Floracid
Floracid: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. Use in the elderly
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Floracid
ATX code: J01MA12
Active ingredient: levofloxacin (levofloxacin)
Manufacturer: PJSC "Valenta Pharmaceuticals" (Russia)
Description and photo update: 2019-26-08
Prices in pharmacies: from 245 rubles.
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Floracid is a drug with a broad spectrum of antibacterial action.
Release form and composition
Dosage form of release of Floracid - film-coated tablets: biconvex, oblong, pinkish-cream, on one side with a risk; on a cross-section - two layers (5, 7 or 10 pieces in blisters, in a cardboard box 1 package).
Composition of 1 tablet:
- active substance: levofloxacin - 250 or 500 mg (in the form of hemihydrate);
- additional components: Kollidone CL (crospovidone), sodium lauryl sulfate, Kollidone 30 (povidone), microcrystalline cellulose, magnesium stearate;
- shell: macrogol (polyethylene glycol 6000), hydroxypropyl cellulose (hyprolose), hydroxypropyl methylcellulose (hypromellose), yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172).
Pharmacological properties
Pharmacodynamics
Levofloxacin belongs to the group of fluoroquinolones and is a levorotatory isomer of ofloxacin. It is a blocker of DNA gyrase (topoisomerase II) and topoisomerase IV, which inhibits DNA synthesis, prevents supercoiling and stitching of DNA breaks, and leads to deep morphological changes in the cell membrane and walls, as well as in the cytoplasm.
Levofloxacin demonstrates activity against various strains of microorganisms both in vivo and in vitro.
The efficacy of Floracid in vivo against bacteria of the following species has been proven: Clostridium perfringens, Enterococcus faecalis, Serratia marcescens, Staphylococcus epidermidis, Staphylococcus aureus, Providencia stuartii, Providencia rettgeri, Streptococcus rettgeri, Streptococcus Streptococcus miracus, Proteinus vulptocus, Proteinus pneumonis, Streptococcus mi. streptococci, Morganella morganii, Enterobacter sakazakii, Enterobacter agglomerans, Enterobacter aerogenes, Enterobacter cloacae, Citrobacter freundii, Citrobacter diversus, Escherichia coli, Bordetella pertussis, Haemophilus parainfluenzae, Haemophilus influenzae, Acinetobacter baumannii, Acinetobacter anitratus, Acinetobacter calcoaceticus, Klebsiella oxytoca, Klebsiella pneumoniae, Mycoplasma pneumoniae, Legionella pneumoniae, Chlamydia pneumoniae, Moraxella catarrhalis,Pseudomonas fluorescens, Pseudomonas aeruginosa.
The following microorganisms are also susceptible to levofloxacin in vitro (MIC is less than 2 mg / l):
- anaerobic microorganisms: Veillonella spp., Bacteroides fragilis, Propionibacterium spp., Bifidobacterium spp., Peptostreptococcus spp., Fusobacterium spp.;
- aerobic gram-negative microorganisms: Serratia spp., Acinetobacter spp., Salmonella spp., Actinobacillus actinomycetemcomitans, Pseudomonas spp., Eikenella corrodens, Providencia spp., Enterobacter spp., Pasteurella spp. (including Pasteurella multocida, Pasteurella dagmatis, Pasteurella canis), Gardnerella vaginalis, Neisseria meningitides, Neisseria gonorrhoeae (penicillinase and non-penicillinase-producing strains), Klebsiella spp., Helicobacter pylori, Haemcrei;
- aerobic gram-positive microorganisms: Streptococcus spp. groups C and G, Corynebacterium diphtheria, Staphylococcus spp. (CNS), Staphylococcus spp. (coagulase-negative strains sensitive or moderately susceptible to methicillin), Listeria monocytogenes, Enterococcus spp.;
- other microorganisms: Ureaplasma urealyticum, Bartonella spp., Rickettsia spp., Chlamydia psittaci, Chlamydia trachomatis, Mycoplasma hominis, Mycobacterium spp. (including Mycobacterium tuberculosis, Mycobacterium leprae), Legionella spp.
