Powder for solution for injection "Florazid" is used for the indications listed below.
Treatment of the following infections in adults and children, including newborns:
- nosocomial pneumonia;
- respiratory tract infections in patients with cystic fibrosis;
- bacterial meningitis;
- chronic otitis media;
- malignant otitis externa;
- complicated urinary tract infections;
- complicated infections of the skin and soft tissues;
- complicated abdominal infections;
- bone and joint infections;
- peritonitis associated with dialysis in patients undergoing continuous ambulatory peritoneal dialysis.
Treatment of bacteremia occurring in patients as a result of any of the above infections.
Ceftazidime can be used to treat patients with neutropenia and fever that results from a bacterial infection.
Ceftazidime can be used to prevent infectious complications during prostate surgery (transurethral resection).
When prescribing ceftazidime, one should take into account its antibacterial spectrum, which is directed mainly against gram-negative aerobes.
Ceftazidime should be used with other antibacterial agents if the microorganisms causing the infection are expected to be outside the spectrum of action of ceftazidime.
The drug should be prescribed in accordance with existing official recommendations for the prescription of antibacterial agents.
Pharmacodynamics and pharmacokinetics
Is Floracid an antibiotic or not?
The active ingredient of the product is broad-spectrum antibiotic the fluoroquinolone . It is the left-handed isomer of ofloxacin .
The substance blocks the enzymes topoisomerase 4 and topoisomerase 2 in the DNA of the harmful agent. Thus, the processes of supercoiling and DNA , and irreversible destructive changes occur in the cytoplasm of the cell and its membrane.
The drug has a wide antibacterial spectrum. As a result of research, it was proven that the antibiotic is active in a living organism against: Escherichia coli, Staphylococcus aureus, Moraxella catarrhalis, Providencia rettgeri, Legionella pneumoniae, Enterobacter aerogenes, Enterococcus faecalis, Streptococcus pyogenes Viridans group streptococci, Enterobacter sakazakii, Enterobacter cloacae, Haemophilus influenzae , Klebsiella pneumoniae, Proteus mirabilis, Haemophilus parainfluenzae, Pseudomonas fluorescens, Mycoplasma pneumoniae, Acinetobacter baumannii, Bordetella pertussis, Citrobacter freundii, Klebsiella oxytoca, Proteus vulgaris, Providencia stuartii, Clostridium perfringens, Streptococcus pneumoniae, Enterobacter agglo merans, Streptococcus agalactiae, Pseudomonas aeruginosa, Chlamydia pneumoniae, Acinetobacter calcoaceticus, Citrobacter diversus, Staphylococcus epidermidis, Morganella morganii, Acinetobacter anitratus, Serratia marcescens.
The product is effective in vivo against:
- aerobic gram-positive organisms (Enterococcus spp., Staphylococcus spp. Staphylococcus spp. Corynebacterium diphtheriae, Streptococcus spp., etc.);
- aerobic gram-negative organisms (Acinetobacter spp., Eikenella corrodens, Gardnerella vaginalis, Helicobacter pylori, Neisseria gonorrhoeae Neisseria meningitidis, Providencia spp., Pasteurella spp. Actinobacillus actinomycetemcomitans, Enterobacter spp., etc.);
- anaerobic microorganisms (Bacteroides fragilis, Fusobacterium spp., Propionibacterium spp., Bifidobacterium spp., Peptostreptococcus spp., Veillonella spp., etc.);
- other microorganisms (Bartonella spp., Chlamydia trachomatis, Mycobacterium spp. Mycoplasma hominis, Ureaplasma urealyticum, Rickettsia spp., Chlamydia psittaci, Legionella spp.).
Levofloxacin exhibits moderate activity against Corynebacterium urealyticum, Enterococcus faecium, Staphylococcus haemolyticus Campylobacter jejuni, Bacteroides thetaiotaomicron, Bacteroides ovatus, Porphyromonas spp. Corynebacterium xerosis, Staphylococcus epidermidis Burkholderia cepacia, Campylobacter coli, Bacteroides vulgatus, Prevotella spp.
