Moflaxa ® tablets are used to treat the following bacterial infections caused by microorganisms sensitive to moxifloxacin in patients aged 18 years and older. Moxifloxacin should be prescribed only when the use of antibacterial agents that are usually recommended for the initial treatment of subsequent infections is inappropriate or when the indicated treatment has been ineffective.
Acute bacterial sinusitis (diagnosed with a high degree of probability). Exacerbation of chronic bronchitis (diagnosed with a high degree of probability). Community-acquired pneumonia, except for severe pneumonia. Mild to moderate pelvic inflammatory disease (including upper genital tract infections in women, including salpingitis and endometritis), not associated with tubo-ovarian abscess or pelvic abscess.
The tablet form of the drug "Moflaxa ®" is not recommended for use as monotherapy for mild and moderate pelvic inflammatory disease, but can be used in combination with other appropriate antibacterial agents (for example, cephalosporins) due to the increased resistance of moxifloxacin to Neisseria gonorrhoeae (with the exception of moxifloxacin-resistant strains of N. gonorrhoeae).
The tablet form of the drug "Moflaksa®" can be used to complete a course of treatment in which the initial therapy with the parenteral form of the drug "Moflaksa®" was effective and was prescribed according to the following indicators:
community-acquired pneumonia; complicated infections of the skin and subcutaneous tissues.
The tablet form of the drug "Moflaxa ®" is not recommended for the initial treatment of any infections of the skin and subcutaneous tissues or in case of severe community-acquired pneumonia.
Composition
The active substance is moxifloxacin (one tablet contains 400 mg of moxifloxacin in the form of moxifloxacin hydrochloride).
Excipients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate; coating: hypromellose, macrogol, titanium dioxide (E 171), red iron oxide (E 172).
Contraindication
Hypersensitivity to moxifloxacin or other quinolones or any of the excipients of the drug; age under 18 years; pregnancy or breastfeeding; tendon diseases associated with quinolone treatment in history; congenital or diagnosed acquired prolongation of the QT interval; electrolyte imbalance, in particular, with uncorrected hypokalemia; clinically significant bradycardia; clinically significant heart failure with reduced left ventricular ejection fraction; symptomatic arrhythmias in history;
The drug should not be used concomitantly with other drugs that prolong the QT interval.
Due to limited clinical data, the use of moxifloxacin is also contraindicated in cases of impaired liver function (Child-Pugh class C) and elevated transaminase levels (5 times the upper limit of normal).
Method of application
It is recommended to take one tablet (400 mg) of moxifloxacin per day.
The tablets should be taken without chewing, with sufficient water. The drug can be taken regardless of the time of meals.
The duration of therapy with the tablet form of the drug "Moflaksa ®" depends on the type of infections and is:
exacerbation of chronic bronchitis - 5-10 days; community-acquired pneumonia - 10 days; acute bacterial sinusitis - 7 days; mild and moderate pelvic inflammatory disease - 14 days.
Stepped (intravenous and oral) therapy. In studies of stepped therapy, it has been reported that most patients switched from intravenous to oral moxifloxacin administration within 4 days (communicable disease pneumonia) or 6 days (complicated skin and subcutaneous tissue infections). The recommended total duration of treatment with moxifloxacin tablets and solution is 7-14 days for community-acquired pneumonia and 7-21 days for complicated skin and subcutaneous tissue infections. Exceeding the indicated dose (400 mg once daily) and duration of treatment for each indication is not recommended.
Application features
Drivers
No studies on the effects of moxifloxacin on the ability to drive and use machines have been conducted. However, fluoroquinolones, including moxifloxacin, may impair the ability to drive or use machines due to central nervous system reactions (such as dizziness, acute transient loss of vision) or acute transient loss of consciousness (syncope). Patients should be advised to observe their reaction to moxifloxacin before driving or operating machinery.
Overdose
Coadministration of activated charcoal with a 400 mg oral dose of moxifloxacin will reduce the systemic exposure of the drug by more than 80%. In the event of an overdose resulting from drug ingestion, administration of activated charcoal at the initial stage of absorption may be effective in preventing increased systemic exposure to moxifloxacin.
Side effects
The adverse reactions listed below (common - ≥ 1/100, <1/10) were observed with a frequency of less than 3%, with the exception of nausea and diarrhea.
Infectious complications: superinfection resulting from bacterial or fungal resistance, such as oral or vaginal candidiasis.
From the nervous system: headache, dizziness.
Cardiovascular system: prolongation of the QT interval in patients with hypokalemia.
On the part of the digestive system: nausea, vomiting, abdominal pain, diarrhea.
Hepatobiliary disorders - increased transaminase levels.
Storage conditions
Store in the original package in order to protect from moisture. This medicinal product does not require any special temperature storage conditions. Keep out of the reach of children.
Shelf life - 3 years.
