Tavanik
Description current as of 06/19/2014
- Latin name: Tavanic
- ATX code: J01MA12
- Active ingredient: Levofloxacin
- Manufacturer: GmbH Sanofi-Aventis Deutschland, Germany, produced for export for LLC Sanofi-Aventis Ukr., Ukraine
Compound
The drug is produced in the form of tablets and solution for infusion.
Table of contents:
- Tavanik
- Compound
- Release form
- pharmachologic effect
- Pharmacodynamics and pharmacokinetics
- Indications for use
- Contraindications
- Side effects
- Instructions for use Tavanik (Method and dosage)
- Interaction
- Terms of sale
- Storage conditions
- Best before date
- Tavanika's analogs
- With alcohol
- Reviews about Tavanika
- Tavanika price (where to buy)
- WER.RU
- ZdravZone
- Pharmacy IFC
- BIOSPHERE
- Tavanik
- Release forms
- Tavanik instructions
- Reviews from doctors about tavanika
- Patient reviews about tavanika
- Patient Questions
- Instructions for use of tavanik
- pharmachologic effect
- Pharmacokinetics
- Release form, composition and packaging
- Dosage regimen
- Overdose
- Drug interactions
- Side effect
- Indications
- Contraindications for use
- Use during pregnancy and breastfeeding
- Use for liver dysfunction
- Use for renal impairment
- Use in children
- special instructions
One Tavanic 500 mg tablet contains 0.5 g of levofloxacin and excipients (crospovidone, MCC, sodium stearyl fumarate, hypromellose, macrogol 8000, E171, talc, E172 red and yellow).
Tablets of 0.25 g of levofloxacin contain the same excipients.
Per 100 ml solution of levofloxacin 0.5 g + sodium hydroxide, water, sodium chloride, concentrated hydrochloric acid.
Release form
The tablets are flat-cylindrical, convex, dim yellow-pink in color, scored. In packs of 3, 7, 5 and 10 blisters.
The solution is transparent yellow-green, bottles of 500 mg.
pharmachologic effect
The medicine is an antibacterial agent.
Pharmacodynamics and pharmacokinetics
It should be noted that levofloxacin is much stronger than ofloxacin. The product exhibits bactericidal activity against aerobic, anaerobic, gram-positive and negative microorganisms. In particular, cocci, streptococci, various intracellular pathogens, Haemophilus influenzae, enterobacteria and Pseudomonas aeruginosa.
In the patient's body it quickly (within 2 hours) penetrates almost all organs affected by bacteria. It is usually excreted by the kidneys within 6-8 hours. In people with kidney disease, pharmacokinetic parameters may change.
Indications for use
The antibiotic Tavanik in tablet form is prescribed for:
The solution is used to treat:
Contraindications
The drug is contraindicated in:
Side effects
Instructions for use Tavanik (Method and dosage)
The dosage of the antibiotic and the duration of treatment should be prescribed by the attending physician, it all depends on the disease and its severity.
According to the instructions for Tavanik, the tablets are taken orally. They can be crushed and broken.
For sinusitis, bronchitis, genitourinary infections and prostatitis, the daily dose is 0.25-0.5 g per day at a time. The course ranges from three to 14 days. For prostatitis - 28.
Infections of soft tissue, skin and hypodermis are treated within one to two weeks. 0.25-0.5 g once or twice a day.
For septicemia and infections of the abdominal area, take 500 mg of medication once a day for one to two days.
For kidney disease, the daily dosage should be reduced.
Infusion of the solution is carried out slowly, over at least an hour. No more than two weeks. If necessary, switch to tablet form.
Interaction
Particular care should be taken when combined with antacids containing magnesium and aluminum, sucralfate, and iron supplements.
Terms of sale
Requires a prescription.
Storage conditions
In a dark, cool place.
Solution for infusion, after opening, use within 3 hours.
Best before date
Tavanika's analogs
The closest analogues of Tavanik: Zolev, Leflokad, Levobakt, Glevo, Levobax, Levocin, Levoxa, Lebel, Levomak, Levotor, Levoximed, Levostad, Levoflox, Levocel, Levofloxacin, Levoflocin, Leflok, Loxof, Tigeron, Lexid, Floxium.
The price of analogues may differ significantly from the original.
With alcohol
Tavanic and alcohol, like other antibiotics, do not combine.
Reviews about Tavanika
Reviews from doctors: The antibiotic Tavanik is an excellent remedy, it has a wide spectrum of action. And, as a rule, if you follow the general recommendations when taking antibiotics, it is well tolerated. While taking the medicine, you should consume more fermented milk products, drugs to protect the gastrointestinal tract, eat well, drink plenty of fluids and follow a rest regime.
Reviews for Tavanic 500 mg on forums are different. Someone writes about how serious and poorly tolerated the drug is and that they were afraid to take it because of the number of side effects. However, those who have taken it note its high effectiveness in combating a large list of diseases caused by various bacteria. If the regimen and dosage are followed, the medicine is well tolerated. Sometimes headache and slight dizziness were noted.
Tavanika price (where to buy)
The price of Tavanik 500 mg is approximately 964 rubles for 10 tablets.
You can buy a bottle of infusion solution in Moscow for up to 1,600 rubles for 500 mg. You can buy tablets for 1000 rubles (10 tablets of 500 mg each).
- Online pharmacies in Russia Russia
- Online pharmacies in Kazakhstan Kazakhstan
WER.RU
ZdravZone
Pharmacy IFC
BIOSPHERE
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Amina: Until recently, I was afraid to take glycine, because I thought that there would be an excess in the body.
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Source: http://medside.ru/tavanik
Tavanik
Release forms
Sale: by prescription
Shelf life: 36 months.