Corynebacterium jeikeium, Staphylococcus spp. Alcaligenes xylosoxidans, Mycobacterium avium, Staphylococcus aureus are resistant to the drug.
Food intake has virtually no effect on the absorption of the antibiotic. It is rapidly and completely absorbed through the gastrointestinal tract , reaching maximum plasma concentrations after 1.3 hours. The half-life is 7 hours. Up to 40% binds to plasma proteins. Penetrates into the urinary system , cerebrospinal fluid , alveoli , sputum and bronchial mucosa. In the liver, the medicine is oxidized.
About 80% of the drug is excreted by the kidneys within two days, a small amount is excreted through the intestines (three days).
Floracid tablets 500 mg No. 5
Compound
Active substance: levofloxacin (in the form of levofloxacin hemihydrate) -250.0 mg or 500.0 mg. Excipients: crospovidone - 14.0 mg or 28.0 mg, magnesium stearate - 3.9 mg or 7.8; sodium lauryl supphag - 5.0 mg or 10.0 mg, povidone - 15.0 mg or 30.0 mg. microcrystalline cellulose - 98.2 mg or 196.4 and; colloidal silicon dioxide (aerosil) - 3.9 mg or 7.8 mg Shell composition: Opadry II (series 85): (partially gts-dropped polyvinyl stylet, titanium dioxide E 171, macro gol-3350, talc, iron dye yellow oxide E172, iron dye red oxide E172) - 20.0 mg or 40.0 mg Description: Film-coated tablets, pinkish-cream color, oblong, biconvex with a score on one side. The cross section shows two layers.
Pharmacokinetics
After oral administration, levofloxacin is quickly and almost completely absorbed from the gastrointestinal tract. Food intake has little effect on the speed and completeness of absorption. The bioavailability of 500 mg of levofloxacin is 100%. With a single dose of 500 mg of levofloxacin, the maximum concentration (Cmax) in blood plasma is 5.2-6.9 mcg/ml, the time to reach the maximum concentration (TCmax) is 1.3 hours, the half-life (T^) is 6-8 hours Bonding with plasma proteins is 30-40%. Penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, urinary system organs, bone tissue, cerebrospinal fluid, prostate gland, polymorphonuclear leukocytes, alveolar macrophages. In the liver, a small portion is oxidized and/or deacetylated. It is excreted from the body primarily by the kidneys by glomerular filtration and tubular secretion. About 87% of the dose is excreted unchanged by the kidneys within 48 hours, less than 4% is excreted through the intestines within 72 hours
Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- acute sinusitis;
- exacerbation of chronic bronchitis;
- extra-large pneumonia;
- complicated kidney and urinary tract infections (including pyelonephritis);
- uncomplicated urinary tract infections;
- bacterial prostatitis;
— infections of the skin and soft tissues;
— intraabdominal infection;
— for complex treatment of drug-resistant forms of tuberculosis
Contraindications
- hypersensitivity to levofloxacin or other quinolones;
-epilepsy;
- tendon damage due to previous treatment with quinolones;
-childhood and adolescence (up to 18 years);
- pregnancy and lactation period.
