more sensitive to drugs that extend the QT interval. Elderly patients are also more susceptible to drugs that affect the QT interval.
Lengthening the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia.
The degree of lengthening of the QT interval may increase with increasing concentration of moxifloxacin in the blood plasma, therefore, do not exceed the recommended dose. 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 9000 patients treated with moxifloxacin had cardiovascular complications or fatal cases associated with lengthening of the QT interval. When using the drug Moflaxia, the risk of developing ventricular arrhythmias in patients with conditions predisposing to arrhythmias may increase.
In this regard, the drug Moflaxia is contraindicated in:
– changes in the electrophysiological parameters of the heart, expressed in lengthening of the QT interval: congenital or acquired documented lengthening of the QT interval, electrolyte disturbances, especially with uncorrected hypokalemia of clinically significant bradycardia of clinically significant heart failure with a reduced left ventricular ejection fraction, a history of rhythm disturbances accompanied by clinical symptoms of
– use with other drugs that extend the QT interval (see Interaction with other drugs).
The drug Moflaxia should be used with caution:
– in patients with potentially proarrhythmic conditions, such as acute myocardial ischemia and cardiac arrest
– in patients with cirrhosis (since in this category of patients the risk of developing an extended QT interval cannot be ruled out).
When taking moxifloxacin, cases of fulminant hepatitis have been reported, potentially leading to the development of liver failure (including fatal cases) (see section Side effects). The patient should be informed that in case of symptoms of liver failure, it is necessary to consult a doctor before continuing treatment with Moflaxia.
When taking moxifloxacin, cases of the development of bullous skin lesions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, have been reported (see section Adverse Effects). The patient should be informed that in case of symptoms of skin or mucous membranes, it is necessary to consult a doctor before continuing treatment with Moflaxia.
The use of quinolone preparations is associated with a possible risk of seizures. The drug Moflaxia should be used with caution in patients with diseases of the central nervous system and with disorders of the central nervous system, predisposing to seizures or lowering the threshold of convulsive activity.
The use of broad-spectrum antibacterial drugs, including the drug Moflaxia, is associated with a risk of pseudomembranous colitis. This diagnosis should be borne in mind in patients who develop severe diarrhea during treatment with Moflaxia. In this case, appropriate therapy should be prescribed immediately. Drugs that inhibit intestinal motility are contraindicated in the development of severe diarrhea.
Moflaxia should be used with caution in patients with gravis myasthenia gravis due to a possible exacerbation of the disease.
During treatment with quinolones, including moxifloxacin, it is possible to develop tendonitis and tendon rupture, especially in elderly patients and patients receiving glucocorticosteroids. Cases that occurred within a few months after completion of treatment are described. At the first symptoms: pain or inflammation at the site of injury, the drug Moflaxia should be stopped and the affected limb relieved.
When using quinolones, photosensitivity reactions are noted. However, during preclinical and clinical studies, as well as the use of moxifloxacin in clinical practice, no photosensitivity reactions were observed.
However, patients receiving Moflaxia should avoid exposure to direct sunlight and ultraviolet light.
The use of the drug Moflaxia 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. In the case of suspected or confirmed infections caused by MRSA, appropriate antibacterial drugs should be used for therapy (see Pharmacodynamics section).
The ability of moxifloxacin to inhibit the growth of mycobacteria can cause in vitro interaction of moxifloxacin with the test for Mycobacterium spp., which leads to false negative results in the analysis of patient samples, which during this period is treated with the drug Moflaxia.
Patients who have been treated with quinolones, including moxifloxacin, have reported cases of sensory or sensorimotor polyneuropathy, leading to paresthesia, hypesthesia, dysesthesia, or weakness. Patients who are treated with Moflaxia 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 (see section Side effects).
Mental reactions can occur even after the first use of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions progress to suicidal thoughts and behavior with a tendency to self-harm, including suicide attempts (see section Side effects). If such reactions develop in patients, the drug Moflaxia should be discontinued and necessary measures taken. Caution must be exercised when using the drug Moflaxia in patients with a history of psychosis and psychiatric diseases.
Due to the widespread and growing 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. gonorrhoehe is excluded. If it is not possible to exclude the presence of N. gonorrhoeae resistant to fluoroquinolones, it is necessary to resolve the issue of supplementing empirical therapy with moxifloxacin with an appropriate antibiotic that is active against N. gonorrhoeae (e.g. cephalosporin).
Dysglycemia
As with other fluoroquinolones, the use of the drug Moflaxia showed a change in blood glucose concentration, including hypo- and hyperglycemia. During the treatment with moxifloxacin, dysglycemia occurred mainly in elderly patients with diabetes mellitus receiving concomitant therapy with hypoglycemic drugs for oral administration (for example, sulfonylurea preparations) or insulin. When treating patients with diabetes, careful monitoring of blood glucose concentration is recommended (see section Side effects).
Impact on the ability to drive transp. Wed and fur.: Fluoroquinolones, including moxifloxacin, may impair 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.
Composition
1 film-coated tablet contains:
Core:
active ingredient: moxifloxacin hydrochloride 454.75 mg, equivalent to moxifloxacin 400.00 mg
excipients: cellulose microcrystalline sodium 32.05 mg 32.05 mg , magnesium stearate 6.00 mg
Film sheath: hypromellose 12.60 mg, macrogol-4000 4.20 mg, titanium dioxide (E171) 3.78 mg, iron dye red oxide (E172) 0.42 mg.
Storage conditions
At a temperature not exceeding 25 ° C, in the original packaging.
Keep out of the reach of children.
Shelf life
2 years.
Do not use the drug after the expiration date.
Terms and conditions
prescription
lekarstvennaja form
tablets
Appointment
Adults doctor’s prescription
Indications
From respiratory tract infections, From skin infections, From inflammation of the lungs, From infectious diseases, From sinusitis, From boils, From urinary tract infections, Bronchitis50 From sinusitis7 From sinusitis61 pathways, From infectious diseases, From pneumonia, From sinusitis, From urinary tract infections, Bronchitis, From skin infections