Sale: by prescription
Storage: 15-25C (room temperature)
Shelf life: 60 months.
Tavanik instructions
Tavanic is a patented synthetic antimicrobial agent representing the group of fluoroquinolones. The pharmacologically active substance in the composition of tavamin, its driving therapeutic force is the levorotatory isomer of ofloxacin - levofloxacin, which has a wide spectrum of action and is active against most known virulent strains of microorganisms. The action of tavamin is based on its ability to block the enzymes DNA gyrase and topoisomerase IV, disrupt supercoiling and cross-linking of DNA breaks, suppress DNA synthesis, thereby causing destructive structural changes in the cytoplasm, membranes and walls of bacterial cells.
Tavamin’s “trophy room” (read: the number of pathogenic strains to which its bactericidal effect extends) is filled with such enviable specimens as aerobic gram-positive Corynebacterium (diphtheriae and striatum species), Enterococcus spp. (including faecalis species), Listeria monocytogenes, Staphylococcus spp. (including epidermidis, aureus), Streptococcus spp. (including species of pneumoniae, pyogenes, viridans, agalactiae and groups C and G), aerobic gram-negative Acinetobacter spp. (including baumannii species), Actinobacillus actinomycetemcomitans, Eikenella corrodens, Citrobacter freundii, Enterobacter spp. (including aerogenes, agglomerans, cloacae species), Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus ducreyi, Gardnerella vaginalis, Klebsiella oxytoca, Helicobacter pylori, Klebsiella spp.
(including pneumoniae species), Moraxella catarrhalis, Morganella morganii, Neisseria meningitidis, Neisseria gonorrhoeae, Pasteurella spp. (including conis, dagmatis, multocida species), Proteus vulgaris, Proteus mirabilis, Providencia spp. (rettgeri, stuartii), Pseudomonas aeruginosa, Serratia spp. (including marcescens species), Salmonella spp., anaerobic Bifidobacterium spp., Bacteroides fragilis, Clostridium perfringens, Veillonella spp., Fusobacterium spp., Propionibacterium spp. Tavanic is also active against intracellular parasites that are difficult to reach pharmacologically: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Legionella pneumophila, Ricketsia spp, Ureaplasma urealyticum, Mycoplasma hominis, Mycoplasma pneumoniae.
Tavanik is available in two dosage forms: tablets and solution for infusion (the latter form is more relevant for use in hospitals). The tablets can be taken at any time, regardless of meals (food does not affect the absorption of the drug), with a sufficient (ml) amount of water. The tablet may be divided into two along the dividing groove. The dosage regimen is determined by the attending physician based on the nature and severity of the infection, as well as the sensitivity to tavanic of the suspected pathogen.
Reviews from doctors about tavanika
A modern, highly effective drug from the group of fluoroquinolones. Used in the treatment of inflammatory diseases of the urological tract, such as pyelonephritis, cystitis, prostatitis, orchitis, epididymitis. I'm especially pleased with the price reduction. Since the high price limited the possibilities of using this drug.
“Tavanik” is an original drug, which makes it easier to tolerate and has proven effectiveness.
We can confidently say that the drug “Tavanic” (levofloxacin) in modern urology in the treatment of urinary tract infections is our everything. And what makes it such, in the line of fluoroquinolones, is a number of outstanding qualities: excellent effectiveness at a very reasonable price, minimization of side effects with low toxicity, and finally, achievement of a therapeutic effect with relatively short courses of treatment. But the most important thing, perhaps, is not even this! What makes it the king of fluoroquinolones, in my opinion, are truly royal qualities: 1) single dose use (judge for yourself, who in our modern age of super speeds would scrupulously follow a two- or three-fold dose of the drug); 2) versatility - this is a respiratory uroantiseptic, two in one, like the famous Snickers, it acts on both the pathological microflora of the upper respiratory tract and bacteria that like to live in the urinary tract! A simple local therapist or paramedic does not have to guess, in conditions of diagnostic deficiency, what is causing the patient’s fever: the kidneys or the lungs? Time is running out, and the patient needs immediate treatment; 3) low resistance to it on the part of pathological microflora, the ability to prescribe it again after a short time, and even a third time after a certain time, etc. Well, which of the modern drugs can boast such an impressive set of qualities that are extremely necessary for people?
Naturally, like all things in the world, the drug is not ideal, but its negative qualities stem, oddly enough, from its best properties - the extremely widespread use of this medicine, due to its effectiveness, leads to the fact that microorganisms slowly but surely turn to it adapt, which makes it in some cases not entirely effective. It is problematic to prescribe it in children and pregnant women. In addition, there is another problem that is not widely covered, namely, the masking of genitourinary tract tuberculosis by the early use of fluoroquinolones, which is much more widespread than is currently believed.
The drug should be prescribed only by a doctor, preferably a urologist, who has a better understanding of the specifics of the drug, doses and side effects. In no case can it be recommended for independent use or in absentia!
One of the most popular antibacterial drugs from the group of fluoroquinolones, very convenient pharmacokinetics, single dosage regimen.
Post-antibacterial diarrhea occurs, the price is quite high.
I use it in clinical practice for the treatment of chronic prostatitis and epididymitis, I recommend strictly following the recommended duration of treatment.
I have not noticed any negative feedback from patients when using it, however, it is better to use it with pro- or prebiotics.
The drug is quite expensive, not everyone can afford it, often you have to buy several packs. Urologists love to use it in their practice, with positive dynamics.
One of the best, in my opinion, among antibiotics recommended for diseases of the urinary system. Wide spectrum of action, short course, an important indicator is the frequency of administration, very effective for chronic and acute prostatitis, orchitis.
