Atovax tablets 400 mg No. 5




Atovaquone tablets are used to treat the following bacterial infections caused by microorganisms susceptible to moxifloxacin in patients aged 18 years and older. Moxifloxacin should only be prescribed 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.Composition
Active ingredient: moxifloxacin;
1 film-coated tablet contains moxifloxacin hydrochloride equivalent to moxifloxacin 400 mg;
Excipients: microcrystalline cellulose, sodium starch (type A), povidone K 29/32, magnesium stearate, Opadry 03F84827 pink coating *;
* Opadry 03F84827 pink: hypromellose, titanium dioxide (E 171), red iron oxide (E 172), polyethylene glycol, talc.
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 meal.
The duration of therapy with the tablet form of Atovax depends on the type of infection 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
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 (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 at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 2 years.
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