Moxetero tablets are used for the indications listed below.
Treatment of the following bacterial infections caused by susceptible microorganisms in patients aged 18 years and older (Moxeter should be prescribed only when the use of antibacterial agents usually recommended for the initial treatment of the following infections is inappropriate or when the indicated treatment has been ineffective):
acute bacterial sinusitis (diagnosed with a high degree of probability); exacerbation of chronic obstructive pulmonary disease, including 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 abscesses (the tableted form of the drug "Moxetero" is not recommended for use as monotherapy for mild to moderate pelvic inflammatory disease, but can be used in combination with other appropriate antibacterial agents (e.g. cephalosporins) due to the increasing resistance of moxifloxacin to Neisseria gonorrhoeae (except for moxifloxacin-resistant strains of N. gonorrhoeae)).
The tablet form of the drug "Moxetero" can be used to complete a course of treatment in which the initial therapy with the parenteral form of moxifloxacin was effective and is prescribed according to the following indicators:
community-acquired pneumonia; complicated infections of the skin and subcutaneous structures.
The tablet form of the drug "Moxetero" is not recommended for the initial treatment of any infections of the skin and subcutaneous structures or in case of severe community-acquired pneumonia.
Attention should be paid to official instructions on the proper use of antibacterial agents.
Composition
The active substance is moxifloxacin (one tablet contains moxifloxacin hydrochloride equivalent to moxifloxacin 400 mg).
Excipients: microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, povidone, magnesium stearate, Opadry Pink 03B34285 (hypromellose (E 464), macrogol, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).
Contraindication
hypersensitivity to moxifloxacin or other quinolones or any of the excipients of the drug; patient age under 18 years; pregnancy or breastfeeding; tendon diseases associated with treatment with quinolones in history.
During studies, changes in cardiac electrophysiology in the form of prolongation of the QT interval were observed after the use of moxifloxacin. Therefore, for safety reasons, the drug is contraindicated in patients with:
Congenital or diagnosed acquired prolongation of the QT interval; electrolyte imbalance, in particular uncorrected hypokalemia; clinically significant bradycardia; clinically significant heart failure with reduced left ventricular ejection fraction; history of symptomatic arrhythmias.
The drug should not be used concomitantly with other drugs that prolong the QT interval.
Due to limited clinical data, the use of the drug is also contraindicated in patients with impaired liver function (Child-Pugh class C) and patients with elevated transaminase levels (5 times the upper limit of normal).
Method of application
Adults
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 meal.
Duration of therapy
The duration of therapy with the tablet form of the drug "Moxetero" depends on the type of infections and is:
exacerbation of chronic obstructive pulmonary disease, including bronchitis - 5-10 days; community-acquired pneumonia - 10 days; acute bacterial sinusitis - 7 days; pelvic inflammatory disease of moderate and moderate severity - 14 days.
According to research, the duration of treatment with the tablet form of the drug "Moxetero" was up to 14 days.
Stepped (intravenous/oral) therapy
In step therapy studies, most patients were switched from intravenous to oral moxifloxacin within 4 days (communicable disease pneumonia) or 6 days (complicated skin and subcutaneous tissue infections). The recommended total duration of treatment with Moxetero tablets and solution for infusion is 7-14 days for community-acquired disease pneumonia and 7-21 days for complicated skin and subcutaneous tissue infections.
Exceeding the specified dose (400 mg once a day) and duration of treatment for each indication is not recommended.
Application features
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). Patients should be advised to observe their reaction to moxifloxacin before driving or operating machinery.
Overdose
In case of accidental overdose, no specific measures are recommended. In case of overdose, the clinical picture should be guided and symptomatic supportive therapy and ECG monitoring should be carried out due to the possibility of QT prolongation.
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 administration, administration of activated charcoal at the initial stage of absorption may be effective in preventing increased systemic exposure to moxifloxacin.
Side effects
The following are adverse reactions from studies with moxifloxacin 400 mg (oral and step therapy). Common (≥ 1/100, < 1/10) adverse reactions that occurred with a frequency of less than 3% are listed, 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.
Cardiac: QT prolongation in patients with hypokalemia.
Gastrointestinal tract: nausea, vomiting, abdominal pain, diarrhea.
Liver and biliary tract disorders: increased transaminase levels.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