It is very convenient to take the drug once a day, you don’t have to take it several times a day and be afraid that you will forget about taking the medicine.
An excellent antibiotic from its group. It is well tolerated by patients, although individual intolerance has not been canceled (as well as to other antibiotics).
Quite a high price. As with most antibiotics, many patients experience dyspepsia.
I always recommend that patients who always experience this side effect take antibiotics along with pre- and probiotics.
Tavanic is one of my favorite antibiotics. This is the breadth of action, and the form of release, and the frequency of administration, and a relatively short course (although I usually still prescribe it the old fashioned way + a couple of days after normalization. For 6 years of regular prescription I have not seen allergic reactions, dysbiosis and other unwanted side effects So I recommend it.
An excellent, effective original drug, levofloxacin, I use in my practice in eradication therapy for Helicobacter pylori infection in a 3- and 4-component regimen. In addition, I use the drug in the treatment of exacerbations of chronic cholecystitis, the syndrome of bacterial overgrowth in the intestines.
Rapidly passing side effects in the form of gastric and intestinal dyspepsia are often observed. I always prescribe probiotics to all patients taking Tavanik!
A very good (if indicated) antibacterial drug. Especially for respiratory and urinary tract infections. Adverse events are rare.
Once upon a time (during the Second World War and post-war years) penicillin worked wonders. Then its illiterate and stereotyped use destroyed the effectiveness of penicillin. Soon other antibiotics began to follow the fate of penicillin.
You must take the full course, no matter how good your condition becomes in the process. And be sure to take the full dose - otherwise you will grow resistant strains of bacteria, which can be very difficult to overcome in the future! There is no need to treat yourself with antibiotics! There is no need to treat viral infections, colds and flu with antibiotics! Moreover, tavanik is the reserve that a good doctor has left to combat resistant pathogens of serious cases, and not to treat snot.
A good, reliable drug with predictable effectiveness and minimal side effects. It is especially effective in the treatment of chronic prostatitis in the acute stage and acute uncomplicated cystitis in women associated with Ureaplasma sp. A single dose per day allows you to achieve maximum compliance on the part of the patient.
Tavanic is an antibiotic belonging to the group of systemic quinolones (fluoroquinolones) and has a broad spectrum of action. Tavanic is used to treat various moderate to mild infectious diseases caused by bacteria sensitive to the action of levofloxacin. Tavanik is most effective in the treatment of acute sinusitis, acute and chronic bronchitis, pneumonia, as well as complicated infectious diseases of the urinary system, skin and soft tissues. Very convenient use of the drug! I often prescribe it for postoperative patients.
Tavanic and alcohol are incompatible. During the course of treatment with Tavanik, you should avoid drinking alcoholic beverages, as this increases side effects and reduces the effectiveness of therapy. Alcohol especially increases the side effects of the drug related to the central nervous system, such as confusion, dizziness, etc. Also, alcohol in combination with tavanik increases the risk of developing erosions of the mucous membranes of the digestive tract.
An original drug with a convenient single dose and slowly developing resistance.
Nausea, insomnia, headaches, dizziness should be prescribed with caution to patients with epilepsy and those who have suffered traumatic brain injury.
One of the few antibiotics that works flawlessly in urology and nephrology.
Great drug! It has proven itself excellent in the treatment of pneumonia, bronchitis, and in patients with a complicated medical history.
Original drug. The patients are satisfied with the price. Well tolerated, no side effects. Positive dynamics are visible very quickly. I recommend it for use in therapeutic practice.
A brilliant broad-spectrum antibiotic that is directly relevant for use in general surgery given its broad profile. And in addition to the surgical profile, it is well used in urological and therapeutic practice.
I advise you to use it in practice, it is very convenient, taken once a day and without side effects.
The drug was well tolerated; dyspeptic symptoms were rarely observed.
An original drug that has proven itself for the treatment of complicated urinary tract infections, chronic prostatitis, etc. Very helpful in outpatient urological practice.
Patient reviews about tavanika
Medicine was prescribed for pyelonephritis. With a clear conscience and with a doctor’s prescription, I bought it at the pharmacy. Out of curiosity, I decided to read about the side effects. I've never seen anything like this before! Everything's there! On the first day of taking the medicine, I deliberately reduced the dosage, and also warned my colleagues what I was allergic to and where the insurance policy was, just in case. It's not every day that you take something that can shake your psyche and cause muscle tears. As a result, the disease subsided, tests confirmed this. And of the side effects of this medicine, I only experienced the wildest fear that appeared after reading the side effects, and nothing more.
I fell ill with ARVI, my nose was stuffy, my temperature rose, I began to feel pressure on the fundus of my right eye, and it began to water. I contacted an ENT specialist. They pierced the right nasal sinus and washed it out. They prescribed Tavanik 500. And the cruelty began. After taking it, about an hour later, my head feels numb and my ears are stuffy. Probably individual intolerance. Be careful, it's not suitable for everyone.
The wife was treated for pneumonia in the hospital. After unsuccessfully prescribed antibiotics, which were of no use for four days, the doctor prescribed tavanic. A noticeable effect came within a day - the temperature subsided, the state of health improved, and it was time to be discharged. No side effects were observed. A good antibiotic helped us out, we don’t regret the money spent - we don’t skimp on our health.
Just recently my aunt had pneumonia. We were scared, and we ran to the therapist, and the therapist prescribed Tavanik. My aunt lived in the city and this made the task very easy, since “Tavanik” is not very common. My aunt recovered very quickly thanks to such a good drug. The quality of Tavanik is very good and this is very pleasing, since nowadays the drugs are of very poor quality. Tavanik has one minus - the price. And, in my opinion, it has no side effects.
