Floxium infusion solution is intended for the treatment of the following infectious diseases in adults:
community-acquired pneumonia; complicated skin and soft tissue infections (for the above infectious diseases, levofloxacin should be prescribed only in cases of insufficient effectiveness of other antibacterial drugs, which are mainly used for the initial treatment of these infections); pyelonephritis and complicated urinary tract infections; chronic bacterial prostatitis; pulmonary anthrax: post-exposure prophylaxis and radical treatment.
Composition
The active substance is levofloxacin (100 ml of solution contains levofloxacin hemihydrate - 512.46 mg, in terms of levofloxacin - 500.0 mg).
Excipients: sodium chloride, sodium hydroxide, concentrated hydrochloric acid, water for injections.
Contraindication
The drug is not prescribed in the following cases:
hypersensitivity to the active pharmaceutical ingredient or to other quinolones or to any other components of the drug; epilepsy; tendon disorders after the use of fluoroquinolones; children and adolescents; pregnancy; breastfeeding.
Method of application
Levofloxacin, solution for infusion should be administered slowly by intravenous infusion 1 or 2 times a day. The dosage depends on the type and severity of the infection and the sensitivity of the possible infectious agent. It is possible to switch from the initial intravenous administration of levofloxacin to the appropriate dose according to the instructions for medical use of the medicinal product in the form of film-coated tablets, based on the patient's condition. Taking into account the biological equivalence of the oral and parenteral forms, the same dosage is possible.
Dosage for patients with normal renal function (creatinine clearance > 50 ml/minute):
community-acquired pneumonia - 500 mg once a day or twice (total duration of treatment - 7-14 days); pyelonephritis - 500 mg once a day (total duration of treatment - 7-10 days); complicated urinary tract infections - 500 mg once a day (total duration of treatment - 7-14 days); chronic bacterial prostatitis - 500 mg once a day (total duration of treatment - 28 days); complicated skin and soft tissue infections - 500 mg once a day or twice (total duration of treatment - 7-14 days); pulmonary anthrax - 500 mg once a day (total duration of treatment - 8 weeks).
The duration of treatment includes intravenous and oral administration. The time of transition from intravenous administration to oral administration depends on the clinical picture, but usually lasts from 2 to 4 days.
Application features
Children
The use of the drug is contraindicated in children, as damage to articular cartilage cannot be ruled out.
Drivers
Some side effects (e.g. dizziness/vertigo, drowsiness, visual disturbances) may impair the patient's ability to concentrate and react and, therefore, may constitute a risk in situations where these abilities are of particular importance (e.g. driving a car or operating machinery).
Overdose
According to animal toxicity studies or clinical pharmacology studies conducted at doses exceeding the therapeutic range, the most serious signs to be expected after acute overdose of levofloxacin solution for infusion are central nervous system symptoms such as confusion, dizziness, impaired consciousness and seizures, and QT prolongation.
During post-marketing studies, central nervous system adverse reactions such as confusion, seizures, hallucinations, and tremor were observed.
Treatment. In cases of overdose, symptomatic treatment should be given. ECG monitoring is necessary, as there is a possibility of QT prolongation. Hemodialysis, including peritoneal dialysis and chronic ambulatory peritoneal dialysis (CHAP), are not effective in removing levofloxacin from the body. There are no specific antidotes.
Side effects
On the part of the psyche: often (from> 1/100 to <1/10) - insomnia.
From the nervous system: often (from> 1/100 to <1/10) - headache, dizziness.
Vascular disorders: often (from> 1/100 to <1/10) - phlebitis.
Gastrointestinal: often (from > 1/100 to <1/10) - diarrhea, nausea, vomiting.
On the part of the digestive system: often (from> 1/100 to <1/10) - increased activity of liver enzymes (ALT / AST, LF, GGTP).
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