Directions for use and doses
Inside, before meals or between meals. Do not chew the tablets and take them with a sufficient amount of liquid (0.5 to 1 glass). Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen. For patients with normal or moderately reduced renal function (creatinine clearance > 50 ml/min), the following dosage regimen is recommended: Sinusitis: 500 mg 1 time per day. The duration of treatment is 10-14 days. Exacerbation of chronic bronchitis: 250 mg or 500 mg 1 time per day. Duration of treatment is 7-10 days. Nosocomial pneumonia: 500 mg 1-2 times a day. Duration of treatment is 7-14 days. Uncomplicated urinary tract infections: 250 mg once a day. Duration of treatment: 3 days. Prostatitis 500 mg - 1 time per day. The duration of treatment is 28 days. Complicated urinary tract infections, including pyelonephritis, 250 mg once a day. Duration of treatment is 7-10 days. Skin and soft tissue infections: 250 mg once a day or 500 mg 1-2 times a day. The duration of treatment is 7-14 days. Intra-abdominal infection: 500 mg 1 time per day. The duration of treatment is 7-14 days (in combination with antibacterial drugs acting on anaerobic flora). Complex treatment of drug-resistant forms of tuberculosis: 500 mg 1-2 times a day. Duration of treatment is up to 3 months. Dosage regimen in patients with impaired renal function: After hemodialysis or continuous ambulatory peritoneal dialysis (CAP), no additional doses are required. If liver function is impaired, no special dose selection is required, since Floracid® is metabolized in the liver only to an extremely small extent. For elderly patients, no change in dosage regimen is required, except in cases of low creatinine clearance. As with the use of other antibiotics, treatment with Floracid® is recommended to be continued for at least 48-72 hours after normalization of body temperature or after reliable eradication of the pathogen. If you miss taking the drug, you should resume taking it as soon as possible and continue to take Floracid® according to the recommended regimen.
Storage conditions
In a place protected from light at a temperature not exceeding 25°C. Keep out of the reach of children.
Best before date
2 years. Do not use after expiration date.
special instructions
When prescribing Floracid® to elderly patients, it should be borne in mind that patients in this group often have impaired renal function. In case of severe pneumonia caused by pneumococcus, Floracid® may not be effective enough. Hospital-acquired infections caused by Pseudomonas aeruginosa may require combination treatment. During treatment with Floracid®, it is possible to develop an attack of seizures in patients with previous brain damage caused, for example, by a stroke or severe trauma. ? Despite the fact that photosensitivity is observed very rarely when using the drug Floracid®, in order to avoid its development, patients should avoid exposure to the sun or ultraviolet irradiation. If pseudomembranous hoarding is suspected, Floracid® should be immediately discontinued and appropriate treatment should be initiated. In such cases, drugs that inhibit intestinal motility should not be used. In elderly patients, when using the drug Floracid®, the likelihood of developing tendinitis increases. When using glucocorticosteroids, the risk of tendon rupture increases. If tendonitis is suspected, Floracid® should be immediately discontinued and appropriate treatment should be initiated, ensuring the affected area remains at rest. When using vitamin K antagonists simultaneously, monitoring of the blood coagulation system is necessary. In patients with glucose-6-phosphate dehydrogenase deficiency, hemolysis is possible.
Conditions for dispensing from pharmacies
On prescription
Dosage form
Film-coated tablets
Manufacturer and organization accepting consumer complaints
OJSC "Vapenta Pharmaceuticals"
Pharmacodynamics
A broad-spectrum antimycotic drug from the group of fgorquinolones, a left-rotating isomer of ofpoxacin. Levofloxacin blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes Levofloxacin is active against most strains of microorganisms both in vitro and in vivo. In vivo effective against Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes and Streptococcus agalactiae, Viridans group streptococci, Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter sakazakii, Escherichia coli, Haemophilus influen zae, Haemophilus parainfluenzae, Klebsiella pneumoniae , Klebsiella oxytoca, Legionella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa, Pseudomonas fluorescens, Chlamydia pneumoniae, Mycoplasma pneumoniae, Acinetobacter anitratus, Adnetobacter baumannii, Adnetobacter calcoaceticus, Bordetella pertussis, Citrobacter diversus, Citrobacter freundii , Morganella morganii, Proteus vulgaris, Providenda rettgeri, Providencia stuartii, Serratia marcescens, Clostridium perfringens. In vitro: Sensitive microorganisms (MIC4 mg/l): Aerobic gram-positive microorganisms: Corynebacterium urealiticum, Corynebaderium xerosis, Enterococcus faecium, Staphylococcus epidermidis (methicillin-resistant strains), Staphylococcus haemolyticus (methicillin-resistant strains). Aerobic gram-negative microorganisms: Burkholderia cepada, Campilobaderjejuni, Campilobacter coli. Anaerobic microorganisms: Baderoides thetaiotaomicmn, Baderoides vulgatus, Baderoides ovaius, Prevotella spp., Porphyromonaa spp. Resistant to levofpoxacin (MIC>_8 mg/l): Aerobic gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus (methicillin-resistant strains), Staphylococcus spp. (coagulase-negative methicillin-resistant strains). Aerobic gram-negative microorganisms: Alcaligenesxylosoxidans. Other microorganisms: Mycobaderium avium.