Recently I became very ill - a sore throat began, my throat hurt so much that it was not easy to even drink water. The doctor prescribed me tavanic because it is a new and strong antibiotic. I bought it at the pharmacy, by the way, this drug is quite expensive, Tavanik, and started taking it. Improvement began on the second day of treatment - my throat hurt less and less, the fever went away. I didn’t notice any special side effects while taking it.
Patient Questions
Instructions for use of tavanik
pharmachologic effect
A synthetic antimicrobial drug from the fluoroquinolone group, a levorotatory isomer of ofloxacin. Has a wide spectrum of antimicrobial action.
Levofloxacin blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, and causes profound morphological changes in the cytoplasm, cell wall and membranes of microbial cells.
Levofloxacin is active against most strains of microorganisms both in vitro and in vivo.
In vitro, aerobic gram-positive microorganisms are sensitive (MIC ≤2 mg/ml; inhibition zone ≤17 mm): Bacillus anthratis, Corynebacterium diphtheriae, Corynebacterium jeikeium, Enterococcus spp. (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (coagulase-negative, methicillin-sensitive/methicillin-moderately sensitive strains), Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis (methicillin-sensitive strains), Staphylococcus spp. (coagulase negative), Streptococcus spp. groups C and G (including Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-sensitive/moderately sensitive/resistant strains), Streptococcus pyogenes, Streptococcus viridans (penicillin-sensitive/resistant strains); aerobic gram-negative microorganisms: Acinetobacter baumannii, Acinetobacter spp ., Actinobacillus actinimycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (including Enterobacter cloacae, Enterobacter aerogenes), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillin-sensitive/resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (strains producing and not producing β-lactamase), Morganella morganii, Neisseria gonnorrhoeae (strains producing and not producing penicillinase), Neisseria meningitidis, Pasteurella spp. (including Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (hospital infections caused by Pseudomonas aeruginosa may require combination treatment), Salmonella spp., Serratia spp. (Serratia marcescens); anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterum spp., Veilonella spp.; other microorganisms: Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp., Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.
Levofloxacin is moderately active (MIC = 4 mg/l; inhibition zone mm) against aerobic gram-positive microorganisms: Corynebacterium urealiticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis (methicillin-resistant strains), Staphylococcus haemolyticus (methicillin-resistant strains); aerobic gram-negative microorganisms: Campilobacter jejuni, Campilobacter coli; anaerobic microorganisms: Prevotella spp., Porphyromonas spp.
Aerobic gram-positive microorganisms are resistant to levofoloxacin (MIC ≥8 mg/l; inhibition zone ≤13 mm): Staphylococcus aureus (methicillin-resistant strains), Staphylococcus spp. (coagulase-negative methicillin-resistant strains); aerobic gram-negative microorganisms: Alcaligenes xylosoxidans; anaerobic microorganisms: Bacteroides thetaiotaomicron; other microorganisms: Mycobacterium avium.
In clinical studies, the drug was effective in treating infections caused by the following microorganisms.
Aerobic gram-positive microorganisms: Enterococcus faecalis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes.
Aerobic gram-negative microorganisms: Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxela (Branhamella) catarrhalis, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens.
Others: Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.
Resistance to levofloxacin develops as a result of a stepwise process of mutations in the genes encoding both type II topoisomerases: DNA gyrase and topoisomerase IV. Other resistance mechanisms, such as the mechanism of influencing the penetration barriers of the microbial cell (a mechanism characteristic of Pseudomonas aeruginosa) and the mechanism of efflux (active removal of the antimicrobial agent from the microbial cell), may also reduce the sensitivity of microorganisms to levofloxacin.
Due to the peculiarities of the mechanism of action of levofloxacin, cross-resistance between levofloxacin and other antimicrobial agents is not usually observed.
Pharmacokinetics
After oral administration, levofloxacin is quickly and almost completely absorbed from the gastrointestinal tract. Eating has little effect on its absorption. The absolute bioavailability when taken orally is %.
After a single dose of levofloxacin at a dose of 500 mg, Cmax in blood plasma is achieved within 1-2 hours and is 5.2±1.2 μg/ml.
The pharmacokinetics of levofloxacin is linear in the dose range from 50 to 1000 mg.
C ss of levofloxacin in plasma when taking 500 mg of levofloxacin 1 or 2 times a day is achieved within 48 hours.
On the 10th day of oral administration of the drug Tavanik ® at a dose of 500 mg 1 time / day, C max of levofloxacin in plasma was 5.7 ± 1.4 μg/ml, and C min of levofloxacin (concentration before taking the next dose) in plasma was 0.5 ± 0.2 μg/ml ml.
On the 10th day of oral administration of the drug Tavanik ® at a dose of 500 mg 2 times a day, the Cmax of levofloxacin in plasma was 7.8±1.1 μg/ml, and the Cmin of levofloxacin (concentration before taking the next dose) in plasma was 3.0+0.9 μg/ml. ml.
Plasma protein binding is 30-40%.
After a single and repeated dose of levofloxacin at a dose of 500 mg, the Vd of levofloxacin averages 100 l, which indicates good penetration of levofloxacin into organs and tissues of the human body.
After a single oral dose of levofloxacin at a dose of 500 mg, Cmax of levofloxacin in the bronchial mucosa and epithelial lining fluid was reached within 1-4 hours and amounted to 8.3 μg/g and 10.8 μg/ml, respectively, with penetration coefficients into the bronchial mucosa and fluid epithelial lining compared to plasma concentrations of 1.1-1.8 and 0.8-3.0, respectively.
After 5 days of taking levofloxacin orally at a dose of 500 mg, the average concentrations of levofloxacin 4 hours after the last dose in the fluid of the epithelial lining were 9.94 μg/ml and in alveolar macrophages - 97.9 μg/ml.
