Factual
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Faktiv is an antimicrobial drug of the fluoroquinolone group of a broad spectrum of bactericidal action; disrupts the processes of repair, replication and transcription of deoxyribonucleic acid (DNA) molecules of gram-positive, gram-negative, atypical and anaerobic bacteria.
Release form and composition
The dosage form of the drug is film-coated tablets: biconvex, oblong, almost white or white; at a dose of 320 mg, there is a risk on both sides (5 or 7 pcs. in blisters or in cans made of polymeric materials, in a cardboard box 1 package / can).
Composition for 1 tablet:
- active substance: gemifloxacin (in the form of sesquihydrate mesylate), equivalent to the content of anhydrous gemifloxacin base - 160 mg or 320 mg;
- auxiliary ingredients: polyvinylpyrrolidone (povidone), magnesium stearate, microcrystalline cellulose, polyplasdone X El-10 (crospovidone);
- film shell: opadray II [hydroxypropyl methylcellulose (hypromellose), macrogol (polyethylene glycol 4000), lactose monohydrate, titanium dioxide].
Indications for use
Fact is used for the treatment of the following infectious and inflammatory diseases caused by microorganisms sensitive to gemifloxacin:
- chronic bronchitis in the acute stage;
- acute sinusitis;
- community-acquired pneumonia, including species caused by multidrug-resistant strains.
Contraindications
Absolute contraindications:
- lengthening of the QT interval on the electrocardiogram (ECG), including congenital diseases;
- tendon lesions as a result of fluoroquinolone therapy;
- the period of pregnancy and lactation (lactation);
- children up to age 18;
- increased individual sensitivity to gemifloxacin, other fluoroquinolones and auxiliary ingredients of the drug.
Relative contraindications: the drug is prescribed with caution in the presence of an increased risk of arrhythmias (including clinically significant bradycardia and acute myocardial ischemia), glucose-6-phosphate dehydrogenase deficiency (due to the risk of a hemolytic effect), epilepsy and a tendency to seizures, taking simultaneously with drugs that prolong the QT interval, for example, class IA antiarrhythmic drugs (procainamide and quinidine) and class III (amiodarone and sotalol), disorders of water-salt balance (hypomagnesemia, hypokalemia), as well as in patients (especially in old age) taking glucocorticosteroids (due to an increased risk of tendon damage).
Method of administration and dosage
The tablets are taken orally whole, washed down with a little water. Since food intake practically does not change the pharmacokinetics of gemifloxacin, the drug is taken regardless of food intake.
Recommended dosing regimen: 320 mg of gemifloxacin 1 time per day.
Duration of therapy:
- community-acquired pneumonia - 7 days (if necessary, the course can be extended for another 7 days);
- acute sinusitis - 5 days;
- exacerbation of chronic bronchitis - 5 days.
No dose adjustment is required in patients with mild to moderate renal insufficiency with creatinine clearance (CC)> 40 ml / min. In case of severe renal failure with CC <40 ml / min and in patients on continuous hemodialysis or long-term outpatient peritoneal dialysis, it is recommended to reduce the dose to 160 mg of gemifloxacin once a day.
In old age, as well as in patients with hepatic insufficiency, it is not required to change the dosage regimen.
Side effects
- digestive system: nausea, diarrhea; sometimes - abdominal pain, flatulence, vomiting, anorexia; in rare cases - abnormal liver function in an acute form, hepatitis, an increase in total bilirubin and hepatic transaminase activity;
- central and peripheral nervous system: in rare cases - anxiety, anxiety, tremor, confusion, paranoid syndrome, hallucinations, depression, drowsiness; individual episodes - sensorimotor or sensory axonal polyneuropathy (manifested by paresthesias, hypesthesia, weakness, and other sensory disorders); in the event of any side effects from the central nervous system, hemifloxacin therapy is discontinued;
- sense organs: in rare cases - taste / smell disorders, visual impairment (change in color perception, diplopia), dizziness, tinnitus, hearing loss;
- hematopoietic system: sometimes - leukopenia; in rare cases, thrombocytopenia; individual episodes - thrombocytopenic purpura, pancytopenia, agranulocytosis, anemia (including hemolytic and aplastic);
- urinary system: in rare cases - crystalluria; isolated episodes - acute renal dysfunction, interstitial nephritis;
- musculoskeletal system: in rare cases - myalgia, arthritis, arthralgia, tendovaginitis, ruptures of the Achilles tendon, tendons of the arm, shoulder, etc.;
- laboratory indicators: in rare cases - a decrease in the level of potassium / calcium, a change in hematocrit, an increase in sodium content, an increase in the activity of creatine phosphokinase;
- hypersensitivity reactions: sometimes - urticaria, pruritus; in some cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), increased photosensitivity, allergic pneumonitis;
- other reactions: in rare cases - superinfection (pseudomembranous colitis, candidiasis), vasculitis.
In case of an overdose of Faktiv, patients undergo gastric lavage, induce vomiting, give plenty of drink, and if necessary, carry out symptomatic therapy. There are currently no data on the specific antidote of gemifloxacin, its elimination from blood plasma during hemodialysis is 20-30%.
special instructions
During therapy with gemifloxacin, a sufficient amount of fluid should be provided provided that the organs of the urinary system are functioning normally.
Taking Faktiv, like other fluoroquinolones, can cause photosensitivity reactions, as a result of which it is important to avoid direct sunlight. At the first symptoms of photosensitization with changes in the skin, like sunburn, drug treatment is stopped.
In patients receiving corticosteroids (glucocorticosteroids), especially in old age, the risk of tendon damage may increase. In case of observation of the first signs of tendonitis (pain, swelling in the tendon area), the use of Faktiv must be stopped, excluded or limited any physical activity and seek medical advice.
With the development of diarrhea after the start of therapy with gemifloxacin, pseudomembranous colitis can be suspected, the most frequent causative agent of which is the anaerobic spore-forming gram-positive bacillus Clostridium difficile. For the disappearance of its symptoms, in most cases, discontinuation of Faktiva is sufficient, but sometimes therapy with antibiotics active against Clostridium difficile may be required.
When driving vehicles and performing other potentially hazardous types of work that require a high speed of psychomotor reactions and increased concentration of attention, care should be taken, especially with the simultaneous use of gemifloxacin and ethanol.
Drug interactions
- antacids containing aluminum and magnesium or ferrous sulfate: reduce the bioavailability of hemifloxacin (between their doses, an interval of at least 3 hours should be observed before taking hemifloxacin and at least 2 hours after);
- sucralfate: reduces the bioavailability of gemifloxacin (take sucralfate no earlier than 2 hours after taking Faktiv);
- oral combined estrogen-gestagenic contraceptives: the bioavailability of gemifloxacin is slightly reduced;
- oral contraceptive drugs containing ethinylestradiol and / or levonorgestrel: their pharmacokinetics are not affected by the course of hemifloxacin.
Analogs
Faktiv analogs are: Siflox, Leflobact, Haileflox, Lefoktsin, Gatifloxacin, etc.
Terms and conditions of storage
Store in a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