Side effects
Allergic reactions:
Sometimes: itching and redness of the skin. Rarely: urticaria, bronchospasm, suffocation. Very rare: swelling of the skin and mucous membranes (for example, in the face and larynx), anaphylactic shock; allergic pneumonitis; vasculitis In some cases: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and exudative erythema multiforme.
From the digestive system: Often: nausea, diarrhea, increased activity of alanine aminotransferase (ALT), aspartate aminotransferase (AST). Sometimes: loss of appetite, vomiting, abdominal pain, digestive disorders. Rarely: increased levels of bilirubin in the blood serum, diarrhea with blood (in very rare cases, may be a sign of intestinal inflammation and pseudomembranous colitis), dysbiosis. Very rarely; hepatitis.
From the side of substance deception: Very rarely: hypoglycemia (manifested by a sharp increase in appetite, nervousness, perspiration, trembling). Experience with the use of other quinolones indicates that they can cause exacerbation of porphyria; in some cases, a similar effect cannot be excluded when using levofloxacin.
From the iental nervous system and peripheral nervous system: Sometimes: headache, dizziness and/or stupor, drowsiness, sleep disturbances. Rare: depression, anxiety, psychotic reactions (eg, hallucinations), paresthesia in the hands, tremors, restlessness, convulsions and confusion. Very rare: visual and hearing impairment, impaired taste and smell, decreased tactile sensitivity.
From the cardiovascular system: Rarely: tachycardia, decreased blood pressure. Very rare: vascular collapse. In some cases: prolongation of the QT interval.
From the musculoskeletal system: Rarely: tendon damage (including tendinitis), joint and muscle pain. Very rare: tendon rupture (for example, Achilles tendon can be observed within 48 hours after the start of treatment and can be bilateral); arthralgia, myapgia, muscle weakness, which is of particular importance for patients with bulbar syndrome. In some cases: muscle damage (rhabdomyolysis).
From the urinary system: Rarely: increased creatinine levels in the blood serum. Very rare: impaired renal function up to acute renal failure, interstitial nephritis.
From the hematopoietic organs: Sometimes: eosinophilia, leukopenia. Rarely: neutropenia; thrombocytopenia, hemorrhages. Very rare: agranulocytosis. In some cases: hemolytic anemia; pan cytopenia. Other Sometimes: asthenia. Very rare: development of superinfections, fever, photosensitivity.
Interaction
Quinolones may enhance the ability of drugs (including non-steroidal anti-inflammatory drugs, theophylpine) to lower the seizure threshold. The effect of levofloxacin is significantly reduced when used simultaneously with sucralfate, magnesium- or aluminum-containing antacids, as well as with iron salts (the interval between taking levofloxacin and these drugs should be at least 2 hours). No interaction was detected with calcium carbonate. The elimination (renal clearance) of levofloxacin is slightly slowed down by the action of cimetidine and probenecid, which has virtually no clinical significance. Levofloxacin slightly increases the half-life (T1) of cyclosporine from blood plasma. Concomitant use with glucocorticosteroids increases the risk of tendon rupture.
Overdose
Symptoms: confusion, dizziness, disturbances of consciousness and seizures of the epileptic type, nausea, erosive lesions of the mucous membranes, prolongation of the QT interval.