Cmax with penetration coefficients of 2-5 compared to plasma concentrations.
After 3 days of taking levofloxacin at a dose of 500 mg 1 time or 2 times a day, the Cmax of levofloxacin in the alveolar fluid was reached 2-4 hours after taking the drug and amounted to 4.0 and 6.7 mcg/ml, respectively, with a penetration coefficient compared with plasma concentrations components 1.
Levofloxacin penetrates well into cortical and cancellous bone tissue, both in the proximal and distal parts of the femur with a penetration coefficient (bone tissue/plasma) of 0.1-3. C max of levofloxacin in the cancellous bone tissue of the proximal femur after oral administration of the drug at a dose of 500 mg was approximately 15.1 mcg/g (2 hours after taking the drug).
Levofloxacin penetrates poorly into the cerebrospinal fluid.
After oral administration of levofloxacin at a dose of 500 mg 1 time/day for 3 days, the average concentration of levofloxacin in prostate tissue was 8.7 mcg/g, the average prostate/plasma concentration ratio was 1.84.
Mean urinary concentrations 8 to 12 hours after oral administration of 150, 300, and 600 mg levofloxacin were 44 mcg/mL, 91 mcg/mL, and 162 mcg/mL, respectively.
Levofloxacin is metabolized to a small extent (5% of the dose taken). Its metabolites are demethyllevofloxacin and levofloxacin N-oxide, which are excreted by the kidneys. Levofloxacin is stereochemically stable and does not undergo chiral transformations.
After oral administration, levofloxacin is eliminated from plasma relatively slowly (T 1/2 hour). It is excreted mainly in the urine (more than 85% of the dose taken). The total clearance of levofloxacin after a single dose of 500 mg was 175±29.2 ml/min.
There are no significant differences in the pharmacokinetics of levofloxacin when administered intravenously and orally, which confirms that oral administration and intravenous administration are interchangeable.
Pharmacokinetics in special groups of patients
The pharmacokinetics of levofloxacin do not differ between men and women.
Pharmacokinetics in elderly patients do not differ from those in young patients, with the exception of differences in pharmacokinetics associated with differences in QC.
In renal failure, the pharmacokinetics of levofloxacin changes. As renal function declines, renal excretion and renal clearance decrease and T1 /2 increases.
Pharmacokinetics in renal failure after a single oral dose of Tavanic ® at a dose of 500 mg
Release form, composition and packaging
The film-coated tablets are pale yellowish-pink in color, oblong, biconvex, with a dividing groove on both sides.
Excipients: hypromellose - 5.4 mg, crospovidone - 7 mg, microcrystalline cellulose - 33.87 mg, sodium stearyl fumarate - 5 mg.
Film shell composition: hypromellose - 5.433 mg, macrogol.288 mg, titanium dioxide (E171) - 1.358 mg, talc - 0.407 mg, red iron oxide (E172) - 0.007 mg, yellow iron oxide (E172) - 0.007 mg.
3 pcs. - blisters (1) - cardboard packs.
5 pieces. - blisters (1) - cardboard packs.
7 pcs. - blisters (1) - cardboard packs.
10 pieces. - blisters (1) - cardboard packs.
Dosage regimen
The drug is taken orally at 250 or 500 mg 1 or 2 times a day. The tablets should be taken without chewing and with a sufficient amount of liquid (0.5 to 1 glass). If necessary, tablets can be broken along the dividing groove.
The drug can be taken before meals or at any time between meals, because. food intake does not affect the absorption of the drug.
The drug should be taken at least 2 hours before or 2 hours after taking antacids containing magnesium and/or aluminum, zinc, iron salts or taking sucralfate.
Considering that the bioavailability of levofloxacin when using the drug Tavanik ® in tablets is equal to%, if the patient is transferred from IV administration of the drug to taking tablets, treatment should be continued at the same dose that was used with IV infusion.
The dosage regimen is determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen. The duration of treatment varies depending on the course of the disease.
For patients with normal renal function (creatinine clearance >50 ml/min), the following dosage regimen and duration of treatment are recommended.
Acute sinusitis: 2 tablets. 250 mg or 1 tablet. 500 mg 1 time/day (corresponding to 500 mg levofloxacin) days.
Exacerbation of chronic bronchitis: 2 tablets. 250 mg or 1 tablet. 500 mg 1 time/day (corresponding to 500 mg levofloxacin) days.
Community-acquired pneumonia: 2 tablets. 250 mg or 1 tablet. 500 mg 1-2 times/day (corresponding to mg of levofloxacin) days.
Uncomplicated urinary tract infections: 1 tablet. 250 mg 1 time / day (respectively 250 mg of levofloxacin) - 3 days.
Complicated urinary tract infections: 2 tablets. 250 mg 1 time/day (corresponding to 250 mg levofloxacin) or 1 tablet. 500 mg 1 time/day (respectively 500 mg of levofloxacin) days.
Pyelonephritis: 2 tablets. 250 mg 1 time/day or 1 tablet. 500 mg 1 time/day (respectively 500 mg of levofloxacin) days.
Chronic bacterial prostatitis: 2 tablets. 250 mg or 1 tablet. 500 mg 1 time / day (respectively 500 mg of levofloxacin) - 28 days.
Infections of the skin and soft tissues: 2 tablets. 250 mg or 1 tablet. 500 mg 1-2 times/day (corresponding to mg of levofloxacin) days.
Prevention and treatment of anthrax through airborne transmission: 2 tablets. 250 mg or 1 tablet. 500 mg (respectively 500 mg of levofloxacin) 1 time / day - up to 8 weeks.