Moderate activity of levofloxacin (MIC exceeds 4 mg / l) was recorded in relation to the following microorganisms:
- anaerobic microorganisms: Porphyromonas spp., Bacteroides thetaiotaomicron, Bacteroides ovatus, Bacteroides vulgatus, Prevotella spp.;
- aerobic gram-negative microorganisms: Campylobacter coli, Campylobacter jejuni, Burkholderia cepacia;
- aerobic gram-positive organisms: Staphylococcus haemolyticus (methicillin-resistant strains), Staphylococcus epidermidis (methicillin-resistant strains), Corynebacterium xerosis, Corynebacterium urealyticum, Enterococcus faecium.
The following microorganisms are resistant to levofloxacin (MIC exceeds 8 mg / l):
- aerobic gram-negative microorganisms: Alcaligenes xylosoxidans;
- aerobic gram-positive microorganisms: Staphylococcus spp. (coagulase-negative methicillin resistant strains), Staphylococcus aureus (methicillin resistant strains), Corynebacterium jeikeium;
- other microorganisms: Mycobacterium avium.
Pharmacokinetics
After oral administration of Floracid, levofloxacin is rapidly and almost 100% absorbed from the gastrointestinal tract. The degree and rate of absorption depend little on food intake. Bioavailability when taking Floracid at a dose of 500 mg is close to 100%. When levofloxacin is taken orally at a dose of 500 mg, its maximum concentration in blood plasma varies from 5.2 to 6.9 μg / ml, and it is reached in about 1.3 hours. The half-life is 6-8 hours.
The degree of binding to plasma proteins reaches 30-40%. Levofloxacin penetrates well into organs and tissues and is determined in alveolar macrophages, bronchial mucosa, lungs, sputum, polymorphonuclear leukocytes, prostate gland, organs of the urinary system, cerebrospinal fluid, bone tissue. In the liver, the active substance is deacetylated and / or oxidized in small quantities.
Levofloxacin is excreted from the body mainly in the urine through tubular secretion and glomerular filtration. Approximately 87% of the dose taken is excreted unchanged through the kidneys within 48 hours, and less than 4% is excreted in the faeces within 72 hours.
Indications for use
According to the instructions, Floracid is prescribed for the treatment of the following diseases of an infectious and inflammatory etiology, which are caused by microorganisms that are sensitive to the action of levofloxacin:
- soft tissue / skin infections;
- bacterial prostatitis;
- community-acquired pneumonia;
- intra-abdominal infections;
- acute sinusitis;
- chronic bronchitis in cases of exacerbation;
- complicated urinary tract / kidney infections, including pyelonephritis;
- uncomplicated urinary tract infections;
- tuberculosis in drug-resistant forms (along with other drugs).
Contraindications
Absolute:
- anamnestic data on tendon lesions associated with the intake of quinolones;
- epilepsy;
- age up to 18 years;
- pregnancy and lactation;
- individual intolerance to the components of Floracid or other quinolones.
Relative (Floracid is prescribed with caution and under medical supervision in case of the following diseases / conditions):
- deficiency of glucose-6-phosphate dehydrogenase (due to the likelihood of hemolysis of erythrocytes);
- old age (due to the high likelihood of decreased kidney function).
Instructions for the use of Floracid: method and dosage
Floracid tablets are taken orally with a sufficient amount of liquid (1 / 2-1 glass), preferably before meals or between meals, the tablets should not be chewed.
The doctor determines the dosage regimen individually, depending on the severity / nature of the disease, as well as the sensitivity of the infectious agent to the action of Floracid.
