Levofloxacin is a synthetic broad spectrum antibacterial drug belonging to the fluoroquinolone group.
Release form and composition
Levofloxacin Dosage Forms:
- Film-coated tablets (5, 7, or 10 pieces in a blister pack, in a cardboard pack of 1, 2, 3, 4, 5, or 10 packs; 5, 10, 20, 30, 40, 50, or 100 pieces in plastic cans, in a carton box of 1 can);
- Solution for infusion (100 ml in bottles, 1 bottle in a cardboard box or 35 bottles in a cardboard box; 100 ml in bottles for blood and blood substitutes, 1 bottle in a cardboard box or 35 bottles in a cardboard box).
The composition of the tablets:
- Active ingredient: levofloxacin (in the form of hemihydrate) - 250 or 500 mg;
- Auxiliary components: sodium carboxymethyl starch, magnesium stearate, povidone, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium;
- Shell composition: White Opadry, incl. macrogol 3350, titanium dioxide, talc and polyvinyl alcohol.
The composition of the solution (in 100 ml):
- Active ingredient: levofloxacin (in the form of hemihydrate) - 500 mg;
- Auxiliary components: hydrochloric acid, anhydrous glucose, sodium edetate, water for injection.
Indications for use
Infectious and inflammatory diseases caused by bacteria susceptible to levofloxacin:
- Urinary tract infections, including those complicated (including pyelonephritis);
- Inflammation of the prostate gland;
- Infections of the abdominal organs;
- Community-acquired pneumonia;
- Exacerbation of chronic bronchitis;
- Acute sinusitis;
- Infections of soft tissue and skin;
- Bacteremia and septicemia associated with the above diseases.
- Pathological conditions of tendons after the use of other fluoroquinolones in history;
- Lactation period;
- Children and adolescents up to 18 years;
- Hypersensitivity to the drug.
Relative (special caution required):
- Deficiency of glucose-6-phosphate dehydrogenase;
- High risk of developing kidney failure in geriatric patients;
- Elderly age.
Dosing and Administration
Levofloxacin tablets should be taken orally before meals or between meals 1-2 times a day, swallowing them whole and washed down with plenty of water.
Levofloxacin solution is administered intravenously.
The scheme of the drug depends on the severity of the disease and the pathological process, as well as the sensitivity of the pathogen.
With normal and slightly reduced kidney function (creatinine clearance ≤50 ml / minute), the following treatment regimens are recommended:
- Sinusitis: 500 mg 1 time per day for 10-14 days;
- Community-acquired pneumonia: 500 mg 1-2 times a day for 7-14 days;
- Exacerbation of chronic bronchitis: 250-500 mg 1 time per day for 7-14 days;
- Prostatitis: 500 mg 1 time per day for 28 days;
- Uncomplicated urinary tract infections: 250 mg 1 time per day, the course of treatment - 3 days;
- Complicated urinary tract infections, incl. pyelonephritis: 250 mg 1 time per day for 7-10 days;
- Infections of the skin and soft tissues: 250 mg once a day or 500 mg 1-2 times a day for 1-2 weeks;
- Infections of the abdominal cavity: 250-500 mg 1 time per day for 1-2 weeks. Levofloxacin is prescribed in combination with other antimicrobial agents active against anaerobic pathogens;
- Bacteremia and septicemia: 250-500 mg intravenously 1-2 times a day, then at the same dose orally, the course of treatment is 1-2 weeks.
When treating Levofloxacin, it is necessary to adhere to the rule concerning all antibacterial agents: taking the drug should be continued after reliable elimination or at least another 48-72 hours after normalization of body temperature.
For patients with impaired renal function, the dose is determined depending on creatinine clearance (CK):
- CC 20-50 ml / minute: with the appointment of a standard daily dose of 250 mg in 1 reception and in this case, the starting dose is 250 mg, in the future - 125 mg; with the appointment of a daily dose of 500 mg in 1 reception in this case, the initial dose is 500 mg, subsequently - 250 mg; with the appointment of a daily dose of 1000 mg in 2 doses starting dose in this case is 500 mg, in the future - 250 mg;
- CC 10-19 ml / minute: with the appointment of a standard daily dose of 250 mg in 1 reception and in this case, the starting dose is 250 mg, in the future - 125 mg every 48 hours; with the appointment of a daily dose of 500 mg in 1 reception in this case, the initial dose is 500 mg, in the following - 125 mg 1 time per day; with the appointment of a daily dose of 1000 mg in 2 doses, the starting dose in this case is 500 mg, then 125 mg every 12 hours;
- QC less than 10 ml / minute and patients on dialysis, including continuous ambulatory peritoneal dialysis: with the appointment of a standard daily dose of 250 mg in 1 reception and in this case, the starting dose is 250 mg, in the future - 125 mg every 48 hours; with the appointment of a daily dose of 500 mg in 1 reception in this case, the initial dose is 500 mg, in the following - 125 mg 1 time per day; with the appointment of a daily dose of 1000 mg in 2 doses, the starting dose in this case is 500 mg, then 125 mg 1 time per day.