Treatment: symptomatic. Levofloxacin is not eliminated by dialysis. There is no specific antidote
Impact on the ability to drive vehicles and operate machinery
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Indications for use
The drug is prescribed for diseases caused by microorganisms sensitive to the antibiotic :
- with chronic bronchitis in the acute phase;
- pyelonephritis and other urinary tract and kidney infections, usually complicated;
- prostatitis of bacterial etiology;
- for intra-abdominal infection ;
- for acute sinusitis ;
- pneumonia;
- for urinary tract infections;
- for the treatment of skin and soft tissue infections;
- as part of complex therapeutic procedures for resistant forms of tuberculosis .
Storage conditions
Store in original packaging at a temperature not exceeding 25°C, out of the reach of children. The prepared solution can be stored for no more than 8 hours at a temperature not exceeding 25°C and no more than 24 hours at a temperature from 2°C to 8°C.
Shelf life: 2 years.
Product description certified by the manufacturer Swiss Perinterals
.
Verified
Sevryukov Alexander Viktorovich
Contraindications
The product is contraindicated:
- for epilepsy ;
- allergies to levofloxacin ;
- during pregnancy and lactation ;
- children and teenagers;
- for joint damage caused by quinolones ;
- hypersensitivity to quinolone .
Caution should be used in the elderly and in gluc-6 phosphate dehydrogenase .
Side effects
Adverse reactions that occur most often:
- diarrhea , increased levels and activity of liver enzymes, nausea and vomiting (in 10% of cases);
- In 1% of cases, the following were observed: skin itching and redness, epigastric pain , loss of appetite, dyspepsia , drowsiness , headaches , dizziness , leukopenia , asthenia and eosinophilia .
Rarely and very rarely appeared:
- urticaria , edema , anaphylactic reactions , vasculitis , suffocation , bronchospasm ;
- dysbacteriosis , hepatitis , blood in stool, hypoglycemia ;
- depression , hallucinations , confusion , distortion of tastes and smells, deterioration of hearing and vision;
- tachycardia , vascular collapse , severe decrease in blood pressure ;
- tendinitis , myalgia , pain in muscles and joints, arthralgia ;
- disorders of the kidneys, increased creatinine in the blood;
- neutropenia , hemorrhages , agranulocytosis , thrombocytopenia ;
- fever and sensitivity to light.
Steven-Johnson syndrome , erythema , Lyell's syndrome , QT , rhabdomyolysis , pancytopenia , and hemolytic anemia have been reported in isolated cases .
Instructions for use of Floracid (Method and dosage)
The drug is taken orally. It is better to take the tablets before or during meals, without chewing, with plenty of liquid.
The duration of administration and daily dosage should be determined by the doctor depending on the nature and severity of the disease, the sensitivity of microorganisms to the antibiotic .
According to the instructions for Floracid, for patients with normal renal function:
- for the treatment of urinary tract infections, take 250 mg of the drug, from 3 to 10 days, depending on the severity of the disease;
- for sinusitis, 500 mg per day is prescribed for 10-14 days;
- for prostatitis – 500 mg per day, 28 days;
- during an exacerbation of chronic bronchitis, take 250-500 mg of antibiotic per day, course – 7-10 days;
- for the treatment of infections of the skin and subcutaneous layer, 250-1000 mg of the drug per day is prescribed for 7-14 days;
- for pneumonia - from 500 to 1000 mg per day, one or two weeks;
- for resistant forms of tuberculosis – 500 or 1000 mg of the drug, 90 days, in combination with other drugs;
- for intra-abdominal infections, 500 mg is prescribed for one or two weeks.
After hemodialysis or continuous ambulatory peritoneal dialysis, additional doses are not required.
Antibiotic treatment continues for at least two days after the temperature normalizes and the number of bacteria .
For persons with kidney disease:
- if the CC reaches 10-19 ml per minute, then you can take 125 mg 1 or 2 times a day, or once every two days;
- if CC is 20-50 ml/min, prescribe 125-250 mg 1-2 times a day;
- if CC is less than 10 ml/min, the maximum daily dosage is 125 mg.