The recommended dosage regimen for patients with normal or moderately reduced renal function (with creatinine clearance> 50 ml / min):
- infections of soft tissues / skin: once a day, 250 mg or 1-2 times a day, 500 mg for 7-14 days;
- sinusitis: once a day, 500 mg for a course of 10-14 days;
- intra-abdominal infections: once a day, 500 mg for 7-14 days in combination with antibacterial drugs that act on the anaerobic flora;
- exacerbation of chronic bronchitis: once a day, 250-500 mg for 7-10 days;
- community-acquired pneumonia: 1–2 times a day, 500 mg for 7–14 days;
- prostatitis: once a day, 500 mg for 28 days;
- urinary tract infections in a complicated course, including pyelonephritis: once a day, 250 mg for a course of 7-10 days;
- infections of the urinary tract in an uncomplicated course: once a day, 250 mg for 3 days;
- tuberculosis in drug-resistant forms (in combination with other drugs): 1–2 times a day, 500 mg for a course of up to 3 months.
In the presence of functional disorders of the kidneys, the regimen of application of Floracid is adjusted (doses for oral administration: the first dose; further doses, depending on creatinine clearance - 50–20 ml / min / 19–10 ml / min / <10 ml / min, including h patients on hemodialysis and continuous ambulatory peritoneal dialysis):
- 250 mg / 24 hours: 250 mg; 1 time a day, 125 mg / 1 time every 2 days, 125 mg / 1 time every 2 days, 125 mg;
- 500 mg / 24 hours: 500 mg; 1 time per day, 250 mg / 1 time per day, 125 mg / 1 time per day, 125 mg;
- 500 mg / 12 hours: 500 mg; 2 times a day, 250 mg / 2 times a day, 125 mg / 1 time a day, 125 mg.
For elderly patients, the dose of Floracid is adjusted only if there is evidence of functional impairment of the kidneys.
After normalization of body temperature or reliable destruction of the pathogen, therapy is continued for another 2-3 days.
If you skip taking a single dose, it should be taken as soon as possible, continuing to take Floracid further according to the prescribed scheme.
Side effects
Possible side reactions of Floracid (> 10% - very often;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare):
- central and peripheral nervous system: sometimes - headache, numbness, dizziness, sleep disturbances, drowsiness; rarely - anxiety, depression, psychotic reactions, paresthesia in the hands, agitation, trembling, confusion, convulsions; very rarely - disturbances of smell, taste sensitivity, hearing, vision, decreased tactile sensitivity;
- musculoskeletal system: rarely - tendon lesions (including tendonitis), muscle / joint pain; very rarely - rupture of the Achilles tendon (can appear within 2 days from the start of taking Floracid and be bilateral in nature), myalgia, arthralgia, muscle weakness (should be taken into account with bulbar syndrome); in some cases - rhabdomyolysis;
- cardiovascular system: rarely - tachycardia, lowering blood pressure; very rarely - vascular collapse; in some cases - lengthening of the QT interval;
- hematopoietic system: sometimes - leukopenia, eosinophilia; rarely - thrombocytopenia, neutropenia, hemorrhages; very rarely - agranulocytosis; in some cases - pancytopenia, hemolytic anemia;
- urinary system: rarely - increased serum creatinine levels in the blood; very rarely - interstitial nephritis, functional renal impairment up to acute renal failure;
- digestive system: often - diarrhea, nausea, increased activity of aspartate aminotransferase, alanine aminotransferase; sometimes - digestive disorders, abdominal pain, loss of appetite, vomiting; rarely - diarrhea with blood (it should be borne in mind that in very rare cases this disorder is a symptom of pseudomembranous colitis, intestinal inflammation), dysbiosis, increased serum bilirubin levels in the blood; very rarely - hepatitis;
- metabolism: very rarely - hypoglycemia (manifested as nervousness, perspiration, a sharp increase in appetite, trembling); exacerbation of porphyria (according to data on the use of other quinolones);
- allergic reactions: sometimes - redness / itching of the skin; rarely - bronchospasm, urticaria, choking; very rarely - vasculitis, allergic pneumonitis, anaphylactic shock, edema of the mucous membranes and skin (for example, in the larynx and face); in some cases - exudative erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome;
- others: sometimes asthenia; very rarely - fever, photosensitivity, development of superinfection.
