Moxifloxacin-Pharmex tablets are used to treat the following bacterial infections caused by susceptible microorganisms in patients aged 18 years and over. Moxifloxacin should be prescribed only when the use of antibacterial agents that are 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 abscess. Moxifloxacin tablets are not recommended for use as monotherapy in mild to moderate pelvic inflammatory disease, but may be used in combination with other appropriate antibacterial agents (e.g. cephalosporins) due to the increasing resistance of Neisseria gonorrhoeae to moxifloxacin (except for moxifloxacin-resistant strains of N. gonorrhoeae).
The tablet form of moxifloxacin 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 moxifloxacin is not recommended for initial treatment of any skin and subcutaneous infections 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 436.8 mg of moxifloxacin hydrochloride, which corresponds to 400 mg of moxifloxacin).
Excipients: croscarmellose sodium, microcrystalline cellulose, lactose polyhydrate, magnesium stearate
Shell: hydroxypropylmethylcellulose, macrogol 4000, titanium dioxide (E 171), iron oxide red (E 172).
Contraindication
Hypersensitivity to moxifloxacin or other quinolones or to any of the excipients of the drug.
Age up to 18 years.
Pregnancy and breastfeeding.
Patients with a history of tendon disorders associated with quinolone treatment.
Changes in cardiac electrophysiology such as QT prolongation have been 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 are 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.
Duration of therapy
The duration of therapy with the tablet form of moxifloxacin depends on the type of infection and is:
exacerbation of chronic obstructive pulmonary disease, including bronchitis - 5-10 days; community-acquired pneumonia - 10 days; acute bacterial sinusitis - 7 days; mild and moderate pelvic inflammatory disease - 14 days.
According to clinical studies, the duration of treatment with the tablet form of moxifloxacin was up to 14 days.
Stepped (intravenous oral) therapy
In clinical studies, with stepwise therapy, most patients 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 moxifloxacin 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.
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 (e.g. 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.
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 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 were observed at 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.
Cardiac: QT prolongation in patients with hypokalemia.
Gastrointestinal tract: nausea, vomiting, abdominal pain, diarrhea.
Hepatobiliary 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 - 2 years.
