In one tablet, Factive - 320 or 160 mg hemifloxacin mesylate(in the form of sesquihydrate). Auxiliary compounds are: MCC 43.9 mg or 21.95 mg; povidone 14.7 mg or 7.35 mg; crospovidone 23.4 mg or 11.7 mg; magnesium stearate 7.8 mg or 3.9 mg, respectively.
In the shell: hypromellose, lactose monohydrate, macrogol and titanium dioxide - components Opadry II (13 or 6.5 mg, respectively, depending on the dosage).
The tablets are film-coated. They are white or grayish in color, oblong, biconvex. 320 mg tablets have risks on both sides, and 160 mg tablets have only one side.
The drug is sold in blister packs or in polymer banks of 5-7 tablets.
Antibacterial and antimicrobial.
Pharmacodynamics and pharmacokinetics
Antibiotic Factiv has a broad bactericidal effect on GRAM + and GRAM-microorganisms, which is due to disruption of the processes of replication, restoration and transcription in bacterial DNA due to a high degree of affinity and suppression of enzymatic activity DNA gyrase and topoisomerase II, IVinvolved in the growth of bacteria. Established that to hemifloxacinsensitive:
- Aerobic GRAM + microorganisms: Streptococcus pneumoniae, pyogenes, viridans, agalactiae, milleri, anginosus, constellatus, mitis and so forth; Staphylococcus aureus, epidermidis, saprophyticus, haemolyticus and so forth; Enterococcus faecalis and faecium.
- Aerobic GRAM microorganisms: Hemophilus influenzae, parainfluenzae and other species Hemophilus; Moraxella catarrhalis and other species; Klebsiella pneumoniae, oxytoca and others; Escherichia coli; Neisseria gonorrhoeae; Acinetobacter iwoffi, anitratus, calcoaceticus, haemolyticus and etc.; Citrobacter freundii, koseri and etc.; Enterobacter aerogenes; Salmonella, Shigella; Serratia marcescens; Proteus mirabilis, vulgaris and other types Proteus; Pseudomonas aeruginosa; Morganella morganii; Providencia; Yersinia; Bordetella pertussis.
- Atypical: Mycoplasma pneumoniae, Legionella pneumophila, Coxiella burnetii; Chlamydia pneumoniae and their other types.
- Anaerobic: Porphyromonas, Prevotella, Peptostreptococcus, Fusobacterium, Clostridium non-perfringens and perfringen.
Pharmacokinetics is linear, provided that the accepted dose is in the range of 40-640 mg.
Hemifloxacinin the digestive tract is subject to rapid absorption. To achieve the maximum level in plasma, 0.5-2 hours are necessary, as a result of subsequent use, the active substance binds to plasma proteids by 55-73%, easily penetrates into lung tissue. The drug practically does not accumulate in the tissues - up to 30% of a dose of 640 mg in 1 week. A small amount is metabolized in the liver (35%). Pharmacokinetic properties do not change from diet and diet.
The elimination process is carried out by the intestine (in healthy patients - approximately 62% of the dose), as well as the urinary system (in healthy patients - approximately 37%). The elimination half-life from blood plasma and urine is 8 and 15 hours, respectively. Through hemodialysis, it is possible to remove from plasma up to 20-30% of the dose taken.
Indications for use
Effective in infectious and inflammatory diseases that were caused by susceptible to hemifloxacinmicroorganisms, for example:
- with exacerbation chronic bronchitis;
- at acute sinusitis;
- with community-acquired pneumoniathat can even be triggered multiresistant strains.
- hypersensitivity to the active substance of the Fact - hemifloxacin, as well as fluoroquinolones;
- acquired or congenital lengthening of the QT interval recorded on the ECG;
- other tendon injuries fluoroquinolones;
- breast-feeding and pregnant women;
- minors (safety of use in pediatrics has not been established).