Patients with impaired renal function (creatinine clearance ≤50 ml/min) require adjustment of the dosage regimen depending on the magnitude of the clearance, because Levofloxacin is primarily excreted by the kidneys.
then 125 mg/24 h
then 250 mg/24 h
then 250 mg/12 h
then 125 mg/48 h
then 125 mg/24 h
then 125 mg/12 h
then 125 mg/48 h
then 125 mg/24 h
then 125 mg/24 h
* No additional doses are required after hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
If liver function is impaired, no dosage adjustment is required, since levofloxacin is only slightly metabolized in the liver.
For elderly patients, no adjustment of the dosage regimen is required, except in cases where the CC is reduced to 50 ml/min or lower.
Skipping a drug dose
If you accidentally miss taking the drug, you must take the tablet as soon as possible and continue to take Tavanik ® according to the recommended dosage regimen.
Overdose
Symptoms: Based on data obtained from animal studies, the most important expected symptoms of an acute overdose of Tavanic ® are central nervous system symptoms (impaired consciousness, including confusion, dizziness and convulsions). During post-marketing use of the drug in overdose, CNS effects have been observed, including confusion, convulsions, hallucinations and tremor. Nausea and erosions of the gastrointestinal mucosa are possible. In clinical and pharmacological studies conducted with doses of levofloxacin exceeding therapeutic levels, prolongation of the QT interval was shown.
Treatment: symptomatic therapy, careful monitoring of the patient, including ECG monitoring. In case of acute overdose of Tavanik ® tablets, gastric lavage and administration of antacids are indicated to protect the gastric mucosa. Levofloxacin is not eliminated by dialysis (hemodialysis, peritoneal dialysis and continuous peritoneal dialysis). There is no specific antidote.
Drug interactions
Combinations requiring caution
Preparations containing divalent or trivalent cations, such as zinc and iron salts, antacids containing magnesium and/or aluminum, didanosine (only dosage forms containing aluminum or magnesium as a buffer) are recommended to be taken at least 2 hours before or after 2 hours after taking Tavanic ® tablets.
Calcium salts have a minimal effect on the absorption of levofloxacin when taken orally.
The effect of Tavanic ® is significantly weakened by simultaneous use of sucralfate. For patients receiving levofloxacin and sucralfate, it is recommended that sucralfate be taken 2 hours after taking levofloxacin.
No pharmacokinetic interaction of levofloxacin with theophylline was detected. The concentration of levofloxacin with simultaneous use of fenbufen increases only by 13%. However, with the simultaneous administration of quinolones and theophylline, NSAIDs and other drugs that reduce the threshold of convulsive readiness of the brain, a pronounced decrease in the threshold of convulsive readiness of the brain is possible.
In patients receiving levofloxacin in combination with indirect anticoagulants (for example, warfarin), an increase in prothrombin time/INR and/or bleeding was observed, incl. and heavy. Therefore, with the simultaneous use of indirect anticoagulants and levofloxacin, regular monitoring of blood coagulation parameters is necessary.
When simultaneous use of levofloxacin and drugs that interfere with the renal tubular secretion of levofloxacin, such as probenecid and cimetidine, caution should be exercised, especially in patients with renal failure. The elimination (renal clearance) of levofloxacin is slowed down by cimetidine by 24% and probenecid by 34%. This is unlikely to be of clinical significance if renal function is normal.
Levofloxacin increased the half- of cyclosporine by 33%. Because this increase is clinically insignificant; no dose adjustment of cyclosporine is required when used concomitantly with levofloxacin.
Concomitant use of corticosteroids increases the risk of tendon rupture.
Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs that prolong the QT interval (for example, class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics).
Clinical and pharmacological studies conducted to study the possible pharmacokinetic interaction of levofloxacin with digoxin, glibenclamide, ranitidine and warfarin showed that the pharmacokinetics of levofloxacin when used simultaneously with these drugs does not change sufficiently to be of clinical significance.
Side effect
Determination of the frequency of side effects: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10,000, <1 /1000), very rare (<1/10,000, including isolated reports), frequency unknown (it is not possible to determine the frequency of occurrence from available data).
Data obtained in clinical trials and post-marketing use of the drug
From the medium-vascular system: rarely - sinus tachycardia, palpitations, decreased blood pressure; frequency unknown (post-marketing data) - prolongation of the QT interval, ventricular arrhythmias, ventricular tachycardia, ventricular tachycardia of the “pirouette” type, which can lead to cardiac arrest.
From the hematopoietic system: infrequently - leukopenia, eosinophilia; rarely - neutropenia, thrombocytopenia; frequency unknown (post-marketing data) - pancytopenia, agranulocytosis, hemolytic anemia.
From the nervous system: often - headache, dizziness; infrequently - drowsiness, tremor, dysgeusia (taste perversion); rarely - paresthesia, convulsions; frequency unknown (post-marketing data) - peripheral sensory neuropathy, peripheral sensorimotor neuropathy, dyskinesia, extrapyramidal disorders, loss of taste, parosmia (disorder of the sense of smell, especially the subjective sensation of an objectively absent smell), including loss of smell, syncope, benign intracranial hypertension .
Mental disorders: often - insomnia; infrequently - feeling of anxiety, confusion; rarely - mental disorders (hallucinations, paranoia), depression, agitation (excitement), sleep disturbances, nightmares; frequency unknown (post-marketing data) - mental disorders with behavioral disorders with self-harm, including suicidal thoughts and suicide attempts.
On the part of the organ of vision: very rarely - visual disturbances, such as blurriness of the visible image; frequency unknown (post-marketing data) - transient vision loss, uveitis.
From the respiratory system: infrequently - shortness of breath; frequency unknown (post-marketing data) - bronchospasm, allergic pneumonitis.