Side effects
Circulatory and lymphatic systems: often (≥ 1/100 and < 1/10) - eosinophilia and thrombocytosis.
vascular disorders: often (≥ 1/100 and < 1/10) - phlebitis or thrombophlebitis at the site of drug administration.
Gastrointestinal disorders: often (≥ 1/100 and < 1/10) - antibiotic-associated diarrhea.
Hepatobiliary reactions: often (≥ 1/100 and < 1/10) - transient increase in the level of one or more liver enzymes (ALT, AST, LDH, GGT, alkaline phosphatase).
Skin and subcutaneous tissues: often (≥ 1/100 and < 1/10) - maculopapular rash or urticaria.
Interaction
When combined with nonsteroidal anti-inflammatory drugs and theophylline , the likelihood of seizures increases.
Preparations containing iron, sucralfate , and magnesium-containing antacids reduce the effectiveness of levofloxacin .
The risk of tendon rupture increases significantly when taking an antibiotic simultaneously with GCS .
The drug does not interact with calcium carbonate .
The half-life of the drug is prolonged by the action of cimetidine and probenecid .
Various vitamin K can affect the blood coagulation system; blood counts should be monitored.
Note!
Description of the drug Florazid por. d/r-ra d/in. fl. 1g No. 1 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
special instructions
Taking levofloxacin with alcohol is not recommended.
Elderly patients often have impaired renal function; the drug should be prescribed to them with caution.
After a stroke or severe brain injury, the likelihood of seizures increases while taking an antibiotic .
When taking the drug, you should not be exposed to intense ultraviolet radiation for a long time, for example, in the sun, to avoid a hypersensitivity reaction.
pseudomembranous colitis is suspected , treatment should be stopped immediately and drugs that inhibit gastrointestinal .
During the treatment of pneumonia caused by pneumococci and other diseases caused by Pseudomonas aeruginosa , it is additionally necessary to prescribe auxiliary agents to combat the disease.
While taking Floracid, you should not operate machinery or machines due to decreased concentration.
It should be remembered that:
- in individuals with deficiency of the enzyme glucose-6-phosphate dehydrogenase, hemolysis of red blood cells may occur ; it is necessary to control blood clotting when combining the drug with vitamin K antagonists;
- tendonitis increases .
Floracid's analogs
Level 4 ATX code matches:
Siflox
Hyleflox
Leflobakt
Lefoccin
Gatifloxacin
Ofloxacin
Faktiv
Tigeron
Lebel
Zanotsin
Lomefloxacin
Eleflox
Lomflox
Pefloxacin
Tsiprobay
Sparflo
Tariwid
Zoflox
Abaktal
Moxifloxacin
Analogues with the same active ingredient: Glevo, Levoflox , Lebel, Levofloxabol, Ivacin, Leflobakt, Levotek, Levostar, Levofloxacin, Leobeg, Lefokcin, Maklevo, Tavanik, Flexid, Ecovid, Tanflomed, Eleflox .
Reviews of Floracid
The antibiotic has good reviews. Most reports describe improvements after urogenital infections ( cystitis, urethritis, prostatitis ); improvements occur already on the second day of taking the drug. Adverse reactions occur infrequently, mainly when the drug is taken incorrectly or when combined with alcohol.
It should be remembered that levofloxacin is a strong antibiotic and should not be taken without consulting your doctor.
Features of application
Pregnant
Data on the treatment of pregnant women with ceftazidime are limited. The drug should be prescribed to pregnant women only when the benefits of its use outweigh the possible risks.
Ceftazidime is excreted into breast milk in small amounts but is not expected to affect breastfed infants at therapeutic doses. Ceftazidime can be used during breastfeeding.
Drivers
No relevant studies have been conducted. But the occurrence of adverse reactions such as dizziness may affect the ability to drive vehicles or use other machinery.