Usually prescribed with caution
- patients at risk of developing arrhythmias, bradycardiaor acute myocardial ischemia;
- patients having glucose-6-phosphate dehydrogenase deficiency and prone to high probability hemolytic reaction;
- combination with steroids, especially - in old age due to the risk of tendon damage;
- at epilepsy or propensity to cramps;
- therapy of drugs lengthening the QT interval, including antiarrhythmic drugs 1-A class (Procainamide, Quinidine), 3 classes (Sotalol, Amiodarone);
- with disturbances in water-electrolyte balance, for example, with hypokalemia, hypomagnesemia.
- itchy skin, hives, various manifestations of hypersensitivity reactions: Stevens-Johnson syndrome, Lyell's syndrome, allergic pneumonitisincreased photosensitivity;
- nausea, diarrhea, flatulenceabdominal pain, vomiting, anorexia;
- the occurrence of acute liver failure or hepatitis A;
- tremor, drowsiness, increased anxiety, anxiety and confusion, are possible hallucinations and development paranoid syndrome, depressionsensory or sensorimotor axonopathyaccompanied by paresthesiasand hypesthesiaviolation of sensitivity and weakness;
- visual impairment (change in color perception, diplopia) taste perception, smell, possible tinnitus and hearing impairment;
- hematological disorders leukopenia, thrombocytopenia, thrombocytopenic purpura, pancytopenia, agranulocytosis, hemolyticor aplastic anemia;
- crystalluria, interstitial nephritisrenal failure;
- changes in laboratory parameters: elevated levels of sodium, potassium, total bilirubin, calcium, increased platelet count, liver concentration transaminaseand creatine phosphokinasea decrease in the number of neutrophils, a change hematocrit;
- vasculitis, arthralgia, arthritis, tenosynovitistendon ruptures, myalgiadevelopment superinfection(candidiasis, pseudomembranous colitis).
Fact, instructions for use (method and dosage)
You need to take the tablets orally inside, chewing and drinking with a small amount of clean water. The standard daily dose is 320 mg per 1 dose.
The treatment regimen for various diseases
- Daily dose for community-acquired pneumonia is 320 mg. The course usually lasts 7 days.
- If the patient is found exacerbation of chronic bronchitis or acute sinusitis, then the therapy includes 5 days of 320 mg.
Dose adjustment in patients with various forms of renal failure
- Mild and moderate forms of renal failure (creatinine clearance> 40 ml per minute) - dosage adjustment is not carried out, since there is a slight increase in excretion time hemifloxacin, no change Cmax.
- Severe form (<40 ml per minute), during hemodialysisconstant ambulatory peritoneal dialysis daily dose is reduced to 160 mg.
Measures for acute overdose:
- vomiting induction or gastric lavage;
- heavy drinking;
- dynamics monitoring;
- symptomatic therapy;
No specific antidote found.
In combination with antacidscontaining aluminum, magnesium or iron sulfate, from sucralfate, estrogen-progesterone oral contraceptives bioavailability decreases hemifloxacin, therefore, it is recommended to withstand the interval between taking drugs - 2-3 hours.
Terms of sale
At the pharmacy you may be required to present a prescription.
Dryness and protection from light rays, temperature no higher than +25 ° C.
Keep the drug out of the reach of children.
To be used for 3 years, subject to storage conditions and packaging integrity.
Analogs of the FactMatches for ATX Level 4 code:SyfloxHailefloxLeflobactLefoccinGatifloxacinOfloxacinTigeronLebelZanocinLomefloxacinElefloxLomfloxPefloxacinTsiprobaySparfloTarividZofloxAbactalMoxifloxacinLevofloxacin
The greatest number of release forms exists for such antibiotic drugs:
Reviews about the Fact
The drug is often advised and praised by patients, indicating its effectiveness, the possibility of combination with other drugs and a low probability of adverse reactions. This is a new generation antibiotic that can help with acute infectious and inflammatory processes.
Factual price, where to buy
It is possible to buy Fact in tablets with a dosage of 320 mg packing No. 7 for about 1410 rubles.
- Online Pharmacies in Russia
LuxPharma * special offer
- Fact (Hemifloxacin) tab. 320mg 5pcs