From the liver and biliary tract: often - increased activity of ALT, AST, alkaline phosphatase, GGT; infrequently - increased concentration of bilirubin in the blood; frequency unknown (post-marketing data) - severe liver failure, including cases of acute liver failure (sometimes fatal), especially in patients with severe underlying disease (for example, sepsis); hepatitis, jaundice.
From the urinary tract: infrequently - increased concentration of creatinine in the blood serum; rarely - acute renal failure (for example, due to the development of interstitial nephritis).
From the skin and subcutaneous tissues: infrequently - rash, itching, urticaria, hyperhidrosis; frequency unknown (post-marketing data) - toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative erythema multiforme, photosensitivity reactions (increased sensitivity to solar and UV radiation), leukocytoclastic vasculitis. Reactions from the skin and mucous membranes can sometimes develop even after the first dose of the drug.
From the immune system: infrequently - urticaria; rarely - angioedema; frequency unknown (post-marketing data) - anaphylactic shock, anaphylactoid shock. Anaphylactic and anaphylactoid reactions can sometimes develop even after taking the first dose of the drug.
From the musculoskeletal system: infrequently - arthralgia, myalgia; rarely - tendon damage, including tendonitis (for example, Achilles tendon), muscle weakness, which can be especially dangerous in patients with pseudoparalytic myasthenia gravis; frequency unknown (post-marketing data) - rhabdomyolysis, tendon rupture (for example, Achilles tendon; this side effect can be observed within 48 hours after the start of treatment and can be bilateral), ligament rupture, muscle rupture, arthritis.
From the side of metabolism: infrequently - anorexia; rarely - hypoglycemia, especially in patients with diabetes mellitus (possible symptoms of hypoglycemia: voracious appetite, nervousness, perspiration, trembling); frequency unknown - hyperglycemia, hypoglycemic coma.
Infectious and parasitic diseases: infrequently - fungal infections, development of resistance of pathogenic microorganisms.
General reactions: infrequently - asthenia; rarely - pyrexia (fever); frequency unknown - pain (including pain in the back, chest, limbs).
Other possible adverse effects that apply to all fluoroquinolones
Very rarely - attacks of porphyria in patients already suffering from this disease.
Indications
Bacterial infections caused by microorganisms sensitive to levofloxacin in adults:
- exacerbation of chronic bronchitis;
- uncomplicated urinary tract infections;
- complicated urinary tract infections (including pyelonephritis);
— chronic bacterial prostatitis;
— infections of the skin and soft tissues;
— for complex treatment of drug-resistant forms of tuberculosis;
— prevention and treatment of anthrax through airborne transmission.
When using the drug Tavanik ®, official national recommendations for the proper use of antibacterial drugs, as well as the sensitivity of microorganisms in a particular country, should be taken into account.
Contraindications for use
- pseudoparalytic myasthenia gravis (myasthenia gravis);
- tendon lesions associated with a history of taking fluoroquinolones;
- childhood and adolescence up to 18 years of age (due to incomplete growth of the skeleton, since the risk of damage to cartilaginous growth points cannot be completely eliminated);
— pregnancy (the risk of damage to the cartilaginous growth points of the fetus cannot be completely excluded);
- the period of breastfeeding (the risk of damage to the cartilaginous growth points of bones in a child cannot be completely eliminated);
- hypersensitivity to levofloxacin or other quinolones, as well as to any of the excipients of the drug.
- in patients predisposed to the development of seizures (in patients with previous lesions of the central nervous system, in patients simultaneously receiving drugs that reduce the threshold of convulsive readiness of the brain, such as fenbufen, theophylline);
- in patients with latent or manifest deficiency of glucose-6-phosphate dehydrogenase (increased risk of hemolytic reactions when treated with quinolones);
- in patients with impaired renal function (mandatory monitoring of renal function is required, as well as correction of the dosage regimen);
- in patients with known risk factors for prolongation of the QT interval: in elderly patients; in female patients; in patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia); with congenital long QT syndrome; with heart disease (heart failure, myocardial infarction, bradycardia); while taking medications that can prolong the QT interval (class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics);
- in patients with diabetes mellitus receiving oral hypoglycemic drugs, for example, glibenclamide or insulin (the risk of hypoglycemia increases);
- in patients with severe adverse reactions to other fluoroquinolones, such as severe neurological reactions (increased risk of similar adverse reactions when using levofloxacin);
- in patients with psychosis or in patients with a history of mental illness.
Use during pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy and in breastfeeding women.
Use for liver dysfunction
In case of liver dysfunction, no special dose selection is required, since Tavanik ® is metabolized in the liver to an extremely small extent.
Use for renal impairment
Patients with impaired renal function require adjustment of the dosage regimen depending on the value of CC.
* - long-term ambulatory peritoneal dialysis.
No additional doses are required after hemodialysis or DAPD.
Use in children
special instructions
Hospital-acquired infections caused by Pseudomonas aeruginosa may require combination treatment.
The prevalence of acquired resistance in cultured strains of microorganisms may vary by geographic region and over time. In this regard, information on drug resistance in a specific country is required. For the treatment of severe infections or if treatment is ineffective, a microbiological diagnosis must be established with the isolation of the pathogen and determination of its sensitivity to levofloxacin.
There is a high probability that methicillin-resistant strains of Staphylococcus aureus will be resistant to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for the treatment of established or suspected infections caused by methicillin-resistant strains of Staphylococcus aureus unless laboratory tests have confirmed the sensitivity of this microorganism to levofloxacin.
