Moksetero of the tab. of p/o of 400 mg No. 10

tablets "Moksetero" are applied at indications which are provided below.

Treatment of the following bacterial infections caused by microorganisms, sensitive to drug, at patients aged from 18 years (it is only necessary to appoint the medicine "Moksetero" when use of antibacterial agents which usually recommend for initial treatment of the following infections is inexpedient or when the specified treatment was inefficient):

• sharp bacterial sinusitis (diagnosed with high degree of probability);
• exacerbation of a chronic obstructive disease of lungs, inclusive with bronchitis (diagnosed with high degree of probability);
• not hospital pneumonia, except for community-acquired pneumonia with a heavy course;
• inflammatory diseases of bodies of a small pelvis moderate and moderate severity (including infectious damage of an upper part of a reproductive system at women, including a salpingitis and an endometritis), not associated with tubo-ovarian abscess or abscesses of bodies of a small pelvis (the tableted form of the medicine "Moksetero" is not recommended for application as monotherapy at inflammatory diseases of bodies of a small pelvis moderate and moderate severity, but it can be applied in a combination with other appropriate antibacterial agents (for example cephalosporins) because of growing resistance of a moksifloksatsin to Neisseria gonorrhoeae (except for moksifloksatsinrezistentny strains of N. gonorrhoeae)).

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

• community-acquired pneumonia;
• complicated infections of skin and hypodermic structures.

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

Should pay attention to official instructions for appropriate use of antibacterial agents.

Structure

Active ingredient - moxifloxacin (one tablet supports a moksifloksatsin of a hydrochloride it is equivalent to a moksifloksatsin of 400 mg).

Excipients: microcrystalline cellulose, sodium of a kroskarmelloz, silicon dioxide colloidal waterless, povidone, magnesium stearate, Opadry Pink 03B34285 (gipromelloza (E 464), macrogoal, titan dioxide (E 171), ferrous oxide red (E 172), iron oxide yellow (E 172).

Contraindication

• hypersensitivity to a moksifloksatsin or other hinolona or any of medicine excipients;
• age of the patient 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.

during the researches after application of a moksifloksatsin observed changes in a heart electrophysiology in the form of lengthening of an interval of QT. Therefore for safety reasons medicine is contraindicated to patients with:

• congenital or diagnosed acquired lengthening of an interval of QT;
• violations 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 the use of medicine is also contraindicated to patients with an abnormal liver function (class C on classification of Chaylda-Pyyu) and to patients with the increased level of Transaminases (is 5 times higher than the upper bound of norm).

Route of administration

Adult

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.

therapy Duration

Duration of therapy by the tableted form of the medicine "Moksetero" depends on type of infections and is:

• exacerbation of a chronic obstructive disease of lungs, inclusive with bronchitis - 5-10 days;
• community-acquired pneumonia - 10 days;
• sharp bacterial sinusitis - 7 days;
• inflammatory diseases of bodies of a small pelvis moderate and moderate severity - 14 days.

according to researches up to 14 days.

with

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 for infusions of Moksetero is 7-14 days of community-acquired pneumonia and 7-21 days for the complicated infections of leather and hypodermic fabrics.

does not recommend 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). Patients should recommend to watch the reaction to moxifloxacin before steering motor transport or to work with 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 prevention increase in systemic action of a moksifloksatsin.

Side effects

side effects gained on the basis of researches using a moksifloksatsin of 400 mg (oral and step therapy) Below. Are given frequent ((≥ 1/100, <1/10) side reactions which were observed with a frequency less than 3%, except for nausea and diarrhea.

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

from nervous system: headache, dizziness.

from heart: extension of a QT interval at patients with a hypopotassemia.

from a digestive tract: nausea, vomiting, abdominal pain, diarrhea.

from a liver and biliary tract: increase in level of Transaminases.

to Store

in original packing at a temperature not above 25 °C, out of children's reach.

Expiration date - 3 years.