Tablets "Moflaksa ^® " are applied to treatment of the bacterial below-mentioned infections caused by microorganisms, sensitive to a moksifloksatsin, at patients aged from 18 years. It is only necessary to appoint moxifloxacin when use of antibacterial agents which usually recommend for initial treatment of the following infections is inexpedient or when the specified treatment was inefficient.

1. Acute bacterial sinusitis (diagnosed with high degree of probability).
2. Exacerbation of chronic bronchitis (diagnosed with high degree of probability).
3. Not hospital pneumonia, except for community-acquired pneumonia with a heavy course.
4. Inflammatory diseases of the bodies of a small pelvis of moderate and average degree (including infectious damage of an upper part of a reproductive system at women, including a salpingitis and an endometritis) which are not associated with tubo-ovarian abscess or abscesses of bodies of a small pelvis.

for application as monotherapy at inflammatory diseases of bodies of a small pelvis of moderate and average degree, but can be applied in a combination with other appropriate antibacterial agents (for example with cephalosporins) because of growing resistance of a moksifloksatsin to Neisseria gonorrhoeae (except for moksifloksatsinrezistentny strains of N. gonorrhoeae).

Tableted form of medicine "Moflaksa ^® " can be applied to the termination of a course of treatment in which starting therapy by a parenteral form of the medicine "Moflaksa®" was effective and it is intended according to such indications:

• community-acquired pneumonia;
• complicated infections of leather and hypodermic fabrics.

for starting treatment of any infections of leather and hypodermic fabrics or in case of a heavy current of community-acquired pneumonia.

Structure

Active ingredient - moxifloxacin (one tablet contains 400 mg of a moksifloksatsin in the form of a moksifloksatsin of a hydrochloride).

Excipients: microcrystalline cellulose, sodium of a kroskarmelloz, magnesium stearate; cover: gipromelloza, macrogoal, titan dioxide (E 171), ferrous oxide red (E 172).

Contraindication

• hypersensitivity to a moksifloksatsin or other hinolona or any of medicine excipients;
• age up to 18 years;
• pregnancy or period of feeding by a breast;
• a disease of sinews, connected with treatment of a hinolonama in the anamnesis;
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• inborn or diagnosed the acquired lengthening of an interval of QT;
• violation of electrolytic balance, in particular, at not corrected hypopotassemia;
• clinically significant bradycardia;
• clinically significant heart failure with reduced fraction of emission of a left ventricle;
• symptomatic arrhythmias in the anamnesis;

Drug should not be used along with other medicines which extend QT interval.

In connection with limited clinical data at an abnormal liver function (class C on classification of Chaylda-Pyyu) and the increased level of Transaminases (is 5 times higher than the upper bound of norm).

Route of administration

Is recommended to be accepted on one tablet (400 mg) of a moksifloksatsin a day.

should take the Pill without chewing, washing down with enough water. The medicament can be taken irrespective of meal time.

Duration of therapy by the tableted form of medicine "Moflaksa ^® " depends on type of infections and makes:

• exacerbation of chronic bronchitis - 5-10 days;
• community-acquired pneumonia - 10 days;
• sharp bacterial sinusitis - 7 days;
• inflammatory diseases of bodies of a small pelvis of moderate and average degree - 14 days.

Step (intravenous and peroral) therapy. It was reported that during the researches step ​​ most of patients passed therapies from introduction of a moksifloksatsin, intravenous on the oral way, within 4 days (community-acquired pneumonia) or 6 days (the complicated infections of leather and hypodermic fabrics). The recommended general duration of treatment by tablets and solution of a moksifloksatsin is 7-14 days for community-acquired pneumonia and 7-21 days for the complicated infections of leather and hypodermic fabrics. It is not recommended to exceed the specified dose (400 mg of 1 times a day) and treatment duration for each indication.

Feature of application

Drivers

Researches of influence of a moksifloksatsin on ability to steer motor transport and to work with mechanisms. However ftorkhinolona, including moxifloxacin, can lead to deterioration in ability to steer motor transport or other mechanisms because of emergence of reactions from the central nervous system (such as dizziness, sharp temporary loss of sight) or a sharp short-term loss of consciousness (syncope). Patients should recommend to watch the reaction to moxifloxacin before steering motor transport or to work with other mechanisms.

in case of accidental overdose by

any specific actions. In case of overdose it is necessary to be guided by a clinical picture and to carry out symptomatic maintenance therapy and ECG monitoring in connection with a possibility of lengthening of an interval of QT.

Simultaneous use of activated carbon with a dose of a moksifloksatsin of 400 mg will orally lead

to reduction of system availability of medicine more than for 80%. In case of overdose as a result of intake of medicine the use of activated carbon at an initial stage of absorption can be effective for prevention of increase in systemic action of a moksifloksatsin.

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Side effects

Side reactions given below (frequent - ≥ 1/100, <1/10), were observed with a frequency less than 3%, except for nausea and diarrhea.

Infectious complications: superinfection, arisen owing to bacterial or fungal resistance, for example oral or vaginal candidiasis.

from nervous system: headache, dizziness.

from a cardiovascular system: lengthening of a QT interval at patients with a hypopotassemia.

from digestive system: nausea, vomiting, abdominal pain, diarrhea.

Gepatobiliarny violations - increase in level of Transaminases.

to Store

in original packing for protection against moisture influence. For medicine special temperature storage conditions are not required. To store out of children's reach.

Expiration date - 3 years.