Ozerlik film-coated tablets 400 mg No. 10




The mechanism of action of the drug is associated with the inhibition of DNA gyrase and topoisomerase IV. Gatifloxacin, which belongs to the 8-methoxyfluoroquinolones, is active against a wide range of gram-negative and gram-positive microorganisms, therefore it is indicated for the treatment of diseases caused by various pathogens.
The antibacterial effect of gatifloxacin is provided by inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an important enzyme involved in the DNA replication of pathogens. Topoisomerase IV is an enzyme that plays a leading role in the division of chromosomes during bacterial cell division.
Gatifloxacin is effective against bacteria resistant to β-lactam and macrolide antibiotics.
Indications for use
Treatment of infectious and inflammatory processes caused by microorganisms sensitive to the drug:
respiratory tract infections (including acute bronchitis, exacerbation of chronic bronchitis, acute sinusitis, community-acquired pneumonia); kidney and urinary tract infections (including complicated urinary tract infections, acute pyelonephritis, uncomplicated urinary tract infections (cystitis)); uncomplicated urethral gonorrhea in men; endocervical gonorrhea in women.Contraindication
Hypersensitivity to gatifloxacin and other fluoroquinolones in history or to other components of the drug. Diabetes mellitus, diseases of the central nervous system (epilepsy, reduced seizure threshold).
Method of administration and doses
The drug should be taken regardless of meals, usually once a day.
Dosage for adult patients with normal renal function
indication | daily dose | Number of receptions per day | duration of treatment |
Acute bronchitis, exacerbation of chronic bronchitis | 400 mg | 1 time | 5-7 days |
acute sinusitis | 400 mg | 1 time | 10 days |
community-acquired pneumonia | 400 mg | 1 time | 7-14 days |
Uncomplicated urinary tract infections (cystitis): | 400 mg | 1 time | 3 received |
Complicated urinary tract infections: | 400 mg | 1 time | 7-10 days |
acute pyelonephritis | 400 mg | 1 time | 7-10 days |
Uncomplicated urethral gonorrhea in men | 400 mg | 1 time | one-time |
Endocervical gonorrhea in women | 400 mg | 1 time | one-time |
Since gatifloxacin is excreted primarily by the kidneys, patients with creatinine clearance <40 ml/min, including patients on hemodialysis or long-term ambulatory peritoneal dialysis, require dosage adjustment.
The following dosage adjustments are recommended for patients with renal impairment:
CC, ml/min | Starting dose | Next dose |
≥ 40 | 400 | 400 mg daily |
<40 | 400 | 200*mg daily |
hemodialysis | 400 | 200*mg daily |
Long-term outpatient peritoneal dialysis | 400 | 200*mg daily |
* Use in appropriate dosage.
The regimen with a single use of the drug at a dose of 400 mg (for the treatment of uncomplicated urinary tract infections and gonorrhea) does not require dose adjustment in patients with impaired renal function.
Overdose
Symptoms: lethargy, confusion, decreased respiratory rate, dizziness, nausea, vomiting, diarrhea, abdominal pain, seizures, tremor, psychosis, visual and hearing impairment, prolongation of the QT interval on the ECG, increased manifestations of adverse reactions.
Treatment: gastric lavage. The patient should be under medical supervision and receive symptomatic treatment. Appropriate hydration therapy should be used. Gatifloxacin is not sufficiently effectively removed from the body by hemodialysis (approximately 14% within 4 hours) or by forced hemodialysis (approximately 11% after 8 days).
Special instructions
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy.
Breastfeeding should be discontinued during treatment.
Children
The drug is contraindicated in children.
Ability to influence reaction speed when driving vehicles or other mechanisms
If adverse reactions from the nervous system are observed during treatment, you should refrain from driving vehicles and working with other mechanisms.
Composition
active ingredient: gatifloxacin
1 tablet contains gatifloxacin sesquihydrate equivalent to gatifloxacin 400 mg
excipients: corn starch, K-30, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, croscarmellose sodium, Opadry 0ZV52014 yellow: hydroxypropylmethylcellulose, titanium dioxide (E 171), macrogol, quinoline yellow (E 104), iron oxide yellow (E 172).
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep out of reach of children.
Shelf life - 3 years.
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