Like other quinolones, levofloxacin should be used with great caution in patients with a predisposition to seizures: in patients with previous lesions of the central nervous system, such as stroke, severe traumatic brain injury; in patients simultaneously receiving drugs that lower the seizure threshold of the brain, such as fenbufen and other similar NSAIDs, as well as other drugs that lower the seizure threshold, such as theophylline.
Diarrhea that develops during or after treatment with levofloxacin, especially severe, persistent and/or bloody, may be a symptom of pseudomembranous colitis caused by Clostridium difficile. If pseudomembranous colitis is suspected, treatment with levofloxacin should be stopped immediately and specific antibiotic therapy (vancomycin, teicoplanin or oral metronidazole) should be started immediately. Drugs that inhibit intestinal motility are contraindicated.
Rarely observed, tendonitis with quinolones, including levofloxacin, can lead to rupture of tendons, including the Achilles tendon. This side effect can develop within 48 hours after starting treatment and can be bilateral. Elderly patients are more prone to developing tendinitis. The risk of tendon rupture may increase with simultaneous use of GCS. If tendinitis is suspected, treatment with Tavanic ® should be stopped immediately and appropriate treatment of the affected tendon should be initiated, for example by providing sufficient immobilization.
Levofloxacin may cause serious, potentially fatal hypersensitivity reactions (angioedema, anaphylactic shock), even at initial doses. Patients should immediately stop taking the drug and consult a doctor.
Cases of severe bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been observed with the use of levofloxacin. If any reactions develop from the skin or mucous membranes, the patient should immediately consult a doctor and not continue treatment until consultation with a specialist.
Cases of liver necrosis, including the development of fatal liver failure, have been reported with the use of levofloxacin, mainly in patients with severe underlying diseases (for example, sepsis). The patient should be warned about the need to stop treatment and urgently consult a doctor if signs and symptoms of liver damage appear, such as anorexia, jaundice, dark urine, itching, abdominal pain.
Because Levofloxacin is excreted mainly by the kidneys; in patients with impaired renal function, mandatory monitoring of renal function is required, as well as adjustment of the dosage regimen. When treating elderly patients, it should be borne in mind that patients in this group often suffer from impaired renal function.
Although photosensitivity with levofloxacin is very rare, to prevent its development, patients are not recommended to be unnecessarily exposed to strong sunlight or artificial ultraviolet radiation (for example, visiting a solarium) during treatment and for 48 hours after the end of treatment with levofloxacin.
As with the use of other antibiotics, the use of levofloxacin, especially for a long time, can lead to increased proliferation of microorganisms (bacteria and fungi) that are insensitive to it, which can cause changes in the microflora that is normally present in humans, which can result in the development of superinfection . Therefore, during treatment, the patient’s condition should be re-evaluated, and if superinfection develops during treatment, appropriate measures should be taken.
Very rare cases of QT prolongation have been reported in patients receiving fluoroquinolones, including levofloxacin. When using fluoroquinolones, including levofloxacin, caution should be exercised in patients with known risk factors for prolongation of the QT interval: in patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia); with congenital long QT syndrome, with heart disease (heart failure, myocardial infarction, bradycardia), while taking medications that can prolong the QT interval, such as class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics. Elderly and female patients may be more sensitive to drugs that prolong the QT interval. Therefore, fluoroquinolones, including levofloxacin, should be used with caution in them.
Patients with latent or manifest glucose-6-phosphate dehydrogenase deficiency are predisposed to hemolytic reactions when treated with quinolones, which should be taken into account when treated with levofloxacin.
As with other quinolones, cases of hyperglycemia and hypoglycemia have been observed with the use of levofloxacin, usually in patients with diabetes mellitus receiving concomitant treatment with oral hypoglycemic drugs (for example, glibenclamide) or insulin. Cases of hypoglycemic coma have been reported. In patients with diabetes mellitus, careful monitoring of blood glucose concentrations is required.
Sensory and sensorimotor peripheral neuropathy, which may have a rapid onset, has been reported in patients receiving fluoroquinolones, including levofloxacin. If the patient develops symptoms of neuropathy, levofloxacin should be discontinued. This minimizes the possible risk of developing irreversible changes.
Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Post-marketing adverse reactions, including pulmonary failure requiring mechanical ventilation and death, have been associated with the use of fluoroquinolones in patients with myasthenia gravis. The use of levofloxacin in patients with an established diagnosis of pseudoparalytic myasthenia gravis is not recommended.
The use of levofloxacin for the prevention and treatment of airborne anthrax is based on data on the sensitivity of Bacillus anthracis to it from in vitro and experimental studies in animals, as well as on limited data from the use of levofloxacin in humans. The attending physician should refer to national and/or international documents that reflect the collectively developed point of view on the treatment of anthrax.
With the use of quinolones, including levofloxacin, the development of psychotic reactions has been reported, which in very rare cases progressed to the development of suicidal ideation and behavior disorders with self-harm (sometimes after taking a single dose of levofloxacin). If such reactions develop, treatment with levofloxacin should be discontinued and appropriate therapy should be prescribed. The drug should be prescribed with caution to patients with psychosis or patients with a history of mental illness.
If any visual impairment develops, immediate consultation with an ophthalmologist is necessary.
In patients taking levofloxacin, the determination of opiates in urine may lead to false-positive results, which should be confirmed by more specific methods.
Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and subsequently lead to false-negative results of the bacteriological diagnosis of tuberculosis.
Impact on the ability to drive vehicles and operate machinery
Side effects of Tavanic ® such as dizziness or vertigo, drowsiness and visual disturbances may reduce psychomotor reactions and the ability to concentrate. This may pose a risk in situations where these abilities are of particular importance (for example, when driving a car, when servicing machinery, when performing work in an unstable position).
Source: http://protabletky.ru/tavanic/