After hemodialysis and permanent ambulatory peritoneal dialysis, the introduction of additional doses of Levofloxacin is not required.
- The digestive system: often - nausea, diarrhea, increased activity of liver enzymes; rarely, severe diarrhea with blood in the feces, an increase in serum bilirubin; sometimes - a decrease or loss of appetite, dyspeptic disorders, abdominal pain, vomiting; very rarely - hepatitis;
- Central and peripheral nervous system: sometimes - sleep disorders, drowsiness, headache, torpor, dizziness; rarely - various discomfort in the type of paresthesia of the hands, psychomotor agitation, confusion, anxiety, anxiety, tremor, depression, psychotic reactions (sometimes accompanied by hallucinations), convulsive syndrome; very seldom - deterioration of sensitivity of tactile receptors, disturbance of taste sensitivity, smell, sight and hearing;
- Immune system: hypersensitivity to solar and ultraviolet radiation, allergic pneumonitis, reddening of the skin and itching, vasculitis, a sudden sharp decrease in blood pressure up to the development of shock; rarely, anaphylactoid and anaphylactic reactions (urticaria, marked asphyxiation, bronchospasm), swelling of the face and throat, and other surfaces of the skin and mucous membranes (very rarely); in some cases - epidermal toxic necrolysis, exudative erythema multiforme;
- Metabolism: very rarely - a decrease in the level of glucose in the blood with subsequent possible signs, such as wolf appetite, perspiration, trembling, nervousness (this must be taken into account for patients with diabetes mellitus);
- Cardiovascular system: rarely - rapid heartbeat, hypotension, very rarely - prolongation of the QT interval on the ECG, vascular collapse;
- Urinary system: rarely - an increase in serum creatinine level; very rarely, acute renal failure due to interstitial nephritis;
- Hematopoietic system: sometimes - thrombocytopenia, neutropenia, a decrease in the level of leukocytes and eosinophils, the development of severe infections (worsening of well-being, persistent fever and recurrence of fever); very rarely - agranulocytosis, hemolytic anemia, pancytopenia;
- Musculoskeletal system: rarely - muscle and joint pain, tendon lesions (including tendonitis), tendon rupture (usually Achilles), muscle weakness (this should be taken into account in patients with bulbar syndrome); in individual cases - rhabdomyolysis and other muscle lesions;
- Others: sometimes - general weakness; very rarely - fever.
When using Levofloxacin, as well as other antimicrobial drugs, the development of a secondary infection or superinfection is possible.
Experience with other fluoroquinolone drugs suggests that Levofloxacin may cause an exacerbation of porphyria.
With the simultaneous use of fenbufen or other nonsteroidal anti-inflammatory drugs with a similar chemical formula, convulsive readiness increases. While taking Levofloxacin, a sudden onset of seizures may occur in patients with a history of brain damage due to stroke, trauma or other diseases.
During treatment it is forbidden to consume alcoholic beverages, it is recommended to avoid exposure to the sun and visiting the solarium.
The drug may not be sufficiently effective in severe pneumonia of pneumococcal origin.
In some hospital infections (for example, caused by Pseudomonas aeruginosa), combination therapy is necessary.
In the event of symptoms that suggest the development of pseudomembranous colitis, it is necessary to immediately cancel Levofloxacin and carry out appropriate therapeutic measures. You should not prescribe drugs that inhibit intestinal motility.
Although rare, Levofloxacin can lead to the development of tendinitis, which can cause tendon rupture (usually Achilles). The risk of rupture increases in older people and with simultaneous use of glucocorticosteroids. If there is reason to suspect tendonitis, the drug should be discontinued, appropriate treatment should be prescribed and limbs should be kept quiet.
With caution, the drug should be used in patients with deficiency of glucose-6-phosphate dehydrogenase, because possible hemolysis.
Because of the risk of damage to the articular cartilage, Levofloxacin is not used in pediatrics.
The drug can cause visual disturbances, drowsiness and dizziness, so during treatment you should refrain from driving and working with mechanisms.
Iron-containing drugs, sucralfate and antacids containing magnesium and aluminum, reduce the effectiveness of levofloxacin, so between their techniques must be observed at least 2-hour intervals.
Levofloxacin enhances the action of drugs that reduce the threshold of convulsive readiness. A similar reaction is observed with the simultaneous reception of other quinolones. A decrease in the threshold is also noted when applying theophylline, fenbufen and other non-steroidal anti-inflammatory drugs like them.
Probenecid and cimetidine reduce renal clearance of levofloxacin. Clinically it can manifest itself only in violation of renal function. Care must be taken when prescribing these drugs.
When glucocorticosteroids are used, the risk of tendon rupture increases significantly.
In the case of concomitant administration of indirect anticoagulants, it is necessary to control the blood coagulation parameters.
Levofloxacin increases the half-life of cyclosporine.
Terms and conditions of storage
Keep out of reach of children, protected from moisture and light at a temperature up to 25 ºС.
Shelf life - 3 years.