Overdose
Symptoms of an overdose of Floracid include prolongation of the QT interval, blurred consciousness, impaired consciousness and seizures of the type of epileptic seizures, dizziness, erosive lesions of the mucous membranes, nausea. The appointment of symptomatic treatment is recommended. The elimination of levofloxacin by dialysis is ineffective. The specific antidote to this active substance is unknown.
special instructions
In cases of suspicion of pseudomembranous colitis, Floracid is immediately canceled and appropriate therapy is started. The use of drugs that can lead to inhibition of intestinal motility is prohibited.
With a burdened history of brain damage due to severe trauma, stroke, or for other reasons, seizures may develop.
For the treatment of nosocomial infections that are caused by Pseudomonas aeruginosa, Floracid can be used concurrently with other drugs.
To avoid the development of photosensitivity, patients are advised to avoid intense ultraviolet radiation or prolonged exposure to the sun.
In the treatment of severe pneumococcal pneumonia, therapy with Floracid may not be effective enough.
The likelihood of tendonitis is higher in elderly patients. The risk of tendon rupture increases when used with glucocorticosteroids. In cases of suspicion of tendonitis, the use of Floracid is immediately discontinued and appropriate treatment is initiated, while resting the affected area must be ensured.
When combined with vitamin K antagonists, monitoring of the state of the blood coagulation system is required.
Influence on the ability to drive vehicles and complex mechanisms
During the period of application of Floracid, care must be taken when driving vehicles and performing other potentially dangerous work.
Application during pregnancy and lactation
It is contraindicated to take Floracid during pregnancy and while breastfeeding.
Pediatric use
For patients under the age of 18, Floracid is not prescribed.
Use in the elderly
Due to the high likelihood of a decrease in renal function, elderly patients should be careful when taking Floracid.
Drug interactions
In cases of the combined use of Floracid with certain drugs / substances, the following effects may occur:
- sucralfate, antacids containing magnesium or aluminum, as well as iron salts: a significant decrease in the effect of levofloxacin (with combined use, the interval between doses of these drugs must be observed at least 2 hours);
- glucocorticosteroids: increased likelihood of tendon rupture;
- drugs that can lower the seizure threshold, including theophylline, non-steroidal anti-inflammatory drugs: increasing the ability to lower it;
- cyclosporin: a slight increase in the half-life of levofloxacin;
- cimetidine, probenecid: slight delay in excretion (renal clearance) of levofloxacin.
Analogs
Floracid analogues are: Eleflox, Haileflox, Ashlev, Ivacin, Levoflox, Levofloxacin, Lefsan, Leflobakt, MAKLEVO, Remedia, etc.
Terms and conditions of storage
Store in a dark, dry place at temperatures up to 25 ° C. Keep out of the reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Floracide
Mostly reviews of Floracid as an antibacterial drug are positive. Most patients report that in the treatment of urogenital infections (prostatitis, urethritis, cystitis), the improvement in well-being occurs as early as the second day after starting to take Floracid. In this case, adverse reactions are rarely observed, mainly when the dosage regimen prescribed by the doctor is not followed or when Floracid is combined with alcoholic beverages. Since levofloxacin is a strong antibiotic, many patients do not advise in this case to self-medicate.
Price for Floracid in pharmacies
The approximate price of Floracid with a dosage of 500 mg is 440-560 rubles (the package contains 5 tablets) or 859-1120 rubles (the package contains 10 tablets).
Floracid: prices in online pharmacies
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Drug name Price Pharmacy |
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Floracid 500 mg film-coated tablets 5 pcs. 245 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
